Gonoshasthaya seeks quick registration, marketing permission

Staff Correspondent | New Age Jun 19,2020

Gonoshasthaya Kendra founder and trustee board member Dr Zafrullah Chowdhury on Friday urged the Directorate General of Drug Administration to issue registration to the rapid COVID-19 testing kit and permit its marketing based on the recommendations from Bangabandhu Sheikh Mujib Medical University.

‘I thank BSMMU for recommending the Gonoshasthaya Kendra’s Rapid Dot Blot Kit for testing COVID-19. I hope that the DGDA, considering the present coronavirus situation, will immediately implement the recommendations by giving registration to and marketing permission for the antibody kit,’ he said in a press statement.

The freedom fighter physician said that the percentage of the kit’s effectiveness was a scientific matter and scientists were upgrading its effectiveness.

GK issued the statement as part of their reaction over the BSMMU report.

DGDA director general Major General Md Mahbubur Rahman was not found for comments despite efforts.

But DGDA officials said that the drug regulation agency was yet to decide whether to approve the kit.

DGDA deputy director and spokesperson Md Ayub Hossain on Thursday told New Age that their evaluation committee was yet to decide the fate of the antibody testing kit as the BSMMU report could not be analysed yet.

On Wednesday, BSMMU vice-chancellor Kanak Kanti Barua said that the Dot Blot kit could successfully diagnose only 11–40 per cent of the patients who were tested within two weeks of showing COVID-19 symptoms.

BSMMU made three recommendations about using the GK antibody kit.

It said that the kit would be useful in making decisions about plasma collection, in ending the quarantine period and lockdowns as part of the pandemic control as the kit could identify 70 per cent cases when it was used to test those who had already recovered from the infection.

BSMMU report also recommended that the kit might be used in those areas where people had no access to the RT-PCR test and in testing those who had coronavirus infection symptoms but were found negative in the PCR test.

Gonoshasthaya Kendra concern Gonoshasthaya-RNA Biotech Limited’s researchers have developed two Rapid Dot Blot Kits — one for antibody test and the other for antigen test — and BSMMU trialled the performance of the antibody kit upon a DGDA instruction.

After 34 days of trial, BSMMU submitted the report on the antibody kit while the antigen kit trial remained suspended for technical problems, as said by the authorities, at a time when the country is in an acute crisis due to the COVID-19 pandemic.

On May 13 GK handed over specimens of the Rapid Dot Blot Kits to the BSMMU authorities for the performance trial.

GK claimed that their kits were able to test a lot of people in a short time at a low cost while the PCR test was costly and time consuming.

Bijon Kumar Sil, the lead researcher and a medical teacher who has developed the COVID-19 testing kits, told New Age that they found a 100 per cent success in the GK clinical trial of their antibody test kit.