Latest Covid-19 test kit needs wider sampling, say health experts

PETALING JAYA: With China developing a fast Covid-19 test claimed to be as accurate as the gold standard polymerase chain reaction (PCR) lab test, health experts say it is encouraging but much needs to be proven before it can be called a game changer.

Universiti Malaya professor of epidemiology and public health Prof Dr Sanjay Rampal said while it is encouraging to see so many new test kits being developed by various researchers, there is a need to be very cautious with early results.

He said the results are likely to be over-optimistic as it is still early in the test kit development phase and only a small sample size had been recruited.

His remarks come following news that Chinese scientists have developed a new coronavirus test that is as accurate as a PCR lab test, with results available within four minutes.

The usual PCR tests take hours.

China is one of the world’s biggest makers of coronavirus test kits and in Malaysia, out of the 116 RTK self-test products approved for sale by the Medical Device Authority (MDA), a majority comes from China.

“We should place greater emphasis on test kits that have been researched using large sample sizes and under real-world settings such as clinics, workplaces or schools.

“The diagnostic properties of these new test kits tend to reduce when the test kit is researched outside lab-controlled environments,” Prof Sanjay pointed out when contacted yesterday.

In a peer-reviewed article published on Feb 7 in the journal Nature Biomedical Engineering, a team of researchers from Fudan University in Shanghai said their sensor – which uses microelectronics to analyse genetic material from swabs – can reduce the need for time-consuming Covid-19 lab tests.

This appears to be a solution as some countries experience heavy backlogs and high volumes of Covid-19 testings due to the rapid spread of the highly infectious Omicron variant.

“We implemented an electromechanical biosensor for the detection of SARS-CoV-2 into an integrated and portable prototype device, and show that it detected (virus RNA) in less than four minutes,” the team said in the paper, referring to the official name of the Covid-19 pathogen.

Their trial involved taking samples from 33 people in Shanghai who were infected with the coronavirus, with PCR tests conducted in parallel.

The results from their method were a “perfect” match with the PCR tests, according to the article.

Universiti Malaya Tropical Infectious Diseases Research and Education Centre director Prof Dr Sazaly Abu Bakar noted that this far into the pandemic, a better test for Covid-19 cannot be called a “game changer” but should be seen as an improved tool for better testing.

“If it is to come into Malaysia, the MDA must authorise it first,” he said.