Battling COVID-19 – Malaysia Making Steady Progress with IVDs

Battling COVID-19: Malaysia Making Steady Progress with IVDs

It is commendable how Malaysia is effectively battling the COVID-19 pandemic. While the government should be credited for making decisive strategies and implementing them meticulously, the Malaysian population also deserves to be appreciated for their patience and cooperation.

As the world struggles to contain the pandemic, it gives hope to see how some small APAC countries like Malaysia are emerging as leaders in controlling the devastating impact of the pandemic by responding early and effectively.

It is commendable how Malaysia is effectively battling the COVID-19 pandemic. While the government should be credited for making decisive strategies and implementing them meticulously, the Malaysian population also deserves to be appreciated for their patience and cooperation.

As the world struggles to contain the pandemic, it gives hope to see how some small APAC countries like Malaysia are emerging as leaders in controlling the devastating impact of the pandemic by responding early and effectively.

On May 4th, 2020, OECD published a report titled “Testing for Covid-19: A way to lift confinement restrictions”. The report highlighted the role of in vitro diagnostic (IVD) tests as countries worldwide are slowly relaxing the stringent measures taken for implementing social distancing as a measure to control the pandemic. The best exit strategy being recommended is testing, tracking, and tracing (TTT).

The OECD report defines three goals while developing testing strategies as suppressing the resurgence of local outbreaks, identifying people with immunity, and gaining intelligence on the evolution of the epidemic including identifying the threshold for herd immunity. For all the three goals, effective strategies for use of IVDs – molecular as well as serologic tests – are discussed.

For instance, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) tests are recognized as the most effective tests for identifying infected people, while serological tests are recommended mainly for detecting those who already had an infection and have developed antibodies.

IVD companies across the world are responding to this ongoing pandemic by developing new tests suitable for fast and accurate diagnosis of SARS-CoV-2, the virus behind COVID-19. The importance of RT-PCR tests as confirmation tests is recognized widely and are categorized as the gold standard tests for COVID-19, while immunoassays are largely used for screening as they are cost-effective and faster.

Table -1 lists the many leading as well as niche players in the IVD markets that have already launched RT-PCR tests targeting multiple genes in SARS-CoV-2 in order to achieve high sensitivity and specificity.

 

Table 1: Selected Commercial RT-PCR Assays for COVID-19 Diagnosis

Company Assay Gene Targets a
 Abbott, USA  Abbott Real Time SARS-C0V-2 assay  RdRP and N
 ADT Biotech, Malaysia   LyteStarTM2019-nCoV RT-PCR Kit  E and RdRp
 Cepheid, USA  SAR-CoV-2 Xpert Xpress  N2 and E
 Hologic, USA  Panther Fusion SARS- CoV-2 Assay  ORF1ab
 JN Medsys, Singapore  ProTect COVID-19 RT-qPCR Kit  N2, N2, and N3 b 
 Kogene Biotech, S. Korea  Powercheck 2019-nCoV RT PCR kit  RdRP and E
 Luminex, USA  ARIES SARS-CoV-2 Assay  ORF1ab and N
 Mediven, Malaysia  GenoAmp Real-Time RT-PCR SARS-CoV-2   RdRP, S, and N
 Roche, Switzerland  Cobas SARS-CoV-2 test  ORF1 and E
 SD Biosensor, South Korea  STANDARD M n-CoV Real-Time Detection Kit;  RdRP and E
 Seegene, South Korea  Allplex 2019-nCOV Assay  RdRP, E and N
 SolGent, South Korea  DiaPlexQTM Novel Coronavirus (2019-nCoV) Detection Kit  ORF1a and N
 Thermo Fisher Scientific, USA  TaqPath COVID-19 Combo Kit  ORF1ab, N, and S

Targeted Genes on SARS-CoV-2 Genome; b Also targets Human RNase P

 

Handling the Pandemic: Malaysia’s Approach

The Malaysian government took quick and effective steps to control large scale gatherings in the country, especially after new infections were traced back to a religious event in February, which was attended by over 15,000 people. With limited knowledge about the new enemy that the country needs to confront, the government acted fast taking effective measures to control the infection from spreading.

As the country was not equipped to do the required number of tests, social distancing was the immediate choice available for the government. The movement control order (MCO), which became effective on March 18, 2020, played a critical role in containing the spread of the pandemic and saving lives, as the chart below illustrates. By Mid-April, the number of new cases in Malaysia started declining significantly.

Figure 1: New COVID-19 Cases in Malaysia per Week

Battling COVID-19 - Malaysia Making Steady Progress with IVDs

The government has been relaxing the MCO cautiously in phases since 4th May to restart economic activities. The chart above indicates that the new cases continue to decline, even though many businesses have started functioning in the country since early May. The approaches taken by the Malaysian government for restarting economic activities without compromising safety are very much in line with the TTT approach highlighted in the recent OECD report.

 

Role of IVDs in Containing COVID-19 as Malaysia Moves Forward

Malaysia has already opened most of the economic activities and MCO has been relaxed in many areas. Certain pockets are identified as hotspots, and the government is monitoring these areas closely to control infections from spreading.

The country is moving forward, relying heavily on IVDs. RT-PCR tests were the key IVDs used during the initial phases of the pandemic, including during the MCO period. The RT-PCR tests being used in the country for COVID-testing include tests from ASEAN-based IVD companies such as Mediven, ADT Biotech, and JN Medsys, in addition to tests from various multinational companies.

By Mid-April, Malaysia expanded its testing capacity to 11,500 RT-PCR tests per day through 43 laboratories across Malaysia. This was further increased later by employing China-based BGI’s automated RT-PCR testing devices. Used by the Institute for Medical Research (IMR) and Kota Kinabalu Public Health Laboratory (in Sabah, East Malaysia), these devices offer additional capacities of 6,000 tests per day.

In Malaysia, PCR tests in the private sector cost between RM400 and RM 700 for individual users. Results can take 24 to 48 hours. Such high costs and delays in getting results pose as major challenges for using them for expanded testing in Malaysia. Other challenges include the need for skilled personals for testing. Hence, instead of PCR, rapid tests are being considered for fast screening. Immunoassays are particularly suitable for large scale testing for identifying people who are infected and developed antibodies against the virus.

The Institute of Medical Research (IMR) and the National Public Health Laboratory (NPHL) have been validating various antibody rapid tests for expanding COVID-19 testing in the country. The recommended antibody rapid tests in the country include Lionrun Shanghai Liangrun Diagnostics Kit, Wondfo, Vazyme, Standard Q Covid-19 igM/IgG Combo, and Healgen.

Antigen rapid tests have also been approved by the MOH for screening. Malaysia has recently procured 200,000 antigen rapid tests from South Korea-based SD Biosensor, branded as Standard Q Covid-19 Ag. These tests have an accuracy of 84.4% and specificity of 100%. Though not as accurate as PCR tests, these tests offer a cost-effective option for large-scale testing.

Since antigen rapid tests require biosafety cabinets, they are not planned for private clinics. Instead, the government plans to use them in senior care centres and also for screening foreign workers. They have also been distributed in the airports and borders, where biosafety cabinets will be established. Overall, the demand for IVDs in Malaysia per month for COVID-19 testing can be over $100 million in the coming months.

The multi-level battling of COVID-19 pandemic in Malaysia, including stringent social distancing measures, have played critical roles in saving lives. The progress in controlling the disease has been commendable, particularly in comparison with the devastation this virus has created in many advanced nations such as Italy, Spain, the U.K, and the United States.

Though the country is still on its way to contain the pandemic, fast, and decisive actions by the government is being proven to be effective, as of now.

Syamala AriyanchiraBy Syamala Ariyanchira

May 18, 2020

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