Prof Datuk Dr Subramaniam Muniandy
KUCHING (May 18): The Malaysian Medical Association (MMA) has called on the Ministry of Health via Medical Device Authority (MDA) to immediately audit all RTK Antigen test kits available in the country.
MMA president Prof Datuk Dr Subramaniam Muniandy said this should be followed by regular audits due to concerns over the quality of some of the RTK Antigen test kits.
He said the association has received complaints from practitioners over some RTK Antigen test kits failing to detect Covid-19 positive cases.
“There are about 17 RTK Antigen test kits that have been approved by the Medical Device Authority but not all have been of acceptable quality,” he said in a statement.
“We are deeply concerned as false negatives in test results can also lead to further spread of Covid-19 in the community.”
Under standard operating procedures (SOPs) for Covid-19 testing, Dr Subramaniam explained those who received a positive test result via RTK Antigen screening would require an RT PCR test to confirm.
He also questioned whether regular audits were being conducted once the RTK Antigen test kits were approved and released into the market.
“The quality of RTK Antigen kits are paramount for the practitioner to pick-up positive cases,” he stressed.
Dr Subramaniam said RTK Antigen kits are an important tool in the fight against Covid-19 because they are a fast and effective method of screening to detect Covid-19 infections.
The quicker an infection is detected, the quicker the positive cases can be isolated to prevent further spread of virus, he said.
“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.
“There should also be a proper platform online for practitioners to issue complaints on any issues encountered when using the test kits.”
Dr Subramaniam said the association 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,” he added.