THE Department of Health–Cordillera (DOH–CAR) acknowledges the use of rapid antibody test kits, but said these alone do not detect the novel coronavirus (Sars-CoV-2), which causes the coronavirus disease (Covid-19).
Doctor Amelita Pangilinan, DOH–CAR director, explained that rapid antibody tests are done to help identify suspect cases but do not actually detect the virus in the patients.
“In acquiring rapid diagnostic test kits, a Food and Drugs Administration license and validation coming from the Research Institute for Tropical Medicine or RITM is needed,” Pangilinan said.
Pangilinan said the rapid test yields a faster result compared to the real-time reverse transcription polymerase chain reaction (RT-PCR) test conducted by accredited laboratories.
However, use of rapid test is done with caution as it measures antibodies and not the viral load itself.
Pangilinan said it takes time for a sick person to develop antibodies and the rapid test might yield a negative result for patients who have been infected but have not yet developed antibodies.
A positive result due to cross reaction with other bacteria or viruses is also possible. But a RT-PCR test is still required.
“It is not actually a screening test because it has its uses, it can be used for research, surveillance and for those who got well from the Covid-19. This is not a standalone test kit for coronavirus,” Pangilinan added.
The Food and Drug Administration (FDA) has approved 39 rapid antibody test kits with varying specifications as of May 8, 2020.
As of May 5, 2020, the FDA in the Philippines has also approved 38 RT-PCR test kits for commercial use.
As a safety precaution, the FDA requires that the product inserts or label of the rapid test kits state that “this 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.
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