The Food and Drug Administration (FDA) approved on Monday the use of rapid test kits (RTKs) for coronavirus disease 2019 (Covid-19).
“We approve kits that are registered and used in countries with advanced technology and wide experience with Covid-19. We want the people to have access to testing but of course, proper evaluation and safeguards will still be in place,” FDA director-general Eric Domingo said in a statement.
Domingo said the five different brands of point-of-care test kits are registered for use in countries with reliable regulatory agencies such as China and Singapore.
As a safety precaution, the FDA shall require the product inserts or label of the RTKs to state the following: “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. Confirmatory testing is required.”
The Department of Health considers the use of polymerase chain reaction (PCR)-based test kits as the “gold standard” for diagnosing Covid-19 infections but other faster alternatives have been developed such as the RTKs.
While the rapid test kits will yield a faster result compared to PCR-based kits, Domingo underscored the importance of having a trained health professional to evaluate and interpret the results.
“We have to be very cautious in using these rapid test kits because they measure antibodies and not the viral load itself. The body takes time to develop antibodies and this might give a negative result for patients who have been infected but 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 added.
The FDA called on the local government chief executives, heads of agencies, hospitals, and private companies to be cautious in using these test kits.
It also requested doctors to help in testing and guide patients in the interpretation of the results.
The FDA also approved the PCR-based SARS Cov2 kit by Gene Xpert from Abbott Laboratories which can detect the virus within 5 minutes.
To date, the FDA has approved 17 PCR-based test kits for commercial use. (PNA)