Bangabandhu Sheikh Mujib Medical University (BSMMU) has already completed trial of the Gonoshasthaya Kendra-developed antibody test and may submit its report to the drug administration by Wednesday.
"The committee concerned is now processing data of the antibody kit's performance trial. We think we can submit the report by Wednesday," BSMMU Vice Chancellor Prof Kanak Kanti Barua told The Daily Star yesterday.
Gonoshasthaya Kendra officials say they are eagerly waiting for the report to be submitted to the Directorate General of Drug Administration (DGDA) and then for registration, which can allow mass production and distribution of the kit -- GR-Rapid Dot Blot.
Gonoshasthaya Kendra Founder and Trustee Dr Zafrullah Chowdhury said it was frustrating that the kit developed in March was yet to get the approval when many of the countries like the USA, the UK as well as European Union had already given approval for such kits.
Asked, Prof Kanak Kanti Barua said performance trial of a drug or a kit was solely a scientific matter. "As a VC, I have nothing to intervene."
A team of Bangladeshi scientists -- Dr Bijon Kumar Sil, the lead researcher, Nihad Adnan, Raeed Jamiruddin and Firoz Ahmed -- developed the antibody kit. They also developed an antigen kit.
RT-PCR, a test presently considered as the gold standard and suggested by the World Health Organization (WHO), is widely used for diagnosing novel coronavirus. It uses samples swabbed from the nose and throat to detect the presence of the virus, but the testing is expensive and time-consuming.
On the other hand, the antibody test takes less than 15 minutes. The kit can detect antibody that develops six to seven days after an individual is infected with Covid-19. The antigen kit can diagnose the infection soon after one is infected.
Dr Bijon Kumar Sil says results could be nearly 100 percent accurate if samples from each patient is run through both tests.
He also said Bangladesh could have gone for large-scale tests if approval had come earlier. It could have largely prevented the spread of new coronavirus infection, he said.
Last week, Dr Zafrullah said this is a time of grave crisis and the authorities should work on an emergency basis, especially when it is an issue of life and death.
There has, however, been a series of events that led to the delay.
When Gonoshasthaya first approached the drug administration on April 26 for validation of the kit, the latter suggested that Gonoshasthaya goes through the contract research organization (CRO), but Gonoshasthaya refused to do it saying it would raise the price of the kit and that CROs were "a vehicle of corruption".
Later, on April 30, the DGDA allowed Gonoshasthaya to have the performance trial at the BSMMU, which then formed a committee and on May 12 wrote a formal letter asking Gonoshasthaya to supply kits.
Since May 13, Gonoshasthaya has supplied 500 antibody and 500 antigen kits to the BSMMU. The trial of antibody kit is over, but the trial of the antigen kit has been suspended as Gonoshasthaya Kendra found discrepancies in the process of collection of saliva samples.
Dr Mohib Ullah Khondoker, coordinator of the Gonoshasthaya's Covid-19 Rapid Dot Blot Project, said clear saliva was needed for the antigen test, but they found presence of cough, which was why they wrote to the BSMMU on June 2, requesting suspension of the antigen trial.
"We have, meanwhile, developed a device to properly collect saliva. We will supply those devices to the BSMMU in two to three days so that they can continue to work on that," he told The Daily Star.
He said as the antibody test was complete, Gonoshasthaya wrote to the DGDA seeking a preapproval on import of reagents so that once DGDA registers the antibody kit with it, they can immediately go for importing reagents.
Last week, Dr Zafrullah also said many countries like Britain, USA, European Union, Germany and India have already started antibody tests.
Many countries are considering mass antibody testing as a way to speed up the reopening of economies devastated by lockdowns and to introduce more tailored social distancing measures.
Health experts say Bangladesh, which had been in shutdown for nearly two months and now has partially reopened to save the economy, needs to go for antibody testing for the same reason.
"No one in the world has yet developed this combined [antibody and antigen] test. Now, just as we have developed it, other big foreign companies can also try and develop the combined testing. Then, we will fall behind others," he said.