PUTRAJAYA: The Health Ministry has given conditional approval for Covid-19 home self-test kits to be used by the Malaysian public.
The Medical Device Authority (MDA) said in 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.
“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.
“These self-test kits do not replace the real-time diagnostic function of RT-PCR (reverse-transcription polymerase chain reaction) tests, but it has the 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 to purchase.
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”, it said, adding that another 15 are currently undergoing laboratory tests.
Companies interested in obtaining a conditional approval, the MDA said, must have an establishment licence under the Medical Devices Act 2012 (Act 737).
“These self-test kits must undergo technical evaluation and performance testing, ” it added.
Meanwhile, the self-test kits can help ramp up testing, said the Malaysian Pharmacists Society (MPS).
Its president Amrahi Buang said the Covid-19 self-test kits can only be used for screening for Covid-19 and not as a diagnostics tool.
“If the self-test kits give you a positive result, then there must be a follow up with an RT-PCR test, ” he said, adding that this will help eliminate false positives.
The RT-PCR test is still considered the gold standard in diagnosing Covid-19 and is able to detect minute quantities of Covid-19 virus’ ribonucleic acid (RNA) in nasal or throat swab samples.
A quick check by The Star found several pharmacies in the Klang Valley had already started taking pre-orders for self test-kits even before the approval by the ministry.
Some allow customers to secure a booking with a deposit while others do not.
A pharmacist told The Star that demand for the Covid-19 self-test kits is high and the outlet has been getting many enquiries.
One pharmacy had started taking pre-orders on its Facebook page for the Covid-19 RTK-Antigen saliva self-test kit but the link was down as of press time.
Another outlet, which was offering a similar Covid-19 saliva self-test kit for RM39.90 for one and six for RM219.60 on pre-order, had run out of stock.
Amrahi said anyone can sell a product online, but the MPS has safeguards in place such as signing a memorandum of understanding with online e-commerce sites, including Shopee, to ensure that its members and the public are protected.
“The shopfront in Shopee has to be a registered pharmacy, they must also show their Poison Licence Type A and must be a member of MPS.
“This is to prevent the sale of fake pharmaceutical products, ” he said.
Legitimate pharmacies on Shopee will bear the “MPS verified” logo.
