‘Di aabutin ng siyam-siyam! Rapid antibody test kits for COVID-19 gets FDA’s nod
The Food and Drug Administration (FDA) has approved the use of five rapid test kits for coronavirus disease 2019 (COVID-19) amid the rising number of confirmed cases in the country.
In a statement, FDA said the approved test kits are already registered for use in China and Singapore.
FDA Director General Eric Domingo said the rapid test kits will yield faster results than the PCR-based kits, whose use is currently exclusive to the Research Institute of Tropical Medicine and a number of sub-national laboratories.
However, Domingo cautioned that the only medical professionals should be allowed to use the rapid test kits, and they are not for personal use.
“The body takes time to develop antibodies have not yet developed antibodies. A positive result due to cross reaction with other bacteria or viruses is also possible, which is why a confirmatory PCR based test is still required,” he said.
Domingo said the test kits’ should have a label which read: “The product is strictly for medical professional use only and not intended for personal use. The administration of the test and interpretation of results should be done by a trained health professional. Confirmatory testing is required.”
FDA also approved the SARS Cov2 kit by Gene Xpert from Abbott Laboratories, which can detect COVID-19 within five minutes.