Mpox test kits not for public, says MDA


PETALING JAYA: Mpox test kits are not for public use, says Medical Device Authority (MDA) chief executive officer Dr P Muralitharan.

He said that only authorised professionals are allowed to handle monkeypox (mpox) test kits and added that any sales of test kits is illegal.

"The test kit is only approved to be handled by authorised professionals such as licensed medical practitioners and the kit should not be handled by the public," said Dr Muralitharan in a statement on Thursday (Aug 29).

“Any sale and purchase of the kit in pharmacies, stores or e-commerce platforms will be a violation of the Medical Device Act 2012 (Act 737)," he added.

Dr Muralitharan said that if the kit is not handled properly, there is a possibility that the results obtained may not be accurate and enable the virus transmission among the public.

“The public is advised not to buy any monkey pox test kit or self-test using such kits. Please report to the MDA feedback management system at femes.mda.gov.my," he added.

On Aug 28, the Health Ministry had stated that a total of 13 laboratories are capable of conducting mpox detection tests.

”These are eight government laboratories and five private ones and two have the capacity for genetic sequencing to identify virus variants," it said.

The ministry added in a statement on Wednesday (Aug 28) that as of Tuesday (Aug 27) there have been 33 suspected cases of mpox reported at health facilities.

Out of these, 32 have been confirmed negative, while one is still awaiting lab results.

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Mpox , Test kits , Certified , MDA , Sale , Illegal , Medical Device

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