SARS-CoV-2 Serology Testing Ramping Up to Address Next Stages of Pandemic

A number of academic and commercial labs are ramping up the development of serology tests for SARS-CoV-2, which could help manage the pandemic as it moves past its initial phases.

Serology tests look for the presence of host antibodies against disease, which can indicate whether a person has been exposed to an infectious agent and potentially whether they have developed a measure of immunity against it.

In the case of SARS-CoV-2, such tests could help identify people who have had the virus and recovered from it, allowing them to safely return to work. Additionally, they could provide researchers with information on the spread and scope of infections. While much of the initial effort around testing has focused on scaling PCR-based testing for the virus, serology tests will likely play a larger role in managing the virus in coming months.

Presumably anticipating the need for these tests, the US Food and Drug Administration announced on March 16, 2020 that it would be substantially loosening its regulations for SARS-CoV-2 serology tests, noting that it “does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2,” provided that test makers have validated their assay, notified the FDA of the assay, and include with the assay notice that the test has not been reviewed by the FDA, that false negatives and false positives are possible, and that the results should not be used alone to determine infection status.

Source: https://www.360dx.com/infectious-disease/sars-cov-2-serology-testing-ramping-address-next-stages-pandemic