Gonoshasthaya seeks temporary registration to antibody kit
Gonoshasthaya will go to Bangabandhu Sheikh Mujib Medical University for the external validation of the kit. If the BSMMU cannot do it, they will go to the icddr,b for the kit’s trial
Gonoshasthaya Kendra has applied to the Directorate General of Drug Administration (DGDA) for issuing registration to its antibody rapid test kit temporarily, taking the internal validation report into consideration.
Dr Muhibullah Khandaker, coordinator of the GR Covid-19 Dot Blot project, said this through a press release on Monday afternoon.
"The director general of drug administration listened to us and assured us of providing all-out support in a meeting held on July 5. IEDCR Principal Scientific Officer Dr ASM Alamgir and its Deputy Director Salauddin were present there," he said.
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"We have submitted our internal validation report summary, following the Umbrella Guidelines of the US Food and Drug Administration (FDA), and the antibody kit design to the DGDA. We have applied for the temporary registration to the kit," he added.
The DGDA has asked to conduct another trial of the kit following the FDA Umbrella Guidelines. Gonoshasthaya will go to Bangabandhu Sheikh Mujib Medical University for the external validation of the kit. If the BSMMU cannot do it, they will go to the icddr,b for the kit's trial, the press release said.
Dr Muhibullah said there is now no policy on antigen kits. The guideline is likely to be finalised by July 8.
