COVID-19

Important information about COVID-19 antibody testing

The test is designed to detect antibodies to SARS-CoV-2, the virus that causes COVID-19. Antibodies are proteins that the body produces in response to infections. The antibodies can be produced even if a person has few or no symptoms during the infection.

It generally takes some time after infection for antibodies to be produced and become detectable in blood (sometimes up to 3 weeks). We do not know yet how good this test is at detecting antibodies in persons that have received the SARS-CoV-2 vaccine. Antibodies are generally detectable in the blood for a period of time after a person has recovered from the infection and after the virus that caused the infection is no longer detectable by laboratory methods.

Sometimes the antibodies developed in response to an infection protect us from getting that same infection again. But, it is important to know that we do not yet know whether this is true for COVID-19. Even if you have recovered and have antibodies, there is a chance that you still have the virus and you can infect others, it is still critical to keep taking measures to avoid getting infected again and/or spreading infection.

The antibody test is not meant for detecting an active infection. The swab test (sometimes also known as a molecular, RNA or PCR test) should be used to test for active infection.

A negative antibody test result means that antibodies were not detected in your blood sample. This can have several possible meanings. It could mean that:

• You have not been infected with SARS-CoV-2, or
• You have been infected with SARS-CoV-2, but your antibodies have not reached a sufficient level for the test to be able to detect them, or
• You have been infected with SARS-CoV-2, but there has not been enough time for antibodies to develop (it can take up to one to three weeks to develop antibodies after someone is infected, sometimes longer).
• We do not yet know what a negative test result means for people that have been vaccinated with the SARS-CoV-2 vaccine.

A positive antibody test result means that antibodies were detected in your blood sample. This can have a couple of possible meanings. It could mean that:

• You have been infected with SARS-CoV-2 at some point in the past, or
• You were vaccinated with the SARS-CoV-2 vaccine (but we do not yet know if you are protected from infection or how long that protection if there is any may last), or
• Uncommonly, you may have developed antibodies from an earlier infection with a different virus related to SARS-CoV-2 and the laboratory test cannot distinguish between these other virus antibodies and those antibodies generated in response to SARS-CoV-2.

COVID-19 testing statements

• This test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2 (COVID-19), indicating recent or prior infection.
• The antibody tests have not been FDA cleared or approved;
• The antibody tests have been authorized by FDA under an EUA for use by authorized laboratories;
• The antibody tests have been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and,
• The antibody tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• The cobas SARS-CoV-2 & Influenza A/B Test and the Quest SARS-CoV-2 RT-PCR test and other molecular tests (“Tests”) have not been FDA cleared or approved.
• The tests have been authorized by the FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform moderate and high complexity tests. The Roche test has been authorized only for the detection of RNA from SARS-CoV-2 virus, Influenza A virus, and Influenza B virus and not any other viruses or pathogens.
• The Roche test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and differentiation of SARS-CoV-2 virus, Influenza A, and Influenza B under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.
• The Quest test and other molecular tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
• The Quest test and other molecular tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• Health Plans should be aware that currently available vaccines in the US target the spike protein and, based upon timing of vaccination, could provide a positive result with this test.
• The CDC has not issued guidelines about the use of serology testing related to vaccination. Antibody response related to COVID-19 vaccines have not been studied in vaccine recipients.