KUALA LUMPUR – The Malaysian Medical Association (MMA) is urging the government to conduct an immediate audit on the quality of Covid-19 test kits, following complaints raised by several practitioners on their efficacy.
MMA president Prof Datuk Dr Subramaniam Muniandy questioned the quality of some of the Antigen Rapid Test Kit (RTK-Ag) swabs available in the market.
Currently, 17 RTK-Ag kits have been approved by the Medical Device Authority (MDA), although not all “have been of acceptable quality”.
“Some of these kits have failed in detecting positive cases,” Dr Subramaniam 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.”
The RTK-Ag test kits cost less than the more elaborate reverse transcription-polymerase chain reaction (RT-PCR) screenings, and its results can be obtained almost immediately.
However, in July last year, the Health Ministry said RTK-Ag tests could produce false or negative results 10% of the time, owing to its sensitivity level of 90%.
Dr Subramaniam said under the current standard operating procedures for testing, those who receive a positive test result via RTK-Ag screening will require an RT-PCR test to confirm the diagnosis.
“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-Ag kits is paramount for the practitioner to pick up positive cases,” he said.
“RTK-Ag 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.”
Dr Subramaniam also highlighted concern over the efficacy of RTK-Ag kits to detect new variants of the virus.
He said updates are needed as there are reports of the variants spreading across the country.
Dr Subramaniam urged the Health Ministry, through the MDA, to conduct an audit followed by regular audits on all test kits available in the market.
The ministry, he added, must also provide an online platform for medical practitioners to file complaints on issues encountered with any test kits.
“Aside from this, MMA is also concerned over the lack of transparency on the approval process of the saliva test kits,” he said.
“We hope there are no middlemen taking advantage of the Covid-19 situation through commercialisation of the test kits or monopoly of the market.” – The Vibes, May 18, 2021
