Rapid Test Kit: Gonoshasthaya finally gets nod for validation

In a dramatic development, the Directorate General of Drug Administration has allowed Gonoshasthaya Kendra to submit its home-grown rapid test kits for Covid-19 to BSMMU or icddr,b for validation.

"The drug administration has written to us saying we can either submit our kits to icddr,b or Bangabandhu Sheikh Mujib Medical University [BSMMU]," said Dr Zafrullah Chowdhury, founder and trustee of Gonoshasthaya Kendra.

"This is a very welcome development," he told The Daily Star yesterday.

The DGDA has also written to BSMMU and icddr,b, requesting them to cooperate in the validation process of the kit -- Rapid Dot Blot -- that can test for both antibody and antigen in human blood.

He said Gonoshasthaya also contacted BSMMU, where it wants to submit the kits developed by a team of its scientists -- Bijon Kumar Sil, Nihad Adnan, Raeed Jamiruddin, Firoz Ahmed and Mohibullah Khondoker.

This approval by the DGDA is a significant shift from its earlier position that Gonoshasthaya must go through any of the contract research organisations (CROs) to validate the test kit.

When a Gonoshasthaya team went to the DGDA on April 26, the latter's Director General Maj Gen Mahbubur Rahman had instructed it to go through the CROs.

The same day, Zafrullah held a press conference to tell the public that the DGDA was not cooperating with them for the kit validation despite the risks of the Covid-19 infecting more people every day.

The following day, the health ministry held a press conference and said Bangladesh was not going for rapid test kits for now as the World Health Organization does not recommend it and that there are high rates of inaccurate results in this method.

On April 28, Gonoshasthaya wrote to the DGDA, saying it would not go through the CROs and added that CROs are a vehicle of corruption and that going through them will raise the cost of the kit.

It then requested the DGDA to write to the public institutions like the BSMMU, the Institute of Public Health, Armed Forces Institute of Pathology or the Institute of Epidemiology, Disease Control and Research for validation of the kits.

In line with Gonoshasthaya's request, the DGDA's permission came two days later.

Zafrullah said they are now waiting for the Rapid Dot Blot kit's protocol clearance. The organisation had submitted the kits to the Bangladesh Medical Research Council (BMRC) for this purpose.

"We hope we can get the BMRC clearance in a day or two and then [we will] submit the kits to the BSMMU for validation."

Rapid Dot Blot and RT-PCR will be compared in various ways during the validation process, he said, adding that it should not take more than 10 days.

The rapid test kit is mostly used for surveillance purpose, Zafrullah said, explaining that many of the RMG factories are now open for obvious reasons, but it is not possible to conduct RT-PCR test on all the workers going to the factories because it is expensive, as well as time-consuming.

On the other hand, it takes five to 15 minutes to test with the rapid test kits.

"You set up a testing camp at the entrance of a factory and test the workers and others. Those found negative will be allowed and others [should be sent] to isolation," the veteran physician said.

On the government's concerns of inaccuracy, he said it depends on the quality of kits.

"All tests have some level of errors. Rapid test kits may also have some errors. But the accuracy level of our rapid kit would be no less than that of RT-PCR," he said.

Currently, Bangladesh is using RT-PCR test, which diagnoses the virus in fluids of the nose or throat. It is considered the gold standard for Covid-19, but many countries are also using the antibody test.

Dr Zafrullah said due to the fact that Rapid Dot Blot can test both antibody and antigen, its accuracy is higher than that of only antibody test.

"We believe these results that we have found during our internal testing will come out in the validation as well. We thank the DGDA for allowing us to go directly to BSMMU for validation," he said.

BSMMU Vice-Chancellor Kanak Kanti Barua yesterday told The Daily Star that they have received the letter from the DGDA requesting for validation of the Gonoshasthaya kit.  He said they also have received the letter from Gonoshasthaya Kendra. 

"We will contact Gonoshasthaya Kendra next Saturday. We will need to exchange scientific documents before we go for validation," the VC said.