MMA wants immediate audit of Covid-19 test kits

 

Malaysian Medical Association (MMA) president Dr Subramaniam Muniandy says his group is concerned over the quality of some of the RTK Antigen test kits available in the market and wants the Health Ministry to conduct an immediate audit.

"There are some 17 RTK Antigen test kits that have been approved by the Medical Device Authority (MDA) but not all have been of acceptable quality.

"The MMA has been receiving complaints from a number of practitioners over some of the RTK Antigen test kits used for Covid-19 screening as 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," he added.

Under the SOPs 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 is crucial to practitioners detecting positive cases," said Subramaniam.

"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 Covid-19.

"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," he said.

The MMA, therefore, urged the Health Ministry via the 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.

"Aside from this, MMA is also concerned over the lack of transparency on the approval process of the saliva test kits.

"We hope there are no middlemen 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," said Subramaniam. - Mkini