Over 264 Million Coronavirus Tests Confirmed
The US Centers for Disease Control and Prevention (CDC) reported over 264 million RT-PCR diagnostic tests, excluding antibody and antigen tests, have been performed to confirm if a person has a SARS-CoV-2 virus infection.
As of January 13, 2021, the state of California leads the USA with 32,228,484 coronavirus tests performed, followed by New York (23,777,295), Florida (18,332,836), and Texas (16,064,933).
Previously, the U.S. FDA issued an alert to clinical laboratory staff and providers on January 8, 2021, that the FDA monitors the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant authorized SARS-CoV-2 molecular tests.
That false-negative results can occur with any molecular test for detecting SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test.
“The FDA will continue to monitor SARS-CoV-2 genetic, viral variants to ensure authorized tests continue to provide accurate results for patients,” stated FDA Commissioner Stephen M. Hahn, M.D., in a press statement.
“While these efforts continue, we are working with authorized test developers and reviewing incoming data to ensure that health care providers and clinical staff can quickly and accurately diagnose patients infected with SARS-CoV-2, including those with emerging genetic variants."
As of January 11th, the CDC confirmed (72) B.1.1.7 lineage cases in the USA.
“At this time, we believe the data suggests that the currently authorized COVID-19 vaccines may still be effective against this strain. The FDA will continue to keep health care providers and the public informed of any new information as it becomes available,” concluded Dr. Hahn.
The FDA says it has been monitoring SARS-CoV-2 viral mutations, and their potential impact on testing, throughout the pandemic. The presence of SARS-CoV-2 genetic variants in a patient sample can potentially change a SARS-CoV-2 test's performance.
Tests that rely on the detection of multiple regions of the genome may be less impacted by genetic variation in the SARS-CoV-2 genome than tests that rely on the detection of only a single area.
Three currently authorized molecular tests, MesaBiotech Accula, TaqPath COVID-19 Combo Kit, and Linea COVID-19 Assay Kit, may be impacted by genetic variants of SARS-CoV-2, but the impact does not appear to be significant.
Notably, the detection pattern that appears with the TaqPath and Linea diagnostic tests when certain genetic variants are present may help with the early identification of new variants in patients to reduce the further spread of infection.
The recently identified B.1.1.7 variant has been associated with an increased risk of transmission; therefore, early identification of this variant in patients may help reduce further spread of infection.
The FDA has reminded clinical laboratory staff and health care providers about the risk of false-negative results with all laboratory tests, including molecular tests. Laboratories should expect some false results to occur even when very accurate SARS-CoV-2 tests are used.
Furthermore, the FDA is encouraging stakeholders to report any adverse events or suspected adverse events experienced with molecular tests to detect SARS-CoV-2. Voluntary reports can be submitted through MedWatch, the FDA Safety Information, and Adverse Event Reporting program.
The FDA is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices.
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