PETALING JAYA: The Malaysian Medical Association (MMA) has expressed concern over the quality of some of the RTK Antigen test kits available in the market.
There are about 17 RTK Antigen test kits that have been approved by the Medical Device Authority (MDA) but not all have been of acceptable quality, according to MMA president Datuk Dr. Subramaniam Muniandy. (pix)
“MMA has been receiving complaints from a number of practitioners over some of the RTK Antigen test kits used for Covid-19 screening. Some of these kits have failed in detecting positive cases.” he said in a statement today.
“We are deeply concerned as false negatives in test results can also lead to further spread of Covid-19 in the community.”
Under the SOP for Covid-19 testing, those who receive a positive test result via RTK Antigen screening will require an RT PCR test to confirm.
“The practitioners are concerned that with many kits available now, are regular audits being carried out once the kits are approved and released into the market? The quality of RTK Antigen kits are paramount for the practitioner to pick-up positive cases,” Subramaniam said.
RTK Antigen kits are an important tool in the fight against Covid-19. It is a fast and effective method of screening to detect infections.
The quicker the infection is detected, the quicker we can isolate the positive case and prevent further spread of the virus, he pointed out.
“Also of great concern among practitioners is the efficacy of the RTK Antigen test kits in detecting the newer variants. Updates on its efficacy are urgently needed as there have been reports of the newer variants in the country.
“We therefore urge MOH via MDA to immediately conduct an audit followed by regular audits on all RTK Antigen test kits that are now available in the market. There should also be a proper platform online for practitioners to issue complaints on any issues encountered when using the test kits,” he added.
Subramaniam said MMA is also concerned over the lack of transparency on the approval process of the saliva test kits.
“We hope there are no middle men taking advantage of the Covid-19 situation through commercialisation of the test kits or monopoly of the market. MMA takes a serious view of such practices which should have no place in our country’s healthcare,” he added.
