Govt won’t allow rapid testing kit

The government has decided not to do rapid testing for Covid-19 as the World Health Organization has yet to approve such a test, the health ministry has said.

It also said there is no scope now for the trial of the home-grown rapid test kit developed by the Gonoshasthaya Kendra scientists.

"However, the government will have no objection to accepting the Gonoshasthaya Kendra kits in the future when WHO approves it," said Habibur Rahman Khan, additional secretary (admin) of the health ministry and head of the media cell on Covid-19.

The decision was announced at a press conference at the health ministry yesterday, a day after Gonoshasthaya Kendra criticised the government's drug administration for what it said was taking a bureaucratic approach to validating the rapid test kits, instead of considering the urgent situation in the country.

The rapid test kit, which diagnoses antibodies developed within three to seven days after one is infected with coronavirus, is not being used in any country of the world now. Some countries were using it but stopped after questions were raised regarding accuracy, Habibur Rahman told reporters.

In 30 to 46 percent of the cases, rapid test kits give false positive or false negative results, he said. "If that is the case, think of mental and social impact [the false results would have]."

If a Covid-19 positive patient, thinking they are negative due to an inaccurate result, mingles with others, the virus will spread further, he said, adding, "Considering all these aspects, we are not allowing the test right now."

He said the most reliable kit being used by all the countries for testing Covid-19 is RT-PCR (real-time reverse transcription polymerase chain reaction) that diagnoses the virus from samples collected from a person's nose or throat where the virus can gather.

"We have a stock of more than one lakh RT-PCR kits. Its supply will be continuous. We also have extended testing to 25 facilities across the country. We will facilitate more centres for it. By next week, we can conduct more than 5,000 tests a day," the official said.

He also rejected Gonoshasthaya Kendra Founder and Trustee Dr Zafrullah's allegations that the Directorate General of Drug Administration (DGDA) and the health ministry were not being cooperative with Gonoshasthaya in the kit validation process.

"The way Dr Zafrullah blamed the DGDA and the health ministry is ill-motivated. In fact, Gonoshasthaya Kendra has not maintained protocol in the process. It didn't have adequate preparation for the whole thing and is now putting the blame on us."

Gonoshasthaya Kendra developed the test kit named Rapid Dot Blot, which it says can test for both antibody and antigen in five minutes and would be low-cost.

It organised a kit handover ceremony at the Gonoshasthaya Nagar Hospital on April 25 where the DGDA Director General Maj Gen Dr Mahbubur Rahman was invited. However, he did not attend.

On April 26, a team of Gonoshasthaya, led by Dr Mohibullah Khondoker, went to the DGDA, but its DG asked them to go through the CRO (contract research organisation).

At a press briefing on April 26 afternoon, Zafrullah alleged that the DGDA was displaying bureaucratic procedures and that there could be vested interests in that.

"They [DGDA] asked us to go through the CRO. We then requested them to write the names of the CROs but they did not," he had told reporters. He suggested that it was better for the DGDA to accept the kits and get those validated under their own supervision.

"Instead, they asked us to go to the CROs," Zafrullah said.

At yesterday's press briefing, DGDA Director General Mahbubur Rahman said he was surprised by the way Zafrullah blamed them.

He said all the way from the approval of importing reagents from abroad to inspecting Gonoshasthaya factory in Savar, the DGDA was fully cooperative and Gonoshasthaya even appreciated it in its letters.

"We did not go to the Gonoshasthaya's kit handover ceremony because we said it was at the trial level and there was no need for it," Mahbubur said.

Then, he continued, on April 26 when the Gonoshasthaya team of researchers went to his office, they had a cordial discussion and that the team was informed of the procedure, which requires them to go through a CRO and prepare a protocol for validation.

The protocol then has to be cleared by the Bangladesh Medical Research Council, and only then the application for validation along with the protocols should be submitted to the DGDA advisory committee for approval.

"The team then left with smile. But after half an hour, there was a press briefing by Gonoshasthaya, where they blamed us for non-cooperation," the DG said.

Mahbubur also said they had earlier learned that the Gonoshasthaya kit was meant to test for the antibody, but over the last two to three days Gonoshasthaya is saying that the kit can also test for the antigen (virus).

"There was no proof yet anywhere in the world that the antigen could be found in blood," he said. Nevertheless, he said, if the kit goes through proper trial and is found effective in the future, the DGDA will surely approve it.

About the combination of antibody and antigen test by Rapid Dot Blot test, Zafrullah said, "It was not rocket science. Our scientists have done it and found more than 90 percent accuracy."