Quidel closes Vermont investigation of Sofia test

By LabPulse.com staff writers

August 24, 2020 -- Quidel has completed its investigation of false-positive results for COVID-19 at a testing location in Vermont. The company said it found no testing site- or product-related issues with the Sofia 2 instrument or the Sofia severe acute respiratory syndrome (SARS) Antigen fluorescent immunoassay (FIA).

A few Vermont patients complained of false-positive results because they were subsequently tested and found negative for COVID-19 by polymerase chain reaction (PCR) testing. After inspecting the testing site, analyzing the Vermont site's data, and reviewing approximately 110,000 data points generated at 526 sites in 33 other states currently using Quidel's product, Quidel found no issues with either the testing facility or with the quality of the Sofia products used.

It is likely the Sofia results were true positives and the subsequent PCR method used to retest the patients provided inaccurate results, the firm said.

No further actions are deemed necessary and results were provided to the Vermont Department of Health, the U.S. Centers for Disease Control and Prevention, and the U.S. Food and Drug Administration.

COVID-19 spurs Q2 sales boom at Quidel
Quidel announced that revenue in its second quarter has skyrocketed due to sales of COVID-19 tests.
Quidel updates performance data for Sofia antigen test
Quidel has updated performance data for its Sofia immunoassay test to reflect further studies it conducted as part of its emergency use authorization...
Quidel builds point-of-care respiratory infection panel with BARDA cash
Quidel is developing a point-of-care diagnostic for respiratory infections using $635K in funding from the Biomedical Advanced Research and Development...
Quidel gets amended clearance for coronavirus antigen tests
Quidel has received an amended emergency use authorization from the U.S. Food and Drug Administration to run its rapid antigen diagnostic test for the...
Quidel nets EUA, CE Mark for Lyra Direct SARS-CoV-2 assay
Quidel has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) and the CE Mark for its Lyra Direct SARS-CoV-2...

Copyright © 2020 LabPulse.com

Last Updated ls 8/24/2020 8:16:08 PM

Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.
Subscribe Today
Do you want to be a Microbiology Insider?

When LabPulse gets hot new information, our Insiders are the first to find out. Stay current in today's competitive market by receiving our exclusive free email updates.

Yes, Keep Me Current