Regulator to grant conditional approval for Covid-19 self-test kits
The Medical Device Authority (MDA) has agreed to grant conditional approval for companies to import and distribute Covid-19 self-test kits in Malaysia.
So far, it said two test kits have passed technical and performance evaluations and will be granted conditional approval soon, while another 15 are still being tested.
MDA chief executive Ahmad Shariff Hambali said the...
The Medical Device Authority (MDA) has agreed to grant conditional approval for companies to import and distribute Covid-19 self-test kits in Malaysia.
So far, it said two test kits have passed technical and performance evaluations and will be granted conditional approval soon, while another 15 are still being tested.
MDA chief executive Ahmad Shariff Hambali said the decision was made during its board meeting today, where it also finalised the conditions of the approval.
“With the decision today, Covid-19 test kits can be obtained and used by members of the public as a screening test to get immediate results regarding their infection status before further action is taken.
“These kits do not replace the diagnostic functions of real-time reverse-transcription polymerase chain reaction (Rt-PCR) test for Covid-19, but has the advantage of quickly and easily screening the patient’s status,” he said in a statement today.
The list of approved kits will be displayed on MDA’s website once approval has been granted.
As a condition for approval, the kits must provide clear and easy instructions on how to use and dispose of the kits, to ensure safety and performance of the kits are maintained.
Shariff urged members of the public using these kits to follow label instructions to use them correctly and to dispose of them safely, as well as to report test results.
Previously, Health Ministry director-general Dr Noor Hisham Abdullah said studies by the Institute for Medical Research (IMR) found two self-test kits that have sensitivity above 90 percent.
This means for every 100 people who have Covid-19, the test will correctly identify at least 90 percent of them as positive.
Sampling is done using “deep-throat saliva”, rather than swabbing the back of the throat and nasal cavity.
