LETTER | Public has right to know effectiveness of various test kits

LETTER | 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 has brought up this issue at the highest level on June 2, 2020. However, until now there is no published data on the approved test kits with the Medical Device Authority (MDA) on their website.

“This facility is provided to enable any interested parties to search for registration of medical device under Section 15 of the Medical Device Act 2012 (Act 737). Any party who wishes to know whether a particular medical device is registered under Act 737 may search the device by inserting the device name or registration number in the searching field below.” - as stated on the MDA website under product search.

The Special Cabinet Committee on Anti-Corruption agreed in principle on June 25 with the recommendation of the Malaysia Productivity Corporation (MPC) for all ministries and agencies that issue permits and licenses to provide guidelines for license applications that must be published online.

In a letter dated June 5 from the Health Ministry, it was clearly stated that the general practitioners (GPs) should only use the Covid-19 Antibody Rapid Test Kits approved by the MDA.

On June 11, the MOH updated latest guidelines on the Home Assessment Tool. “On the 13th, you are required to undergo a Covid-19 serological test at a private health clinic/clinic approved by MOH. Ensure that you get a copy of the laboratory result,” it said, referring to the 13th day under quarantine.

Following that, on July 1, an infographic on ”Ujian Antibodi COVID-19 di klinik swasta“ was issued. 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.

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.

As at now, thousands of tests have already been conducted on travellers without the MDA publishing the approved list on their portal (public domain) for doctors and the public to view. As tests are already ongoing, we, therefore, in the best interest of public health and safety, urge the MOH to instruct MDA to immediately publish the approved list on their website with the results on sensitivity and specificity from tests conducted in Malaysia either by IMR (Institute Medical Research) or MKAK (Makmal Kesihatan Awam Kebangsaan).

As a nation, we have successfully managed to flatten the curve in fight against Covid-19. 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 already being used to test our people. The public has a right to know and is assured of the highest quality and effectiveness.

So far, we have been fortunate that cases in the country have not risen exponentially of late. But we should not wait for that to happen. Any compromises in the quality of care can result in a surge right under our noses when you least expect it.

There are around 2-3 million registered foreign workers in the country and so far, we have only managed to test around 33,000. We also have an equally high number of undocumented foreign workers, which pose an even greater challenge to test. 

Migrant workers have been identified as a risk group. The threat of new clusters may still be present and therefore, we should get our house in order. We cannot afford another lockdown.

Dr N Ganabaskaran is the president of the Malaysian Medical Association.

The views expressed here are those of the author/contributor and do not necessarily represent the views of Malaysiakini.