Health
COVID-19 antigen testing is rapid but can lead to false positives
The US Food and Drug Administration has warned laboratory staff and healthcare providers that antigen testing for the virus that causes COVID-19 can give false positive results.
In a letter to stakeholders, the FDA said Tuesday that antigen testing could be used for rapid detection of SARS-CoV-2, but could result in false-positive results, especially if the user does not follow the instructions. Said.
“The FDA is aware of reports of false positive results related to antigen testing used in nursing homes and other environments, and will continue to monitor and monitor these reports and other available information regarding device safety and performance. I’m evaluating it, “said the letter.
Infectious disease experts in the Boston area said that antigen testing, if used properly, is suitable for large-scale screening, but needs to be followed up with more accurate testing.
“If you’re testing a low-risk population, it’s okay to do these tests for screening,” said Dr. Daniel Kritzkes, head of the infectious disease department at Brigham and Women’s Hospital. I will. “But if you get a positive result, I would like to confirm it with a more specific test, such as a PCR (polymerase chain reaction) test using a nasal swab.”
PCR tests are more sensitive and more specific, but slower and more expensive, Kuritzkes said.
The FDA said laboratories should expect some false-positive results even when highly accurate tests are used to screen large populations with low infection rates. It was.
Authorities say healthcare providers and laboratory staff can help ensure accurate reporting of test results by following the instructions and key steps in the testing process recommended by the Centers for Disease Control and Prevention. It was.
For example, the FDA states that this can impact test performance if the test components are not stored properly.
Reading the test before or after the specified time can result in false positives or false positives. In addition, batch processing of multiple samples can make it more difficult to ensure the correct incubation time for each sample, the FDA said.
Authorities also warned that “the risk of mutual contamination when testing patient specimens can lead to false positive results.”
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