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  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 when the body is responding to a specific infection, like COVID-19. In other words, the tests detect the body's immune response to the infection caused by the virus rather than detecting the virus itself. In the early days of an infection when the body's immune response is still building, antibodies may not be detected. This limits the test's effectiveness for diagnosing COVID-19, and this is one reason serology tests should not be used as the sole basis to diagnose COVID-19. Serology tests could play a role in the fight against COVID-19 by helping healthcare professionals identify individuals who may have developed an immune response to SARS-CoV-2. In addition, these test results can aid in determining who may donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19. 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 whether the presence of antibodies conveys a level of immunity that would prevent or reduce the severity of re-infection as well as the duration for which immunity lasts.

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 FDA is conducting in partnership with NIH, CDC, and 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.

We do not currently know the prevalence of SARS-CoV-2 antibody positive individuals in the U.S. population, and prevalence may change based on the duration the virus is in the country and the effectiveness of mitigations. Moreover, prevalence may vary widely between locations and between different groups of people, such as health care workers, due to different rates of infection. In low prevalence populations, which will be much of the asymptomatic general population, 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.

For this page, FDA has summarized the expected performance of the tests it has authorized based on the information FDA reviewed when deciding whether or not to grant these tests an Emergency Use Authorization and assuming a prevalence of 5% 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, FDA experts 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. FDA also is 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 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%)
IgG PPV at prevalence = 5% 84.0% (46.5%; 96.8%)
IgG NPV at prevalence = 5% 100% (99.4%; 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%)
IgG PPV at prevalence = 5% 93.4% (84.0%; 97.3%)
IgG NPV at prevalence = 5% 100% (99.8%; 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%)
IgM PPV at prevalence = 5% 92.0% (85.5%; 95.3%)
IgM NPV at prevalence = 5% 99.7% (99.1%; 99.9%)

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%)
IgM PPV at prevalence = 5% 91.9% (85.4%; 95.3%)
IgM NPV at prevalence = 5% 99.7% (99.1%; 99.9%)

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 (PPA) 89.1% (57/64) (79.1%; 94.6%)
IgM Specificity (NPA) 99.5% (181/182) (97.0%; 99.9%)
IgG Sensitivity (PPA) 96.9% (62/64) (89.3%; 99.1%)
IgG Specificity (NPA) 99.5% (181/182) (97.0%; 99.9%)
Combined Sensitivity (PPA) 98.4% (63/64) (91.7%; 99.7%)
Combined Specificity (NPA) 98.9% (180/182) (96.1%; 99.7%)
Combined PPV at prevalence = 5% 82.5% (55.2%; 94.6%)
Combined NPV at prevalence = 5% 99.9% (99.5%; 100%)

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%)
Combined PPV at prevalence = 5% 80.8% (40.9%; 96.0%)
Combined NPV at prevalence = 5% 100% (99.4%; 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%)
IgG PPV at prevalence = 5% 100% (55.7%; 100%)
IgG NPV at prevalence = 5% 100% (99.4%; 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%)
IgG PPV at prevalence = 5% 93.5% (85.2%; 97.2%)
IgG NPV at prevalence = 5% 99.8% (99.5%; 99.9%)

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%)
IgM PPV at prevalence = 5% 97.3% (90.4%; 99.3%)
IgM NPV at prevalence = 5% 99.8% (99.6%; 99.9%)

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%)
Pan-Ig PPV at prevalence = 5% 67.1% (33.6%; 88.4%)
Pan-Ig NPV at prevalence = 5% 99.8% (99.0%; 100%)

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%)
Pan-Ig PPV at prevalence = 5% 80.8% (40.9%; 96.0%)
Pan-Ig NPV at prevalence = 5% 100% (99.4%; 100%)

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%)
Pan-Ig PPV at prevalence = 5% 88.6% (73.5%; 95.3%)
Pan-Ig NPV at prevalence = 5% 99.9% (99.4%; 100%)

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%)
Combined PPV at prevalence = 5% 56.4% (28.1%; 79.9%)
Combined NPV at prevalence = 5% 99.6% (98.8%; 99.9%)

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%)
Combined PPV at prevalence = 5% 65.1% (41.8%; 82.8%)
Combined NPV at prevalence = 5% 100% (99.7%; 100%)

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%)
IgG PPV at prevalence = 5% 100% (65.7%; 100%)
IgG NPV at prevalence = 5% 100% (99.7%; 100%)

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%)
IgM PPV at prevalence = 5% 64.2% (40.4%; 82.5%)
IgM NPV at prevalence = 5% 99.8% (99.4%; 99.9%)

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 96.7% (29/30) (83.3%; 99.4%)
IgM Specificity 95.0% (76/80) (87.8%; 98.0%)
IgG Sensitivity 96.7% (29/30) (83.3%; 99.4%)
IgG Specificity 95.0% (76/80) (87.8%; 98.0%)
Combined Sensitivity 96.7% (29/30) (83.3%; 99.4%)
Combined Specificity 95.0% (76/80) (87.8%; 98.0%)
Combined PPV at prevalence = 5% 50.4% (26.5%; 72.7%)
Combined NPV at prevalence = 5% 99.8% (99.0%; 100%)

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%)
IgG PPV at prevalence = 5% 98.1% (89.1%; 99.7%)
IgG NPV at prevalence = 5% 100% (99.4%; 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%)
IgM PPV at prevalence = 5% 89.0% (65.9%; 96.7%)
IgM NPV at prevalence = 5% 100% (99.2%; 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%)
Combined PPV at prevalence = 5% 55.2% (39.2%; 70.0%)
Combined NPV at prevalence = 5% 99.7% (99.3%; 99.8%)

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 (PPA) 91.8% (112/122) (85.6%; 95.5%)
IgM Specificity (NPA) 99.3% (2455/2473) (98.9%; 99.5%)
IgM PPV at prevalence = 5% 86.9% (79.7%; 91.6%)
IgM NPV at prevalence = 5% 99.6% (99.2%; 99.8%)

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%)
IgG PPV at prevalence = 5% 87.5% (76.1%; 93.4%)
IgG NPV at prevalence = 5% 99.9% (99.3%; 100%)

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%)
IgG PPV at prevalence = 5% 67.1% (54.5%; 75.5%)
IgG NPV at prevalence = 5% 100% (99.4%; 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
IgG Sensitivity (PPA) 94.4% (102/108) (88.4%; 97.4%)
IgG Specificity (NPA) 98.3% (297/302) (96.2%; 99.3%)
IgG PPV at prevalence = 5% 75.0% (54.9%; 87.9%)
IgG NPV at prevalence = 5% 99.7% (99.4%; 99.9%)

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%)
IgG PPV at prevalence = 5% 59.3% (46.6%; 68.6%)
IgG NPV at prevalence = 5% 100% (99.4%; 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 90.0% (27/30) (74.4%; 96.5%)
IgG Specificity 100% (80/80) (95.4%; 100%)
IgG PPV at prevalence = 5% 100% (46.1%; 100%)
IgG NPV at prevalence = 5% 99.5% (98.6%; 99.8%)

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%)
Pan-Ig PPV at prevalence = 5% 68.6% (57.7%; 77.4%)
Pan-Ig NPV at prevalence = 5% 99.8% (99.6%; 99.9%)

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%)
Pan-Ig (Neutralizing) PPV at prevalence = 5% 100% (52.3%; 100%)
Pan-Ig (Neutralizing) NPV at prevalence = 5% 100% (99.3%; 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 100% (30/30) (88.7%; 100%)
IgM Specificity 100% (80/80) (95.4%; 100%)
IgG Sensitivity 93.3% (28/30) (78.7%; 98.2%)
IgG Specificity 100% (80/80) (95.4%; 100%)
Combined Sensitivity 100% (30/30) (88.7%; 100%)
Combined Specificity 100% (80/80) (95.4%; 100%)
Combined PPV at prevalence = 5% 100% (50.5%; 100%)
Combined NPV at prevalence = 5% 100% (99.4%; 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%)
Combined PPV at prevalence = 5% 80.8% (40.9%; 96.0%)
Combined NPV at prevalence = 5% 100% (99.4%; 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 100% (30/30) (88.7%; 100%)
IgM Specificity 100% (80/80) (95.4%; 100%)
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 97.5% (78/80) (91.3%; 99.3%)
Combined PPV at prevalence = 5% 67.8% (35.0%; 88.4%)
Combined NPV at prevalence = 5% 100% (99.4%; 100%)

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%)
IgG PPV at prevalence = 5% 100% (50.5%; 100%)
IgG NPV at prevalence = 5% 100% (99.4%; 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%)
IgM PPV at prevalence = 5% 80.3% (39.4%; 96.0%)
IgM NPV at prevalence = 5% 99.8% (99.1%; 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%)
Combined PPV at prevalence = 5% 50.5% (30.0%; 70.3%)
Combined NPV at prevalence = 5% 100% (99.6%; 100%)

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%)
IgG PPV at prevalence = 5% 88.4% (73.6%; 95.3%)
IgG NPV at prevalence = 5% 99.8% (99.5%; 99.9%)

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%)
Combined PPV at prevalence = 5% 51.3% (27.7%; 72.9%)
Combined NPV at prevalence = 5% 100% (99.3%; 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%)
Combined PPV at prevalence = 5% 100% (46.1%; 100%)
Combined NPV at prevalence = 5% 99.6% (98.9%; 99.9%)

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%)
(IgM / IgG) PPV at prevalence = 5% 80.3% (39.4%; 96.0%)
(IgM / IgG) NPV at prevalence = 5% 99.8% (99.1%; 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%)
Combined PPV at prevalence = 5% 71.1% (39.2%; 90.2%)
Combined NPV at prevalence = 5% 99.8% (99.3%; 99.9%)

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%)
IgG PPV at prevalence = 5% 100% (81.2%; 100%)
IgG NPV at prevalence = 5% 99.5% (98.8%; 99.8%)

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%)
Pan-Ig PPV at prevalence = 5% 100% (83.7.%; 100%)
Pan-Ig NPV at prevalence = 5% 100% (99.6%; 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%)
IgG PPV at prevalence = 5% 93.6% (76.9%; 98.2%)
IgG NPV at prevalence = 5% 99.8% (98.9%; 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%)
Pan-Ig PPV at prevalence = 5% 95.2% (76.6%; 99.2%)
Pan-Ig NPV at prevalence = 5% 99.6% (99.2%; 99.8%)

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%)
Pan-Ig PPV at prevalence = 5% 96.5% (93.0%; 98.1%)
Pan-Ig NPV at prevalence = 5% 100% (99.4%; 100%)

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%)
Combined PPV at prevalence = 5% 79.7% (38.0%; 95.9%)
Combined NPV at prevalence = 5% 99.6% (98.8%; 99.9%)

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%)
Combined PPV at prevalence = 5% 79.9% (57.2%; 92.1%)
Combined NPV at prevalence = 5% 100% (99.9%; 100%)

Test Facts:


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

Developer: Siemens Healthcare Diagnostics
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%; 99.9%)
IgG PPV at prevalence = 5% 98.0% (92.4%; 99.4%)
IgG NPV at prevalence = 5% 100% (99.6%; 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%)
Pan-Ig PPV at prevalence = 5% 96.5% (89.8%; 98.8%)
Pan-Ig NPV at prevalence = 5% 100% (99.6%; 100%)

Test Facts:


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

Developer: Siemens Healthcare Diagnostics
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%)
IgG PPV at prevalence = 5% 99.0% (94.0%; 99.8%)
IgG NPV at prevalence = 5% 100% (99.6%; 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%)
Pan-Ig PPV at prevalence = 5% 96.6% (87.9%; 99.1%)
Pan-Ig NPV at prevalence = 5% 100% (99.6%; 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%)
Pan-Ig PPV at prevalence = 5% 97.6% (91.3%; 99.3%)
Pan-Ig NPV at prevalence = 5% 100% (99.8%; 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%)
Pan-Ig PPV at prevalence = 5% 96.4% (89.7%; 98.7%)
Pan-Ig NPV at prevalence = 5% 100% (99.8%; 100%)

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%)
IgG PPV at prevalence = 5% 100% (48.9%; 100%)
IgG NPV at prevalence = 5% 99.8% (99.1%; 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%)
Combined PPV at prevalence = 5% 49.6% (25.4%; 72.5%)
Combined NPV at prevalence = 5% 99.6% (98.7%; 99.9%)

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%)
Pan-Ig PPV at prevalence = 5% 67.1% (33.6%; 88.4%)
Pan-Ig NPV at prevalence = 5% 99.8% (99.0%; 100%)

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%)
Pan-Ig PPV at prevalence = 5% 84.6% (62.8%; 94.3%)
Pan-Ig NPV at prevalence = 5% 99.9% (99.3%; 100%)

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%)
Combined PPV at prevalence = 5% 78.7% (62.4%; 88.6%)
Combined NPV at prevalence = 5% 99.9% (99.5%; 100.0%)

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%)
Pan-Ig PPV at prevalence = 5% 80.0% (61.3%; 90.8%)
Pan-Ig NPV at prevalence = 5% 99.4% (99.0%; 99.6%)

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%)
Combined PPV at prevalence = 5% 58.4% (30.9%; 80.4%)
Combined NPV at prevalence = 5% 100% (99.3%; 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

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 93.3% (28/30) (78.7%; 98.2%)
IgG Specificity (NPA) 100% (70/70) (94.8%; 100%)
IgG PPV at prevalence = 5% 100% (44.3%; 100%)
IgG NPV at prevalence = 5% 99.7% (98.8%; 99.9%)

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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