Gonoshasthaya Kendra misleading the public about COVID-19 antibody test kits: DGDA

The Directorate General of Drug Administration has accused the Gonoshasthaya Kendra of misleading the public about its antibody testing kits to detect COVID-19.

Director General Maj Gen Mahbubur Rahman has also refuted the Gonoshasthaya Kendra‘s allegation that the government is not cooperating with it with regards to launch of the kits.

At a news conference on Monday, he explained why there was no government representative at the Apr 25 event where they were to receive samples of the kits.

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 attended the function. 

Gonoshasthaya Kendra Trustee Zafrullah Chowdhury expressed gratitude to Foreign Minister AK Abdul Abul Momen, National Board of Revenue Chairman Abu Hena Md Rahmatul Muneem, customs officials and the DGDA for the import of reagents. He thanked the Prime Minister’s Office for its help to get blood specimen of COVID-19 patients.

But ion Sunday, he accused the DGDA of time-wasting in approving its kit. He alleged the directorate also declined to receive samples of its kit.   

DGDA chief Maj Gen Mahbubur said it approved the import of reagents for the kit when the Gonoshasthaya Kendra applied for permission on Mar 18.

“Rapid test kits were not being used at the time neither is it now. The World Health Organization has not yet recommended the rapid kits as yet,” he said.

“But we approved the import of reagents for trials on some conditions in a meeting on Mar 19 appreciating the fact that a Bangladeshi scientist invented the kits and we may need the kits in future, Mahbubur said.

He said they found in inspections that the Gonoshasthaya Kendra was going for large-scale production instead of trials.

“Moreover, it was our understanding that they would produce antibody kits, but for the last two days, we have seen that the kits will show the presence of antigens in blood. I have no knowledge of any testing kits showing antigens being used anywhere in the world,” DGDA chief said.

He said the DGDA had asked the Gonoshasthaya Kendra not to organise any event for handover of unapproved kits for trials.

“They could organise a big event after approval. But they arranged the function and said many things about the directorate and the ministry,” Mahbubur said.

He said a Gonoshasthaya Kendra delegation came to the DGDA on Sunday and submitted the name of an organisation where the trials will be run.

“But later they organised a news conference and everyone saw how they talked, how they alleged that we are obstructing their work,” the DGDA chief said.

He alleged the GonoShasthaya Kendra tried to belittle the directorate in Sunday’s news conference.

“I am humbly telling everyone that we need every individual’s support now. We need support of the Gonoshasthaya Kendra. But such efforts to belittle people and agencies by presenting false information are unfortunate. I dismiss these [information] and urge them to stop running such propaganda,” he added.          

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 novel coronavirus’ DNA in swab samples from patients’ throat or nose, Mahbubur said.

Some countries, including the US, are using antibody tests that look for antibodies to coronavirus created in the patients’ blood, to understand the spread of the virus in the population of certain areas, but not for diagnosis of patients.

It takes four to five days for antibodies to be created after infection while they can remain in patients’ blood even after recovery.

These factors lead to false results in many cases that can subsequently result in wrong treatment.