COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2
This page is part of the FAQs on Testing for SARS-CoV-2 and provides answers to frequently asked questions related to uses for different types of COVID-19 tests and the settings in which they can be used.
Questions and answers regarding other policies described in the Policy for Coronavirus Disease-2019 Tests are found in other pages in this section.
A: Each Emergency Use Authorization (EUA) for a COVID-19 test includes the settings in which the test is authorized.
The settings authorized in the EUAs are also noted in the EUA tables on the In Vitro Diagnostics EUA page.
- Tests that are noted with an "H" in the Authorized Settings are limited to use in laboratories certified under CLIA that meet requirements to perform high-complexity tests.
- Tests that are noted with an "H" and "M" in the Authorized Settings may be performed in laboratories certified under CLIA to perform high complexity and/or moderate complexity tests.
- Tests that are noted with a "W" in the Authorized Settings are deemed to be CLIA-waived for use in patient care settings operating under a CLIA Certificate of Waiver.
- Tests noted with an "H," "M," and "W" may be used in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests and in patient care settings operating under a CLIA Certificate of Waiver.
In addition to COVID-19 tests issued EUAs, there are SARS-CoV-2 tests that have been authorized through traditional premarket review pathways. The setting in which each test is authorized is also included in the tables of COVID-19 tests granted traditional marketing authorizations.
Facilities Performing COVID-19 Testing
- Facilities, including point-of-care settings such as health clinics, that perform COVID-19 testing must be certified as a laboratory under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by the Centers for Medicare & Medicaid Services (CMS).
- Such laboratories may perform tests for which they meet the qualifications of the authorized settings included in the authorization. Laboratories authorized to use EUA-authorized tests are subject to various conditions that can be found in the EUA.
Point-of-Care Tests
Point-of-care (POC) settings include a variety of settings where testing can be performed near the patient, without transporting the sample for processing elsewhere, such as hospitals, physician offices, urgent care, outreach clinics, pharmacies, and temporary patient care settings that have appropriately trained personnel to perform the test. The term POC can generally be used to refer to near-patient testing with tests that are high, moderate, or waived complexity.
As discussed in the Guidance for Industry and Other Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities, when the FDA issues an EUA for a test, it can indicate whether the test can be performed at a POC setting or only in a laboratory able to handle more complex tests. The FDA must make certain determinations for tests to be deemed to be CLIA waived tests under an EUA, and, in the EUAs, a test authorized to be performed at a POC setting is generally deemed to be CLIA waived.
Generally, for the duration of the emergency declaration, such authorized tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Tests authorized for use at the point-of-care generally are not authorized for home specimen collection or at home testing unless otherwise specified.
Home Sample Collection
Several tests have been authorized to be performed in a laboratory, but for which the samples can be collected at home and sent to the laboratory. Such tests include "Home Collection" in the Attributes column in the authorization tables.
At-Home Tests
The FDA has also authorized COVID-19 tests that may be used at home, which is stated in the authorization. The Authorized Setting for such tests is noted as "Home" in the authorization tables. Tests authorized for home use can generally also be used for self-testing in settings outside of the home, such as offices or schools.
A: Diagnostic testing for COVID-19 looks for infections in individual people when there is a reason to suspect that a specific person may be infected. This includes testing people with signs or symptoms of infection and people without symptoms who have a recent known or suspected COVID-19 exposure.
Some examples of diagnostic testing include testing symptomatic individuals presenting to their healthcare provider, testing individuals who indicate that they were exposed to an individual with a confirmed or suspected case of COVID-19, and testing all individuals present at an event where an attendee was later confirmed to have COVID-19.
Screening testing for COVID-19 looks for infections in individual people even if there is no reason to suspect the specific person has an infection or known COVID-19 exposure. This includes broad screening of people without symptoms (asymptomatic) without known exposure to COVID-19 with the intent of making individual decisions based on the test results. The intent of screening tests is to identify infected people before they develop symptoms or who may never develop symptoms so that steps can be taken to prevent those people from infecting others.
Some examples of screening testing include testing by a workplace or school of all employees, students, and/or faculty returning to the workplace or school regardless of exposure or signs and symptoms, with the intent of using those results to determine who may return or what protective measures to take on an individual basis.
Surveillance testing for COVID-19 includes ongoing systematic activities, including collection, analysis, and interpretation of health-related data, essential to planning, implementing, and evaluating public health practice. Surveillance testing is primarily used to gain information for a population of people (population level data), rather than for an individual person and does not report test results to a patient or their health care provider. It is generally used to monitor for an occurrence, such as an infectious disease outbreak, in a population or community, or to characterize the occurrence once detected, such as looking at the incidence and prevalence of the occurrence. Surveillance testing may be random sampling of a certain percentage of a specific population to monitor for increasing or decreasing infection rates, or prevalence, and determining the population effect from community interventions such as social distancing.
An example of surveillance testing is a testing plan developed by a State Public Health Department to randomly select and sample 1% of all individuals in a city on a rolling basis to determine local infection rates and trends.
A: No, antibody testing should not be used to assess immunity to COVID-19.
See Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers for more information.