Gonoshasthaya coronavirus testing kits get government approval for trial

The Directorate General of Drug Administration has permitted Gonoshasthaya Kendra to run trials of its coronavirus testing kits amid debates over the use of rapid tests.

The non-government institute can now run the trials at the Bangabandhu Sheikh Mujib Medical University or International Centre for Diarrhoeal Disease Research, Bangladesh.  

“We have been saying from the beginning that the kits’ effectiveness must be examined by a third party. Now Gonoshasthaya has agreed to give the kits to the BSMMU or icddr,b for the trials,” Maj Gen Mahbubur Rahman, director general of the DGDA, told bdnewes24.com.

He said the DGDA had already informed BSMMU and icddr,b about its decision.

Both of them can run the trials but one of them will supervise the process, Mahbubur said.   

The DGDA will begin the registration process if the kits pass the trials, he added.

Gonoshasthaya Trustee Zafrullah Chowdhury told bdnews24.com they will sit with the BSMMU to discuss the handover of the kits.

Mohib Ullah Khandaker, the coordinator of the Gonoshasthaya team that developed the kits, said they have validated the kits at their labs but it needs validation by a third laboratory.

“This is the rule. We have been asking the Drug Administration for [the approval of trial following the rules]. They have finally given the permission, though it came late,” he said, referring to a “trivial tug-of-war with the DGDA since Apr 22”.

The Gonoshasthaya Kendra announced the invention of the cheap and fast kits when the novel coronavirus pandemic hit the Bangladesh shores. The DGDA approved the import of reagents for the kits on Mar 19.

The private organisation later postponed the event scheduled for Apr 11 to hand samples of the kits to the DGDA, the World Health Organization, Bangabandhu Sheikh Mujib Medical University, the Institute of Epidemiology, Disease Control and Research and other organisations citing a “technical glitch”.

It organised the event on Apr 25. But representatives from only the US government’s Centers for Disease Control and Prevention attended the function.

Later, Zafrullah accused the DGDA of time-wasting in approving its kit. He alleged the directorate also declined to receive samples of its kit.

Mahbubur refuted the allegation that the government is not cooperating with the Gonoshasthaya Kendra with regards to launch of the kits.

He accused the Gonoshasthaya Kendra of misleading the public about the kits.

He also said a total of 18 rapid test kits were awaiting DGDA’s approval currently, but the directorate will not approve any of the kits without the WHO’s recommendation.

The government will continue relying on RT-PCR test, which looks for the novel coronavirus itself in swab samples from patients’ throat or nose, Mahbubur said.

RAPID TEST

The more common type of rapid diagnostic test marketed for COVID-19 is a test that detects the presence of antibodies in the blood of people believed to have been infected with COVID-19.

The WHO says antibodies are produced over days to weeks after infection with the virus.

The strength of antibody response depends on several factors, including age, nutritional status, severity of disease, and certain medications or infections like HIV that suppress the immune system.

Studies suggest that the majority of patients develop antibody response only in the second week after onset of symptoms, according to the WHO.

This means that a diagnosis of COVID-19 infection based on antibody response will often only be possible in the recovery phase, when many of the opportunities for clinical intervention or interruption of disease transmission have already passed.

Antibody detection tests targeting COVID-19 may also cross-react with other pathogens, including other human coronaviruses and give false-positive results.

Lastly, there has been discussion about whether the rapid tests detecting antibodies could predict whether an individual was immune to reinfection with the COVID-19 virus. There is no evidence to date to support this, the WHO says.

It does not recommend the use of antibody-detecting rapid diagnostic tests for patient care but “encourages the continuation of work to establish their usefulness in disease surveillance and epidemiologic research”.