Gonoshasthaya Antibody Test: Kit to be placed before icddr,b for trial
Gonoshasthaya Kendra is now set to get its antibody rapid test kit trialed by the icddr,b following the Umbrella Guideline of the US Food and Drug Administration (FDA), as sought by the drug administration.
"The director general of drug administration listened to us and wanted to provide us all-out assistance. He wanted another trial of the kit following the FDA Umbrella Guideline," said Dr Bijon Kumar Sil, who led the Gonoshasthaya team that developed the kit, after a meeting with the drug administration yesterday.
Bangabandhu Sheikh Mujib Medical University (BSMMU) does not have the capacity at this moment to conduct trial of the kit following the FDA Umbrella Guidelines, he said.
"The icddr,b can do it. We will go to the icddr,b in a day or two," Bijon said.
Gonoshasthaya Kendra scientists developed the kit -- Rapid Dot Blot -- early March and got it trialed by the BSMMU between May and mid-June.
In its report submitted to the Directorate General of Drug Administration (DGDA) on June 17, the BSMMU said the kit is effective in 11-40 percent of the cases when tested in the first or second week of the infection and should not be used for diagnosing Covid-19.
However, it recommended that the kit be used in the cases where RT-PCR tests are not available. It can also be used for assessing what part of a community has been infected by the coronavirus through antibody test.
After BSMMU's submission of the report to the DGDA, Gonoshasthaya applied for the registration of the kit, but the DGDA refused it saying that the rapid test kit had not met the standard set by the government's technical committees.
The committee fixed the sensitivity and specificity of a rapid antibody test kit at 90 percent and 95 percent respectively following the FDA Umbrella Guideline.
But the sensitivity of Gonoshasthaya's antibody test kit was 69.7 percent and specificity was 96 percent, DGDA said.
In reaction, Mohib Ullah Khondoker, project coordinator of GR Rapid Dot Blot, said the FDA guidelines referenced by the DGDA were not considered by the BSMMU during its trial.
More than a week after that, the Gonoshasthaya scientists held a meeting with the DGDA yesterday.
"Trial of the kit following FDA Umbrella Guidelines does not take much time. Trial of 100 to 150 kits can give a proper result…it may take a maximum of seven days."
Taking the time, which would require for other procedures, into account, the total time would not exceed 15 days," Bijon said.
The BSMMU also began the trial of the antigen kit developed by Gonoshasthaya in recent times, but suspended it midway citing a problem in the sample collection process.
Bijon yesterday said, "We have requested the drug administration to set the procedures of the antigen kit trial beforehand so that it does not create any problem at a later stage. The guideline is likely to be finalised by next Wednesday."
Mohib Ullah Khondoker said the drug administration assured them that it would issue a no objection certificate (NOC) to import reagents required to make kits.
Asked about his reaction, Gonoshasthaya Kendra Founder Dr Zafrullah Chowdhury said he welcomed the decision of the drug administration, but he was a bit frustrated as the authorities were taking a long time to approve the kit.
"I would be really happy if the process of trial and approval would happen at the fastest manner. We will surely follow the drug administration's guideline, but at the same time we expect that the next steps would be completed in a speedy manner," he said.
He urged the government machinery to deeply realise the Covid-19 situation and act accordingly to save lives.
"You work and also allow us to work. The function of the government is not to create any barricade, but to remove it," said Dr Zafrullah, a prominent public health expert.
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