(Reuters) – The US Food and Drug Administration on Tuesday said it was warning clinical lab workers and healthcare providers that false positives do may occur with the COVID-19 antigen assays.
The decision comes after reports of false-positive results in relation to tests used in nursing homes. [bit.ly/389ohyw]
The US agency said false positives could occur when users do not follow instructions for using the antigen test for rapid detection of SARS-CoV-2.
The antigen test detects proteins on the surface of the virus. They require an unpleasant nasal or throat swab and can give results faster than molecular tests ̵1; detecting genetic material in the virus – but are considered to be less accurate.
Countries trying to stop the second wave of COVID-19 are turning to faster, cheaper but less accurate tests to avoid delays and deficiencies that have hampered rapid diagnostic and tracing efforts. infected people.
The FDA issued the first emergency use license (EUA) for the COVID-19 antigen test in May.
The US government has signed agreements with a number of companies including Becton Dickinson BDX.N and Quidel Corp QDEL.O provides antigen tests to nursing homes in the United States to try to identify outbreaks more quickly and stop the wave of the virus.
In September, Becton Dickinson, which is supplying 750,000 SARS-CoV-2 antigen tests to the US government, said it is investigating reports from US nursing homes that coronavirus test equipment. They are giving false positives.
Report by Mrinalika Roy in Bengaluru; Edited by Maju Samuel