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Gonoshasthaya Kendra develops kits, awaits govt approval

Bangladeshi private hospital Gonoshasthaya Kendra claimed to have developed Rapid Dot Blot, a low-priced testing kit that can examine samples to detect Covid-19 as fast as in 15 minutes.

"We have already applied to the government for its approval of using the kit on field level seven days back and have been waiting for the approval," said Dr Zafrullah Chowdhury, trustee of the hospital.

Refuting Gonoshasthaya Kendra official's claim, Major General Md Mahbubur Rahman, Director General & Licensing Authority of the Directorate General of Drug Administration (DGDA), however, said: "Not seven days ago, they have just applied for permission on Wednesday."

Dr Zafrullah said production cost of each kit would be between Tk200 and Tk250 and they have plans to sell it without any profit. “If the government does not impose any tax or VAT, the market price will remain the same,” he said.

"A technical team of Gonoshasthaya-RNA Biotech Limited developed the kit at a cost of Tk2 crore. After two-months, of research, Prof Dr Bijon Kumar Sil, head of the Department of Microbiology at Gono Bishwabidyalay, and his four associates--Dr Nihad Adnan, Dr Mohd Raed Jamiruddin, Dr Firoze Ahmed and Dr Muhibullah Khandaker--invented the kit," said Dr Zafrullah.

While explaining the technique, Dr Nihad Adnan said even though Reverse Transcription Polymerase Chain Reaction (RT-PCR) is the gold standard to look for the RNA virus with mucus samples, the dot blot test looks for antibodies that are created in response to a given virus, and since for each virus the body generates a different kind of antibody, the dot blot test will be able to detect the presence of the Covid-19 virus.

According to the organization, Prof Bijon has vast experience of inventing another test-kit to detect SARS virus. During the SARS outbreak in 2003, he was in Singapore and fought the disease successfully. Two years earlier, he joined the university and has since been working to prevent the Dengue disease.

Dr Zafrullah said: "If the government would not understand the urgency of the Covid-19 situation, why would it make us wait for a week?

"It is the government's ignorance and bureaucratic complication (in dealing with the situation)," he added.

The DGDA director-general said that they have to test the kit with a third party laboratory, such as icddr,b. “Also considering the serious public health concern, we will inspect the lab where the kit would be developed,” he added.

Although the "Rapid Dot Blot" system is not recognized by the World Health Organization (WHO), it's up to Gonoshasthaya Kendra as to how quickly the kit will be developed, because permission depends on proper protocol including successful trial, the DG added.

However, Meerjady Sabrina Flora, director of the Institute of Epidemiology, Disease Control and Research (IEDCR) said: “A team from Gonoshasthaya Kendra came to us and discussed their newly developed kit. After proper testing, we will consider to use it.”

Diagnostic method

Jahangirnagar University (JU) Associate Professor Dr Nihad Adnan, a member of the four-member team, said the popular standard tests for coronavirus are Reverse Transcription Polymerase Chain Reaction (RT-PCR) and antibody assays.

RT-PCR confirms by sequencing nasopharyngeal swab or sputum sample, taking few hours to two-days time to publish the result. Whereas, antibody assays use blood serum, saliva and sputum samples to provide the results within few minutes, confirms by sequencing, and predicts the type of treatment required.

The new kit can detect coronavirus within 10-15 minutes and indicate the need to undergo RT-PCR or antibody assays testing, Dr Nihad added.

A high-level skilled team headed by Dr Bijon Kumar, a member of Rapid Dot Blot SARS POC kit development team, started working from February to design and develop the production of the testing kits.

The virus SARS-CoV-2 has changed its genetic structure approximately 384 times since its first appearance in November 2019.

The JU associate professor said every time this virus has affected a new nation, it changed its genetic structure to adapt to the new environment and population, for which the diagnostic methods need to be ethnic group-specific.

“We have developed the kit and to check whether it works, we need to collect samples from someone infected or was in the prevalence of the virus, which is possible with permission from the DGDA," she added.

A Biosafety level 2 plus lab preparation, necessary reagents, and equipment procurement are at the last stage, said the researcher, adding: “If DGDA gives the approval, the kit will be ready to be produced for dot blot within one month and will be available for lateral flow in the next two to three weeks.”

As of now, over 190,000 people have been infected by the strain, which spread from China’s Wuhan city at the end of December 2019.