(Eagle News) – The Food and Drug Administration (FDA) has approved the commercial use of 16 rapid antibody test kits, amid efforts to expand testing for COVID-19.
In an advisory issued on Saturday, April 18, the FDA said that the approved test kits “have have completed necessary documentary requirements and have undergone review and evaluation”.
The FDA explained that the rapid test kits “detect the presence of antibodies in an individual’s blood or serum”, specifically identified as Total Antibody, IgG antibody, and IgM antibody.
“Total antibody signifies the collective response of the patient’s immune system. IgM antibodies represent response to a current or recent infection while IgG antibodies represent response from a past infection”, the FDA advisory read.
According to the FDA, some of the approved test kits detect only one antibody, either IgM and IgG, while some detect total antibodies. Other kits can also detect both IgM and IgG at the same time, but give separate result for each.
Hence, “[i]t s important to consider the timing of the infection and the condition of the patient during the time of specimen collection”, and the choice of test kit must depend on the information the doctor wants to obtain and the specifications of the kit.
The FDA also reminded the public that the rapid test kits, although packaged as easy to use, are “strictly for medical professional use only” and must be administered by trained health professionals, with the results to be interpreted by licensed physicians.
“Confirmatory PCR based testing is still the gold standard”, the FDA advisory reiterated.
Eagle News Service
