Prior to COVID-19, most people did not spend much time thinking about blood tests.
Today, testing for the novel coronavirus has become the cornerstone for battling the disease and understanding who has an active infection or who was previously exposed.
To understand the latter and the prevalence of the disease, having access to antibody tests is important. Earlier on, regulatory bodies such as the Centers for Disease Control and Prevention (CDC) raised concerns about initial antibody tests on the market and their reliability.
Now there are several highly-reliable tests available, including Abbott’s.
"At Abbott, we have been developing highly reliable infectious disease tests since the development of the first HIV test," said Mary Rodgers, Ph.D., principal scientist at Abbott. "We've taken this same approach with our COVID-19 tests so that healthcare workers have access to reliable tests to conduct large-scale testing."
Determining a Test's Accuracy
To understand a test’s accuracy, scientist look at the following items:
- Sensitivity: The test’s ability to correctly identify those with the disease (limiting false negatives).
- Specificity: The test’s ability to correctly identify those without the disease (limiting false positives).
Abbott's antibody test – which looks at the IgG antibody – demonstrated both a sensitivity and specificity of greater than 99 percent 14 days or more after symptoms started. IgG antibodies may remain months to possibly years after a person has recovered. More research is needed on how long antibodies stay in the body.
It is also important for hospital labs to validate tests and confirm they are seeing the same results from the test manufacturers. The University of Washington School of Medicine was one of the first health systems to receive Abbott’s antibody tests to validate its performance.
A study, published in the Journal of Clinical Microbiology, found that the test had 99.9% specificity and 100% sensitivity for detecting the IgG antibodies in patients 17 days or more after symptoms began.
Today, hospitals and reference laboratories in all 50 states are implementing Abbott’s antibody testing. The data generated from these tests could help uncover new insights around the virus, including the prevalence in communities and cities across the U.S.
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The SARS-CoV-2 IgG assay has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of the IgG antibody against SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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.
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