PETALING JAYA: False-positive or false-negative results from unapproved Covid-19 test kits will affect statistics on cases reported daily in Malaysia, as the performance or quality of unapproved kits may be suspect, said Universiti Malaya Institute of Biological Research virologist Dr Muhamad Afiq Aziz.
On Monday, the Medical Device Authority (MDA) said in a statement that it had revoked its conditional approval for two brands of Covid-19 Rapid-Test Kits (RTK) from China as they failed to comply with the approval conditions set by the authority.
Muhamad Afiq said as the nation moves towards an endemic phase, regular testing is necessary to protect the people.
He added that choosing an MDA-approved test kit is crucial to ensure the safety and accuracy of results.
“We use rapid test kits to check our Covid-19 status before we return to work or school. If the kit we use is not approved by the regulatory body, it will affect our decision whether to go into quarantine.
“A good test kit is important as an extra safeguard to control virus transmission at work, school or other places.”
Muhamad Afiq reminded the public to only purchase MDA-approved test kits.
The kits that were revoked by MDA are Deepblue by Innovac Technology Sdn Bhd and Wiz Biotech by Conan Medical Technology Berhad.
MDA’s conditional approval, which started in July, is a temporary move for test kits so that the devices could be supplied and used immediately to facilitate the detection and control of Covid infections in the country.
In other countries, test kits have also been granted temporary or conditional approval such as through Emergency Use Authorisation in the US and Provisional or Interim Authorisation in the United Kingdom and Singapore.
MDA has advised consumers not to purchase or use Covid self-test kits that do not comply with its requirements as they may be unsafe.
On Monday, Health Minister Khairy Jamaluddin tweeted that his ministry had received several complaints about Covid-19 test kits that are currently available in the market.
“MDA has tested 22 brands of test kits and as of now, we have obtained results from 12. We have found that two brands do not meet the required standards. Conditional approval for both the brands have been revoked,” he said.
