The Directorate General of Drug Administration on Sunday asked Gonoshasthaya Kendra for further performance trial of their updated Rapid Dot Blot Antibody Kit by an external entity as the regulatory authority couldn’t consider the internal trial report for final permission.
A five-member GK team met the DGDA and other officials of the health ministry at the DGDA office in the capital’s Mohakhali at around 12:30pm on the day.
After the scheduled meeting, kit development programme coordinator and Gonoshasthaya Samajvittik Medical College vice-principal Dr Mohib Ullah Khondoker said that the DGDA asked GK for a performance trial of the antibody kit again by a third party like ICDDR,B or BSMMU while for the antigen kit they gave a format for its further development.
‘We have to get an external validation again — like what BSMMU did with regard to sensitivity and specifity of our kit, which were upgraded in the meantime,’ he said.
Gonoshasthaya is yet to decide whether the performance trial would be conducted at BSMMU or ICDDR,B, he said.
He said that they requested the DGDA to give the approval for the kit based on the internal trial report as the kit was immediately needed but the DGDA disagreed.
It is not possible to market the antibody kit in the next 30 days even if everything goes normally, he said.
‘They assured us that they would give us the permission for re-agent importing for the antigen kit,’ he said.
The lead scientist of the kit development team, Bijon Kumar Sil, said that in their clinical trial they found 97.7 per cent sensitivity and 96 per cent specificity of the kit whereas the government guideline required 90 per cent and 95 per cent respectively.
Another scientist of the kit development team, Firoz Ahmed, said that BSMMU originally trialled their kit’s performance as per the decision of the DGDA as per their study design but in the meantime the DGDA set a different guideline for the kit.
‘The DGDA has binned BSMMU’s first report and asked for further trial,’ he said.
He explained that BSMMU trialled the GK antibody kit among suspected COVID-19 patients but the new guideline asked that it should be tested among confirmed patients so that it became easy to achieve the target.
According to government rules, DGDA deputy director Md Salah Uddin said, the internal trial report is not acceptable for the regulatory authority and therefore they recommended the external trial of the antibody kit.
‘GK wants to improve their antigen kit, so we gave them some suggestions,’ he said further.
Asked, he said that only GK wanted the permission for the kit production but 20 to 30 other firms applied for importing them.
He said that in both cases the external validation was a must.
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