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(Reuters) – The U.S. Food and Drug Administration said Tuesday that it is alerting clinical laboratory personnel and healthcare providers that false positive results can occur with COVID-19 antigen tests.
The decision was made following reports of false positive results associated with tests used in nursing homes. [bit.ly/389ohyw]
The US agency said false positive results can occur when users do not follow the instructions for using antigen tests for rapid detection of SARS-CoV-2.
Antigen tests detect proteins on the surface of the virus. They require an uncomfortable nasal or pharyngeal swab and can produce results more quickly than molecular tests, which detect genetic material in the virus, but are considered less accurate.
Countries struggling to contain a second wave of COVID-19 are turning to faster, cheaper but less accurate tests to avoid the delays and shortages that have plagued efforts to diagnose and track those infected quickly.
The FDA issued the first Emergency Use Authorization (EUA) for a COVID-19 antigen test in May.
The United States government has signed agreements with several companies, including Becton Dickinson. BDX.N and Quidel Corp QDEL.O provide antigen testing to US nursing homes in an attempt to identify outbreaks more quickly and stem the tide of the virus.
In September, Becton Dickinson, who is supplying 750,000 of her SARS-CoV-2 antigen test to the US government, said she is investigating reports from American nursing homes that her rapid coronavirus test kit is producing results. false positives.
Report of Mrinalika Roy in Bengaluru; Edited by Maju Samuel
