by SHAHEERA AZNAM SHAH / pic credit: mediven.com.my
THE demand for Covid-19 test kits has been overwhelming as the Delta variant of the coronavirus drives another global surge of infection rates.
In Malaysia, for instance, daily infection rates have surpassed the 17,000 mark despite the movement restriction order.
Despite the encouraging numbers in vaccination capacity, forecasts suggest the country could tally infection numbers as high as 24,000 daily cases in September as the virus spreads.
Due to the surge, manufacturers have seized the opportunity to fabricate diagnostic kits for home use and to supply to medical institutions and health facilities.
Medical Innovation Ventures Sdn Bhd (Mediven) — a Covid-19 test kit supplier to the Ministry of Health (MoH) run hospitals, district clinics and the National Public Health Lab Laboratory — has begun to develop diagnostics kits for self-testing.
A representative from Mediven told The Malaysian Reserve (TMR) the Covid-19 diagnostics has become its main source of revenue as the manufacturer is currently focusing on distributing the kits, both for professional and home use, locally and abroad.
“The sharp spike of cases recently in our country has required more testing to fulfil the recommendation by the World Health Organisation to meet the 5% positivity rate threshold.
“Malaysia is carrying out about 120,000 tests daily and we still need to increase the test capacity to ensure we are doing enough testing for the number of people who are getting infected and have the correct understanding of the level of virus transmission in the community,” the spokesperson said.
The Malaysian-based diagnostics test manufacturer currently has two Covid-19 self-tests — ProDetectTM Covid-19 Antigen Rapid Self-Test and ProDetect® COVID-19 Antigen Rapid Self-Test (Oral Fluid).
As of July 29, both products have yet to be listed under Medical Device Authority’s (MDA) approved self-test Covid-19 test kits, or the conditional approval, by the ministry.
As of the time of writing, MDA has listed six self-test Covid-19 test kits, which detect RTK-Antigen, and were approved based on the decision on the consensus of the Covid-19 Test Kit Expert committee.
Reszon Diagnostic International Sdn Bhd, who had received the conditional approval for its Salixium-Covid-19 Antigen Rapid Test, said it has been ramping up production to a seven-digit figure each month.
“We have been ramping up our local production to aim for a few million kits output each month in order to support Malaysia’s situation.
“As Malaysian become more aware of the availability of self-test kits, we will continue to increase this product line to cater for the local demand,” a spokesperson told TMR.
With such production scale, the spokesperson said Reszon Diagnostic is now preparing to widen its distribution market globally, specifically to countries with high infectivity rates that could benefit from self-testing.
Another manufacturer, Bursa Malaysia-listed Hong Seng Consolidated Bhd recently secured another government contract to supply polymerase chain reaction (PCR) test kits for MoH after fulfilling its previous deal.
“The demand for Covid-19 tests in Malaysia has definitely increased due to the mass testing and spike in cases,” Hong Seng Consolidated Bhd ED Christopher Chan told TMR.
At present, the group’s holding company, HS Bio Sdn Bhd, is applying for MDA approval for its Covid-19 saliva test for home use.
“Our holding company, HS Bio, is in the middle of applying for MDA approval for saliva kits that have been recommended by our partner, Fosun Group from China.
“Such kits have been recommended by them due to successful widespread use and success in helping China to open up their economy since last year,” Chan said in an email reply.
The group secured an RM112.32 million contract from MoH to supply Covid-19 PCR tests for Institute for Medical Research (IMR) and Public Health Laboratory Kota Kinabalu, Sabah, through its 51%-indirect unit, Pantasniaga Sdn Bhd.
In February, the group bagged an RM34.25 million contract to supply similar products to IMR which was completed in March.
According to Bernama, Putrajaya plans to have price controls on test kits to ensure affordability to the public.