FDA approves 5 COVID-19 rapid test kits

The Philippine Food and Drug Administration has approved five new Rapid Antibody Test Kits for COVID-19.

Approved tests include:

• NANJING VAZYME 2019-nCoV IgG/IgM Detection Kit
• NOVEL CORONAVIRUS (2019-NCOV) IgM/IgG ANTIBODY DETECTION KIT (COLLOIDAL GOLD METHOD)
• DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-CoV-2) (COLLOIDAL GOLD)
• 2019-nCoV ANTIBODY TEST (COLLOIDAL GOLD)
• SARS-CoV-2 ANTIBODY TEST (LATERAL FLOW METHOD)

As a precaution, the FDA requires all Rapid Test Kits to have the following label: “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.”

According to DG Domingo, “The rapid test kits will yield a faster result compared to PCR based kits, but it is important that a trained health professional will 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,”

The FDA also urges local government chief executives, heads of agencies, hospitals, and private companies to ask doctors to help in testing and guiding patients for the interpretation of the results. The DOH has also been called to increase the number of capable laboratories capable of performing the PCR confirmatory tests.

The UP-National Institute of Health (UP-NIH) made COVID-19 test kit will be approved within the week, according to ABS CBN.

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Source: Yugatech