Gonoshasthaya Kendra founder and trustee board member Dr Zafrullah Chowdhury on Saturday said that the Directorate General of Drug Administration told GK officials that the DGDA would examine the updated GK antibody kit today.
If the DGDA gives us the permission tomorrow (Sunday) we will produce 5,000 sets of the antibody kit by the next 15 days for the mass people,’ said Zafrullah while taking to New Age on Saturday afternoon.
Noted freedom-fighter physician Zafrullah has been under treatment at Gonoshasthaya Nagar Hospital in the city for various health complications.
Zafrullah said that GK researchers in the meantime updated the GK antibody kit in accordance with the DGDA guideline and the DGDA invited them to present the relevant scientific documents.
I hope that the DGDA will be fully satisfied with our kit now and will give the permission [to use it],’ he said.
The kit development team leader, scientist Bijon Kumar Sil, told New
Age that they developed the sensitivity of the kit so that it could detect antibody with high level of efficiency.
He said that the DGDA recommended 90 per cent sensitivity and 95 per cent specificity for the kit’s approval that GK kit was certain to have achieved.
On June 25, the DGDA turned down Gonoshasthaya Kendra’s COVID-19 testing Rapid Dot Blot Kit as it did not meet the minimum 90 per cent sensitivity and 95 per cent specificity requirements as per the USFDA’s umbrella guideline on serological test and international standard.
Gonoshasthaya-RNA Biotech Limited’s researchers have developed two Rapid Dot Blot Kits — one for antibody test and the other for antigen test — and Bangabandhu Sheikh Mujib Medial University trialled the performance of the antibody kit according to the DGDA decision.
The antigen kit trial remains suspended for technical problems, as said by the authorities, when the country is in an acute crisis due to the COVID-19 pandemic.
Gonoshasthaya Kendra on June 16 finally applied for the approval of their antibody kit after the BSMMU found a 70 per cent success in their trial of the tool.
The DGDA rejected the kit, providing a guideline for updating the kit so that it could get the approval for marketing for specific purposes like sero surveillance and plasma therapy.
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