SARS-CoV-2 Semi-Quantitative Total Antibody, Spike

Serum or plasma

1.5 mL

0.7 mL (Note: This volume does not allow for repeat testing.)

Gel-barrier tube, red-top tube, or serum transfer tube, or plasma from lithium heparin tube, EDTA, or sodium citrate tube

Qualitative and semi-quantitative detection of antibodies to SARS-CoV-2 spike protein receptor binding domain (RBD). Aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The performance of this test has not been established in individuals that have received a COVID-19 vaccine. The clinical significance of a positive or negative antibody result following COVID-19 vaccination has not been established and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination.

This test should not be used to diagnose or exclude acute SARS-CoV-2 infection. The results should always be assessed in conjunction with patient's medical history, clinical presentation, and other findings. A negative test result does not rule out the possibility of an infection with SARS-CoV-2. Serum or plasma samples from the very early (pre-seroconversion) phase can yield negative findings. Therefore, this test cannot be used to diagnose an acute infection. It has also been reported that certain patients with confirmed infection do not develop SARS-CoV-2 antibodies. Furthermore, waning of antibody titers has been reported in some individuals within a range of months after infection, a feature which has also been reported for other coronaviruses.

This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is 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. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.

Electrochemiluminescence Immunoassay (ECLIA)

FDA-authorized Fact sheets for patients and providers canbe accessed at the following link: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd