Govt to allow antibody kit for sero surveillance, plasma therapy

The government has decided to allow production and import of Rapid Antibody testing kits for particular purposes like sero surveillance and plasma therapy after government’s advisory committee finalised a guideline in this regard.

The Directorate General of Drug Administration said that following the guideline they would permit rapid kit to be used for sero surveillance and convalescent plasma therapy as the Directorate General of Health Services had given the decision for that.

They would not allow the kit for acute stage and diagnosis purpose but for research, they said.

To get the permission DGDA has set minimum 90 per cent sensitivity and 95 per cent specificity on the basis of USFDA’s umbrella guideline on serological test and international standard.

DGDA have unveiled the notice dated June 24 on their website.

The public health emergency, drug-medical devices ect evaluation and recommendation committee head and former pro-vice chancellor of BSMMU Professor Mohammed Kamal told New Age that they had finalised a guideline for antibody kit in the meantime realising the importance and necessity of the kit in Bangladesh.

Former dean of Basic Science and Para Clinical Science of the university, Kamal, said that after that any organisation, who wants to produce or import the kit, should maintain the guideline.

Dhaka Medical College medicine department professor and also a member of the committee Mujibur Rahman said that the kit was allowed for research and antibody testing for collecting plasma.

He said that the committee finalised a guideline only but final approval would be given by the DGDA following the conditions.

DGDA’s spokesperson and deputy director Ayub Hossain did not make any comment in this regard and said that they had posted circular on their website.

Antibody kit issue was much discussed after the Gonoshasthaya Kendra declared that they had developed a cost effective and quick responding kit to detect COVID-19 patients.

Kamal said that the GK kit would certainly be cost effective than imported ones; but the GK needed to develop its quality.

In BSMMU trial the kit was found 70 per cent successful.

‘I prefer Gonoshasthaya Kendra kit but they need to improve it and they have the scope, I think,’ he said.

He said that the committee decided not to use the kit for diagnosis as any false diagnosis might spread the disease.

Antibody kit cannot detect the presence of virus perfectly before two weeks of infection or growing of enough antibody in body.

Dhaka University pharmacy department chairman Professor Sitesh Chandra Bachar among others was member of the 12-member committee.

News Courtesy: www.newagebd.net