Health Desk- 06 July, 2020: 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 on Sunday.
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.
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.