The test produces results in 24 hours and provides a more accurate assessment
by AFIQ AZIZ / pic by ARIF KARTONO
MALAYSIA Automotive, Robotics and IoT Institute (MARii) said it expects to commercialise a locally developed device that can tell whether someone has immunity to Covid-19 soon.
MARii CEO Datuk Madani Sahari said the ImmuSAFE COVID+ biochip that was developed by Sengenics Sdn Bhd has been certified with 100% sensitivity and specificity, meaning that it is highly accurate for public use and will be valuable in measuring the effectiveness of any future vaccines.
The test, which produces results in 24 hours, will also provide a more accurate assessment whether to allow people to go back to work after being exposed to the virus.
The developers expect the device will be used to complement existing nasal swab test kits used to detect the virus in humans.
Madani said MARii had already obtained the validation for the product from the Institute of Medical Research, an agency under the Health Ministry.
“We are hoping to get the approval by the Medical Device Authority by this week before we can start to commercialise ImmuSAFE,” he told the press after launching the test kit in Cyberjaya yesterday.
Madani said ImmuSAFE is the world’s first lab-based, multi-antigen and multi-domain Covid-19 serology test — an examination of blood serum comprising nine functionally validated regions of the N and S proteins of SARS-CoV-2.
Through the device, authorities can identify how much someone’s antibody correlates with ongoing protection and development of durable immunity against future SARS-CoV-2 infection.
“This makes it an ideal platform for applications in both Covid-19 studies and vaccine clinical trials,” Madani said.
Through MARii’s capabilities in big data management, telematics and data analytics, this collaboration with Sengenics’ accurate test capabilities opens possibilities for data-driven management of the Covid-19 pandemic.
“This is highly essential to balance health protection for Malaysians with the need to keep the economy sustainable. With this, we can identify those who are immune to the virus, and how long their immune system can last.
“As such, these groups may not have to be quarantined and instead, they can go to work while observing the standard operating procedures. This will help revive the economy, which is one of the main concerns of Covid-19 impacts,” Madani said.
The test kit, which has been produced, is expected to be used in some laboratories throughout the nation.
Madani guaranteed that the kit, upon commercialisation, will be made affordable to the public. He said it will cost less than the RT-PCR swab test which is about RM300 per examination.
“It is not just about the sensitivity or the validity of the results, but must make sense economically, meaning that it must be affordable,” Madani said.
Sengenics CEO Dr Arif Anwar said the research and development for the product had cost the company up to US$6 million (RM24.9 million) and the firm is also looking for other partners around the world to distribute the facility.
Manufactured in Malaysia, the test would require 24 hours before the result could be obtained.
MARii is expected to develop an automation system, so the results could be obtained within the same day, hence, increasing the test frequency.
All data collected via the test will be safeguarded in the Covid-19 Intelligent Management System developed by MARii.