Locally manufactured kits bring a host of advantages and benefits to the nation and society
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 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.”
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