KUALA LUMPUR, July 12 — The Malaysian Medical Association (MMA) today urged the Medical Device Authority (MDA) to publish the list of approved Covid-19 test kits with their verified accuracy.
The doctors’ group noted that the website of the government agency under the Ministry of Health (MOH) only states that people may search for a medical device by inserting the device name and registration number on its site.
“The Malaysian Medical Association (MMA) is deeply concerned about the lack of transparency in the approval process of the various rapid test kits, be it antibody or antigen test kits being widely used now,” MMA president Dr N. Ganabaskaran said in a statement.
He cited a June 5 letter from MOH that said general practitioners (GPs) should only use Covid-19 antibody rapid test kits approved by the MDA.
On June 11, he said, MOH updated the latest guidelines on the Home Assessment Tool, which stated that one is required to undergo a Covid-19 serological (antibody) test at a private clinic approved by MOH on the 13th day of quarantine.
After that, MOH published an infographic on July 1 that instructed private clinics to report results from antibody rapid tests on the 13th day of quarantine for individuals placed under home quarantine upon return from abroad.
“These matters that can have a direct impact on the health and lives of the public have been poorly managed and coordinated. The Prime Minister has only earlier this month, called on civil servants to not work in silos to help ensure the government functioned efficiently. Moreover, we are in a time of crisis,” said Dr Ganabaskaran.
“Without the published list and lack of transparency, there is no control over the use of the various kits and there is no verification process. The earlier special access given to some companies was not allowed for commercial use. Our numerous meetings and requests in the best interest of public health and safety in the fight against Covid-19 seemed to have fallen on deaf ears,” he added.
MMA urged MOH to instruct MDA to immediately publish the approved list of Covid-19 test kits on MDA’s website, with the results on sensitivity and specificity from tests conducted in Malaysia either by the Institute of Medical Research (IMR) or the National Public Health Laboratory (MKAK).
Sensitivity measures how often a test correctly generates a positive result for people who have the condition that’s being tested for. A test that’s highly sensitive will flag almost everyone who has the disease and not generate many false-negative results.
Specificity measures a test’s ability to correctly generate a negative result for people who don’t have the condition that’s being tested for. A high-specificity test will correctly rule out almost everyone who doesn’t have the disease and won’t generate many false-positive results.
“Tests are important in keeping our numbers of infections low and preventing clusters. Therefore, we should insist on the best, most reliable test kits available. These are test kits [that] are already being used to test our people. The public has a right to know and be assured of the highest quality and effectiveness,” said Dr Ganabaskaran.
As of today, the Sarawak Disaster Management Committee (SDMC) has reported six Covid-19 cases with false negative results from the antigen rapid test kit (RTK) at the Kuala Lumpur International Airport (KLIA), as they later tested positive for the coronavirus with the gold-standard RT-PCR test in Sarawak.
Health director-general Dr Noor Hisham Abdullah told CodeBlue Thursday that MOH was reviewing the use of antigen rapid tests at both the KLIA and klia2 airports, following reports of inaccurate results.
He said 68,556 antigen RTK have been run as of July 7, out of which 166 people (0.24 per cent) tested positive for coronavirus, adding that the specificity of the antigen RTK used at KLIA and klia2 was 100 per cent, but the test’s sensitivity was 85 per cent. He did not reveal the brand of the test.