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  7. EUA Authorized Serology Test Performance
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

EUA Authorized Serology Test Performance

About this Page

Serology tests detect the presence of antibodies in the blood from the body’s adaptive immune response to an infection, like COVID-19. They do not detect the virus itself. In the early days of an infection when the body's adaptive immune response is still building, antibodies may not be detected. This limits the test's effectiveness for diagnosing current COVID-19 and is one reason serology tests should not be used to diagnose or exclude acute COVID-19 infection. Serology tests play a role in the fight against COVID-19 by helping health care professionals identify individuals who may have developed an adaptive immune response to SARS-CoV-2. However, to use serology tests properly, it is important to understand their performance characteristics and limitations. Moreover, studies are underway to address questions that will better inform the appropriate use of these tests, such as which antibodies may indicate a level of protection that would prevent or reduce the severity of infection or re-infection as well as the duration for which this protection may last.

The performance of these tests is described by their "sensitivity," or their ability to identify those with antibodies to SARS-CoV-2 (true positive rate), and their "specificity," or their ability to identify those without antibodies to SARS-CoV-2 (true negative rate). A test's sensitivity can be estimated by determining whether or not it is able to detect antibodies in blood samples from patients who have been confirmed to have COVID-19 with a nucleic acid amplification test, or NAAT. In some validation studies of these tests, like the one the FDA is conducting in partnership with the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA), the samples used, in addition to coming from patients confirmed to have COVID-19 by a NAAT, may also be confirmed to have antibodies present using other serology tests. A test's specificity can be estimated by testing large numbers of samples collected and frozen before SARS-CoV-2 is known to have circulated to demonstrate that the test does not produce positive results in response to the presence of other causes of a respiratory infection, such as other coronaviruses.

These estimates of sensitivity and specificity are just that: estimates. They include 95% confidence intervals, which are the range of estimates we are about 95% sure a test's sensitivity and specificity will fall within given how many samples were used in the performance validation. The more samples used to validate a test, the smaller the confidence interval becomes, meaning that we can be more confident in the estimates of sensitivity and specificity provided.

Tests are also described by their Positive and Negative Predictive values (PPV and NPV). These measures are calculated using a test's sensitivity, its specificity, and using an assumption about the percentage of individuals in the population who have antibodies to SARS-CoV-2 (which is called "prevalence" in these calculations). Every test returns some false positive and false negative results. The PPV and NPV help those who are interpreting these tests understand, given how prevalent individuals with antibodies are in a population, how likely it is that a person who receives a positive result from a test truly does have antibodies to SARS-CoV-2 and how likely it is that a person who receives a negative result from a test truly does not have antibodies to SARS-CoV-2. The PPV and NPV of a test depend heavily on the prevalence of what that test is intended to detect. Because all tests will return some false positive and some false negative results, including tests that detect antibodies to SARS-CoV-2, broad use of the tests, when not appropriately informed by other relevant information, such as clinical history or diagnostic test results, could identify too many false-positive individuals.

The prevalence of SARS-CoV-2 antibody positive individuals varies across the United States, and prevalence is changing as the virus infects more individuals and as more individuals are vaccinated. In low prevalence populations, the result of a single antibody test is not likely to be sufficiently accurate to make an informed decision regarding whether or not an individual has had a prior infection or truly has antibodies to the virus. A second test, typically one assessing for the presence of antibodies to a different viral protein, generally would be needed to increase the accuracy of the overall testing results.

Methodology

For this page, the FDA has summarized the expected performance of the tests it has authorized based on the information the FDA reviewed when deciding whether or not to grant these tests an Emergency Use Authorization and with prevalence assumptions ranging from 5% to 50% for PPV and NPV calculations. For tests that had multiple validation studies or where the tests showed variable performance in samples collected at different times after symptom onset, the FDA analysts selected the results they considered to be most representative of expected test performance. This is an incomplete representation of the performance of these tests. Always refer to the complete instructions for use to put these estimates into the proper context and to understand how to use and interpret these tests. The FDA is also providing a calculator that will allow users to see the estimated performance of a single test or two independent tests based on their performance characteristics and the estimated prevalence of SARS-CoV-2 antibodies in the target population.

Test Performance

Abbott AdviseDx SARS-CoV-2 IgG II (Alinity)

Developer: Abbott Laboratories Inc.
Test: AdviseDx SARS-CoV-2 IgG II (Alinity)
Technology: Semi-quantitative High Throughput CMIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 98.1% (51/52) (89.9%; 99.7%)
IgG Specificity (NPA) 99.6% (2000/2008) (99.2%; 99.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 92.8% (95% CI: 85.8%; 96.3%) 99.9% (95% CI: 99.5%; 100%)
10.0% 96.5% (95% CI: 92.7%; 98.2%) 99.8% (95% CI: 98.9%; 100%)
15.0% 97.7% (95% CI: 95.3%; 98.9%) 99.7% (95% CI: 98.2%; 99.9%)
20.0% 98.4% (95% CI: 96.6%; 99.2%) 99.5% (95% CI: 97.5%; 99.9%)
25.0% 98.8% (95% CI: 97.4%; 99.4%) 99.4% (95% CI: 96.7%; 99.9%)
30.0% 99.1% (95% CI: 98.0%; 99.5%) 99.2% (95% CI: 95.8%; 99.9%)
35.0% 99.3% (95% CI: 98.4%; 99.6%) 99.0% (95% CI: 94.8%; 99.8%)
40.0% 99.4% (95% CI: 98.7%; 99.7%) 98.7% (95% CI: 93.6%; 99.8%)
45.0% 99.5% (95% CI: 98.9%; 99.8%) 98.4% (95% CI: 92.3%; 99.7%)
50.0% 99.6% (95% CI: 99.1%; 99.8%) 98.1% (95% CI: 90.7%; 99.7%)

Test Facts:


Abbott AdviseDx SARS-CoV-2 IgG II (Architect)

Developer: Abbott Laboratories Inc.
Test: AdviseDx SARS-CoV-2 IgG II (Architect)
Technology: Semi-quantitative High Throughput CMIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 98.1% (52/53) (90.1%; 99.7%)
IgG Specificity (NPA) 99.6% (1999/2008) (99.2%; 99.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 92.0% (95% CI: 84.8%; 95.7%) 99.9% (95% CI: 99.5%; 100%)
10.0% 96.1% (95% CI: 92.2%; 97.9%) 99.8% (95% CI: 98.9%; 100%)
15.0% 97.5% (95% CI: 94.9%; 98.7%) 99.7% (95% CI: 98.3%; 99.9%)
20.0% 98.2% (95% CI: 96.4%; 99.1%) 99.5% (95% CI: 97.6%; 99.9%)
25.0% 98.6% (95% CI: 97.2%; 99.3%) 99.4% (95% CI: 96.8%; 99.9%)
30.0% 98.9% (95% CI: 97.8%; 99.5%) 99.2% (95% CI: 95.9%; 99.9%)
35.0% 99.2% (95% CI: 98.3%; 99.6%) 99.0% (95% CI: 94.9%; 99.8%)
40.0% 99.3% (95% CI: 98.6%; 99.6%) 98.8% (95% CI: 93.7%; 99.8%)
45.0% 99.4% (95% CI: 98.9%; 99.7%) 98.5% (95% CI: 92.4%; 99.7%)
50.0% 99.5% (95% CI: 99.1%; 99.8%) 98.1% (95% CI: 90.9%; 99.7%)

Test Facts:


Abbott Alinity i SARS-CoV-2 IgG

Developer: Abbott
Test: Alinity i SARS-CoV-2 IgG
Technology: High Throughput CMIA
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (34/34) (89.9%; 100%)
IgG Specificity (NPA) 99.0% (99/100) (94.6%; 99.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 84.0% (95% CI: 46.5%; 96.8%) 100% (95% CI: 99.4%; 100%)
10.0% 91.7% (95% CI: 64.7%; 98.4%) 100% (95% CI: 98.8%; 100%)
15.0% 94.6% (95% CI: 74.4%; 99.0%) 100% (95% CI: 98.1%; 100%)
20.0% 96.2% (95% CI: 80.5%; 99.3%) 100% (95% CI: 97.4%; 100%)
25.0% 97.1% (95% CI: 84.6%; 99.5%) 100% (95% CI: 96.5%; 100%)
30.0% 97.7% (95% CI: 87.6%; 99.6%) 100% (95% CI: 95.6%; 100%)
35.0% 98.2% (95% CI: 89.9%; 99.7%) 100% (95% CI: 94.5%; 100%)
40.0% 98.5% (95% CI: 91.7%; 99.7%) 100% (95% CI: 93.3%; 100%)
45.0% 98.8% (95% CI: 93.1%; 99.8%) 100% (95% CI: 91.9%; 100%)
50.0% 99.0% (95% CI: 94.3%; 99.8%) 100% (95% CI: 90.3%; 100%)

Test Facts:


Abbott ARCHITECT SARS-CoV-2 IgG

Developer: Abbott
Test: ARCHITECT SARS-CoV-2 IgG
Technology: High Throughput CMIA
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (88/88) (95.8%; 100%)
IgG Specificity (NPA) 99.6% (1066/1070) (99.0%; 99.9%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 93.4% (95% CI: 84.0%; 97.3%) 100% (95% CI: 99.8%; 100%)
10.0% 96.7% (95% CI: 91.8%; 98.7%) 100% (95% CI: 99.5%; 100%)
15.0% 97.9% (95% CI: 94.6%; 99.2%) 100% (95% CI: 99.3%; 100%)
20.0% 98.5% (95% CI: 96.2%; 99.4%) 100% (95% CI: 99.0%; 100%)
25.0% 98.9% (95% CI: 97.1%; 99.6%) 100% (95% CI: 98.6%; 100%)
30.0% 99.1% (95% CI: 97.7%; 99.7%) 100% (95% CI: 98.2%; 100%)
35.0% 99.3% (95% CI: 98.2%; 99.7%) 100% (95% CI: 97.8%; 100%)
40.0% 99.4% (95% CI: 98.5%; 99.8%) 100% (95% CI: 97.3%; 100%)
45.0% 99.5% (95% CI: 98.8%; 99.8%) 100% (95% CI: 96.7%; 100%)
50.0% 99.6% (95% CI: 99.0%; 99.9%) 100% (95% CI: 95.9%; 100%)

Test Facts:


Abbott Laboratories AdviseDx SARS-CoV-2 IgM (Alinity i)

Developer: Abbott Laboratories Inc.
Test: AdviseDx SARS-CoV-2 IgM (Alinity i)
Technology: High Throughput CMIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 95.0% (38/40) (83.5%; 98.6%)
IgM Specificity (NPA) 99.6% (2972/2985) (99.3%; 99.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 92.0% (95% CI: 85.5%; 95.3%) 99.7% (95% CI: 99.1%; 99.9%)
10.0% 96.0% (95% CI: 92.6%; 97.7%) 99.4% (95% CI: 98.2%; 99.8%)
15.0% 97.5% (95% CI: 95.2%; 98.6%) 99.1% (95% CI: 97.1%; 99.8%)
20.0% 98.2% (95% CI: 96.6%; 99.0%) 98.8% (95% CI: 96.0%; 99.7%)
25.0% 98.6% (95% CI: 97.4%; 99.2%) 98.4% (95% CI: 94.7%; 99.5%)
30.0% 98.9% (95% CI: 98.0%; 99.4%) 97.9% (95% CI: 93.3%; 99.4%)
35.0% 99.2% (95% CI: 98.4%; 99.5%) 97.4% (95% CI: 91.8%; 99.3%)
40.0% 99.3% (95% CI: 98.7%; 99.6%) 96.8% (95% CI: 90.0%; 99.1%)
45.0% 99.4% (95% CI: 98.9%; 99.7%) 96.1% (95% CI: 88.0%; 98.9%)
50.0% 99.5% (95% CI: 99.1%; 99.7%) 95.2% (95% CI: 85.7%; 98.6%)

Test Facts:


Abbott Laboratories AdviseDx SARS-CoV-2 IgM (Architect)

Developer: Abbott Laboratories Inc.
Test: AdviseDx SARS-CoV-2 IgM (Architect)
Technology: High Throughput CMIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 95.0% (38/40) (83.5%; 98.6%)
IgM Specificity (NPA) 99.6% (2952/2965) (99.3%; 99.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 91.9% (95% CI: 85.4%; 95.3%) 99.7% (95% CI: 99.1%; 99.9%)
10.0% 96.0% (95% CI: 92.5%; 97.7%) 99.4% (95% CI: 98.2%; 99.8%)
15.0% 97.5% (95% CI: 95.2%; 98.5%) 99.1% (95% CI: 97.1%; 99.8%)
20.0% 98.2% (95% CI: 96.5%; 99.0%) 98.8% (95% CI: 96.0%; 99.7%)
25.0% 98.6% (95% CI: 97.4%; 99.2%) 98.4% (95% CI: 94.7%; 99.5%)
30.0% 98.9% (95% CI: 98.0%; 99.4%) 97.9% (95% CI: 93.3%; 99.4%)
35.0% 99.2% (95% CI: 98.4%; 99.5%) 97.4% (95% CI: 91.8%; 99.3%)
40.0% 99.3% (95% CI: 98.7%; 99.6%) 96.8% (95% CI: 90.0%; 99.1%)
45.0% 99.4% (95% CI: 98.9%; 99.7%) 96.1% (95% CI: 88.0%; 98.9%)
50.0% 99.5% (95% CI: 99.1%; 99.7%) 95.2% (95% CI: 85.7%; 98.6%)

Test Facts:


Access Bio CareStart COVID-19 IgM/IgG

Developer: Access Bio, Inc.
Test: CareStart COVID-19 IgM/IgG
Technology: Lateral Flow
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 89.1% (57/64) (79.1%; 94.6%)
IgM Specificity 99.5% (181/182) (97.0%; 99.9%)
IgG Sensitivity 96.9% (62/64) (89.3%; 99.1%)
IgG Specificity 99.5% (181/182) (97.0%; 99.9%)
Combined Sensitivity 98.4% (63/64) (91.7%; 99.7%)
Combined Specificity 98.9% (180/182) (96.1%; 99.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 82.5% (95% CI: 55.2%; 94.6%) 99.9% (95% CI: 99.5%; 100%)
10.0% 90.9% (95% CI: 72.2%; 97.4%) 99.8% (95% CI: 99.0%; 100%)
15.0% 94.1% (95% CI: 80.5%; 98.3%) 99.7% (95% CI: 98.5%; 100%)
20.0% 95.7% (95% CI: 85.4%; 98.8%) 99.6% (95% CI: 97.9%; 99.9%)
25.0% 96.8% (95% CI: 88.6%; 99.1%) 99.5% (95% CI: 97.2%; 99.9%)
30.0% 97.5% (95% CI: 90.9%; 99.3%) 99.3% (95% CI: 96.4%; 99.9%)
35.0% 98.0% (95% CI: 92.6%; 99.4%) 99.2% (95% CI: 95.5%; 99.9%)
40.0% 98.4% (95% CI: 94.0%; 99.5%) 99.0% (95% CI: 94.5%; 99.8%)
45.0% 98.7% (95% CI: 95.0%; 99.6%) 98.7% (95% CI: 93.4%; 99.8%)
50.0% 98.9% (95% CI: 95.9%; 99.7%) 98.4% (95% CI: 92.0%; 99.7%)

Test Facts:


Access Bio, Inc. CareStart EZ COVID-19 IgM/IgG

Developer: Access Bio, Inc.
Test: CareStart EZ COVID-19 IgM/IgG
Technology: Lateral Flow
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 86.7% (26/30) (70.3%; 94.7%)
IgM Specificity 100% (80/80) (95.4%; 100%)
IgG Sensitivity 96.7% (29/30) (83.3%; 99.4%)
IgG Specificity 100% (80/80) (95.4%; 100%)
Combined Sensitivity 100% (30/30) (88.7%; 100%)
Combined Specificity 100% (80/80) (95.4%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 50.5%; 100%) 100% (95% CI: 99.4%; 100%)
10.0% 100% (95% CI: 68.3%; 100%) 100% (95% CI: 98.7%; 100%)
15.0% 100% (95% CI: 77.4%; 100%) 100% (95% CI: 97.9%; 100%)
20.0% 100% (95% CI: 82.9%; 100%) 100% (95% CI: 97.1%; 100%)
25.0% 100% (95% CI: 86.6%; 100%) 100% (95% CI: 96.2%; 100%)
30.0% 100% (95% CI: 89.2%; 100%) 100% (95% CI: 95.2%; 100%)
35.0% 100% (95% CI: 91.2%; 100%) 100% (95% CI: 94.0%; 100%)
40.0% 100% (95% CI: 92.8%; 100%) 100% (95% CI: 92.7%; 100%)
45.0% 100% (95% CI: 94.1%; 100%) 100% (95% CI: 91.1%; 100%)
50.0% 100% (95% CI: 95.1%; 100%) 100% (95% CI: 89.4%; 100%)

Test Facts:


ACON Laboratories ACON SARS-CoV-2 IgG/IgM Rapid Test

Developer: ACON Laboratories, Inc.
Test: ACON SARS-CoV-2 IgG/IgM Rapid Test
Technology: Lateral Flow
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 96.7% (29/30) (83.3%; 99.4%)
IgM Specificity 98.8% (79/80) (93.3%; 99.8%)
IgG Sensitivity 100% (30/30) (88.7%; 100%)
IgG Specificity 97.5% (78/80) (91.3%; 99.3%)
Combined Sensitivity 100% (30/30) (88.7%; 100%)
Combined Specificity 96.2% (77/80) (89.5%; 98.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 58.4% (95% CI: 30.9%; 80.4%) 100% (95% CI: 99.3%; 100%)
10.0% 74.8% (95% CI: 48.5%; 89.7%) 100% (95% CI: 98.6%; 100%)
15.0% 82.5% (95% CI: 59.9%; 93.2%) 100% (95% CI: 97.8%; 100%)
20.0% 87.0% (95% CI: 67.9%; 95.1%) 100% (95% CI: 96.9%; 100%)
25.0% 89.9% (95% CI: 73.9%; 96.3%) 100% (95% CI: 95.9%; 100%)
30.0% 92.0% (95% CI: 78.4%; 97.1%) 100% (95% CI: 94.8%; 100%)
35.0% 93.5% (95% CI: 82.0%; 97.7%) 100% (95% CI: 93.6%; 100%)
40.0% 94.7% (95% CI: 85.0%; 98.1%) 100% (95% CI: 92.2%; 100%)
45.0% 95.6% (95% CI: 87.4%; 98.5%) 100% (95% CI: 90.6%; 100%)
50.0% 96.4% (95% CI: 89.5%; 98.7%) 100% (95% CI: 88.8%; 100%)

Test Facts:


ADVAITE RapCov Rapid COVID-19 Test

Developer: ADVAITE, Inc.
Test: RapCov Rapid COVID-19 Test
Technology: Lateral Flow
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 90.0% (27/30) (74.4%; 96.5%)
IgG Specificity (NPA) 95.2% (99/104) (89.2%; 97.9%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 49.6% (95% CI: 26.7%; 71.1%) 99.5% (95% CI: 98.5%; 99.8%)
10.0% 67.5% (95% CI: 43.4%; 83.8%) 98.8% (95% CI: 96.9%; 99.6%)
15.0% 76.8% (95% CI: 54.9%; 89.2%) 98.2% (95% CI: 95.2%; 99.4%)
20.0% 82.4% (95% CI: 63.3%; 92.1%) 97.4% (95% CI: 93.3%; 99.1%)
25.0% 86.2% (95% CI: 69.7%; 94.0%) 96.6% (95% CI: 91.3%; 98.8%)
30.0% 88.9% (95% CI: 74.8%; 95.2%) 95.7% (95% CI: 89.0%; 98.5%)
35.0% 91.0% (95% CI: 78.8%; 96.2%) 94.6% (95% CI: 86.6%; 98.1%)
40.0% 92.6% (95% CI: 82.2%; 96.9%) 93.5% (95% CI: 83.9%; 97.7%)
45.0% 93.9% (95% CI: 85.0%; 97.4%) 92.1% (95% CI: 81.0%; 97.2%)
50.0% 94.9% (95% CI: 87.4%; 97.9%) 90.5% (95% CI: 77.7%; 96.6%)

Test Facts:


Assure Tech. Assure COVID-19 IgG/IgM Rapid Test Device

Developer: Assure Tech. (Hangzhou Co., Ltd)
Test: Assure COVID-19 IgG/IgM Rapid Test Device
Technology: Lateral Flow
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 100% (30/30) (88.7%; 100%)
IgM Specificity 98.8% (79/80) (93.3%; 99.8%)
IgG Sensitivity 90.0% (27/30) (74.4%; 96.5%)
IgG Specificity 100% (80/80) (95.4%; 100%)
Combined Sensitivity 100% (30/30) (88.7%; 100%)
Combined Specificity 98.8% (79/80) (93.3%; 99.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 80.8% (95% CI: 40.9%; 96.0%) 100% (95% CI: 99.4%; 100%)
10.0% 89.9% (95% CI: 59.4%; 98.1%) 100% (95% CI: 98.7%; 100%)
15.0% 93.4% (95% CI: 69.9%; 98.8%) 100% (95% CI: 97.9%; 100%)
20.0% 95.2% (95% CI: 76.7%; 99.1%) 100% (95% CI: 97.0%; 100%)
25.0% 96.4% (95% CI: 81.4%; 99.3%) 100% (95% CI: 96.1%; 100%)
30.0% 97.2% (95% CI: 84.9%; 99.5%) 100% (95% CI: 95.0%; 100%)
35.0% 97.7% (95% CI: 87.6%; 99.6%) 100% (95% CI: 93.9%; 100%)
40.0% 98.2% (95% CI: 89.8%; 99.7%) 100% (95% CI: 92.5%; 100%)
45.0% 98.5% (95% CI: 91.5%; 99.7%) 100% (95% CI: 90.9%; 100%)
50.0% 98.8% (95% CI: 92.9%; 99.8%) 100% (95% CI: 89.2%; 100%)

Test Facts:


Babson Diagnostics aC19G1

Developer: Babson Diagnostics, Inc.
Test: Babson Diagnostics aC19G1
Technology: High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (29/29) (88.3%; 100%)
IgG Specificity (NPA) 100% (100/100) (96.3%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 55.7%; 100%) 100% (95% CI: 99.4%; 100%)
10.0% 100% (95% CI: 72.6%; 100%) 100% (95% CI: 98.7%; 100%)
15.0% 100% (95% CI: 80.8%; 100%) 100% (95% CI: 97.9%; 100%)
20.0% 100% (95% CI: 85.7%; 100%) 100% (95% CI: 97.1%; 100%)
25.0% 100% (95% CI: 88.8%; 100%) 100% (95% CI: 96.1%; 100%)
30.0% 100% (95% CI: 91.1%; 100%) 100% (95% CI: 95.1%; 100%)
35.0% 100% (95% CI: 92.8%; 100%) 100% (95% CI: 93.9%; 100%)
40.0% 100% (95% CI: 94.1%; 100%) 100% (95% CI: 92.5%; 100%)
45.0% 100% (95% CI: 95.1%; 100%) 100% (95% CI: 91.0%; 100%)
50.0% 100% (95% CI: 96.0%; 100%) 100% (95% CI: 89.2%; 100%)

Test Facts:


Beckman Coulter Access SARS-CoV-2 IgG

Developer: Beckman Coulter, Inc.
Test: Access SARS-CoV-2 IgG
Technology: High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 96.8% (92/95) (91.1%; 98.9%)
IgG Specificity (NPA) 99.6% (1395/1400) (99.2%; 99.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 93.5% (95% CI: 85.2%; 97.2%) 99.8% (95% CI: 99.5%; 99.9%)
10.0% 96.8% (95% CI: 92.4%; 98.6%) 99.6% (95% CI: 99.0%; 99.9%)
15.0% 98.0% (95% CI: 95.1%; 99.1%) 99.4% (95% CI: 98.4%; 99.8%)
20.0% 98.5% (95% CI: 96.5%; 99.4%) 99.2% (95% CI: 97.8%; 99.7%)
25.0% 98.9% (95% CI: 97.3%; 99.5%) 99.0% (95% CI: 97.1%; 99.6%)
30.0% 99.1% (95% CI: 97.9%; 99.6%) 98.7% (95% CI: 96.3%; 99.5%)
35.0% 99.3% (95% CI: 98.3%; 99.7%) 98.3% (95% CI: 95.4%; 99.4%)
40.0% 99.4% (95% CI: 98.6%; 99.8%) 97.9% (95% CI: 94.4%; 99.3%)
45.0% 99.6% (95% CI: 98.9%; 99.8%) 97.5% (95% CI: 93.2%; 99.1%)
50.0% 99.6% (95% CI: 99.1%; 99.8%) 96.9% (95% CI: 91.8%; 98.9%)

Test Facts:


Beckman Coulter Access SARS-CoV-2 IgM

Developer: Beckman Coulter, Inc.
Test: Access SARS-CoV-2 IgM
Technology: High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 96.7% (146/151) (92.5%; 98.6%)
IgM Specificity (NPA) 99.9% (1398/1400) (99.5%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 97.3% (95% CI: 90.4%; 99.3%) 99.8% (95% CI: 99.6%; 99.9%)
10.0% 98.7% (95% CI: 95.2%; 99.6%) 99.6% (95% CI: 99.2%; 99.8%)
15.0% 99.2% (95% CI: 96.9%; 99.8%) 99.4% (95% CI: 98.7%; 99.7%)
20.0% 99.4% (95% CI: 97.8%; 99.8%) 99.2% (95% CI: 98.1%; 99.6%)
25.0% 99.6% (95% CI: 98.3%; 99.9%) 98.9% (95% CI: 97.5%; 99.5%)
30.0% 99.7% (95% CI: 98.7%; 99.9%) 98.6% (95% CI: 96.9%; 99.4%)
35.0% 99.7% (95% CI: 99.0%; 99.9%) 98.2% (95% CI: 96.1%; 99.2%)
40.0% 99.8% (95% CI: 99.2%; 99.9%) 97.8% (95% CI: 95.2%; 99.1%)
45.0% 99.8% (95% CI: 99.3%; 100%) 97.4% (95% CI: 94.2%; 98.8%)
50.0% 99.9% (95% CI: 99.4%; 100%) 96.8% (95% CI: 93.0%; 98.6%)

Test Facts:


Beckman Coulter, Inc. Access SARS-CoV-2 IgG II

Developer: Beckman Coulter, Inc.
Test: Access SARS-CoV-2 IgG II
Technology: Semi-quantitative High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 98.9% (90/91) (94.0%; 99.8%)
IgG Specificity (NPA) 100% (93/93) (96.0%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 55.5%; 100%) 99.9% (95% CI: 99.7%; 100%)
10.0% 100% (95% CI: 72.5%; 100%) 99.9% (95% CI: 99.3%; 100%)
15.0% 100% (95% CI: 80.7%; 100%) 99.8% (95% CI: 98.9%; 100%)
20.0% 100% (95% CI: 85.6%; 100%) 99.7% (95% CI: 98.5%; 100%)
25.0% 100% (95% CI: 88.8%; 100%) 99.6% (95% CI: 98.0%; 99.9%)
30.0% 100% (95% CI: 91.0%; 100%) 99.5% (95% CI: 97.4%; 99.9%)
35.0% 100% (95% CI: 92.7%; 100%) 99.4% (95% CI: 96.8%; 99.9%)
40.0% 100% (95% CI: 94.1%; 100%) 99.3% (95% CI: 96.0%; 99.9%)
45.0% 100% (95% CI: 95.1%; 100%) 99.1% (95% CI: 95.2%; 99.8%)
50.0% 100% (95% CI: 96.0%; 100%) 98.9% (95% CI: 94.2%; 99.8%)

Test Facts:


Beijing Wantai Biological Pharmacy Enterprise WANTAI SARS-CoV-2 Ab ELISA

Developer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Test: WANTAI SARS-CoV-2 Ab ELISA
Technology: ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity 96.7% (29/30) (83.3%; 99.4%)
Pan-Ig Specificity 97.5% (78/80) (91.3%; 99.3%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 67.1% (95% CI: 33.6%; 88.4%) 99.8% (95% CI: 99.0%; 100%)
10.0% 81.1% (95% CI: 51.7%; 94.1%) 99.6% (95% CI: 98.0%; 99.9%)
15.0% 87.2% (95% CI: 62.9%; 96.2%) 99.4% (95% CI: 96.9%; 99.9%)
20.0% 90.6% (95% CI: 70.6%; 97.3%) 99.2% (95% CI: 95.6%; 99.9%)
25.0% 92.8% (95% CI: 76.2%; 98.0%) 98.9% (95% CI: 94.3%; 99.8%)
30.0% 94.3% (95% CI: 80.5%; 98.4%) 98.6% (95% CI: 92.7%; 99.7%)
35.0% 95.4% (95% CI: 83.8%; 98.7%) 98.2% (95% CI: 91.1%; 99.7%)
40.0% 96.3% (95% CI: 86.5%; 99.0%) 97.8% (95% CI: 89.2%; 99.6%)
45.0% 96.9% (95% CI: 88.7%; 99.2%) 97.3% (95% CI: 87.0%; 99.5%)
50.0% 97.5% (95% CI: 90.6%; 99.3%) 96.7% (95% CI: 84.6%; 99.4%)

Test Facts:


Beijing Wantai Biological Pharmacy Enterprise WANTAI SARS-CoV-2 Ab Rapid Test

Developer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Test: WANTAI SARS-CoV-2 Ab Rapid Test
Technology: Lateral Flow
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity 100% (30/30) (88.7%; 100%)
Pan-Ig Specificity 98.8% (79/80) (93.3%; 99.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 80.8% (95% CI: 40.9%; 96.0%) 100% (95% CI: 99.4%; 100%)
10.0% 89.9% (95% CI: 59.4%; 98.1%) 100% (95% CI: 98.7%; 100%)
15.0% 93.4% (95% CI: 69.9%; 98.8%) 100% (95% CI: 97.9%; 100%)
20.0% 95.2% (95% CI: 76.7%; 99.1%) 100% (95% CI: 97.0%; 100%)
25.0% 96.4% (95% CI: 81.4%; 99.3%) 100% (95% CI: 96.1%; 100%)
30.0% 97.2% (95% CI: 84.9%; 99.5%) 100% (95% CI: 95.0%; 100%)
35.0% 97.7% (95% CI: 87.6%; 99.6%) 100% (95% CI: 93.9%; 100%)
40.0% 98.2% (95% CI: 89.8%; 99.7%) 100% (95% CI: 92.5%; 100%)
45.0% 98.5% (95% CI: 91.5%; 99.7%) 100% (95% CI: 90.9%; 100%)
50.0% 98.8% (95% CI: 92.9%; 99.8%) 100% (95% CI: 89.2%; 100%)

Test Facts:


Bio-Rad Laboratories BioPlex 2200 SARS-CoV-2 IgG

Developer: Bio-Rad Laboratories
Test: BioPlex 2200 SARS-CoV-2 IgG
Technology: Semi-quantitative Bead-based Fluorescent Immunoassay
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 93.9% (231/246) (90.2%; 96.3%)
IgG Specificity (NPA) 99.9% (1556/1557) (99.6%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 98.7% (95% CI: 92.9%; 99.8%) 99.7% (95% CI: 99.5%; 99.8%)
10.0% 99.4% (95% CI: 96.5%; 99.9%) 99.3% (95% CI: 98.9%; 99.6%)
15.0% 99.6% (95% CI: 97.8%; 99.9%) 98.9% (95% CI: 98.3%; 99.3%)
20.0% 99.7% (95% CI: 98.4%; 100%) 98.5% (95% CI: 97.6%; 99.1%)
25.0% 99.8% (95% CI: 98.8%; 100%) 98.0% (95% CI: 96.8%; 98.8%)
30.0% 99.8% (95% CI: 99.1%; 100%) 97.5% (95% CI: 95.9%; 98.4%)
35.0% 99.9% (95% CI: 99.3%; 100%) 96.8% (95% CI: 95.0%; 98.0%)
40.0% 99.9% (95% CI: 99.4%; 100%) 96.1% (95% CI: 93.8%; 97.6%)
45.0% 99.9% (95% CI: 99.5%; 100%) 95.2% (95% CI: 92.5%; 97.0%)
50.0% 99.9% (95% CI: 99.6%; 100%) 94.2% (95% CI: 91.0%; 96.4%)

Test Facts:


Bio-Rad Platelia SARS-CoV-2 Total Ab

Developer: Bio-Rad Laboratories, Inc
Test: Platelia SARS-CoV-2 Total Ab
Technology: ELISA
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 98.0% (49/50) (89.5%; 99.6%)
Pan-Ig Specificity (NPA) 99.3% (596/600) (98.3%; 99.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 88.6% (95% CI: 73.5%; 95.3%) 99.9% (95% CI: 99.4%; 100%)
10.0% 94.2% (95% CI: 85.4%; 97.7%) 99.8% (95% CI: 98.8%; 100%)
15.0% 96.3% (95% CI: 90.3%; 98.5%) 99.6% (95% CI: 98.2%; 99.9%)
20.0% 97.4% (95% CI: 92.9%; 99.0%) 99.5% (95% CI: 97.4%; 99.9%)
25.0% 98.0% (95% CI: 94.6%; 99.2%) 99.3% (95% CI: 96.6%; 99.9%)
30.0% 98.4% (95% CI: 95.8%; 99.4%) 99.1% (95% CI: 95.6%; 99.8%)
35.0% 98.8% (95% CI: 96.6%; 99.5%) 98.9% (95% CI: 94.6%; 99.8%)
40.0% 99.0% (95% CI: 97.2%; 99.6%) 98.7% (95% CI: 93.4%; 99.8%)
45.0% 99.2% (95% CI: 97.7%; 99.7%) 98.4% (95% CI: 92.0%; 99.7%)
50.0% 99.3% (95% CI: 98.1%; 99.7%) 98.0% (95% CI: 90.4%; 99.6%)

Test Facts:


Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test

Developer: Biocan Diagnostics Inc.
Test: Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test
Technology: Lateral Flow
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 90.0% (27/30) (74.4%; 96.5%)
IgM Specificity 98.7% (78/79) (93.2%; 99.8%)
IgG Sensitivity 93.3% (28/30) (78.7%; 98.2%)
IgG Specificity 96.2% (76/79) (89.4%; 98.7%)
Combined Sensitivity 93.3% (28/30) (78.7%; 98.2%)
Combined Specificity 96.2% (76/79) (89.4%; 98.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 56.4% (95% CI: 28.1%; 79.9%) 99.6% (95% CI: 98.8%; 99.9%)
10.0% 73.2% (95% CI: 45.2%; 89.4%) 99.2% (95% CI: 97.4%; 99.8%)
15.0% 81.3% (95% CI: 56.8%; 93.0%) 98.8% (95% CI: 96.0%; 99.7%)
20.0% 86.0% (95% CI: 65.0%; 95.0%) 98.3% (95% CI: 94.4%; 99.5%)
25.0% 89.1% (95% CI: 71.3%; 96.2%) 97.7% (95% CI: 92.6%; 99.4%)
30.0% 91.3% (95% CI: 76.1%; 97.0%) 97.1% (95% CI: 90.7%; 99.2%)
35.0% 93.0% (95% CI: 80.0%; 97.6%) 96.4% (95% CI: 88.6%; 99.0%)
40.0% 94.2% (95% CI: 83.2%; 98.1%) 95.6% (95% CI: 86.3%; 98.8%)
45.0% 95.3% (95% CI: 85.9%; 98.4%) 94.6% (95% CI: 83.7%; 98.5%)
50.0% 96.1% (95% CI: 88.1%; 98.7%) 93.5% (95% CI: 80.7%; 98.2%)

Test Facts:


BioCheck SARS-CoV-2 IgG and IgM Combo Test

Developer: BioCheck, Inc.
Test: BioCheck SARS-CoV-2 IgG and IgM Combo Test
Technology: CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 95.5% (105/110) (89.8%; 98.0%)
IgM Specificity (NPA) 97.2% (139/143) (93.0%; 98.9%)
IgG Sensitivity (PPA) 99.1% (109/110) (95.0%; 99.8%)
IgG Specificity (NPA) 100% (143/143) (97.4%; 100%)
Combined Sensitivity (PPA) 99.1% (109/110) (95.0%; 99.8%)
Combined Specificity (NPA) 97.2% (139/143) (93.0%; 98.9%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 65.1% (95% CI: 41.8%; 82.8%) 100% (95% CI: 99.7%; 100%)
10.0% 79.7% (95% CI: 60.2%; 91.0%) 99.9% (95% CI: 99.4%; 100%)
15.0% 86.2% (95% CI: 70.6%; 94.2%) 99.8% (95% CI: 99.1%; 100%)
20.0% 89.9% (95% CI: 77.3%; 95.8%) 99.8% (95% CI: 98.7%; 100%)
25.0% 92.2% (95% CI: 82.0%; 96.8%) 99.7% (95% CI: 98.3%; 99.9%)
30.0% 93.8% (95% CI: 85.4%; 97.5%) 99.6% (95% CI: 97.8%; 99.9%)
35.0% 95.0% (95% CI: 88.0%; 98.0%) 99.5% (95% CI: 97.2%; 99.9%)
40.0% 95.9% (95% CI: 90.1%; 98.4%) 99.4% (95% CI: 96.6%; 99.9%)
45.0% 96.7% (95% CI: 91.8%; 98.7%) 99.2% (95% CI: 95.8%; 99.9%)
50.0% 97.3% (95% CI: 93.2%; 98.9%) 99.1% (95% CI: 94.9%; 99.8%)

Test Facts:


BioCheck SARS-CoV-2 IgG Antibody Test Kit

Developer: BioCheck, Inc.
Test: BioCheck SARS-CoV-2 IgG Antibody Test Kit
Technology: CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 99.1% (109/110) (95.0%; 99.8%)
IgG Specificity (NPA) 100% (143/143) (97.4%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 65.7%; 100%) 100% (95% CI: 99.7%; 100%)
10.0% 100% (95% CI: 80.1%; 100%) 99.9% (95% CI: 99.4%; 100%)
15.0% 100% (95% CI: 86.5%; 100%) 99.8% (95% CI: 99.1%; 100%)
20.0% 100% (95% CI: 90.1%; 100%) 99.8% (95% CI: 98.7%; 100%)
25.0% 100% (95% CI: 92.4%; 100%) 99.7% (95% CI: 98.3%; 99.9%)
30.0% 100% (95% CI: 94.0%; 100%) 99.6% (95% CI: 97.9%; 99.9%)
35.0% 100% (95% CI: 95.1%; 100%) 99.5% (95% CI: 97.3%; 99.9%)
40.0% 100% (95% CI: 96.0%; 100%) 99.4% (95% CI: 96.7%; 99.9%)
45.0% 100% (95% CI: 96.7%; 100%) 99.3% (95% CI: 96.0%; 99.9%)
50.0% 100% (95% CI: 97.3%; 100%) 99.1% (95% CI: 95.1%; 99.8%)

Test Facts:


BioCheck SARS-CoV-2 IgM Antibody Test Kit

Developer: BioCheck, Inc.
Test: BioCheck SARS-CoV-2 IgM Antibody Test Kit
Technology: CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 95.5% (105/110) (89.8%; 98.0%)
IgM Specificity (NPA) 97.2% (139/143) (93.0%; 98.9%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 64.2% (95% CI: 40.4%; 82.5%) 99.8% (95% CI: 99.4%; 99.9%)
10.0% 79.1% (95% CI: 58.9%; 90.9%) 99.5% (95% CI: 98.8%; 99.8%)
15.0% 85.8% (95% CI: 69.5%; 94.1%) 99.2% (95% CI: 98.1%; 99.7%)
20.0% 89.5% (95% CI: 76.3%; 95.7%) 98.8% (95% CI: 97.3%; 99.5%)
25.0% 91.9% (95% CI: 81.1%; 96.8%) 98.5% (95% CI: 96.5%; 99.3%)
30.0% 93.6% (95% CI: 84.7%; 97.5%) 98.0% (95% CI: 95.5%; 99.2%)
35.0% 94.8% (95% CI: 87.4%; 98.0%) 97.5% (95% CI: 94.4%; 98.9%)
40.0% 95.8% (95% CI: 89.6%; 98.4%) 97.0% (95% CI: 93.2%; 98.7%)
45.0% 96.5% (95% CI: 91.3%; 98.7%) 96.3% (95% CI: 91.8%; 98.4%)
50.0% 97.2% (95% CI: 92.8%; 98.9%) 95.5% (95% CI: 90.1%; 98.1%)

Test Facts:


Biohit Healthcare (Hefei) Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit

Developer: Biohit Healthcare (Hefei)
Test: Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit
Technology: Lateral Flow
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 96.7% (29/30) (83.3%; 99.4%)
IgM Specificity (NPA) 95.0% (76/80) (87.8%; 98.0%)
IgG Sensitivity (PPA) 96.7% (29/30) (83.3%; 99.4%)
IgG Specificity (NPA) 95.0% (76/80) (87.8%; 98.0%)
Combined Sensitivity (PPA) 96.7% (29/30) (83.3%; 99.4%)
Combined Specificity (NPA) 95.0% (76/80) (87.8%; 98.0%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 50.4% (95% CI: 26.5%; 72.7%) 99.8% (95% CI: 99.0%; 100%)
10.0% 68.2% (95% CI: 43.2%; 84.9%) 99.6% (95% CI: 97.9%; 99.9%)
15.0% 77.3% (95% CI: 54.7%; 89.9%) 99.4% (95% CI: 96.8%; 99.9%)
20.0% 82.9% (95% CI: 63.1%; 92.7%) 99.1% (95% CI: 95.5%; 99.8%)
25.0% 86.6% (95% CI: 69.5%; 94.4%) 98.8% (95% CI: 94.1%; 99.8%)
30.0% 89.2% (95% CI: 74.6%; 95.6%) 98.5% (95% CI: 92.5%; 99.7%)
35.0% 91.2% (95% CI: 78.7%; 96.5%) 98.1% (95% CI: 90.7%; 99.7%)
40.0% 92.8% (95% CI: 82.0%; 97.1%) 97.7% (95% CI: 88.8%; 99.6%)
45.0% 94.1% (95% CI: 84.9%; 97.6%) 97.2% (95% CI: 86.6%; 99.5%)
50.0% 95.1% (95% CI: 87.3%; 98.1%) 96.6% (95% CI: 84.1%; 99.4%)

Test Facts:


bioMérieux VIDAS SARS-CoV-2 IgG

Developer: bioMérieux SA
Test: VIDAS SARS-CoV-2 IgG
Technology: ELFA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (29/29) (88.3%; 100%)
IgG Specificity (NPA) 99.9% (988/989) (99.4%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 98.1% (95% CI: 89.1%; 99.7%) 100% (95% CI: 99.4%; 100%)
10.0% 99.1% (95% CI: 94.5%; 99.8%) 100% (95% CI: 98.7%; 100%)
15.0% 99.4% (95% CI: 96.5%; 99.9%) 100% (95% CI: 98.0%; 100%)
20.0% 99.6% (95% CI: 97.5%; 99.9%) 100% (95% CI: 97.1%; 100%)
25.0% 99.7% (95% CI: 98.1%; 99.9%) 100% (95% CI: 96.2%; 100%)
30.0% 99.8% (95% CI: 98.5%; 100%) 100% (95% CI: 95.2%; 100%)
35.0% 99.8% (95% CI: 98.8%; 100%) 100% (95% CI: 94.0%; 100%)
40.0% 99.8% (95% CI: 99.0%; 100%) 100% (95% CI: 92.7%; 100%)
45.0% 99.9% (95% CI: 99.2%; 100%) 100% (95% CI: 91.2%; 100%)
50.0% 99.9% (95% CI: 99.4%; 100%) 100% (95% CI: 89.5%; 100%)

Test Facts:


bioMérieux VIDAS SARS-CoV-2 IgM

Developer: bioMérieux SA
Test: VIDAS SARS-CoV-2 IgM
Technology: ELFA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 100% (23/23) (85.7%; 100%)
IgM Specificity (NPA) 99.4% (306/308) (97.7%; 99.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 89.0% (95% CI: 65.9%; 96.7%) 100% (95% CI: 99.2%; 100%)
10.0% 94.5% (95% CI: 80.3%; 98.4%) 100% (95% CI: 98.4%; 100%)
15.0% 96.5% (95% CI: 86.6%; 99.0%) 100% (95% CI: 97.5%; 100%)
20.0% 97.5% (95% CI: 90.2%; 99.3%) 100% (95% CI: 96.5%; 100%)
25.0% 98.1% (95% CI: 92.4%; 99.5%) 100% (95% CI: 95.3%; 100%)
30.0% 98.5% (95% CI: 94.0%; 99.6%) 100% (95% CI: 94.1%; 100%)
35.0% 98.8% (95% CI: 95.2%; 99.7%) 100% (95% CI: 92.7%; 100%)
40.0% 99.0% (95% CI: 96.1%; 99.7%) 100% (95% CI: 91.1%; 100%)
45.0% 99.2% (95% CI: 96.8%; 99.8%) 100% (95% CI: 89.3%; 100%)
50.0% 99.4% (95% CI: 97.3%; 99.8%) 100% (95% CI: 87.2%; 100%)

Test Facts:


Cellex qSARS-CoV-2 IgG/IgM Rapid Test

Developer: Cellex, Inc.
Test: qSARS-CoV-2 IgG/IgM Rapid Test
Technology: Lateral Flow
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Combined Sensitivity (PPA) 93.8% (120/128) (88.2%; 96.8%)
Combined Specificity (NPA) 96.0% (240/250) (92.8%; 97.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 55.2% (95% CI: 39.2%; 70.0%) 99.7% (95% CI: 99.3%; 99.8%)
10.0% 72.3% (95% CI: 57.6%; 83.1%) 99.3% (95% CI: 98.6%; 99.6%)
15.0% 80.5% (95% CI: 68.3%; 88.7%) 98.9% (95% CI: 97.8%; 99.4%)
20.0% 85.4% (95% CI: 75.4%; 91.7%) 98.4% (95% CI: 96.9%; 99.2%)
25.0% 88.7% (95% CI: 80.3%; 93.7%) 97.9% (95% CI: 95.9%; 98.9%)
30.0% 90.9% (95% CI: 84.0%; 95.0%) 97.3% (95% CI: 94.8%; 98.6%)
35.0% 92.7% (95% CI: 86.8%; 96.0%) 96.6% (95% CI: 93.6%; 98.3%)
40.0% 94.0% (95% CI: 89.1%; 96.7%) 95.8% (95% CI: 92.2%; 97.9%)
45.0% 95.0% (95% CI: 90.9%; 97.3%) 94.9% (95% CI: 90.5%; 97.4%)
50.0% 95.9% (95% CI: 92.4%; 97.8%) 93.9% (95% CI: 88.7%; 96.8%)

Test Facts:


Diabetomics, Inc. CovAb SARS-CoV-2 Ab Test

Developer: Diabetomics, Inc.
Test: CovAb SARS-CoV-2 Ab Test
Technology: Lateral Flow, Oral Fluid
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 97.1% (67/69) (90.0%; 99.2%)
Pan-Ig Specificity (NPA) 97.4% (76/78) (91.1%; 99.3%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 66.6% (95% CI: 34.8%; 88.1%) 99.8% (95% CI: 99.4%; 100%)
10.0% 80.8% (95% CI: 53.0%; 94.0%) 99.7% (95% CI: 98.8%; 99.9%)
15.0% 87.0% (95% CI: 64.2%; 96.1%) 99.5% (95% CI: 98.1%; 99.9%)
20.0% 90.4% (95% CI: 71.7%; 97.2%) 99.3% (95% CI: 97.3%; 99.8%)
25.0% 92.7% (95% CI: 77.2%; 97.9%) 99.0% (95% CI: 96.5%; 99.7%)
30.0% 94.2% (95% CI: 81.3%; 98.4%) 98.7% (95% CI: 95.5%; 99.7%)
35.0% 95.3% (95% CI: 84.5%; 98.7%) 98.4% (95% CI: 94.4%; 99.6%)
40.0% 96.2% (95% CI: 87.1%; 98.9%) 98.1% (95% CI: 93.2%; 99.5%)
45.0% 96.9% (95% CI: 89.2%; 99.1%) 97.6% (95% CI: 91.8%; 99.3%)
50.0% 97.4% (95% CI: 91.0%; 99.3%) 97.1% (95% CI: 90.1%; 99.2%)

Test Facts:


DiaSorin LIAISON SARS-CoV-2 IgM Assay

Developer: DiaSorin, Inc.
Test: DiaSorin LIAISON SARS-CoV-2 IgM Assay
Technology: CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 91.8% (112/122) (85.6%; 95.5%)
IgM Specificity 99.3% (2455/2473) (98.9%; 99.5%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 86.9% (95% CI: 79.7%; 91.6%) 99.6% (95% CI: 99.2%; 99.8%)
10.0% 93.3% (95% CI: 89.2%; 95.8%) 99.1% (95% CI: 98.4%; 99.5%)
15.0% 95.7% (95% CI: 92.9%; 97.3%) 98.6% (95% CI: 97.5%; 99.2%)
20.0% 96.9% (95% CI: 94.9%; 98.1%) 98.0% (95% CI: 96.5%; 98.9%)
25.0% 97.7% (95% CI: 96.1%; 98.6%) 97.3% (95% CI: 95.4%; 98.5%)
30.0% 98.2% (95% CI: 97.0%; 98.9%) 96.6% (95% CI: 94.1%; 98.1%)
35.0% 98.5% (95% CI: 97.6%; 99.1%) 95.7% (95% CI: 92.7%; 97.6%)
40.0% 98.8% (95% CI: 98.0%; 99.3%) 94.8% (95% CI: 91.1%; 97.1%)
45.0% 99.0% (95% CI: 98.4%; 99.4%) 93.7% (95% CI: 89.3%; 96.4%)
50.0% 99.2% (95% CI: 98.7%; 99.5%) 92.4% (95% CI: 87.3%; 95.7%)

Test Facts:


DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG

Developer: DiaSorin
Test: LIAISON SARS-CoV-2 S1/S2 IgG
Technology: High Throughput CMIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 97.6% (40/41) (87.4%; 99.6%)
IgG Specificity (NPA) 99.3% (1082/1090) (98.6%; 99.6%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 87.5% (95% CI: 76.1%; 93.4%) 99.9% (95% CI: 99.3%; 100%)
10.0% 93.7% (95% CI: 87.1%; 96.7%) 99.7% (95% CI: 98.6%; 100%)
15.0% 95.9% (95% CI: 91.5%; 97.9%) 99.6% (95% CI: 97.8%; 99.9%)
20.0% 97.1% (95% CI: 93.8%; 98.5%) 99.4% (95% CI: 96.9%; 99.9%)
25.0% 97.8% (95% CI: 95.3%; 98.9%) 99.2% (95% CI: 95.9%; 99.9%)
30.0% 98.3% (95% CI: 96.3%; 99.1%) 99.0% (95% CI: 94.8%; 99.8%)
35.0% 98.6% (95% CI: 97.0%; 99.3%) 98.7% (95% CI: 93.6%; 99.8%)
40.0% 98.9% (95% CI: 97.6%; 99.4%) 98.4% (95% CI: 92.2%; 99.7%)
45.0% 99.1% (95% CI: 98.0%; 99.5%) 98.0% (95% CI: 90.5%; 99.6%)
50.0% 99.3% (95% CI: 98.4%; 99.6%) 97.6% (95% CI: 88.7%; 99.6%)

Test Facts:


DiaSorin, Inc. LIAISON SARS-CoV-2 TrimericS IgG

Developer: DiaSorin, Inc.
Test: LIAISON SARS-CoV-2 TrimericS IgG
Technology: Semi-quantitative High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 96.9% (31/32) (84.3%; 99.4%)
IgG Specificity (NPA) 99.5% (1889/1899) (99.0%; 99.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 90.6% (95% CI: 82.1%; 94.8%) 99.8% (95% CI: 99.2%; 100%)
10.0% 95.3% (95% CI: 90.6%; 97.5%) 99.7% (95% CI: 98.3%; 99.9%)
15.0% 97.0% (95% CI: 93.9%; 98.4%) 99.4% (95% CI: 97.3%; 99.9%)
20.0% 97.9% (95% CI: 95.6%; 98.9%) 99.2% (95% CI: 96.2%; 99.9%)
25.0% 98.4% (95% CI: 96.7%; 99.1%) 99.0% (95% CI: 95.0%; 99.8%)
30.0% 98.7% (95% CI: 97.4%; 99.3%) 98.7% (95% CI: 93.6%; 99.8%)
35.0% 99.0% (95% CI: 97.9%; 99.5%) 98.3% (95% CI: 92.1%; 99.7%)
40.0% 99.2% (95% CI: 98.3%; 99.6%) 97.9% (95% CI: 90.4%; 99.6%)
45.0% 99.3% (95% CI: 98.6%; 99.6%) 97.5% (95% CI: 88.5%; 99.5%)
50.0% 99.5% (95% CI: 98.9%; 99.7%) 97.0% (95% CI: 86.3%; 99.4%)

Test Facts:


Diazyme Laboratories Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit

Developer: Diazyme Laboratories, Inc.
Test: Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit
Technology: High Throughput CLIA
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (29/29) (88.3%; 100%)
IgG Specificity (NPA) 97.4% (830/852) (96.1%; 98.3%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 67.1% (95% CI: 54.5%; 75.5%) 100% (95% CI: 99.4%; 100%)
10.0% 81.1% (95% CI: 71.7%; 86.7%) 100% (95% CI: 98.7%; 100%)
15.0% 87.2% (95% CI: 80.1%; 91.2%) 100% (95% CI: 97.9%; 100%)
20.0% 90.6% (95% CI: 85.1%; 93.6%) 100% (95% CI: 97.0%; 100%)
25.0% 92.8% (95% CI: 88.4%; 95.1%) 100% (95% CI: 96.1%; 100%)
30.0% 94.3% (95% CI: 90.7%; 96.2%) 100% (95% CI: 95.0%; 100%)
35.0% 95.4% (95% CI: 92.5%; 96.9%) 100% (95% CI: 93.9%; 100%)
40.0% 96.3% (95% CI: 93.8%; 97.5%) 100% (95% CI: 92.5%; 100%)
45.0% 96.9% (95% CI: 94.9%; 98.0%) 100% (95% CI: 90.9%; 100%)
50.0% 97.5% (95% CI: 95.8%; 98.3%) 100% (95% CI: 89.2%; 100%)

Test Facts:


Diazyme Laboratories Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit

Developer: Diazyme Laboratories, Inc.
Test: Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit
Technology: CLIA
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 94.4% (102/108) (88.4%; 97.4%)
IgM Specificity (NPA) 98.3% (297/302) (96.2%; 99.3%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 75.0% (95% CI: 54.9%; 87.9%) 99.7% (95% CI: 99.4%; 99.9%)
10.0% 86.4% (95% CI: 72.0%; 93.9%) 99.4% (95% CI: 98.7%; 99.7%)
15.0% 91.0% (95% CI: 80.3%; 96.0%) 99.0% (95% CI: 97.9%; 99.5%)
20.0% 93.4% (95% CI: 85.3%; 97.2%) 98.6% (95% CI: 97.1%; 99.4%)
25.0% 95.0% (95% CI: 88.5%; 97.9%) 98.2% (95% CI: 96.1%; 99.1%)
30.0% 96.1% (95% CI: 90.8%; 98.3%) 97.6% (95% CI: 95.1%; 98.9%)
35.0% 96.8% (95% CI: 92.6%; 98.7%) 97.0% (95% CI: 93.9%; 98.6%)
40.0% 97.4% (95% CI: 93.9%; 98.9%) 96.4% (95% CI: 92.6%; 98.3%)
45.0% 97.9% (95% CI: 95.0%; 99.1%) 95.6% (95% CI: 91.0%; 97.9%)
50.0% 98.3% (95% CI: 95.9%; 99.3%) 94.7% (95% CI: 89.2%; 97.5%)

Test Facts:


Emory Medical Laboratories SARS-CoV-2 RBD IgG test

Developer: Emory Medical Laboratories
Test: SARS-CoV-2 RBD IgG test
Technology: ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (30/30) (88.7%; 100%)
IgG Specificity (NPA) 96.4% (615/638) (94.6%; 97.6%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 59.3% (95% CI: 46.6%; 68.6%) 100% (95% CI: 99.4%; 100%)
10.0% 75.5% (95% CI: 64.8%; 82.2%) 100% (95% CI: 98.7%; 100%)
15.0% 83.0% (95% CI: 74.5%; 88.0%) 100% (95% CI: 97.9%; 100%)
20.0% 87.4% (95% CI: 80.6%; 91.2%) 100% (95% CI: 97.1%; 100%)
25.0% 90.2% (95% CI: 84.7%; 93.2%) 100% (95% CI: 96.2%; 100%)
30.0% 92.2% (95% CI: 87.7%; 94.7%) 100% (95% CI: 95.1%; 100%)
35.0% 93.7% (95% CI: 89.9%; 95.7%) 100% (95% CI: 93.9%; 100%)
40.0% 94.9% (95% CI: 91.7%; 96.5%) 100% (95% CI: 92.6%; 100%)
45.0% 95.8% (95% CI: 93.1%; 97.1%) 100% (95% CI: 91.1%; 100%)
50.0% 96.5% (95% CI: 94.3%; 97.6%) 100% (95% CI: 89.3%; 100%)

Test Facts:


EUROIMMUN SARS-COV-2 ELISA (IgG)

Developer: EUROIMMUN
Test: SARS-COV-2 ELISA (IgG)
Technology: ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 90.0% (27/30) (74.4%; 96.5%)
IgG Specificity (NPA) 100% (80/80) (95.4%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 46.1%; 100%) 99.5% (95% CI: 98.6%; 99.8%)
10.0% 100% (95% CI: 64.3%; 100%) 98.9% (95% CI: 97.1%; 99.6%)
15.0% 100% (95% CI: 74.1%; 100%) 98.3% (95% CI: 95.5%; 99.4%)
20.0% 100% (95% CI: 80.2%; 100%) 97.6% (95% CI: 93.7%; 99.1%)
25.0% 100% (95% CI: 84.4%; 100%) 96.8% (95% CI: 91.8%; 98.9%)
30.0% 100% (95% CI: 87.4%; 100%) 95.9% (95% CI: 89.7%; 98.5%)
35.0% 100% (95% CI: 89.7%; 100%) 94.9% (95% CI: 87.4%; 98.2%)
40.0% 100% (95% CI: 91.5%; 100%) 93.8% (95% CI: 84.8%; 97.7%)
45.0% 100% (95% CI: 93.0%; 100%) 92.4% (95% CI: 82.0%; 97.2%)
50.0% 100% (95% CI: 94.2%; 100%) 90.9% (95% CI: 78.8%; 96.7%)

Test Facts:


Genalyte Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2

Developer: Genalyte, Inc.
Test: Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2
Technology: Photonic Ring Immunoassay (PRI)
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 96.1% (174/181) (92.2%; 98.1%)
Pan-Ig Specificity (NPA) 97.7% (842/862) (96.4%; 98.5%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 68.6% (95% CI: 57.7%; 77.4%) 99.8% (95% CI: 99.6%; 99.9%)
10.0% 82.2% (95% CI: 74.2%; 87.9%) 99.6% (95% CI: 99.1%; 99.8%)
15.0% 88.0% (95% CI: 82.1%; 92.0%) 99.3% (95% CI: 98.6%; 99.7%)
20.0% 91.2% (95% CI: 86.6%; 94.2%) 99.0% (95% CI: 98.0%; 99.5%)
25.0% 93.2% (95% CI: 89.6%; 95.6%) 98.7% (95% CI: 97.4%; 99.4%)
30.0% 94.7% (95% CI: 91.7%; 96.5%) 98.3% (95% CI: 96.7%; 99.2%)
35.0% 95.7% (95% CI: 93.3%; 97.2%) 97.9% (95% CI: 95.8%; 99.0%)
40.0% 96.5% (95% CI: 94.5%; 97.7%) 97.4% (95% CI: 94.9%; 98.7%)
45.0% 97.1% (95% CI: 95.5%; 98.2%) 96.9% (95% CI: 93.8%; 98.5%)
50.0% 97.6% (95% CI: 96.3%; 98.5%) 96.2% (95% CI: 92.5%; 98.1%)

Test Facts:


GenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit

Developer: GenScript USA Inc.
Test: cPass SARS-CoV-2 Neutralization Antibody Detection Kit
Technology: ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig (Neutralizing) Sensitivity (PPA) 100% (26/26) (87.1%; 100%)
Pan-Ig (Neutralizing) Specificity (NPA) 100% (88/88) (95.8%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 52.3%; 100%) 100% (95% CI: 99.3%; 100%)
10.0% 100% (95% CI: 69.8%; 100%) 100% (95% CI: 98.5%; 100%)
15.0% 100% (95% CI: 78.6%; 100%) 100% (95% CI: 97.7%; 100%)
20.0% 100% (95% CI: 83.9%; 100%) 100% (95% CI: 96.8%; 100%)
25.0% 100% (95% CI: 87.4%; 100%) 100% (95% CI: 95.7%; 100%)
30.0% 100% (95% CI: 89.9%; 100%) 100% (95% CI: 94.6%; 100%)
35.0% 100% (95% CI: 91.8%; 100%) 100% (95% CI: 93.3%; 100%)
40.0% 100% (95% CI: 93.3%; 100%) 100% (95% CI: 91.8%; 100%)
45.0% 100% (95% CI: 94.5%; 100%) 100% (95% CI: 90.1%; 100%)
50.0% 100% (95% CI: 95.4%; 100%) 100% (95% CI: 88.2%; 100%)

Test Facts:


Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette

Developer: Hangzhou Biotest Biotech
Test: RightSign COVID-19 IgG/IgM Rapid Test Cassette
Technology: Lateral Flow
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 100% (30/30) (88.7%; 100%)
IgM Specificity (NPA) 100% (80/80) (95.4%; 100%)
IgG Sensitivity (PPA) 93.3% (28/30) (78.7%; 98.2%)
IgG Specificity (NPA) 100% (80/80) (95.4%; 100%)
Combined Sensitivity (PPA) 100% (30/30) (88.7%; 100%)
Combined Specificity (NPA) 100% (80/80) (95.4%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 50.5%; 100%) 100% (95% CI: 99.4%; 100%)
10.0% 100% (95% CI: 68.3%; 100%) 100% (95% CI: 98.7%; 100%)
15.0% 100% (95% CI: 77.4%; 100%) 100% (95% CI: 97.9%; 100%)
20.0% 100% (95% CI: 82.9%; 100%) 100% (95% CI: 97.1%; 100%)
25.0% 100% (95% CI: 86.6%; 100%) 100% (95% CI: 96.2%; 100%)
30.0% 100% (95% CI: 89.2%; 100%) 100% (95% CI: 95.2%; 100%)
35.0% 100% (95% CI: 91.2%; 100%) 100% (95% CI: 94.0%; 100%)
40.0% 100% (95% CI: 92.8%; 100%) 100% (95% CI: 92.7%; 100%)
45.0% 100% (95% CI: 94.1%; 100%) 100% (95% CI: 91.1%; 100%)
50.0% 100% (95% CI: 95.1%; 100%) 100% (95% CI: 89.4%; 100%)

Test Facts:


Hangzhou Laihe Biotech LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)

Developer: Hangzhou Laihe Biotech
Test: LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
Technology: Lateral Flow
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 96.7% (29/30) (83.3%; 99.4%)
IgM Specificity 100% (80/80) (95.4%; 100%)
IgG Sensitivity 100% (30/30) (88.7%; 100%)
IgG Specificity 98.8% (79/80) (93.3%; 99.8%)
Combined Sensitivity 100% (30/30) (88.7%; 100%)
Combined Specificity 98.8% (79/80) (93.3%; 99.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 80.8% (95% CI: 40.9%; 96.0%) 100% (95% CI: 99.4%; 100%)
10.0% 89.9% (95% CI: 59.4%; 98.1%) 100% (95% CI: 98.7%; 100%)
15.0% 93.4% (95% CI: 69.9%; 98.8%) 100% (95% CI: 97.9%; 100%)
20.0% 95.2% (95% CI: 76.7%; 99.1%) 100% (95% CI: 97.0%; 100%)
25.0% 96.4% (95% CI: 81.4%; 99.3%) 100% (95% CI: 96.1%; 100%)
30.0% 97.2% (95% CI: 84.9%; 99.5%) 100% (95% CI: 95.0%; 100%)
35.0% 97.7% (95% CI: 87.6%; 99.6%) 100% (95% CI: 93.9%; 100%)
40.0% 98.2% (95% CI: 89.8%; 99.7%) 100% (95% CI: 92.5%; 100%)
45.0% 98.5% (95% CI: 91.5%; 99.7%) 100% (95% CI: 90.9%; 100%)
50.0% 98.8% (95% CI: 92.9%; 99.8%) 100% (95% CI: 89.2%; 100%)

Test Facts:


Healgen COVID-19 IgG/IgM Rapid Test Cassette

Developer: Healgen
Test: COVID-19 IgG/IgM Rapid Test Cassette
Technology: Lateral Flow
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 100% (30/30) (88.7%; 100%)
IgM Specificity (NPA) 100% (80/80) (95.4%; 100%)
IgG Sensitivity (PPA) 96.7% (29/30) (83.3%; 99.4%)
IgG Specificity (NPA) 97.5% (78/80) (91.3%; 99.3%)
Combined Sensitivity (PPA) 100% (30/30) (88.7%; 100%)
Combined Specificity (NPA) 97.5% (78/80) (91.3%; 99.3%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 67.8% (95% CI: 35.0%; 88.4%) 100% (95% CI: 99.4%; 100%)
10.0% 81.6% (95% CI: 53.2%; 94.2%) 100% (95% CI: 98.6%; 100%)
15.0% 87.6% (95% CI: 64.4%; 96.2%) 100% (95% CI: 97.9%; 100%)
20.0% 90.9% (95% CI: 71.9%; 97.3%) 100% (95% CI: 97.0%; 100%)
25.0% 93.0% (95% CI: 77.3%; 98.0%) 100% (95% CI: 96.0%; 100%)
30.0% 94.5% (95% CI: 81.4%; 98.4%) 100% (95% CI: 94.9%; 100%)
35.0% 95.6% (95% CI: 84.6%; 98.7%) 100% (95% CI: 93.7%; 100%)
40.0% 96.4% (95% CI: 87.2%; 99.0%) 100% (95% CI: 92.4%; 100%)
45.0% 97.0% (95% CI: 89.3%; 99.2%) 100% (95% CI: 90.8%; 100%)
50.0% 97.6% (95% CI: 91.1%; 99.3%) 100% (95% CI: 88.9%; 100%)

Test Facts:


Immunodiagnostic Systems IDS SARS-CoV-2 IgG

Developer: Immunodiagnostic Systems Ltd.
Test: IDS SARS-CoV-2 IgG
Technology: CLIA
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 97.6% (41/42) (87.7%; 99.6%)
IgG Specificity (NPA) 99.6% (552/554) (98.7%; 99.9%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 93.4% (95% CI: 77.9%; 98.1%) 99.9% (95% CI: 99.3%; 100%)
10.0% 96.8% (95% CI: 88.2%; 99.1%) 99.7% (95% CI: 98.6%; 100%)
15.0% 97.9% (95% CI: 92.2%; 99.4%) 99.6% (95% CI: 97.8%; 99.9%)
20.0% 98.5% (95% CI: 94.4%; 99.6%) 99.4% (95% CI: 97.0%; 99.9%)
25.0% 98.9% (95% CI: 95.7%; 99.7%) 99.2% (95% CI: 96.0%; 99.9%)
30.0% 99.1% (95% CI: 96.6%; 99.8%) 99.0% (95% CI: 94.9%; 99.8%)
35.0% 99.3% (95% CI: 97.3%; 99.8%) 98.7% (95% CI: 93.7%; 99.8%)
40.0% 99.4% (95% CI: 97.8%; 99.9%) 98.4% (95% CI: 92.3%; 99.7%)
45.0% 99.6% (95% CI: 98.2%; 99.9%) 98.1% (95% CI: 90.7%; 99.7%)
50.0% 99.6% (95% CI: 98.5%; 99.9%) 97.7% (95% CI: 88.9%; 99.6%)

Test Facts:


InBios SCoV-2 Detect IgG ELISA

Developer: InBios
Test: SCoV-2 Detect IgG ELISA
Technology: ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity 100% (30/30) (88.7%; 100%)
IgG Specificity 100% (80/80) (95.4%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 50.5%; 100%) 100% (95% CI: 99.4%; 100%)
10.0% 100% (95% CI: 68.3%; 100%) 100% (95% CI: 98.7%; 100%)
15.0% 100% (95% CI: 77.4%; 100%) 100% (95% CI: 97.9%; 100%)
20.0% 100% (95% CI: 82.9%; 100%) 100% (95% CI: 97.1%; 100%)
25.0% 100% (95% CI: 86.6%; 100%) 100% (95% CI: 96.2%; 100%)
30.0% 100% (95% CI: 89.2%; 100%) 100% (95% CI: 95.2%; 100%)
35.0% 100% (95% CI: 91.2%; 100%) 100% (95% CI: 94.0%; 100%)
40.0% 100% (95% CI: 92.8%; 100%) 100% (95% CI: 92.7%; 100%)
45.0% 100% (95% CI: 94.1%; 100%) 100% (95% CI: 91.1%; 100%)
50.0% 100% (95% CI: 95.1%; 100%) 100% (95% CI: 89.4%; 100%)

Test Facts:


InBios SCoV-2 Detect IgM ELISA

Developer: InBios International, Inc.
Test: SCoV-2 Detect IgM ELISA
Technology: ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 96.7% (29/30) (83.3%; 99.4%)
IgM Specificity 98.8% (79/80) (93.3%; 99.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 80.3% (95% CI: 39.4%; 96.0%) 99.8% (95% CI: 99.1%; 100%)
10.0% 89.6% (95% CI: 57.9%; 98.0%) 99.6% (95% CI: 98.1%; 99.9%)
15.0% 93.2% (95% CI: 68.6%; 98.8%) 99.4% (95% CI: 96.9%; 99.9%)
20.0% 95.1% (95% CI: 75.5%; 99.1%) 99.2% (95% CI: 95.7%; 99.9%)
25.0% 96.3% (95% CI: 80.5%; 99.3%) 98.9% (95% CI: 94.4%; 99.8%)
30.0% 97.1% (95% CI: 84.1%; 99.5%) 98.6% (95% CI: 92.9%; 99.7%)
35.0% 97.7% (95% CI: 86.9%; 99.6%) 98.2% (95% CI: 91.2%; 99.7%)
40.0% 98.1% (95% CI: 89.2%; 99.7%) 97.8% (95% CI: 89.4%; 99.6%)
45.0% 98.4% (95% CI: 91.0%; 99.7%) 97.3% (95% CI: 87.2%; 99.5%)
50.0% 98.7% (95% CI: 92.5%; 99.8%) 96.7% (95% CI: 84.8%; 99.4%)

Test Facts:


Innovita (Tangshan) Biological Technology Innovita 2019-nCoV Ab Test (Colloidal Gold)

Developer: Innovita (Tangshan) Biological Technology Co., Ltd.
Test: Innovita 2019-nCoV Ab Test (Colloidal Gold)
Technology: Lateral Flow
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 93.3% (28/30) (78.7%; 98.2%)
IgM Specificity 98.8% (79/80) (93.3%; 99.8%)
IgG Sensitivity 93.3% (28/30) (78.7%; 98.2%)
IgG Specificity 98.8% (79/80) (93.3%; 99.8%)
Combined Sensitivity 100% (30/30) (88.7%; 100%)
Combined Specificity 97.5% (78/80) (91.3%; 99.3%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 67.8% (95% CI: 35.0%; 88.4%) 100% (95% CI: 99.4%; 100%)
10.0% 81.6% (95% CI: 53.2%; 94.2%) 100% (95% CI: 98.6%; 100%)
15.0% 87.6% (95% CI: 64.4%; 96.2%) 100% (95% CI: 97.9%; 100%)
20.0% 90.9% (95% CI: 71.9%; 97.3%) 100% (95% CI: 97.0%; 100%)
25.0% 93.0% (95% CI: 77.3%; 98.0%) 100% (95% CI: 96.0%; 100%)
30.0% 94.5% (95% CI: 81.4%; 98.4%) 100% (95% CI: 94.9%; 100%)
35.0% 95.6% (95% CI: 84.6%; 98.7%) 100% (95% CI: 93.7%; 100%)
40.0% 96.4% (95% CI: 87.2%; 99.0%) 100% (95% CI: 92.4%; 100%)
45.0% 97.0% (95% CI: 89.3%; 99.2%) 100% (95% CI: 90.8%; 100%)
50.0% 97.6% (95% CI: 91.1%; 99.3%) 100% (95% CI: 88.9%; 100%)

Test Facts:


Inova Diagnostics, Inc. QUANTA Flash SARS-CoV-2 IgG

Developer: Inova Diagnostics, Inc.
Test: QUANTA Flash SARS-CoV-2 IgG
Technology: Semi-quantitative High Throughput CLIA
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (29/29) (88.3%; 100%)
IgG Specificity (NPA) 99.9% (1027/1028) (99.5%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 98.2% (95% CI: 89.4%; 99.7%) 100% (95% CI: 99.4%; 100%)
10.0% 99.1% (95% CI: 94.7%; 99.8%) 100% (95% CI: 98.7%; 100%)
15.0% 99.5% (95% CI: 96.6%; 99.9%) 100% (95% CI: 98.0%; 100%)
20.0% 99.6% (95% CI: 97.6%; 99.9%) 100% (95% CI: 97.1%; 100%)
25.0% 99.7% (95% CI: 98.2%; 99.9%) 100% (95% CI: 96.2%; 100%)
30.0% 99.8% (95% CI: 98.6%; 100%) 100% (95% CI: 95.2%; 100%)
35.0% 99.8% (95% CI: 98.9%; 100%) 100% (95% CI: 94.0%; 100%)
40.0% 99.9% (95% CI: 99.1%; 100%) 100% (95% CI: 92.7%; 100%)
45.0% 99.9% (95% CI: 99.2%; 100%) 100% (95% CI: 91.2%; 100%)
50.0% 99.9% (95% CI: 99.4%; 100%) 100% (95% CI: 89.5%; 100%)

Test Facts:


Jiangsu Well Biotech Orawell IgM/IgG Rapid Test

Developer: Jiangsu Well Biotech
Test: Orawell IgM/IgG Rapid Test
Technology: Lateral Flow
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 93.1% (54/58) (83.6%; 97.3%)
IgM Specificity 95.9% (93/97) (89.9%; 98.4%)
IgG Sensitivity 100% (58/58) (93.8%; 100%)
IgG Specificity 99.0% (96/97) (94.4%; 99.8%)
Combined Sensitivity 100% (58/58) (93.8%; 100%)
Combined Specificity 94.8% (92/97) (88.5%; 97.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 50.5% (95% CI: 30.0%; 70.3%) 100% (95% CI: 99.6%; 100%)
10.0% 68.3% (95% CI: 47.5%; 83.3%) 100% (95% CI: 99.2%; 100%)
15.0% 77.4% (95% CI: 59.0%; 88.8%) 100% (95% CI: 98.8%; 100%)
20.0% 82.9% (95% CI: 67.1%; 91.8%) 100% (95% CI: 98.3%; 100%)
25.0% 86.6% (95% CI: 73.1%; 93.8%) 100% (95% CI: 97.7%; 100%)
30.0% 89.3% (95% CI: 77.7%; 95.1%) 100% (95% CI: 97.1%; 100%)
35.0% 91.3% (95% CI: 81.4%; 96.0%) 100% (95% CI: 96.4%; 100%)
40.0% 92.8% (95% CI: 84.5%; 96.8%) 100% (95% CI: 95.5%; 100%)
45.0% 94.1% (95% CI: 87.0%; 97.4%) 100% (95% CI: 94.6%; 100%)
50.0% 95.1% (95% CI: 89.1%; 97.8%) 100% (95% CI: 93.4%; 100%)

Test Facts:


Kantaro Biosciences COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit

Developer: Kantaro Biosciences, LLC
Test: COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit
Technology: Semi-quantitative 2-Step ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 99.1% (233/235) (97.0%; 99.8%)
IgG Specificity (NPA) 99.6% (283/284) (98.0%; 99.9%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 93.7% (95% CI: 72.2%; 98.8%) 100% (95% CI: 99.8%; 100%)
10.0% 96.9% (95% CI: 84.6%; 99.4%) 99.9% (95% CI: 99.7%; 100%)
15.0% 98.0% (95% CI: 89.7%; 99.6%) 99.8% (95% CI: 99.5%; 100%)
20.0% 98.6% (95% CI: 92.5%; 99.8%) 99.8% (95% CI: 99.2%; 99.9%)
25.0% 98.9% (95% CI: 94.3%; 99.8%) 99.7% (95% CI: 99.0%; 99.9%)
30.0% 99.2% (95% CI: 95.5%; 99.9%) 99.6% (95% CI: 98.7%; 99.9%)
35.0% 99.3% (95% CI: 96.4%; 99.9%) 99.5% (95% CI: 98.4%; 99.9%)
40.0% 99.5% (95% CI: 97.0%; 99.9%) 99.4% (95% CI: 98.0%; 99.8%)
45.0% 99.6% (95% CI: 97.6%; 99.9%) 99.3% (95% CI: 97.5%; 99.8%)
50.0% 99.6% (95% CI: 98.0%; 99.9%) 99.2% (95% CI: 97.0%; 99.8%)

Test Facts:


Luminex xMAP SARS-CoV-2 Multi-Antigen IgG Assay

Developer: Luminex Corporation
Test: xMAP SARS-CoV-2 Multi-Antigen IgG Assay
Technology: High Throughput FMIA
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 96.3% (79/82) (89.8%; 98.7%)
IgG Specificity (NPA) 99.3% (599/603) (98.3%; 99.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 88.4% (95% CI: 73.6%; 95.3%) 99.8% (95% CI: 99.5%; 99.9%)
10.0% 94.2% (95% CI: 85.5%; 97.7%) 99.6% (95% CI: 98.9%; 99.9%)
15.0% 96.2% (95% CI: 90.3%; 98.5%) 99.4% (95% CI: 98.2%; 99.8%)
20.0% 97.3% (95% CI: 93.0%; 99.0%) 99.1% (95% CI: 97.5%; 99.7%)
25.0% 98.0% (95% CI: 94.6%; 99.2%) 98.8% (95% CI: 96.7%; 99.6%)
30.0% 98.4% (95% CI: 95.8%; 99.4%) 98.4% (95% CI: 95.7%; 99.5%)
35.0% 98.7% (95% CI: 96.6%; 99.5%) 98.1% (95% CI: 94.7%; 99.3%)
40.0% 99.0% (95% CI: 97.2%; 99.6%) 97.6% (95% CI: 93.5%; 99.2%)
45.0% 99.2% (95% CI: 97.7%; 99.7%) 97.1% (95% CI: 92.2%; 99.0%)
50.0% 99.3% (95% CI: 98.1%; 99.7%) 96.4% (95% CI: 90.6%; 98.8%)

Test Facts:


Megna Health Rapid COVID-19 IgM/IgG Combo Test Kit

Developer: Megna Health, Inc.
Test: Rapid COVID-19 IgM/IgG Combo Test Kit
Technology: Lateral Flow
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 83.3% (25/30) (66.4%; 92.7%)
IgM Specificity 97.5% (78/80) (91.3%; 99.3%)
IgG Sensitivity 100% (30/30) (88.7%; 100%)
IgG Specificity 97.5% (78/80) (91.3%; 99.3%)
Combined Sensitivity 100% (30/30) (88.7%; 100%)
Combined Specificity 95.0% (76/80) (87.8%; 98.0%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 51.3% (95% CI: 27.7%; 72.9%) 100% (95% CI: 99.3%; 100%)
10.0% 69.0% (95% CI: 44.7%; 85.0%) 100% (95% CI: 98.6%; 100%)
15.0% 77.9% (95% CI: 56.3%; 90.0%) 100% (95% CI: 97.8%; 100%)
20.0% 83.3% (95% CI: 64.6%; 92.7%) 100% (95% CI: 96.9%; 100%)
25.0% 87.0% (95% CI: 70.8%; 94.4%) 100% (95% CI: 95.9%; 100%)
30.0% 89.6% (95% CI: 75.8%; 95.6%) 100% (95% CI: 94.8%; 100%)
35.0% 91.5% (95% CI: 79.7%; 96.5%) 100% (95% CI: 93.5%; 100%)
40.0% 93.0% (95% CI: 82.9%; 97.1%) 100% (95% CI: 92.1%; 100%)
45.0% 94.2% (95% CI: 85.6%; 97.7%) 100% (95% CI: 90.4%; 100%)
50.0% 95.2% (95% CI: 87.9%; 98.1%) 100% (95% CI: 88.6%; 100%)

Test Facts:


Mount Sinai Hospital Clinical Laboratory COVID-19 ELISA Antibody Test

Developer: Mount Sinai Hospital Clinical Laboratory
Test: Mt. Sinai Laboratory COVID-19 ELISA Antibody Test
Technology: 2-Step ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Combined Sensitivity (PPA) 92.5% (37/40) (80.1%; 97.4%)
Combined Specificity (NPA) 100% (74/74) (95.1%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 46.1%; 100%) 99.6% (95% CI: 98.9%; 99.9%)
10.0% 100% (95% CI: 64.3%; 100%) 99.2% (95% CI: 97.7%; 99.7%)
15.0% 100% (95% CI: 74.1%; 100%) 98.7% (95% CI: 96.4%; 99.5%)
20.0% 100% (95% CI: 80.2%; 100%) 98.2% (95% CI: 95.0%; 99.4%)
25.0% 100% (95% CI: 84.4%; 100%) 97.6% (95% CI: 93.5%; 99.1%)
30.0% 100% (95% CI: 87.4%; 100%) 96.9% (95% CI: 91.8%; 98.9%)
35.0% 100% (95% CI: 89.7%; 100%) 96.1% (95% CI: 89.9%; 98.6%)
40.0% 100% (95% CI: 91.5%; 100%) 95.2% (95% CI: 87.8%; 98.3%)
45.0% 100% (95% CI: 93.0%; 100%) 94.2% (95% CI: 85.4%; 97.9%)
50.0% 100% (95% CI: 94.2%; 100%) 93.0% (95% CI: 82.7%; 97.5%)

Test Facts:


NanoEntek America FREND COVID-19 total Ab

Developer: NanoEntek America, Inc.
Test: FREND COVID-19 total Ab
Technology: FIA
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
(IgM / IgG) Sensitivity 96.7% (29/30) (83.3%; 99.4%)
(IgM / IgG) Specificity 98.8% (79/80) (93.3%; 99.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 80.3% (95% CI: 39.4%; 96.0%) 99.8% (95% CI: 99.1%; 100%)
10.0% 89.6% (95% CI: 57.9%; 98.0%) 99.6% (95% CI: 98.1%; 99.9%)
15.0% 93.2% (95% CI: 68.6%; 98.8%) 99.4% (95% CI: 96.9%; 99.9%)
20.0% 95.1% (95% CI: 75.5%; 99.1%) 99.2% (95% CI: 95.7%; 99.9%)
25.0% 96.3% (95% CI: 80.5%; 99.3%) 98.9% (95% CI: 94.4%; 99.8%)
30.0% 97.1% (95% CI: 84.1%; 99.5%) 98.6% (95% CI: 92.9%; 99.7%)
35.0% 97.7% (95% CI: 86.9%; 99.6%) 98.2% (95% CI: 91.2%; 99.7%)
40.0% 98.1% (95% CI: 89.2%; 99.7%) 97.8% (95% CI: 89.4%; 99.6%)
45.0% 98.4% (95% CI: 91.0%; 99.7%) 97.3% (95% CI: 87.2%; 99.5%)
50.0% 98.7% (95% CI: 92.5%; 99.8%) 96.7% (95% CI: 84.8%; 99.4%)

Test Facts:


Nirmidas Biotech MidaSpot COVID-19 Antibody Combo Detection Kit

Developer: Nirmidas Biotech, Inc.
Test: MidaSpot COVID-19 Antibody Combo Detection Kit
Technology: Lateral Flow
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 100% (30/30) (88.7%; 100%)
IgM Specificity 98.8% (79/80) (93.3%; 99.8%)
IgG Sensitivity 96.7% (29/30) (83.3%; 99.4%)
IgG Specificity 97.5% (78/80) (91.3%; 99.3%)
Combined Sensitivity 100% (30/30) (88.7%; 100%)
Combined Specificity 96.2% (77/80) (89.5%; 98.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 58.4% (95% CI: 30.9%; 80.4%) 100% (95% CI: 99.3%; 100%)
10.0% 74.8% (95% CI: 48.5%; 89.7%) 100% (95% CI: 98.6%; 100%)
15.0% 82.5% (95% CI: 59.9%; 93.2%) 100% (95% CI: 97.8%; 100%)
20.0% 87.0% (95% CI: 67.9%; 95.1%) 100% (95% CI: 96.9%; 100%)
25.0% 89.9% (95% CI: 73.9%; 96.3%) 100% (95% CI: 95.9%; 100%)
30.0% 92.0% (95% CI: 78.4%; 97.1%) 100% (95% CI: 94.8%; 100%)
35.0% 93.5% (95% CI: 82.0%; 97.7%) 100% (95% CI: 93.6%; 100%)
40.0% 94.7% (95% CI: 85.0%; 98.1%) 100% (95% CI: 92.2%; 100%)
45.0% 95.6% (95% CI: 87.4%; 98.5%) 100% (95% CI: 90.6%; 100%)
50.0% 96.4% (95% CI: 89.5%; 98.7%) 100% (95% CI: 88.8%; 100%)

Test Facts:


Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit

Developer: Nirmidas Biotech, Inc.
Test: Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
Technology: Lateral Flow
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 93.1% (54/58) (83.6%; 97.3%)
IgM Specificity 97.9% (95/97) (92.8%; 99.4%)
IgG Sensitivity 87.9% (51/58) (77.1%; 94.0%)
IgG Specificity 100% (97/97) (96.2%; 100%)
Combined Sensitivity 96.6% (56/58) (88.3%; 99.1%)
Combined Specificity 97.9% (95/97) (92.8%; 99.4%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 71.1% (95% CI: 39.2%; 90.2%) 99.8% (95% CI: 99.3%; 99.9%)
10.0% 83.9% (95% CI: 57.6%; 95.1%) 99.6% (95% CI: 98.6%; 99.9%)
15.0% 89.2% (95% CI: 68.4%; 96.9%) 99.4% (95% CI: 97.8%; 99.8%)
20.0% 92.1% (95% CI: 75.4%; 97.8%) 99.1% (95% CI: 96.9%; 99.8%)
25.0% 94.0% (95% CI: 80.3%; 98.3%) 98.8% (95% CI: 96.0%; 99.7%)
30.0% 95.3% (95% CI: 84.0%; 98.7%) 98.5% (95% CI: 94.9%; 99.6%)
35.0% 96.2% (95% CI: 86.8%; 98.9%) 98.1% (95% CI: 93.6%; 99.5%)
40.0% 96.9% (95% CI: 89.1%; 99.1%) 97.7% (95% CI: 92.2%; 99.4%)
45.0% 97.5% (95% CI: 90.9%; 99.3%) 97.2% (95% CI: 90.6%; 99.2%)
50.0% 97.9% (95% CI: 92.5%; 99.4%) 96.6% (95% CI: 88.8%; 99.1%)

Test Facts:


NOWDiagnostics, Inc. ADEXUSDx COVID-19 Test

Developer: NOWDiagnostics, Inc.
Test: ADEXUSDx COVID-19 Test
Technology: Lateral Flow
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity 93.3% (28/30) (78.7%; 98.2%)
Pan-Ig Specificity 100% (80/80) (95.4%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 47.5%; 100%) 99.7% (95% CI: 98.8%; 99.9%)
10.0% 100% (95% CI: 65.6%; 100%) 99.3% (95% CI: 97.6%; 99.8%)
15.0% 100% (95% CI: 75.2%; 100%) 98.8% (95% CI: 96.2%; 99.7%)
20.0% 100% (95% CI: 81.1%; 100%) 98.4% (95% CI: 94.7%; 99.5%)
25.0% 100% (95% CI: 85.1%; 100%) 97.8% (95% CI: 93.1%; 99.4%)
30.0% 100% (95% CI: 88.0%; 100%) 97.2% (95% CI: 91.3%; 99.2%)
35.0% 100% (95% CI: 90.2%; 100%) 96.5% (95% CI: 89.3%; 99.0%)
40.0% 100% (95% CI: 92.0%; 100%) 95.7% (95% CI: 87.0%; 98.8%)
45.0% 100% (95% CI: 93.4%; 100%) 94.8% (95% CI: 84.5%; 98.5%)
50.0% 100% (95% CI: 94.5%; 100%) 93.8% (95% CI: 81.7%; 98.2%)

Test Facts:


Ortho-Clinical Diagnostics VITROS Anti-SARS-CoV-2 IgG test

Developer: Ortho-Clinical Diagnostics, Inc.
Test: VITROS Anti-SARS-CoV-2 IgG test
Technology: High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 90.0% (36/40) (76.9%; 96.0%)
IgG Specificity (NPA) 100% (407/407) (99.1%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 81.2%; 100%) 99.5% (95% CI: 98.8%; 99.8%)
10.0% 100% (95% CI: 90.1%; 100%) 98.9% (95% CI: 97.5%; 99.6%)
15.0% 100% (95% CI: 93.6%; 100%) 98.3% (95% CI: 96.1%; 99.3%)
20.0% 100% (95% CI: 95.4%; 100%) 97.6% (95% CI: 94.5%; 99.0%)
25.0% 100% (95% CI: 96.5%; 100%) 96.8% (95% CI: 92.8%; 98.7%)
30.0% 100% (95% CI: 97.2%; 100%) 95.9% (95% CI: 90.9%; 98.3%)
35.0% 100% (95% CI: 97.8%; 100%) 94.9% (95% CI: 88.9%; 97.9%)
40.0% 100% (95% CI: 98.2%; 100%) 93.8% (95% CI: 86.6%; 97.4%)
45.0% 100% (95% CI: 98.5%; 100%) 92.4% (95% CI: 84.0%; 96.9%)
50.0% 100% (95% CI: 98.8%; 100%) 90.9% (95% CI: 81.1%; 96.2%)

Test Facts:


Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator

Developer: Ortho-Clinical Diagnostics, Inc.
Test: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator
Technology: High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 100% (49/49) (92.7%; 100%)
Pan-Ig Specificity (NPA) 100% (400/400) (99.0%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 83.7%; 100%) 100% (95% CI: 99.6%; 100%)
10.0% 100% (95% CI: 91.6%; 100%) 100% (95% CI: 99.2%; 100%)
15.0% 100% (95% CI: 94.5%; 100%) 100% (95% CI: 98.7%; 100%)
20.0% 100% (95% CI: 96.1%; 100%) 100% (95% CI: 98.2%; 100%)
25.0% 100% (95% CI: 97.0%; 100%) 100% (95% CI: 97.6%; 100%)
30.0% 100% (95% CI: 97.7%; 100%) 100% (95% CI: 97.0%; 100%)
35.0% 100% (95% CI: 98.1%; 100%) 100% (95% CI: 96.2%; 100%)
40.0% 100% (95% CI: 98.5%; 100%) 100% (95% CI: 95.3%; 100%)
45.0% 100% (95% CI: 98.8%; 100%) 100% (95% CI: 94.3%; 100%)
50.0% 100% (95% CI: 99.0%; 100%) 100% (95% CI: 93.2%; 100%)

Test Facts:


Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator

Developer: Ortho-Clinical Diagnostics, Inc.
Test: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator
Technology: Quantitative High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 91.9% (217/236) (87.8%; 94.8%)
IgG Specificity (NPA) 100% (533/533) (99.3%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 86.6%; 100%) 99.6% (95% CI: 99.4%; 99.7%)
10.0% 100% (95% CI: 93.2%; 100%) 99.1% (95% CI: 98.6%; 99.4%)
15.0% 100% (95% CI: 95.6%; 100%) 98.6% (95% CI: 97.9%; 99.1%)
20.0% 100% (95% CI: 96.8%; 100%) 98.0% (95% CI: 97.0%; 98.7%)
25.0% 100% (95% CI: 97.6%; 100%) 97.4% (95% CI: 96.1%; 98.3%)
30.0% 100% (95% CI: 98.1%; 100%) 96.7% (95% CI: 95.0%; 97.8%)
35.0% 100% (95% CI: 98.5%; 100%) 95.8% (95% CI: 93.8%; 97.3%)
40.0% 100% (95% CI: 98.8%; 100%) 94.9% (95% CI: 92.4%; 96.6%)
45.0% 100% (95% CI: 99.0%; 100%) 93.8% (95% CI: 90.8%; 95.9%)
50.0% 100% (95% CI: 99.2%; 100%) 92.5% (95% CI: 89.0%; 95.0%)

Test Facts:


Phadia AB EliA SARS-CoV-2-Sp1 IgG Test

Developer: Phadia AB
Test: EliA SARS-CoV-2-Sp1 IgG Test
Technology: Semi-quantitative Fluoroenzyme Immunoassay
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 97.6% (80/82) (91.5%; 99.3%)
IgG Specificity (NPA) 99.4% (338/340) (97.9%; 99.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 89.7% (95% CI: 69.5%; 97.0%) 99.9% (95% CI: 99.5%; 100%)
10.0% 94.9% (95% CI: 82.8%; 98.6%) 99.7% (95% CI: 99.0%; 99.9%)
15.0% 96.7% (95% CI: 88.4%; 99.1%) 99.6% (95% CI: 98.5%; 99.9%)
20.0% 97.6% (95% CI: 91.5%; 99.4%) 99.4% (95% CI: 97.9%; 99.8%)
25.0% 98.2% (95% CI: 93.5%; 99.5%) 99.2% (95% CI: 97.2%; 99.8%)
30.0% 98.6% (95% CI: 94.9%; 99.6%) 99.0% (95% CI: 96.4%; 99.7%)
35.0% 98.9% (95% CI: 95.9%; 99.7%) 98.7% (95% CI: 95.6%; 99.6%)
40.0% 99.1% (95% CI: 96.6%; 99.8%) 98.4% (95% CI: 94.6%; 99.6%)
45.0% 99.3% (95% CI: 97.2%; 99.8%) 98.0% (95% CI: 93.4%; 99.5%)
50.0% 99.4% (95% CI: 97.7%; 99.8%) 97.6% (95% CI: 92.0%; 99.3%)

Test Facts:


QIAGEN, GmbH QIAreach Anti-SARS-CoV-2 Total Test

Developer: QIAGEN, GmbH
Test: QIAreach Anti-SARS-CoV-2 Total Test
Technology: Lateral Flow, Digital
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity 100% (30/30) (88.7%; 100%)
Pan-Ig Specificity 97.5% (78/80) (91.3%; 99.3%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 67.8% (95% CI: 35.0%; 88.4%) 100% (95% CI: 99.4%; 100%)
10.0% 81.6% (95% CI: 53.2%; 94.2%) 100% (95% CI: 98.6%; 100%)
15.0% 87.6% (95% CI: 64.4%; 96.2%) 100% (95% CI: 97.9%; 100%)
20.0% 90.9% (95% CI: 71.9%; 97.3%) 100% (95% CI: 97.0%; 100%)
25.0% 93.0% (95% CI: 77.3%; 98.0%) 100% (95% CI: 96.0%; 100%)
30.0% 94.5% (95% CI: 81.4%; 98.4%) 100% (95% CI: 94.9%; 100%)
35.0% 95.6% (95% CI: 84.6%; 98.7%) 100% (95% CI: 93.7%; 100%)
40.0% 96.4% (95% CI: 87.2%; 99.0%) 100% (95% CI: 92.4%; 100%)
45.0% 97.0% (95% CI: 89.3%; 99.2%) 100% (95% CI: 90.8%; 100%)
50.0% 97.6% (95% CI: 91.1%; 99.3%) 100% (95% CI: 88.9%; 100%)

Test Facts:


Quansys Biosciences Q-Plex SARS-CoV-2 Human IgG (4 Plex)

Developer: Quansys Biosciences, Inc.
Test: Q-Plex SARS-CoV-2 Human IgG (4 Plex)
Technology: CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 95.5% (21/22) (78.2%; 99.2%)
IgG Specificity (NPA) 99.7% (583/585) (98.8%; 99.9%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 93.6% (95% CI: 76.9%; 98.2%) 99.8% (95% CI: 98.9%; 100%)
10.0% 96.9% (95% CI: 87.5%; 99.2%) 99.5% (95% CI: 97.6%; 99.9%)
15.0% 98.0% (95% CI: 91.8%; 99.5%) 99.2% (95% CI: 96.3%; 99.9%)
20.0% 98.6% (95% CI: 94.0%; 99.6%) 98.9% (95% CI: 94.8%; 99.8%)
25.0% 98.9% (95% CI: 95.5%; 99.7%) 98.5% (95% CI: 93.1%; 99.7%)
30.0% 99.2% (95% CI: 96.4%; 99.8%) 98.1% (95% CI: 91.4%; 99.7%)
35.0% 99.3% (95% CI: 97.1%; 99.8%) 97.6% (95% CI: 89.4%; 99.6%)
40.0% 99.5% (95% CI: 97.7%; 99.9%) 97.0% (95% CI: 87.2%; 99.5%)
45.0% 99.6% (95% CI: 98.1%; 99.9%) 96.4% (95% CI: 84.7%; 99.3%)
50.0% 99.6% (95% CI: 98.4%; 99.9%) 95.6% (95% CI: 81.9%; 99.2%)

Test Facts:


Quanterix Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test

Developer: Quanterix Corporation
Test: Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test
Technology: Semi-quantitative Paramagnetic Microbead-based Sandwich ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (28/28) (87.9%; 100%)
IgG Specificity (NPA) 99.2% (492/496) (97.9%; 99.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 86.7% (95% CI: 69.3%; 94.4%) 100% (95% CI: 99.4%; 100%)
10.0% 93.2% (95% CI: 82.6%; 97.3%) 100% (95% CI: 98.7%; 100%)
15.0% 95.6% (95% CI: 88.3%; 98.3%) 100% (95% CI: 97.9%; 100%)
20.0% 96.9% (95% CI: 91.5%; 98.8%) 100% (95% CI: 97.0%; 100%)
25.0% 97.6% (95% CI: 93.4%; 99.1%) 100% (95% CI: 96.1%; 100%)
30.0% 98.2% (95% CI: 94.8%; 99.3%) 100% (95% CI: 95.0%; 100%)
35.0% 98.5% (95% CI: 95.8%; 99.4%) 100% (95% CI: 93.8%; 100%)
40.0% 98.8% (95% CI: 96.6%; 99.5%) 100% (95% CI: 92.4%; 100%)
45.0% 99.0% (95% CI: 97.2%; 99.6%) 100% (95% CI: 90.8%; 100%)
50.0% 99.2% (95% CI: 97.7%; 99.7%) 100% (95% CI: 89.0%; 100%)

Test Facts:


Quotient Suisse MosaiQ COVID-19 Antibody Magazine

Developer: Quotient Suisse SA
Test: MosaiQ COVID-19 Antibody Magazine
Technology: Photometric Immunoassay
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 93.0% (80/86) (85.6%; 96.8%)
Pan-Ig Specificity (NPA) 99.8% (407/408) (98.6%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 95.2% (95% CI: 76.6%; 99.2%) 99.6% (95% CI: 99.2%; 99.8%)
10.0% 97.7% (95% CI: 87.4%; 99.6%) 99.2% (95% CI: 98.4%; 99.6%)
15.0% 98.5% (95% CI: 91.7%; 99.7%) 98.8% (95% CI: 97.5%; 99.4%)
20.0% 99.0% (95% CI: 94.0%; 99.8%) 98.3% (95% CI: 96.5%; 99.2%)
25.0% 99.2% (95% CI: 95.4%; 99.9%) 97.7% (95% CI: 95.4%; 98.9%)
30.0% 99.4% (95% CI: 96.4%; 99.9%) 97.1% (95% CI: 94.1%; 98.6%)
35.0% 99.5% (95% CI: 97.1%; 99.9%) 96.4% (95% CI: 92.7%; 98.3%)
40.0% 99.6% (95% CI: 97.6%; 99.9%) 95.5% (95% CI: 91.1%; 97.9%)
45.0% 99.7% (95% CI: 98.1%; 99.9%) 94.6% (95% CI: 89.3%; 97.4%)
50.0% 99.7% (95% CI: 98.4%; 100%) 93.5% (95% CI: 87.3%; 96.9%)

Test Facts:


Roche Elecsys Anti-SARS-CoV-2

Developer: Roche
Test: Elecsys Anti-SARS-CoV-2
Technology: High Throughput ECLIA
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 100% (29/29) (88.3%; 100%)
Pan-Ig Specificity (NPA) 99.8% (5262/5272) (99.7%; 99.9%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 96.5% (95% CI: 93.0%; 98.1%) 100% (95% CI: 99.4%; 100%)
10.0% 98.3% (95% CI: 96.6%; 99.1%) 100% (95% CI: 98.7%; 100%)
15.0% 98.9% (95% CI: 97.8%; 99.4%) 100% (95% CI: 98.0%; 100%)
20.0% 99.2% (95% CI: 98.4%; 99.6%) 100% (95% CI: 97.1%; 100%)
25.0% 99.4% (95% CI: 98.8%; 99.7%) 100% (95% CI: 96.2%; 100%)
30.0% 99.6% (95% CI: 99.1%; 99.8%) 100% (95% CI: 95.2%; 100%)
35.0% 99.6% (95% CI: 99.3%; 99.8%) 100% (95% CI: 94.1%; 100%)
40.0% 99.7% (95% CI: 99.4%; 99.8%) 100% (95% CI: 92.7%; 100%)
45.0% 99.8% (95% CI: 99.5%; 99.9%) 100% (95% CI: 91.2%; 100%)
50.0% 99.8% (95% CI: 99.6%; 99.9%) 100% (95% CI: 89.5%; 100%)

Test Facts:


Roche Elecsys Anti-SARS-CoV-2 S

Developer: Roche Diagnostics, Inc.
Test: Elecsys Anti-SARS-CoV-2 S
Technology: Semi-quantitative High Throughput ECLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 96.6% (225/233) (93.4%; 98.3%)
Pan-Ig Specificity (NPA) 100% (5990/5991) (99.9%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 99.7% (95% CI: 98.1%; 99.9%) 99.8% (95% CI: 99.7%; 99.9%)
10.0% 99.8% (95% CI: 99.1%; 100%) 99.6% (95% CI: 99.3%; 99.8%)
15.0% 99.9% (95% CI: 99.4%; 100%) 99.4% (95% CI: 98.8%; 99.7%)
20.0% 99.9% (95% CI: 99.6%; 100%) 99.1% (95% CI: 98.4%; 99.6%)
25.0% 99.9% (95% CI: 99.7%; 100%) 98.9% (95% CI: 97.8%; 99.4%)
30.0% 100% (95% CI: 99.8%; 100%) 98.5% (95% CI: 97.2%; 99.3%)
35.0% 100% (95% CI: 99.8%; 100%) 98.2% (95% CI: 96.6%; 99.1%)
40.0% 100% (95% CI: 99.8%; 100%) 97.8% (95% CI: 95.8%; 98.8%)
45.0% 100% (95% CI: 99.9%; 100%) 97.3% (95% CI: 94.9%; 98.6%)
50.0% 100% (95% CI: 99.9%; 100%) 96.7% (95% CI: 93.8%; 98.3%)

Test Facts:


Salofa Oy Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette

Developer: Salofa Oy
Test: Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette
Technology: Lateral Flow
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 90.0% (27/30) (74.4%; 96.5%)
IgM Specificity 100% (80/80) (95.4%; 100%)
IgG Sensitivity 93.3% (28/30) (78.7%; 98.2%)
IgG Specificity 98.8% (79/80) (93.3%; 99.8%)
Combined Sensitivity 93.3% (28/30) (78.7%; 98.2%)
Combined Specificity 98.8% (79/80) (93.3%; 99.8%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 79.7% (95% CI: 38.0%; 95.9%) 99.6% (95% CI: 98.8%; 99.9%)
10.0% 89.2% (95% CI: 56.4%; 98.0%) 99.3% (95% CI: 97.5%; 99.8%)
15.0% 92.9% (95% CI: 67.3%; 98.7%) 98.8% (95% CI: 96.1%; 99.7%)
20.0% 94.9% (95% CI: 74.5%; 99.1%) 98.3% (95% CI: 94.6%; 99.5%)
25.0% 96.1% (95% CI: 79.5%; 99.3%) 97.8% (95% CI: 92.9%; 99.4%)
30.0% 97.0% (95% CI: 83.3%; 99.5%) 97.2% (95% CI: 91.1%; 99.2%)
35.0% 97.6% (95% CI: 86.3%; 99.6%) 96.5% (95% CI: 89.0%; 99.0%)
40.0% 98.0% (95% CI: 88.6%; 99.7%) 95.7% (95% CI: 86.8%; 98.8%)
45.0% 98.4% (95% CI: 90.5%; 99.7%) 94.8% (95% CI: 84.2%; 98.5%)
50.0% 98.7% (95% CI: 92.1%; 99.8%) 93.7% (95% CI: 81.4%; 98.2%)

Test Facts:


Shenzhen New Industries Biomedical Engineering MAGLUMI 2019-nCoV IgM/IgG

Developer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Test: MAGLUMI 2019-nCoV IgM/IgG
Technology: CLIA
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 77.5% (110/142) (69.9%; 83.6%)
IgM Specificity (NPA) 99.6% (225/226) (97.5%; 99.9%)
IgG Sensitivity (PPA) 100% (142/142) (97.4%; 100%)
IgG Specificity (NPA) 99.1% (224/226) (96.8%; 99.8%)
Combined Sensitivity (PPA) 100% (142/142) (97.4%; 100%)
Combined Specificity (NPA) 98.7% (223/226) (96.2%; 99.5%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 79.9% (95% CI: 57.2%; 92.1%) 100% (95% CI: 99.9%; 100%)
10.0% 89.3% (95% CI: 73.9%; 96.1%) 100% (95% CI: 99.7%; 100%)
15.0% 93.0% (95% CI: 81.8%; 97.5%) 100% (95% CI: 99.5%; 100%)
20.0% 95.0% (95% CI: 86.4%; 98.2%) 100% (95% CI: 99.3%; 100%)
25.0% 96.2% (95% CI: 89.4%; 98.7%) 100% (95% CI: 99.1%; 100%)
30.0% 97.0% (95% CI: 91.6%; 99.0%) 100% (95% CI: 98.8%; 100%)
35.0% 97.6% (95% CI: 93.2%; 99.2%) 100% (95% CI: 98.5%; 100%)
40.0% 98.0% (95% CI: 94.4%; 99.3%) 100% (95% CI: 98.2%; 100%)
45.0% 98.4% (95% CI: 95.4%; 99.5%) 100% (95% CI: 97.8%; 100%)
50.0% 98.7% (95% CI: 96.2%; 99.5%) 100% (95% CI: 97.3%; 100%)

Test Facts:


Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 IgG (COV2G)

Developer: Siemens Healthcare Diagnostics Inc.
Test: ADVIA Centaur SARS-CoV-2 IgG (COV2G)
Technology: Semi-quantitative High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (42/42) (91.6%; 100%)
IgG Specificity (NPA) 99.9% (1829/1831) (99.6%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 98.0% (95% CI: 92.4%; 99.4%) 100% (95% CI: 99.6%; 100%)
10.0% 99.0% (95% CI: 96.2%; 99.7%) 100% (95% CI: 99.1%; 100%)
15.0% 99.4% (95% CI: 97.6%; 99.8%) 100% (95% CI: 98.5%; 100%)
20.0% 99.6% (95% CI: 98.3%; 99.9%) 100% (95% CI: 97.9%; 100%)
25.0% 99.7% (95% CI: 98.7%; 99.9%) 100% (95% CI: 97.3%; 100%)
30.0% 99.7% (95% CI: 99.0%; 99.9%) 100% (95% CI: 96.5%; 100%)
35.0% 99.8% (95% CI: 99.2%; 99.9%) 100% (95% CI: 95.7%; 100%)
40.0% 99.8% (95% CI: 99.4%; 100%) 100% (95% CI: 94.7%; 100%)
45.0% 99.9% (95% CI: 99.5%; 100%) 100% (95% CI: 93.6%; 100%)
50.0% 99.9% (95% CI: 99.6%; 100%) 100% (95% CI: 92.2%; 100%)

Test Facts:


Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 Total (COV2T)

Developer: Siemens Healthcare Diagnostics
Test: ADVIA Centaur SARS-CoV-2 Total (COV2T)
Technology: High Throughput CMIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 100% (47/47) (92.4%; 100%)
Pan-Ig Specificity (NPA) 99.8% (1586/1589) (99.4%; 99.9%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 96.5% (95% CI: 89.8%; 98.8%) 100% (95% CI: 99.6%; 100%)
10.0% 98.3% (95% CI: 94.9%; 99.4%) 100% (95% CI: 99.2%; 100%)
15.0% 98.9% (95% CI: 96.7%; 99.6%) 100% (95% CI: 98.7%; 100%)
20.0% 99.3% (95% CI: 97.7%; 99.7%) 100% (95% CI: 98.1%; 100%)
25.0% 99.4% (95% CI: 98.2%; 99.8%) 100% (95% CI: 97.5%; 100%)
30.0% 99.6% (95% CI: 98.6%; 99.9%) 100% (95% CI: 96.8%; 100%)
35.0% 99.7% (95% CI: 98.9%; 99.9%) 100% (95% CI: 96.1%; 100%)
40.0% 99.7% (95% CI: 99.1%; 99.9%) 100% (95% CI: 95.2%; 100%)
45.0% 99.8% (95% CI: 99.3%; 99.9%) 100% (95% CI: 94.1%; 100%)
50.0% 99.8% (95% CI: 99.4%; 99.9%) 100% (95% CI: 92.9%; 100%)

Test Facts:


Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 IgG (COV2G)

Developer: Siemens Healthcare Diagnostics Inc.
Test: Atellica IM SARS-CoV-2 IgG (COV2G)
Technology: Semi-quantitative High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (42/42) (91.6%; 100%)
IgG Specificity (NPA) 99.9% (1840/1841) (99.7%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 99.0% (95% CI: 94.0%; 99.8%) 100% (95% CI: 99.6%; 100%)
10.0% 99.5% (95% CI: 97.1%; 99.9%) 100% (95% CI: 99.1%; 100%)
15.0% 99.7% (95% CI: 98.1%; 99.9%) 100% (95% CI: 98.5%; 100%)
20.0% 99.8% (95% CI: 98.7%; 100%) 100% (95% CI: 97.9%; 100%)
25.0% 99.8% (95% CI: 99.0%; 100%) 100% (95% CI: 97.3%; 100%)
30.0% 99.9% (95% CI: 99.2%; 100%) 100% (95% CI: 96.5%; 100%)
35.0% 99.9% (95% CI: 99.4%; 100%) 100% (95% CI: 95.7%; 100%)
40.0% 99.9% (95% CI: 99.5%; 100%) 100% (95% CI: 94.7%; 100%)
45.0% 99.9% (95% CI: 99.6%; 100%) 100% (95% CI: 93.6%; 100%)
50.0% 99.9% (95% CI: 99.7%; 100%) 100% (95% CI: 92.2%; 100%)

Test Facts:


Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 Total (COV2T)

Developer: Siemens Healthcare Diagnostics
Test: Atellica IM SARS-CoV-2 Total (COV2T)
Technology: High Throughput CMIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 100% (42/42) (91.6%; 100%)
Pan-Ig Specificity (NPA) 99.8% (1089/1091) (99.3%; 99.9%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 96.6% (95% CI: 87.9%; 99.1%) 100% (95% CI: 99.6%; 100%)
10.0% 98.4% (95% CI: 93.9%; 99.5%) 100% (95% CI: 99.1%; 100%)
15.0% 99.0% (95% CI: 96.0%; 99.7%) 100% (95% CI: 98.5%; 100%)
20.0% 99.3% (95% CI: 97.2%; 99.8%) 100% (95% CI: 97.9%; 100%)
25.0% 99.5% (95% CI: 97.9%; 99.8%) 100% (95% CI: 97.3%; 100%)
30.0% 99.6% (95% CI: 98.3%; 99.9%) 100% (95% CI: 96.5%; 100%)
35.0% 99.7% (95% CI: 98.7%; 99.9%) 100% (95% CI: 95.7%; 100%)
40.0% 99.7% (95% CI: 98.9%; 99.9%) 100% (95% CI: 94.7%; 100%)
45.0% 99.8% (95% CI: 99.1%; 99.9%) 100% (95% CI: 93.5%; 100%)
50.0% 99.8% (95% CI: 99.3%; 99.9%) 100% (95% CI: 92.2%; 100%)

Test Facts:


Siemens Healthcare Diagnostics Dimension EXL SARS-CoV-2 IgG (CV2G)

Developer: Siemens Healthcare Diagnostics
Test: Dimension EXL SARS-CoV-2 IgG (CV2G)
Technology: Semi-quantitative High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (90/90) (95.9%; 100%)
IgG Specificity (NPA) 100% (1509/1509) (99.7%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 95.2%; 100%) 100% (95% CI: 99.8%; 100%)
10.0% 100% (95% CI: 97.7%; 100%) 100% (95% CI: 99.5%; 100%)
15.0% 100% (95% CI: 98.5%; 100%) 100% (95% CI: 99.3%; 100%)
20.0% 100% (95% CI: 99.0%; 100%) 100% (95% CI: 99.0%; 100%)
25.0% 100% (95% CI: 99.2%; 100%) 100% (95% CI: 98.7%; 100%)
30.0% 100% (95% CI: 99.4%; 100%) 100% (95% CI: 98.3%; 100%)
35.0% 100% (95% CI: 99.5%; 100%) 100% (95% CI: 97.8%; 100%)
40.0% 100% (95% CI: 99.6%; 100%) 100% (95% CI: 97.3%; 100%)
45.0% 100% (95% CI: 99.7%; 100%) 100% (95% CI: 96.8%; 100%)
50.0% 100% (95% CI: 99.7%; 100%) 100% (95% CI: 96.1%; 100%)

Test Facts:


Siemens Healthcare Diagnostics Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)

Developer: Siemens Healthcare Diagnostics
Test: Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)
Technology: High Throughput ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 100% (79/79) (95.4%; 100%)
Pan-Ig Specificity (NPA) 99.9% (1527/1529) (99.5%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 97.6% (95% CI: 91.3%; 99.3%) 100% (95% CI: 99.8%; 100%)
10.0% 98.8% (95% CI: 95.7%; 99.7%) 100% (95% CI: 99.5%; 100%)
15.0% 99.3% (95% CI: 97.3%; 99.8%) 100% (95% CI: 99.2%; 100%)
20.0% 99.5% (95% CI: 98.0%; 99.9%) 100% (95% CI: 98.8%; 100%)
25.0% 99.6% (95% CI: 98.5%; 99.9%) 100% (95% CI: 98.5%; 100%)
30.0% 99.7% (95% CI: 98.8%; 99.9%) 100% (95% CI: 98.0%; 100%)
35.0% 99.8% (95% CI: 99.1%; 99.9%) 100% (95% CI: 97.6%; 100%)
40.0% 99.8% (95% CI: 99.3%; 99.9%) 100% (95% CI: 97.0%; 100%)
45.0% 99.8% (95% CI: 99.4%; 100%) 100% (95% CI: 96.3%; 100%)
50.0% 99.9% (95% CI: 99.5%; 100%) 100% (95% CI: 95.5%; 100%)

Test Facts:


Siemens Healthcare Diagnostics Dimension Vista SARS-CoV-2 IgG (COV2G)

Developer: Siemens Healthcare Diagnostics
Test: Dimension Vista SARS-CoV-2 IgG (COV2G)
Technology: Semi-quantitative High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (90/90) (95.9%; 100%)
IgG Specificity (NPA) 100% (1509/1509) (99.7%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 95.2%; 100%) 100% (95% CI: 99.8%; 100%)
10.0% 100% (95% CI: 97.7%; 100%) 100% (95% CI: 99.5%; 100%)
15.0% 100% (95% CI: 98.5%; 100%) 100% (95% CI: 99.3%; 100%)
20.0% 100% (95% CI: 99.0%; 100%) 100% (95% CI: 99.0%; 100%)
25.0% 100% (95% CI: 99.2%; 100%) 100% (95% CI: 98.7%; 100%)
30.0% 100% (95% CI: 99.4%; 100%) 100% (95% CI: 98.3%; 100%)
35.0% 100% (95% CI: 99.5%; 100%) 100% (95% CI: 97.8%; 100%)
40.0% 100% (95% CI: 99.6%; 100%) 100% (95% CI: 97.3%; 100%)
45.0% 100% (95% CI: 99.7%; 100%) 100% (95% CI: 96.8%; 100%)
50.0% 100% (95% CI: 99.7%; 100%) 100% (95% CI: 96.1%; 100%)

Test Facts:


Siemens Healthcare Diagnostics Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)

Developer: Siemens Healthcare Diagnostics
Test: Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)
Technology: High Throughput ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 100% (79/79) (95.4%; 100%)
Pan-Ig Specificity (NPA) 99.8% (1526/1529) (99.4%; 99.9%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 96.4% (95% CI: 89.7%; 98.7%) 100% (95% CI: 99.8%; 100%)
10.0% 98.3% (95% CI: 94.9%; 99.4%) 100% (95% CI: 99.5%; 100%)
15.0% 98.9% (95% CI: 96.7%; 99.6%) 100% (95% CI: 99.2%; 100%)
20.0% 99.2% (95% CI: 97.6%; 99.7%) 100% (95% CI: 98.8%; 100%)
25.0% 99.4% (95% CI: 98.2%; 99.8%) 100% (95% CI: 98.5%; 100%)
30.0% 99.5% (95% CI: 98.6%; 99.8%) 100% (95% CI: 98.0%; 100%)
35.0% 99.6% (95% CI: 98.9%; 99.9%) 100% (95% CI: 97.6%; 100%)
40.0% 99.7% (95% CI: 99.1%; 99.9%) 100% (95% CI: 97.0%; 100%)
45.0% 99.8% (95% CI: 99.3%; 99.9%) 100% (95% CI: 96.3%; 100%)
50.0% 99.8% (95% CI: 99.4%; 99.9%) 100% (95% CI: 95.5%; 100%)

Test Facts:


Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 IgG (sCOVG)

Developer: Siemens Healthcare Diagnostics Inc.
Test: ADVIA Centaur SARS-CoV-2 IgG (sCOVG)
Technology: Semi-quantitative High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 95.6% (238/249) (92.3%; 97.5%)
IgG Specificity (NPA) 99.9% (1993/1995) (99.6%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 98.0% (95% CI: 93.0%; 99.5%) 99.8% (95% CI: 99.6%; 99.9%)
10.0% 99.1% (95% CI: 96.6%; 99.7%) 99.5% (95% CI: 99.1%; 99.7%)
15.0% 99.4% (95% CI: 97.8%; 99.8%) 99.2% (95% CI: 98.6%; 99.6%)
20.0% 99.6% (95% CI: 98.4%; 99.9%) 98.9% (95% CI: 98.1%; 99.4%)
25.0% 99.7% (95% CI: 98.8%; 99.9%) 98.5% (95% CI: 97.5%; 99.2%)
30.0% 99.8% (95% CI: 99.1%; 99.9%) 98.1% (95% CI: 96.8%; 98.9%)
35.0% 99.8% (95% CI: 99.3%; 99.9%) 97.7% (95% CI: 96.0%; 98.7%)
40.0% 99.8% (95% CI: 99.4%; 100%) 97.1% (95% CI: 95.1%; 98.4%)
45.0% 99.9% (95% CI: 99.5%; 100%) 96.5% (95% CI: 94.0%; 98.0%)
50.0% 99.9% (95% CI: 99.6%; 100%) 95.8% (95% CI: 92.8%; 97.6%)

Test Facts:


Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 IgG (sCOVG)

Developer: Siemens Healthcare Diagnostics Inc.
Test: Atellica IM SARS-CoV-2 IgG (sCOVG)
Technology: Semi-quantitative High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 95.6% (238/249) (92.3%; 97.5%)
IgG Specificity (NPA) 99.9% (1993/1995) (99.6%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 98.0% (95% CI: 93.0%; 99.5%) 99.8% (95% CI: 99.6%; 99.9%)
10.0% 99.1% (95% CI: 96.6%; 99.7%) 99.5% (95% CI: 99.1%; 99.7%)
15.0% 99.4% (95% CI: 97.8%; 99.8%) 99.2% (95% CI: 98.6%; 99.6%)
20.0% 99.6% (95% CI: 98.4%; 99.9%) 98.9% (95% CI: 98.1%; 99.4%)
25.0% 99.7% (95% CI: 98.8%; 99.9%) 98.5% (95% CI: 97.5%; 99.2%)
30.0% 99.8% (95% CI: 99.1%; 99.9%) 98.1% (95% CI: 96.8%; 98.9%)
35.0% 99.8% (95% CI: 99.3%; 99.9%) 97.7% (95% CI: 96.0%; 98.7%)
40.0% 99.8% (95% CI: 99.4%; 100%) 97.1% (95% CI: 95.1%; 98.4%)
45.0% 99.9% (95% CI: 99.5%; 100%) 96.5% (95% CI: 94.0%; 98.0%)
50.0% 99.9% (95% CI: 99.6%; 100%) 95.8% (95% CI: 92.8%; 97.6%)

Test Facts:


Sugentech SGTi-flex COVID-19 IgG

Developer: Sugentech, Inc.
Test: SGTi-flex COVID-19 IgG
Technology: Lateral Flow
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity 96.7% (29/30) (83.3%; 99.4%)
IgG Specificity 100% (80/80) (95.4%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 48.9%; 100%) 99.8% (95% CI: 99.1%; 100%)
10.0% 100% (95% CI: 66.9%; 100%) 99.6% (95% CI: 98.1%; 99.9%)
15.0% 100% (95% CI: 76.2%; 100%) 99.4% (95% CI: 97.0%; 99.9%)
20.0% 100% (95% CI: 82.0%; 100%) 99.2% (95% CI: 95.8%; 99.9%)
25.0% 100% (95% CI: 85.8%; 100%) 98.9% (95% CI: 94.5%; 99.8%)
30.0% 100% (95% CI: 88.6%; 100%) 98.6% (95% CI: 93.0%; 99.7%)
35.0% 100% (95% CI: 90.7%; 100%) 98.2% (95% CI: 91.4%; 99.7%)
40.0% 100% (95% CI: 92.4%; 100%) 97.8% (95% CI: 89.6%; 99.6%)
45.0% 100% (95% CI: 93.7%; 100%) 97.3% (95% CI: 87.5%; 99.5%)
50.0% 100% (95% CI: 94.8%; 100%) 96.8% (95% CI: 85.1%; 99.4%)

Test Facts:


Symbiotica, Inc. COVID-19 Self-Collected Antibody Test System

Developer: Symbiotica, Inc.
Test: COVID-19 Self-Collected Antibody Test System
Technology: ELISA (with home collection)
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (28/28) (87.9%; 100%)
IgG Specificity (NPA) 98.0% (50/51) (89.7%; 99.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 72.9% (95% CI: 31.0%; 93.8%) 100% (95% CI: 99.3%; 100%)
10.0% 85.0% (95% CI: 48.7%; 97.0%) 100% (95% CI: 98.5%; 100%)
15.0% 90.0% (95% CI: 60.1%; 98.1%) 100% (95% CI: 97.7%; 100%)
20.0% 92.7% (95% CI: 68.1%; 98.6%) 100% (95% CI: 96.7%; 100%)
25.0% 94.4% (95% CI: 74.0%; 99.0%) 100% (95% CI: 95.7%; 100%)
30.0% 95.6% (95% CI: 78.5%; 99.2%) 100% (95% CI: 94.6%; 100%)
35.0% 96.5% (95% CI: 82.1%; 99.4%) 100% (95% CI: 93.2%; 100%)
40.0% 97.1% (95% CI: 85.1%; 99.5%) 100% (95% CI: 91.8%; 100%)
45.0% 97.7% (95% CI: 87.5%; 99.6%) 100% (95% CI: 90.1%; 100%)
50.0% 98.1% (95% CI: 89.5%; 99.7%) 100% (95% CI: 88.1%; 100%)

Test Facts:


TBG Biotechnology TBG SARS-CoV-2 IgG / IgM Rapid Test Kit

Developer: TBG Biotechnology Corp.
Test: TBG SARS-CoV-2 IgG / IgM Rapid Test Kit
Technology: Lateral Flow
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 93.3% (28/30) (78.7%; 98.2%)
IgM Specificity 95.0% (76/80) (87.8%; 98.0%)
IgG Sensitivity 93.3% (28/30) (78.7%; 98.2%)
IgG Specificity 96.2% (77/80) (89.5%; 98.7%)
Combined Sensitivity 93.3% (28/30) (78.7%; 98.2%)
Combined Specificity 95.0% (76/80) (87.8%; 98.0%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 49.6% (95% CI: 25.4%; 72.5%) 99.6% (95% CI: 98.7%; 99.9%)
10.0% 67.5% (95% CI: 41.8%; 84.8%) 99.2% (95% CI: 97.4%; 99.8%)
15.0% 76.7% (95% CI: 53.3%; 89.8%) 98.8% (95% CI: 95.9%; 99.7%)
20.0% 82.4% (95% CI: 61.8%; 92.6%) 98.3% (95% CI: 94.3%; 99.5%)
25.0% 86.2% (95% CI: 68.3%; 94.3%) 97.7% (95% CI: 92.5%; 99.4%)
30.0% 88.9% (95% CI: 73.5%; 95.5%) 97.1% (95% CI: 90.6%; 99.2%)
35.0% 91.0% (95% CI: 77.7%; 96.4%) 96.4% (95% CI: 88.4%; 99.0%)
40.0% 92.6% (95% CI: 81.2%; 97.1%) 95.5% (95% CI: 86.1%; 98.8%)
45.0% 93.9% (95% CI: 84.1%; 97.6%) 94.6% (95% CI: 83.4%; 98.5%)
50.0% 94.9% (95% CI: 86.6%; 98.0%) 93.4% (95% CI: 80.5%; 98.2%)

Test Facts:


Thermo Fisher Scientific OmniPATH COVID-19 Total Antibody ELISA Test

Developer: Thermo Fisher Scientific
Test: OmniPATH COVID-19 Total Antibody ELISA Test
Technology: ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity 96.7% (29/30) (83.3%; 99.4%)
Pan-Ig Specificity 97.5% (78/80) (91.3%; 99.3%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 67.1% (95% CI: 33.6%; 88.4%) 99.8% (95% CI: 99.0%; 100%)
10.0% 81.1% (95% CI: 51.7%; 94.1%) 99.6% (95% CI: 98.0%; 99.9%)
15.0% 87.2% (95% CI: 62.9%; 96.2%) 99.4% (95% CI: 96.9%; 99.9%)
20.0% 90.6% (95% CI: 70.6%; 97.3%) 99.2% (95% CI: 95.6%; 99.9%)
25.0% 92.8% (95% CI: 76.2%; 98.0%) 98.9% (95% CI: 94.3%; 99.8%)
30.0% 94.3% (95% CI: 80.5%; 98.4%) 98.6% (95% CI: 92.7%; 99.7%)
35.0% 95.4% (95% CI: 83.8%; 98.7%) 98.2% (95% CI: 91.1%; 99.7%)
40.0% 96.3% (95% CI: 86.5%; 99.0%) 97.8% (95% CI: 89.2%; 99.6%)
45.0% 96.9% (95% CI: 88.7%; 99.2%) 97.3% (95% CI: 87.0%; 99.5%)
50.0% 97.5% (95% CI: 90.6%; 99.3%) 96.7% (95% CI: 84.6%; 99.4%)

Test Facts:


United Biomedical UBI SARS-CoV-2 ELISA

Developer: United Biomedical, Inc.
Test: UBI SARS-CoV-2 ELISA
Technology: ELISA
Target: Spike, Nucleocapsid, and Membrane

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity 89.7% (52/58) (79.2%; 95.2%)
IgG Specificity 100% (97/97) (96.2%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 52.3%; 100%) 99.5% (95% CI: 98.9%; 99.7%)
10.0% 100% (95% CI: 69.8%; 100%) 98.9% (95% CI: 97.7%; 99.5%)
15.0% 100% (95% CI: 78.6%; 100%) 98.2% (95% CI: 96.3%; 99.2%)
20.0% 100% (95% CI: 83.9%; 100%) 97.5% (95% CI: 94.9%; 98.8%)
25.0% 100% (95% CI: 87.4%; 100%) 96.7% (95% CI: 93.3%; 98.4%)
30.0% 100% (95% CI: 89.9%; 100%) 95.8% (95% CI: 91.5%; 98.0%)
35.0% 100% (95% CI: 91.8%; 100%) 94.7% (95% CI: 89.6%; 97.5%)
40.0% 100% (95% CI: 93.3%; 100%) 93.5% (95% CI: 87.4%; 96.9%)
45.0% 100% (95% CI: 94.4%; 100%) 92.2% (95% CI: 85.0%; 96.2%)
50.0% 100% (95% CI: 95.4%; 100%) 90.6% (95% CI: 82.2%; 95.4%)

Test Facts:


University of Arizona COVID-19 ELISA pan-Ig Antibody Test

Developer: University of Arizona Genetics Core for Clinical Services
Test: COVID-19 ELISA pan-Ig Antibody Test
Technology: 2-Step ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 97.5% (39/40) (87.1%; 99.6%)
Pan-Ig Specificity (NPA) 99.1% (317/320) (97.3%; 99.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 84.6% (95% CI: 62.8%; 94.3%) 99.9% (95% CI: 99.3%; 100%)
10.0% 92.0% (95% CI: 78.1%; 97.2%) 99.7% (95% CI: 98.6%; 100%)
15.0% 94.8% (95% CI: 85.0%; 98.2%) 99.6% (95% CI: 97.7%; 99.9%)
20.0% 96.3% (95% CI: 88.9%; 98.7%) 99.4% (95% CI: 96.8%; 99.9%)
25.0% 97.2% (95% CI: 91.4%; 99.0%) 99.2% (95% CI: 95.8%; 99.9%)
30.0% 97.8% (95% CI: 93.2%; 99.3%) 98.9% (95% CI: 94.6%; 99.8%)
35.0% 98.2% (95% CI: 94.5%; 99.4%) 98.7% (95% CI: 93.3%; 99.8%)
40.0% 98.6% (95% CI: 95.5%; 99.5%) 98.3% (95% CI: 91.9%; 99.7%)
45.0% 98.8% (95% CI: 96.3%; 99.6%) 98.0% (95% CI: 90.2%; 99.6%)
50.0% 99.0% (95% CI: 97.0%; 99.7%) 97.5% (95% CI: 88.3%; 99.6%)

Test Facts:


Vibrant America Clinical Labs Vibrant COVID-19 Ab Assay

Developer: Vibrant America Clinical Labs
Test: Vibrant COVID-19 Ab Assay
Technology: High Throughput CLIA
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Combined Sensitivity (PPA) 98.1% (52/53) (90.1%; 99.7%)
Combined Specificity (NPA) 98.6% (494/501) (97.1%; 99.3%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 78.7% (95% CI: 62.4%; 88.6%) 99.9% (95% CI: 99.5%; 100%)
10.0% 88.6% (95% CI: 77.8%; 94.2%) 99.8% (95% CI: 98.9%; 100%)
15.0% 92.5% (95% CI: 84.8%; 96.3%) 99.7% (95% CI: 98.2%; 99.9%)
20.0% 94.6% (95% CI: 88.7%; 97.3%) 99.5% (95% CI: 97.5%; 99.9%)
25.0% 95.9% (95% CI: 91.3%; 98.0%) 99.4% (95% CI: 96.7%; 99.9%)
30.0% 96.8% (95% CI: 93.1%; 98.4%) 99.2% (95% CI: 95.8%; 99.9%)
35.0% 97.4% (95% CI: 94.4%; 98.8%) 99.0% (95% CI: 94.8%; 99.8%)
40.0% 97.9% (95% CI: 95.5%; 99.0%) 98.7% (95% CI: 93.6%; 99.8%)
45.0% 98.3% (95% CI: 96.3%; 99.2%) 98.5% (95% CI: 92.3%; 99.7%)
50.0% 98.6% (95% CI: 96.9%; 99.3%) 98.1% (95% CI: 90.7%; 99.7%)

Test Facts:


Wadsworth New York SARS-CoV Microsphere Immunoassay for Antibody Detection

Developer: Wadsworth Center, New York State Department of Health
Test: New York SARS-CoV Microsphere Immunoassay for Antibody Detection
Technology: MIA
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 88.0% (95/108) (80.5%; 92.8%)
Pan-Ig Specificity (NPA) 98.8% (428/433) (97.3%; 99.5%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 80.0% (95% CI: 61.3%; 90.8%) 99.4% (95% CI: 99.0%; 99.6%)
10.0% 89.4% (95% CI: 77.0%; 95.4%) 98.7% (95% CI: 97.8%; 99.2%)
15.0% 93.1% (95% CI: 84.2%; 97.1%) 97.9% (95% CI: 96.6%; 98.7%)
20.0% 95.0% (95% CI: 88.3%; 97.9%) 97.0% (95% CI: 95.2%; 98.2%)
25.0% 96.2% (95% CI: 90.9%; 98.4%) 96.1% (95% CI: 93.7%; 97.7%)
30.0% 97.0% (95% CI: 92.8%; 98.8%) 95.0% (95% CI: 92.1%; 97.0%)
35.0% 97.6% (95% CI: 94.2%; 99.0%) 93.8% (95% CI: 90.3%; 96.3%)
40.0% 98.1% (95% CI: 95.3%; 99.2%) 92.5% (95% CI: 88.2%; 95.4%)
45.0% 98.4% (95% CI: 96.1%; 99.4%) 90.9% (95% CI: 85.9%; 94.4%)
50.0% 98.7% (95% CI: 96.8%; 99.5%) 89.1% (95% CI: 83.3%; 93.3%)

Test Facts:


Xiamen Biotime Biotechnology BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test

Developer: Xiamen Biotime Biotechnology Co., Ltd.
Test: BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test
Technology: Lateral Flow
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 100% (30/30) (88.7%; 100%)
IgM Specificity 98.8% (79/80) (93.3%; 99.8%)
IgG Sensitivity 96.7% (29/30) (83.3%; 99.4%)
IgG Specificity 97.5% (78/80) (91.3%; 99.3%)
Combined Sensitivity 100% (30/30) (88.7%; 100%)
Combined Specificity 96.2% (77/80) (89.5%; 98.7%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 58.4% (95% CI: 30.9%; 80.4%) 100% (95% CI: 99.3%; 100%)
10.0% 74.8% (95% CI: 48.5%; 89.7%) 100% (95% CI: 98.6%; 100%)
15.0% 82.5% (95% CI: 59.9%; 93.2%) 100% (95% CI: 97.8%; 100%)
20.0% 87.0% (95% CI: 67.9%; 95.1%) 100% (95% CI: 96.9%; 100%)
25.0% 89.9% (95% CI: 73.9%; 96.3%) 100% (95% CI: 95.9%; 100%)
30.0% 92.0% (95% CI: 78.4%; 97.1%) 100% (95% CI: 94.8%; 100%)
35.0% 93.5% (95% CI: 82.0%; 97.7%) 100% (95% CI: 93.6%; 100%)
40.0% 94.7% (95% CI: 85.0%; 98.1%) 100% (95% CI: 92.2%; 100%)
45.0% 95.6% (95% CI: 87.4%; 98.5%) 100% (95% CI: 90.6%; 100%)
50.0% 96.4% (95% CI: 89.5%; 98.7%) 100% (95% CI: 88.8%; 100%)

Test Facts:


ZEUS Scientific ZEUS ELISA SARS-CoV-2 IgG Test System

Developer: ZEUS Scientific, Inc.
Test: ZEUS ELISA SARS-CoV-2 IgG Test System
Technology: ELISA
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity 93.3% (28/30) (78.7%; 98.2%)
IgG Specificity 100% (70/70) (94.8%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 44.3%; 100%) 99.7% (95% CI: 98.8%; 99.9%)
10.0% 100% (95% CI: 62.7%; 100%) 99.3% (95% CI: 97.6%; 99.8%)
15.0% 100% (95% CI: 72.7%; 100%) 98.8% (95% CI: 96.2%; 99.7%)
20.0% 100% (95% CI: 79.1%; 100%) 98.4% (95% CI: 94.7%; 99.5%)
25.0% 100% (95% CI: 83.5%; 100%) 97.8% (95% CI: 93.0%; 99.4%)
30.0% 100% (95% CI: 86.6%; 100%) 97.2% (95% CI: 91.2%; 99.2%)
35.0% 100% (95% CI: 89.1%; 100%) 96.5% (95% CI: 89.2%; 99.0%)
40.0% 100% (95% CI: 91.0%; 100%) 95.7% (95% CI: 87.0%; 98.8%)
45.0% 100% (95% CI: 92.5%; 100%) 94.8% (95% CI: 84.5%; 98.5%)
50.0% 100% (95% CI: 93.8%; 100%) 93.8% (95% CI: 81.6%; 98.2%)

Test Facts:


ZEUS Scientific, Inc. ZEUS ELISA SARS-CoV-2 Total Antibody Test System

Developer: ZEUS Scientific, Inc.
Test: ZEUS ELISA SARS-CoV-2 Total Antibody Test System
Technology: ELISA
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity 93.3% (28/30) (78.7%; 98.2%)
Pan-Ig Specificity 100% (70/70) (94.8%; 100%)

 

Prevalence Assumption Estimate of PPV Estimate of NPV
5.0% 100% (95% CI: 44.3%; 100%) 99.7% (95% CI: 98.8%; 99.9%)
10.0% 100% (95% CI: 62.7%; 100%) 99.3% (95% CI: 97.6%; 99.8%)
15.0% 100% (95% CI: 72.7%; 100%) 98.8% (95% CI: 96.2%; 99.7%)
20.0% 100% (95% CI: 79.1%; 100%) 98.4% (95% CI: 94.7%; 99.5%)
25.0% 100% (95% CI: 83.5%; 100%) 97.8% (95% CI: 93.0%; 99.4%)
30.0% 100% (95% CI: 86.6%; 100%) 97.2% (95% CI: 91.2%; 99.2%)
35.0% 100% (95% CI: 89.1%; 100%) 96.5% (95% CI: 89.2%; 99.0%)
40.0% 100% (95% CI: 91.0%; 100%) 95.7% (95% CI: 87.0%; 98.8%)
45.0% 100% (95% CI: 92.5%; 100%) 94.8% (95% CI: 84.5%; 98.5%)
50.0% 100% (95% CI: 93.8%; 100%) 93.8% (95% CI: 81.6%; 98.2%)

Test Facts:


A note about the performance measures calculated:

In some cases, there may be minor differences between the numbers on this page and those in the instructions for use. Confidence intervals for sensitivity and specificity that appear on this page were calculated per a score method described in CLSI EP12-A2 (2008). See Recognized Consensus Standards. Confidence intervals for PPV and NPV were calculated using the values from the 95% confidence intervals for sensitivity and specificity.

 

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