The FDA said that false-negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus's genome assessed by that test.
Because the B.1.1.7 variant is thought to be more transmissible, "early identification of this variant may help reduce spread of infection", the agency said. The FDA believes the risk that these mutations will impact overall testing accuracy is low.
The FDA is working to ensure authorized tests remain accurate by partnering with test developers and conducting ongoing data analysis to evaluate all now authorized molecular tests.
The number of reported cases is an underestimate of the true number of persons with infection, because many people with symptomatic COVID-19 either do not seek medical care or are not tested and therefore are not included in the tallies of COVID-19 infections reported to public health authorities, said the study. "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".
All those who have tested positive for the new variant of coronavirus strain were kept in single-room isolation at designated healthcare facilities by the respective state governments, the ministry had said earlier.
The FDA said that while the mutations could impact test results, the now authorized vaccines appear to be effective against the new strains. "Utilizing this knowledge, we have begun to develop new assays to detect specific mutations in SARS-CoV-2 and to adapt our assay to address the evolving SARS-CoV-2 threat".
A study not yet reviewed by peers, sent yesterday (7) to the pre-publication repository bioRxiv, revealed that the vaccine against covid-19 developed by the pharmaceutical consortium Pfizer / BioNTech proved to be effective in preventing highly transmissible coronavirus mutations, found in the United Kingdom and South Africa. Previously, Pfizer had touted the "flexibility" of mRNA technology should the need for tweaks to the vaccine be necessary.