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The Medical Device Authority (MDA) issued a statement that its board members took into account public health and safety before agreeing to the conditional import and distribution of Covid-19 self-test kits.
By being able to self-test, it is expected to reduce the burden on health care workers. But it will not replace the real-time diagnostic function of RT-PCR (reverse-transcription polymerase chain reaction) tests.
The MDA stated that the list of approved Covid-19 self-test kits will be displayed on its website as a buyer’s guide for the general public to decide which kit they want to purchase.
So far two Covid-19 self-test kits have passed technical evaluation and performance testing and will be granted import and distribution permission in the near future while another 15 kits are currently undergoing laboratory tests.
Companies keen on obtaining a conditional approval must have an establishment license under the Medical Devices Act 2012 (Act 737) and ensure that these self-test kits undergo technical evaluation and performance testing.
Meanwhile, the Malaysian Pharmacists Society (MPS) stated that these self-tests kits once available will help quicken the screening process. But they cautioned that it can only be used for testing and not as a diagnostic tool.
MPS stated that in the event the self-test kit gives you a positive result, it must be followed up and verified by an RT-PCR test. The RT-PCR is still considered the industry standard in diagnosing Covid-19 and is able to detect minute quantities of the Covid 19 virus in nasal or throat swab samples.
Several pharmacies in the Klang Valley have already started taking pre-orders for self test-kits even before approval by the health ministry. Some allow customers to secure a booking with a deposit while others do not. Demand is said to be high.
-THE MALAYSIA VOICE