The drug administration said Gonoshasthaya Kendra’s rapid test kit will not be registered because it had not met the standard set by the government’s technical committees.
The Technical Committee on Investigational Drugs, Vaccines and Medical Device formed by the health ministry fixed the sensitivity and specificity of a rapid antibody test kit at 90 percent and 95 percent.
But Gonoshasthaya’s antibody test kit’s sensitivity is 69.7 percent and specificity is 96 percent, said a letter sent to Gonoshasthaya Pharmaceuticals on Thursday by the Directorate General of Drug Administration (DGDA).
The committee followed the US Food and Drug Administration guidelines in fixing the levels, said the letter.
DGDA’s Technical Committee on Medical Device also made similar recommendations.
“It has not been possible for the drug administration to register the GR Rapid Dot Blot test kit,” said the letter signed by Director General Maj Gen Md Mahbubur Rahman.
However, the DGDA will provide technical assistance for further development of the kit.
Asked for comment, GR Rapid Dot Blot Project Coordinator Mohib Ullah Khondoker said it was sad that the drug administration has not accepted the recommendations made by the Bangabandhu Sheikh Mujib Medical University (BSMMU).
The BSMMU, which trialled the kit for over a month and sent the report and recommendations to the DGDA on June 17, suggested that the kit be used for assessing what part of a community has been infected by the coronavirus.
The kit is effective in 11-40 percent of the cases when tested in the first or second week of the infection, says the BSMMU report and recommended against using it to detect an infection.
However, the BSMMU recommended that the kit be used in the cases where RT-PCR tests are not available.
Mohib Ullah said the FDA guidelines referenced by the DGDA were not considered by the BSMMU during its trial. The BSMMU is the highest medical academic institution in the country and its recommendations should not be ignored, he added.
“We will soon sit with the BSMMU over the issue,” he told The Daily Star yesterday.
In late April, Gonoshasthaya sought DGDA approval for its rapid test kit. The DGDA asked Gonoshasthaya to go through a contract research organisation, but Gonoshasthaya said the drug administration itself should do it, considering the nature of the emergency.
On April 30, the drug administration allowed Gonoshasthaya to get the kit trialled by the BSMMU or icddr,b. Gonoshasthaya Kendra decided to get the trial done at the BSMMU.