The FDA issued a statement on August 8, saying it has alerted medical examiners and health care workers that some tests may not detect more infectious variants of the virus and present pseudonegative results, but that currently licensed vaccines still have protective power.
U.S. news television channel Spectrum News reported that Food and Drug Administration (FDA) Commissioner Stephen Hahn issued a statement saying, “FDA will continue to monitor genotypic viral variants of coronavirus disease 2019 (COVID-19, New Coronavirus Pneumonia) to ensure that authorized tests continue to provide correct results for patients.”
He said, “As these efforts continue, we are working with authorized test developers and reviewing the data received to ensure that health care and medical examiners can quickly and correctly diagnose infected patients, including those infected with novel variants of the virus.”
Hahn pointed out that the test data show that the two currently licensed vaccines are still effective against the more infectious new variant virus.
Novel variants are mutations of the new coronavirus, such as the strain known as B.1.1.7, which originated in the United Kingdom. The test is designed to find the specific genome of the virus, meaning that any mutation in the virus may make the disease undetectable.
The FDA said the new variant of the virus is particularly likely to cause incorrect results for three licensed assays, Mesa Biotech Accula, TaqPath COVID-19 Combo Kit and Linea COVID-19 Assay Kit.
The FDA noted that the impact was “less than serious” and has notified laboratory staff and healthcare workers of the possibility of false negatives, asking them to combine clinical observations to review such screening results and to use different screening methods when there is doubt about a patient’s diagnosis.
A variant of the virus that has spread in the United Kingdom has also been identified in the United States and many other countries. This virus and the variant found in South Africa have raised global concern because they appear to be more easily transmitted.
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