Scientist questions Gonoshasthaya Kendra’s COVID-19 testing kits

A Bangladeshi scientist based in Japan has questioned the efficacy of the COVID-19 testing kits developed by the Gonoshasthaya Kendra.

Dr Sheikh Mohammed Fazle Akbar, a researcher at the School of Medicine in Ehime University of Japan, says the Gonoshasthaya Kendra needs to answer the questions before the kits could be validated.

COVID-19 diagnosis through blood test is not an accepted process until now, Akbar said in an interview with bdnews24.com.

As of now, looking for the coronavirus itself in swab samples from throat or nose using the reverse transcription polymerase chain reaction or RT-PCR process is considered the most successful method to identify the infection, he said.

“A large number of the virus remain untraced in blood. So if they [Gonoshasthaya Kendra] claim their testing kits are as much sensitive as PCR, they should provide us with a lot of data. Because not even half the patients have had any trace of the virus in their blood,” Dr Akbar said.

These factors have forced the medics across the world to opt for the “painful process of collecting samples from throat and nose”, the researcher said.

“It’s painful for both the patients and those collecting the samples. Sometimes the medical workers get infected,” he said.

“They [Gonoshasthaya] must not hide the scientific factors if they want validation when an established PCR test trusted around the world is already there,” Dr Akbar added.

The Ganashasthaya Kendra has named its kits “GR COVID-19 Rapid Antibody Dot Test”.

Many other countries have developed rapid testing kits for novel coronavirus but those are not being used due to restrictions imposed by the World Health Organisation and other regulatory agencies.

“The kits have been made coordinating antibody and antigen which can identify a coronavirus patient in five minutes,” said Gonoshasthaya researcher Bijon Kumar Sil, who headed the team that developed the kits.

The new kits can accurately detect novel coronavirus infection in no time, he claimed.

“I heard that their testing kits have sensitivity equivalent to the PCR or more. Now, a critical scientific question remains — as of now, testing a blood sample has never yielded more than 35 percent positive cases, so how can we expect a 100 percent sensitivity or a sensitivity equivalent to the PCR?” Dr Akbar asked.

“Blood sample tests initially yielded only 1 percent positive cases. Layer a Chinese paper reported that they got 30 to 35 percent positive cases at different times. Then how do we expect 100 percent?”

“If using antigen yields 100 percent results, then it is a great invention,” he said.

“However,” he added, “I haven’t seen any article anywhere where such tests yield 100 percent results,” he said.

Dr Akbar won plaudits after he developed Nasvac, a medicine to treat Hepatitis-B, after 32 years of research.

After completing his PhD in medical science, he is continuing research work and is chief editor of Euro-Asian Journal of Hepato-Gastroenterology.

He said Gonoshasthaya’s findings were not even published in any peer-reviewed journal, which is a common practice.   

“It would have been a groundbreaking invention if the test can be done by collecting blood samples only,” Dr Akbar said, pointing out the reduced risk of infection of health workers if they do not need to collect swab samples.     

“They are saying that their kits are more sensitive than PCR, then they must have carried out a comparative study. They were supposed to submit the data to other scientists or the regulatory authorities. They would show how many tests they conducted to prove their claim,” the scientist said.

Dr Akbar also pointed out that the US and some other countries were using antibody testing kits because they have reached a a stage in the epidemic when the authorities need to check the spread of the virus.

For internationally recognised validation, the Gonoshasthaya Kendra must explain to a third party if their kits can be used for diagnosis of coronavirus patients for treatment.  

“To put it more scientifically, we need to know the antigen structure after finding one. We know which antigen structure of this virus can be used for testing kits. But they have not said it. I don’t know whether they will provide their literature,” he said.

Dr Akbar warned that there should not be a lack of seriousness during a pandemic.

“It’s not a child’s game,” he said.