Source : Medtech Insight
One of the first COVID-19 tests to gain emergency use authorization (EUA) from the US Food and Drug Administration could be giving false-negative results if not used properly, the agency says.
The FDA issued on 4 January a safety communication for Curative Health Services Inc.’s SARS-CoV-2 molecular diagnostic test. The agency says if users don’t properly follow instructions for the real-time polymerase chain reaction (RT-PCR) test, patients may be misdiagnosed as not having the coronavirus.
“Risks to a patient of a false-negative result include delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events,” the FDA cautioned.
To mitigate the chances of getting false-negative results, regulators say it’s important for users to follow instructions in the “Fact Sheet for Healthcare Providers” that comes with the test. More specifically, the agency recommends nasal swab and oral fluid specimen collection for the test only be taken from people who have shown signs of the disease within the past 14 days.
Regulators also say the specimen collection must be observed or directed by a trained health care worker at the specimen collection site. Further, the test shouldn’t be the sole basis for ruling out that a patient has the coronavirus, and health care providers are encouraged to retest patients if they suspect the patients have the disease – even after a negative result.
Curative’s COVID-19 test was authorized by the FDA in April but had been in use by the City of Los Angeles since March. After receiving its authorization, the company bought KorvaLabs in May, which allowed the company to scale up its testing capabilities.
The FDA has green-lit EUAs to a slew of COVID-19 tests since the pandemic began and many of them since have raised serious concerns about false-negative results. The agency says it continues to regularly monitor the post-authorization use of such tests and will alert users to any serious problems that are detected. ()
By Ferdous Al-Faruque