Accuracy of business antibody kits for SARS-CoV-2 varies extensively: examine

Colored scanning electron microscope image of a cell (blue) that is heavily infected with SARS-CoV-2 virus particles (red) and isolated from a patient sample. The image was taken at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Image Credit: NIAID

According to a study published September 24 in the open access journal PLOS Pathogens by Jonathan Edgeworth and Blair Merrick of, there are big differences in the performance of commercial kits for detecting antibodies to Coronavirus 2 with Severe Acute Respiratory Syndrome (SARS-CoV-2) The NHS Foundation Trust of Guy and St. Thomas, Suzanne Pickering and Katie Doores of King’s College London and colleagues. As noted by the authors, rigorous comparison of antibody testing platforms will influence the use of point-of-care technologies in healthcare and their use in monitoring SARS-CoV-2 infections.

Ear and nose swab tests for SARS-CoV-2 will determine if someone is infected with the virus that causes coronavirus disease 2019 (COVID-19). These tests are highly sensitive – they can detect very low viral RNA levels – and are ideal for the early detection of the virus. How these tests are performed will depend on the time the sample is taken, with viral loads decreasing after the first week of symptoms. In contrast, antibody tests can determine if someone has had the virus in the past. For later diagnosis of illness or delayed-onset syndromes, antibody tests could be an important part of the diagnostic capabilities of hospitals. In the new study, researchers developed their own sensitive and specific antibody test and used it to perform unbiased head-to-head comparisons of ten commercial antibody test kits on an identical panel of 110 SARS-CoV-2 positive blood samples from patients who had COVID-19 and 50 prepandemic negatives were admitted to hospitals.

Among the tests there was a wide range of benefits with specificity – the test’s ability to correctly identify those without disease (true negative rate) – ranging from 82% to 100%, and overall sensitivity – the ability of a test to identify those with the Disease correct (true positive rate) – between 60.9% and 87.3%. However, all of them showed the best results when used 20 days or more after the onset of symptoms, with most tests reaching a sensitivity value greater than 95%. In addition, antibody levels were higher in people with severe illness than in people with asymptomatic or mild illness. When all commercial tests were compared, the lateral flow immunoassays known as Accu-Tell, SureScreen, and Spring showed the highest sensitivity at earlier time points while specificities maintained 98% or greater. Such lateral flow immunoassays are affordable, quick, and easy to use, and if used appropriately, could have significant health benefits.

Co-author Jonathan Edgeworth notes, “We have found that some of the Fast Disposable Kits (LFIAs) are as accurate as our advanced laboratory technologies. Based on these findings, we control LFIAs in the hospital to give doctors a quick and reliable response a range of clinical settings. ”

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More information:
Pickering S., Betancor G., Galão RP, Merrick B., Signell AW, Wilson HD, et al. (2020) Comparative Assessment of Multiple COVID-19 Serological Technologies Supports On-Site Assessment of Lateral Flow Assays in Healthcare Centers in Hospitals and Communities. PLoS Pathog 16 (9): e1008817. Provided by the Public Library of Science

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