Covid-19: Home test kits given conditional approval, says Health Ministry


PUTRAJAYA: The Health Ministry has given conditional approval for Covid-19 home test kits to be used by the Malaysian public.

In a statement, the Medical Device Authority (MDA) said its board members at a meeting on Wednesday (July 14) had agreed to issue conditional approval for the import and distribution of Covid-19 self-test kits.

“Taking into account the importance of public health and safety, the MDA is aware of the need for the public to use Covid-19 self-test kits.

“This is to facilitate the process of detecting and controlling Covid-19 infections, which will also help reduce the burden on the country’s health workers,” said the MDA.

With the availability of Covid-19 self-test kits, the MDA said members of the public will be able to use these devices to get an immediate diagnosis of their infection status, before taking further action.

“These self-test kits do not replace the real-time diagnostic function of RT-PCR (reverse-transcription polymerase chain reaction) tests, but it will have an advantage of screening patients quickly,” it said.

The MDA said the list of approved Covid-19 self-test kits will be displayed on its website as a guide for the public to decide which ones can be purchased.

It said so far, two Covid-19 self-test kits have been approved for usage, while 15 more are currently undergoing laboratory tests.

For companies that are interested to obtain a conditional approval, the MDA said they must have an establishment licence under the Medical Devices Act 2012 (Act 737).

“These self-test kits must undergo a technical evaluation and performance testing process,” said the MDA.

Prior to this, Health director-general Tan Sri Dr Noor Hisham Abdullah said the ministry is evaluating the usage of saliva-based Covid-19 self-test devices.

The Institute of Medical Research (IMR) said two self-test devices have been found to have sensitivity levels of more than 90%.

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