What is a COVID-19 Serological Antibody Test?

Nova Health, a comprehensive provider of quality urgent care, primary care, physical therapy, and musculoskeletal services in Oregon and Montana, offers COVID-19 serological antibody tests at all clinic locations.

Serological tests for SARS-CoV-2 are intended for those individuals who either have symptoms consistent with COVID-19 and had a negative molecular test, or those that were not tested when ill and now have recovered.  This test determines the presence of antibodies to SARS-CoV-2, the virus that causes COVID-19.

Below is a list of frequently asked questions regarding COVID-19 testing, the COVID-19 serological test in particular, the meaning of positive and negative results, and more.

 

Q. How can healthcare professionals confirm COVID-19 infection?

A. Confirmation of infection with SARS-CoV-2 must be made through a combination of clinical evaluation and other applicable tests.

 
Q. What does a COVID-19 positive serologic test result mean?

A. A positive serologic result indicates that an individual has likely produced an immune response to the SARS-CoV-2 virus.

 
Q. What does a COVID-19 negative serologic test result mean?

A. A negative serologic result suggests that an individual has not developed detectable antibodies at the time of testing. While contingent on a variety of factors, a negative result could be due to testing too early in the course of infection, the absence of exposure to the virus, or the lack of an adequate immune response, which may be due to conditions or treatments that suppress immune function.

 
Q. What should a patient do who tests positive for COVID-19?

A. Decisions about ongoing monitoring, treatment, or return to normal activities for patients being treated for suspected infection with SARS-CoV-2 should be made following guidance from a healthcare provider or public health authorities. Social distancing and disease prevention precautions such as wearing face masks and frequent handwashing still applies.

 
Q. Is COVID-19 serologic testing FDA approved?

A. Serum assays have not been FDA cleared or approved. The FDA released guidance on the diagnostic use of serum assays titled, “Policy for Diagnostic Tests for Coronavirus Disease 2019 during the Public Health Emergency – Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers and Food and Drug Administrative Staff.” The serum assay is an Abbott certified test performed at LabCorp high complexity lab.

The guidance states that the FDA authorizes the use of the serum assay test device:

  • Under an Emergency Use Authorization (EUA) for use by authorized laboratories
  • For the detection of SARS-CoV-2 antibodies (e.g., total, IgG, IgA, and IgM), and not for any other viruses or pathogens
  • For the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1).

Recommended Posts