The Directorate General of Drug Administration has again asked Gonoshasthaya Kendra to complete the validation of its Covid-19 antibody test kit through a contract research organisation (CRO) in line with existing rules.
The drug administration issued the directive on Sunday during a meeting with a delegation from Gonoshasthaya Kendra.
Dr Mohib Ullah Khondoker, coordinator of the GR Covid-19 Rapid Dot Blot Kit project of Gonoshasthaya Kendra said this while briefing the media after the meeting.
He said, "The drug administration officials have listened to our arguments positively."
"We had requested the authority give us permission to register our antibody kit taking into account our internal validation report on it. However, they have again asked us to complete external validation of the kit according to the US Food and Drug Administration guidelines – through a CRO – to comply with the prevailing government rules," he continued.
"A policy regarding antigen kits will be finalised next Wednesday and then the drug administration will send us a format," Dr Mohib said, adding that they have been asked to submit protocol updates according to that format.
Claiming that they have already upgraded their antibody test kit, he said they will send their documents to the drug administration on Monday and then the administration will send those for external validation.
On June 24 this year, the government issued a guideline regarding antibody test kits, he mentioned. "We have been asked to submit our documents following that guideline," he added.
Dr Mohib also noted that the drug administration has agreed to provide a No Objection Certificate (NOC) to Gonoshasthaya Kendra on importing reagents to help them continue research activities. "It will take two weeks for us to complete the tasks the drug administration has asked us to do," he added.
Meanwhile, Dr Bijon Kimar Sil, inventor of the Rapid Dot Blot kit, said, "The sensitivity of our antibody kit is 97.77 percent at present, which is higher than the required level of 90 percent as mentioned in the FDA guideline. The sensitivity was 70 percent for the Bangabandhu Sheikh Mujib Medical University (BSMMU) study approval. The result is now null and void."
It has been learned that the Gonoshasthaya-invented kit might be sent to the icddr,b for external validation this time around.
Earlier, on June 17, the BSMMU submitted a report on Gonoshasthaya Kendra's antibody test kit to the drug administration after assessing its performance. However, the administration declined to register the kit as its sensitivity was below the permissible level.