U.S. FDA: Household rapid test kits are more inaccurate for Omicron, or have a false negative

According to Agence France-Presse reported on the 28th, the US Food and Drug Administration (FDA) said on Tuesday (28th) that compared with the early new coronavirus strains, the home new crown rapid detection kit is more likely to give false negative results to the severely mutated Omiljung mutant strain.

Illustration of the report

The news comes at a time when the U.S. is facing a massive surge in infections. Experts say that due to insufficient testing capacity, longer wait times for more accurate nucleic acid testing (PCR testing) of the new crown virus, and extreme shortage of household kits, the United States has not detected all cases of infection.

The FDA said in a statement that it is working with the National Institutes of Health (NIH) to study the performance of home testing tools, also known as "antigen" tests, on samples of living patients containing the Omikejong variant strain.

"Preliminary data suggest that antigen detection tools did detect the Omikejung variant strain, but the sensitivity may be reduced," the agency said. "Sensitivity is a measure of the likelihood of being able to detect a positive result.

The statement added that the previous "antigen" detection performance test, which mainly used heat-inactivated virus samples, rather than better live virus samples, has not until now discovered the decline in its detection performance.

The FDA said it will continue to authorize the use of "antigen" testing on the principle of detecting coronavirus surface proteins, while individual users should continue to follow the instructions. For example, some rapid detection tools instruct the user to perform two tests, at intervals of time, to confirm a negative. If someone tests negative quickly and is thought to be likely to be infected with COVID-19 because of symptoms or exposure to the virus environment, they are still advised to undergo another "gold standard" molecular biometric test — such as a PCR test.

According to the report, molecular biological detection methods can detect the genetic material of viruses with higher accuracy. Because millions of copies of viral RNA can be replicated during detection, even microviruses can be detected. (Editor: SDY)