(Reuters) – The U.S. Meals and Drug Administration acknowledged on Tuesday it’s far alerting clinical laboratory staff and healthcare suppliers that inaccurate positive outcomes can occur with COVID-19 antigen checks.
The resolution used to be made following reports of inaccurate positive outcomes associated with the checks frail in nursing properties.
The U.S. company acknowledged inaccurate positive outcomes would possibly possibly maybe occur when customers accomplish not prepare the instructions for the exercise of antigen checks for immediate detection of SARS-CoV-2.
Antigen checks detect proteins on the skin of the virus. They require an unhappy nasal or throat swab, and can safe outcomes more snappy than molecular checks — which detect genetic discipline subject in the virus — but are regarded as less pretty.
Worldwide locations straining to comprise a 2d wave of COVID-19 are turning to sooner, more affordable but less pretty checks to support faraway from the delays and shortages which have confidence plagued efforts to diagnose and impress these contaminated snappy.
The FDA issued the first emergency exercise authorization (EUA) for a COVID-19 antigen take a look at in Might maybe.
The U.S. authorities has signed agreements with several corporations including Becton Dickinson BDX.N and Quidel Corp QDEL.O to safe antigen checks to U.S. nursing properties in an attempt to name outbreaks sooner and stem the tide of the virus.
In September, Becton Dickinson, which is supplying 750,000 of its SARS-CoV-2 antigen take a look at to the U.S. authorities, acknowledged it’s far investigating reports from U.S. nursing properties that its immediate coronavirus attempting out tools is producing inaccurate-positive outcomes.
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Cite this: By Reuters Personnel. US FDA Warns About Counterfeit Obvious Results From COVID-19 Antigen Assessments – Medscape – Nov 03, 2020.
