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Wednesday, December 10, 2025
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No influenza self-test kits approved in Malaysia due to accuracy concerns

Malaysia’s Medical Device Authority has not approved any influenza self-test kits, citing concerns over saliva-based tests and potential misuse

KUALA LUMPUR: The Medical Device Authority (MDA) has not registered any influenza self-test kits for use in Malaysia.

Deputy Health Minister Datuk Lukanisman Awang Sauni said most available kits use saliva samples, a method found to be less effective.

“The collection of samples through nasal swabs or blood, and carried out under the supervision of a medical practitioner for more accurate results, is more appropriate,” he told the Dewan Negara.

He was responding to Senator Azahar Hassan’s query on the ministry’s justification for not approving the kits amid seasonal cases.

Lukanisman said the Ministry of Health will consider alternative, accessible detection tests to help contain the spread.

Responding to Senator Dr R.A. Lingeswaran on standards compared to the US FDA, he said the MDA sets very high specifications.

“The use of these kits must be taken seriously because we are worried that insensitive kits may be used and misused for certain reasons,” he added.

He cited potential misuse, such as individuals falsely claiming to have influenza to obtain medical leave. – Bernama

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