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PUTRAJAYA – The Health Ministry has instructed the Medical Device Authority of Malaysia (MDA) to summon all suppliers of currently available RTK-Ag Covid-19 self-test kits to establish the issue behind several false negatives reported by users.
Health Minister Khairy Jamaluddin said this as there have been several reports received by his ministry concerning users who were known to be Covid-19 positive but still tested negative on some brands of the rapid test kits.
He said discussions with MDA have since been held following the complaints to evaluate the possible reasons behind the inaccurate readings and make sure quality control measures are being followed by the manufacturers.
“I have asked MDA to call in all the suppliers of the test kits – the saliva test kits, the rapid antigen test kits, to look and evaluate the complaints that we received.
“I have also asked MDA to obtain quality assurances and control information from the suppliers’ principal factories for us to see that these factories are indeed conducting quality assurance checks,” he said during a press conference here.
This follows grouses by several users on social media, claiming varying efficacy of different rapid test kits and possible false negatives being produced.
Khairy said MDA has also been tasked to ensure the quality of these kits are up to par and have been maintained since approval was granted to them.
“Sometimes the test kits are 99% effective at the time they are approved, but this figure could deteriorate if their factories fail to carry out quality control measures.
“So once we can establish all the facts, we will inform the public of any action or recommendations coming from MDA’s checks.”
Separately, Khairy said he had dialogue sessions with the Malaysia Shopping Malls Association concerning the use of the MyTrace contact tracing feature within the MySejahtera app.
“We spoke to them to try and get them to encourage their patrons and customers to enable their MyTrace features on their smartphones whenever they visit these malls or complexes.
“For now, we are more towards advising and encouraging the use of MyTrace instead of forcing it.”
He said that to date, there are around five million registered users of the MyTrace contact tracing system. – The Vibes, February 17, 2022
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