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The Food and Drug Authority (FDA) has described as erroneous claims that the Covid-19 testing device used by passengers at Kotoka International Airport (KIA) may not be able to detect the virus accurately.
“The Food and Drug Authority wishes to assure the public that the device approved for use in the KIA is fit for purpose and the Authority will continue to monitor its performance in accordance with regulatory requirements,” the FDA said.
Dr. Kofi Bonney of the Noguchi Memorial Institute for Medical Research (NMIMR), in an interview with a local radio station, indicated that about half of the tests performed at the airport may be inaccurate.
“Scientifically with the PCR test, within 72 hours, it is enough. I don’t know why we have to do an antigen test that is less sensitive on arrival. If we look at the tests that have been carried out over the years, we have a percentage of sensitivity that varies between 34% and around 80%.
“So if you look at these numbers that mean about half of the people who will take anti-gene tests, the results may not be correct,” he said during the interview.
But, responding to the claim, the FDA said that “the SARS-CoV 2 virus detection at the airport is not a rapid diagnostic test kit (RDT), but a device that detects the virus in nasopharyngeal (nasal) swabs.” .
According to the FDA, it granted market authorization to the device that is capable of detecting ANTIGEN (SARS-CoV-2 Virus) by fluorescence technology after it met the requirements of no less than 99.0% concordance.
The Authority further explained that the specificity of the device, which is also not less than 99.0%, makes it highly unlikely that the test results will be false positives (people who carry other viruses will be classified as SARS-CoV-2) as claimed.
“Nasal samples are not placed on paper, but cartridges that are inserted into the device and the results are displayed electronically on an LCD screen, which can be printed from a computer.
The allusion to “tests performed over the years” and all the statistics given with reference to the performance of PDRs in response to the precision of the antigen test cannot be true for SARS-CoV-2, as the disease has not existed for so long. that data has been collected on the RDT antigen, ”explained the FDA.
He also noted that available data on antibody and antigen PDRs from March 2020 to date show that their sensitivity ranges between 4% and 62% and not between 34% and 80%.
“This is why the FDA has not authorized any Antibody or Antigen RDT kits to date,” the statement added.
– citinewsroom
