Govt denies Gonoshasthaya Covid-19 testing kits approval

The Directorate General of Drug Administration has denied the Gonoshasthaya Kendra the permission to market coronavirus testing kits on the grounds that these have failed sensitivity test.

Minimum 90 per cent sensitivity is required for such kits while the ones of the Gonoshashthaya Pharmaceutical showed 69.7 per cent sensitivity during trial, the DGDA said in a letter to the organisation on Thursday.

The directorate also cited recommendation by a technical committee for the decision not to give Gonoshasthaya the permission to register its kits, reports bdnews24.com.

The Gonoshasthaya Kendra, however, termed the development “unfortunate”.

Muhibullah Khandaker, the coordinator of Gonoshasthaya’s Covid-19 Dot Blot Project, alleged in a statement that the directorate has dismissed the technical committee’s recommendation.

Bangabandhu Sheikh Mujib Medical University, which conducted the trial, had earlier said the kits were ineffective as they could accurately detect only 11-40 per cent of Covid-19 cases in the first two weeks after those patients showed symptoms.