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Researchers from the University of Washington said Abbott’s antibody test for the novel coronavirus (COVID-19) performed well in a recent independent study. The research was published in the Journal of Clinical Microbiology.
Researchers evaluated Abbott’s test in three distinct patient populations. In the study, researchers tested 1,020 serum specimens collected prior to SARS-CoV-2 circulation in the U.S. and found one false positive, indicating a specificity of 99.9%.
The researchers also looked at 125 patients who tested RT-PCR positive for SARS-CoV-2 for which 689 excess serum specimens were available and found sensitivity reached 100% at day 17 after symptom onset and day 13 after PCR positivity.”
These data demonstrate excellent analytical performance of the Abbott SARS-CoV-2 IgG test as well as the limited circulation of the virus in the western United States,” researchers wrote in the study’s abstract. “We expect the availability of high-quality serological testing will be a key tool in the fight against SARS-CoV-2.”
Abbott launched its lab-based serology test for the detection of the antibody IgG in Mid-April. The company, however, hasn’t secured a nod from FDA for the test.
"Health systems will play a critical role in large scale testing, and collaboration with leaders such as the University of Washington helps to ensure that our tests are performing at the highest standards when they are used in real-world settings," said Robert Ford, president and CEO, Abbott. "We want to do our part in providing hospitals and reference labs around the world with access to reliable antibody testing."
Serology or antibody tests have been popping up over the last few weeks and are the next chapter of the COVID-19 story. However, antibody tests have become a huge source of controversy and skepticism. Last week, FDA revised its earlier policy on COVID-19 antibody tests to cut down on false and inappropriate marketing claims that have cropped up around these diagnostics.
Even Roche’s CEO Severin Schwan weighed in on some of the tests. He questioned some of the ethics of the test makers and called some of the diagnostics a ‘disaster,’ according to a report from Reuters.