Extensive Analysis Shows No Issues with Tests or Testing Sites
Vermont Business Magazine Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has completed its investigation regarding a report of discordant results (False Positives) at a testing location in Manchester, Vermont, and found no testing site- or product-related issues with the Sofia 2 instrument or the Sofia SARS Antigen FIA. Quidel also then disputed the VDH's PCR results. The VDH maintains that most of those Quidel positive results were false positives based on PCR testing. However, Quidel claims they are positive COVID-19 cases.
The Vermont Department of Health found subsequent to the Quidel antigen tests that only four of those 65 positive antigen results for COVID-19 then tested positive using the state's PCR test.
Quidel received the complaint in Vermont regarding false positive discrepant results among patients who were subsequently tested and found negative by PCR testing. Quidel said it takes every complaint submission seriously and promptly entered the complaint into its Quality Management System and worked with the testing site to identify a potential root cause.
VDH Commissioner Mark Levine responds to a question regarding the disputed results regarding the Quidel antigen tests from Manchester in July. ORCA Media video screen grab.
The Vermont Department of Health, based on the Quidel antigen tests from the Manchester Medical Center, disputed that an "outbreak" had occurred there in mid-July.
The initial reports from the Manchester Medical Center was that over 50 people had tested positive for COVID-19, which would have been one of the state's biggest spikes. However, when the VDH retested those same people by July 21 using the PCR test, only four of the 52 people had a positive result. The VDH then established a pop-up site in the Manchester region and 1,613 residents were tested which revealed only one additional positive result.
VDH Commissioner Mark Levine said at Governor Scott's press briefing Friday that they are working with the Centers for Disease Control to investigate the discrepancy. He said even after that there might not be a complete determination.
"We as the Health Department and the CDC are more focusing on the epidemiology and how to explain the discordance in what was going on in the region versus what the test results showed and the discordance between the PCR tests and the antigen tests." Levine said.
He said antigen testing can be useful and people should be confident in those tests. But as he has previously stated, positive antigen tests are not considered positive cases in Vermont if it is then confirmed by a PCR test. Many states, he said, use a similar system.
However, he said the state is sticking with the state PCR results that left a gap of nearly 50 positive cases. He said it was "inappropriate" that Quidel had stated that VDH had "inaccurate results" (false negatives) with its PCR testing.
Levine said the FDA determined that the machines and methods were not at fault. He reiterated that in Vermont and in every other state, the PCR test is the standard for determining a positive case.
He said only those Manchester cases that were confirmed by the VDH using the PCR follow up tests will continue to be considered positive cases in Vermont.
Quidel said it examined the complaint thoroughly, including an inspection of the testing site, analysis of the site’s data, and a review of approximately 110,000 data points generated at 526 sites in 33 other states currently using Quidel’s product. The investigation found that there were no issues with either the testing facility or with the quality of the Sofia products used. The results of the investigation determined that no further actions were necessary, and results were provided to the Vermont Department of Health, the Centers for Disease Control and Prevention, and the U.S. Food and Drug Administration.
“Quidel takes every complaint seriously and endeavors to identify the root cause of any complaint received,” said Douglas Bryant, president and CEO of Quidel Corporation. “We conducted a very thorough investigation for this unique complaint in Vermont and believe that it was highly likely that our Sofia® results were true positives and that the subsequent PCR method used to re-test was at risk of providing inaccurate results.”
Quidel currently sells the Sofia® SARS Antigen FIA in the United States under Emergency Use Authorization (EUA) by the FDA.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, COVID-19, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio and to explore exciting employment opportunities, visit quidel.com.
Source: SAN DIEGO--(BUSINESS WIRE)--Quidel Corporation 8.20.2020