By Xavier Kong
DESPITE the good place that MyEG seemingly comes from with its rapid test kits, the Ministry of Health (MoH) holds on to its reasons to withhold approval for the kits, claiming their inefficacy in early detection, as well as pointing out the dangers of self-diagnosis.
The test kits, which were developed by an unnamed company in China, and which have been approved by Chinese authorities as of March 13, are already in use in China, Europe, and the US, according to MyEG Services Bhd, the distributor of the kits in Malaysia and the Philippines.
MyEG also notes that the rapid test kits, which can show results within 30 minutes, have been approved by the European CE mark, which certifies that the kits conform to health, safety, and environmental protection standards. The kits also qualified for emergency use authorisation from the US Food and Drug Administration (FDA), under a policy to accelerate detection and diagnosis during public health emergencies, on March 23.
However, the MoH has reservations about approving the rapid test kits, pointing towards the inefficacy in early detection, as the kits are meant to test for the presence of the Covid-19 IgM and IgG antibodies, which only appear in the body between five and eight days after infection.
“Hence, the test kit, which is currently available in the market to detect antibodies produced due to infection, cannot detect the virus or confirm infection quickly. Therefore, the rapid test kit is not recommended for the purpose of diagnosing Covid-19,” said health director-general Datuk Dr Noor Hisham Abdullah during a press conference on Covid-19 on March 24.
Conversely, the laboratory tests conducted at government health facilities for Covid-19 infection use the Real-Time Reverse Transcription-Polymerase Chain Reaction (rRT-PCR) technique, which detects the presence of the virus itself, rather than the antibodies, according to Dr Noor Hisham.
Furthermore, according to the MoH’s Medical Device Authority (MDA), MyEG had never received permission “to advertise, distribute, or sell Covid-19 test kits.”
The MDA said in a statement on March 24 that the advertisements by MyEG could trigger confusion, encouraging people to purchase the tests, with subsequent danger arising from possible false positives by those not trained to interpret the test results accurately.
“This can increase the risk of infections because we fear the public does not have sufficient knowledge to interpret the test results obtained or handle the situation once the results are known. Tests to detect Covid-19 must be conducted by qualified medical personnel who are trained at ministry-approved health facilities to ensure the handling and treatment of patients are carried out according to set procedures, and with that, contain the outbreak of infection,” read the statement.
When contacted, a representative from the company shared that, as of March 26, approval is still pending from the MoH, almost two weeks after the announcement of the test kits. The MoH could not be reached for comment on this.
This follows the ministry’s ill-informed social media post claiming the test kits were fake, which has since seen clarification from MyEG.
“The acceptance of the test kits worldwide, including in major regions like the US and Europe, is timely amid growing acknowledgement worldwide of the need for faster and more widespread detection capacities in the fight to contain the spread of Covid-19,” said MyEG in a media statement.
The test kits enable the early detection of the Covid-19 virus through the use of blood samples obtained from finger-pricking, without having to send the samples to any external diagnostics laboratories.
“Due to the simplicity of use of the rapid test kits, MyEG believes that it is an accessible and affordable option to increase testing and early detection amongst Malaysians, thus boosting testing capacity in the country and helping reduce the strain on existing public health facilities,” said MyEG in a statement.
However, the MoH is already in collaboration with almost a dozen private companies and healthcare providers to provide home testing without going to designated public sector hospitals to provide a sample.
The companies involved in the home-testing service include Bookdoc, DoctorOnCall, Pantai Premier Pathology Sdn Bhd, Lablink (M) Sdn Bhd (KPJ), Qualitas Medical Group Sdn Bhd, Gleneagles Kuala Lumpur, Twin Tower Medical Centre KLCC, Pantai Hospital Kuala Lumpur, Pantai Hospital Cheras, Pantai Hospital Klang and Pantai Hospital Ayer Keroh, Melaka.
The rapid test kits were available for pre-order in Malaysia at RM99 per test, or RM990 for a set of 10. A company representative shared that, should there be no approval from the MoH, customers would be refunded in full. As of March 26, pre-orders have been halted pending approval from the ministry.
However, this begs a question. If the rapid test kits work as MyEG has advertised, would it not make more sense to sell directly to the government, for distribution and deployment as the government sees fit?
By going directly to the public, the instances of people getting false positives, or worse, false negatives, could very well lead to more outbreak clusters emerging. A worst-case scenario would involve true positives hiding, or thinking they had false positives, while false negatives would take the results at face value and move on to form more outbreak clusters as well.
At the close of the market, MyEG’s shares were last done at 94 sen, up one sen, with 46.6 million shares traded. — March 26, 2020