Researchers Say Abbott ’s Antibody Test Demonstrated High Performance in Study

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 o...
Source: MDDI - Category: Medical Devices Authors: Tags: COVID-19 IVD Source Type: news