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The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential effect of viral mutations, including an emerging version from the United Kingdom known as the B.1.1.7 variant, on approved SARS-CoV-2 molecular tests, which false negative results can occur with almost any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the section of the virus’s genome assessed by that evaluation. The SARS-CoV-2 virus may mutate over time, like all viruses, leading to genetic variation in the population of circulating viral strains, as seen with the B.1.1.7 variant.
The FDA is taking additional actions to ensure authorized tests remain true by working with test developers and conducting ongoing data analysis to appraise all currently authorized molecular tests. The FDA believes the threat that these mutations will impact overall testing accuracy is low.
The FDA has been monitoring SARS-CoV-2 viral mutations, and possible effect on testing, throughout the pandemic. The presence of SARS-CoV-2 genetic variations in a patient sample could possibly change the operation of a SARS-CoV-2 test. Tests that depend on the detection of multiple regions of the genome may be less impacted by genetic variation in the SARS-CoV-2 genome than evaluations that rely on detection of just a single region.
The FDA will continue to monitor SARS-CoV-2 genetic viral variants to ensure authorized tests continue to provide accurate results for patients. 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. 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.”
Stephen M. Hahn, M.D., FDA Commissioner
Three presently authorized molecular tests, MesaBiotech Accula, TaqPath COVID-19 Combo Kit, and Linea COVID-19 Assay Kit, could be impacted by genetic variations of SARS-CoV-2, but the impact doesn’t appear to be significant. Significantly, the detection routine that appears with the TaqPath and Linea diagnostic tests when certain genetic variants are present may assist with early identification of new variants in patients to reduce further spread of disease. The newly identified B.1.1.7 variant was associated with an increased risk of transmission, therefore early identification of the variant in patients can help reduce further spread of disease.
The FDA has educated clinical laboratory staff and health care providers about the risk of false negative results with all laboratory tests, including molecular tests. Laboratories should anticipate some false results to occur even when very exact SARS-CoV-2 evaluations are used. Today’s announcement also provides important advice and recommendations for clinical laboratory staff and medical care providers who use molecular tests for the detection of SARS-CoV-2.
The FDA encourages stakeholders to report any adverse events or suspected adverse events experienced with molecular tests for detection of SARS-CoV-2. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel and clinical lab staff employed by facilities which are performing COVID-19 testing must follow the reporting requirements for authorized laboratories as specified in the test’s Emergency Use Authorization. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
U.S. Food and Drug Administration