| Innovation |
AUGUST , 2021 | THE HEALTH
07
First Malaysian-made Covid-19 self-test kit
Locally manufactured kits bring a host of advantages and benefits to the nation and society
BY KHIRTINI K KUMARAN
THE Salixium Covid-19 Rapid Antigen Rapid Test ( Salixium ) is the first Malaysian-made self-test kit approved by the Ministry of Health ( MoH ) through the Medical Devices Authority ( MDA ) for sale locally .
Salixium was jointly developed and produced by Reszon Diagnostics International Sdn Bhd ( Reszon ) and health technology company MeDKAD Sdn Bhd ( MeDKAD ).
“ This is a first of its kind joint partnership , whereby Reszon and MeDKAD teamed up to develop a comprehensive self-test kit ,” explains EL Law , founder of Reszon .
A comprehensive self-test kit
What sets Salixium apart from the other self-test kits in the market is its combination of dual swab samples requirement and technological integration .
“ By using dual swab samples of nasal and saliva specimens , the detection rate of the Salixium is increased , which also reduces false-negative results ,” shared Law .
The Salixium has 91.23 per cent sensitivity , and its specificity is recorded at 100 per cent .
Each test kit comes with its unique QR code , which is directly linked to the Salixium app , developed by MeDKAD , responsible for the technological integration of the kit .
Users are required to scan the unique
EL Law
By using dual swab samples of nasal and saliva specimens , the detection rate of the Salixium is increased , which also reduces false-negative results .”
— EL Law
QR code from the test kit device before using it . Upon completing the test , they need to capture an image of the test kit device and upload it into the mySALIXIUM app . The vision artificial intelligence will validate the results , and it will be updated automatically to the MySejahtera app .
According to Law , the unique QR code and mySALIXIUM app feature prohibit misuse or reuse of the same test kit and result alteration .
Another important aspect the QR code provides is traceability .
“ Apart from test kit devices , each box carton and test kit packaging have its unique QR code , which allows comprehensive traceability , from the seller , buyer and user , which the MoH appreciates for ease of contact tracing ,” explained Law .
The Salixium comes with detailed instructions for use ( IFU ) to inform the user of the intended purpose and procedure guide for the correct use of the test kit device , QR code and mySALIXIUM app .
“ We have to inform users about proper disposal . Swab and saliva samples should be placed into a proper bag before disposal .”
High demand
Salixium received its approval on July 16 , 2021 and has been available for public purchase in Malaysia since July 19 , 2021 .
Salixium can be purchased for RM39.90 at registered community pharmacies and health facilities .
Law said there had been an increase in demand .
“ Orders are piling up , and so we are ramping up our production . At the moment , the production capacity is about two million a month . However , the capacity will be increased to 10 million a month from September onwards .”
Salixium is also being exported to France , India , Indonesia and the United Arab Emirates .
Benefitting the nation and economy
With the availability of self-test kits such as Salixium , screening processes are expected to speed up while providing more protection as one can self-test in the safety of their own home instead of visiting clinics or health labs .
“ Self-test kits are only considered as an instant screening test . For confirmatory tests , RT-PCR tests are required ,” explained Law .
According to Law , self-test kits are also a viable alternative for the economic sector to conduct a regular screening process for its workforce to ensure the safety of its staff . The results can be obtained in less than 15 minutes .
“ Workers can test themselves at home and share the result documented in their mySALIXIUM app . This is a more responsible and less time-consuming screening process , which would be productive for companies .”
With regards to Salixium , Law said : “ We need to support locally made products . Having a local self-test kit manufacturer and distributor provides the nation with assurance of test kits availability , especially during emergencies .”
Another advantage of manufacturing locally is that it creates job opportunities during the pandemic , especially for those in the B40 and OKU groups .
“ We have 15 labs and about 1,500 workers , strictly adhering to the standard operating procedures ( SOPs ). And in line with ramping up the production capacity , we will be recruiting more workers .” — The Health