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Rapid test kits can produce false negatives – DOH

DOH is not recommending the use of rapid test kits for coronavirus disease 2019 (Covid-2019) because “the antibody they measure doesn’t come out in a person when the infection is just starting.” And so they may produce false negative results.

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The Department of Health (DOH) is not recommending the use of rapid test kits for coronavirus disease 2019 (Covid-2019). This is because “the antibody they measure doesn’t come out in a person when the infection is just starting.” And so they may produce false negative results.

In a public briefing, DOH Undersecretary Maria Rosario Vergeire said that such test kits measure the immunoglobulin, an antibody, which tells if the person had acute and past infection. So these rapid test kits may produce false negative results that could give problems when the patients are released and told to go home as they could then transmit infection to the community.

According to Vergeire, the Food and Drug Administration (FDA) has released an initial list of eight commercially available test kits. But she clarified that these test kits are used in laboratories with Reverse Transcription-Polymerase Chain Reaction machines as they are not rapid or point-of-care test kits.

Vergeire also reported that the 100,000 test kits donated by the Chinese Embassy have already been allocated to the RITM and the sub-national testing laboratories in the country.

While the DOH is open to receiving donated test kits, Vergeire said that the FDA performs a “parallel process” for the donated test kits to ensure that they are of quality. The test kits must also be recognized by reputable national regulatory agencies in Japan, US, South Korea and other countries listed in the FDA circular, or are prequalified by the World Health Organization Emergency Use List. 

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