Gonoshasthaya Kit: BSMMU again delays test results
The submission of the report on Gonoshasthaya Kendra's rapid test kit for Covid-19 has been postponed for the third time in a row by BSMMU officials, frustrating the scientists who developed the kit well before most other countries.
"It is taking some more time to complete the whole work. The committee concerned is trying to submit the report to the drug administration by June 17 or 18," said Prof Dr Kanak Kanti Barua, vice chancellor of Bangabandhu Sheikh Mujib Medical University, while speaking to The Daily Star yesterday.
BSMMU, which was chosen by the Gonoshasthaya Kendra for the performance trial of the GR Rapid Dot Blot, was first scheduled to submit the report by June 10. Later, the date was rescheduled to June 16, which has again been postponed.
Gonoshasthaya Kendra scientists have expressed sheer frustration over the delay in submitting the report to the Directorate General of Drug Administration (DGDA), which is then supposed to authorise approval for mass production.
"We have nothing to say. We are just frustrated, especially when so many countries are using the rapid test kit and when the infection is rising exponentially in Bangladesh," a scientist of the Gonoshasthaya Kendra told The Daily Star.
The team of scientists -- Dr Bijon Kumar Sil, lead researcher, along with Nihad Adnan, Raeed Jamiruddin and Firoz Ahmed -- developed the antibody kit and an antigen kit.
Dr Bijon Kumar Sil said results could be nearly 100 percent accurate if samples from each patient is run through both tests. Bangladesh could have gone for large-scale testing if the approval had come earlier and that could have helped stem the spread and rise in infections.
A Gonoshasthaya Kendra scientist said no one in the world uses more than 200 kits for a performance trial, but the BSMMU has used about 600. It should not have taken more than two weeks to complete the trial and submit the report.
Despite the outbreak of a pandemic, the authorities have been slow in approval of the kit when authorities in India, the US, UK and European Union have been issuing emergency authorisation approval for rapid testing kits.
The Indian Council of Medical Research and All India Institute of Medical Sciences have recommended the use of the first antigen-based testing kit for Covid-19 to enable faster diagnosis at lower rates and without laboratory examinations of samples.
The kit, produced by Korean firm SD Biosensor, which has a manufacturing unit in Manesar of Gurugram, can be used in field settings, reported the Times of India yesterday.
Following a request on March 18, the DGDA approved imports of regents on April 5 and then Gonoshasthaya RNA Biotech Limited, a sister concern of Gonoshasthaya Kendra, developed the kit and first approached the DGDA on April 26 for validation.
On April 30, the DGDA allowed Gonoshasthaya to have the performance trial at the BSMMU, which then formed a committee and on May 12 wrote a formal letter asking Gonoshasthaya to supply kits.
Since May 13, Gonoshasthaya has supplied 600 antibody and 500 antigen kits to the BSMMU. The trial of antibody kit was over by June 5 but no report has yet been submitted. The trial of the antigen kit had been suspended as Gonoshasthaya Kendra found discrepancies in the process of saliva sample collection.
"We have since developed a device to properly collect saliva for the antigen kit. But as the antibody trial report is yet to be submitted, we have not supplied the device yet," said Dr Mohibullah Khondoker, GR-Rapid Dot Blot Project Coordinator.
Gonoshasthaya Founder Dr Zafrullah Chowdhury, before he was infected with coronavirus, had told The Daily Star that the authorities were not realising how big of crisis period this is.
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