Audit COVID-19 test kits for quality assurance, MMA urges

By Prof Datuk Dr Subramaniam Muniandy


THE Malaysian Medical Association (MMA) is concerned 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.

Moreover, 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.

We are deeply concerned as false negatives in test results can also lead to further spread of COVID-19 in the community.

Under the standard operating procedures (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 are paramount for the practitioner to pick-up positive cases.

RTK Antigen kits are an important tool in the fight against COVID-19. It is a fast and effective method of screening to detect COVID-19 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.

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.

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 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. – May 18, 2021


Prof Datuk Dr Subramaniam Muniandy is the president of the Malaysian Medical Association (MMA).

The views expressed are solely of the author and do not necessarily reflect those of Focus Malaysia.

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