A six-member research team conducted performance studies
Bangabandhu Sheikh Mujib Medical University (BSMMU) has found the Covid-19 rapid test kit developed by Gonoshasthaya Kendra ineffective.
A six-member research team reached this conclusion after conducting performance studies on the test kit, BSMMU Vice-Chancellor Prof Kanak Kanti Barua told a press conference on Wednesday.
He told reporters that the committee conducted the trial using Gonoshasthya’s 509 antibody kits. “In their analysis, the committee found the kit dysfunctional in identifying the virus.”
Reached for comments on the development, Gono University lead virologist Prof Bijon Kumar Sil told Dhaka Tribune that they were yet to receive any report from BSMMU.
“We cannot comment until we get that report in our hand,” said Bijon, who led the team that developed the kit for rapid Covid-19 testing.
Kanak Kanti Barua said in the briefing: “This kit is not effective for diagnosing patients with symptoms. Only 11-40% of patients can be diagnosed using these kits in the first two weeks of symptoms.
“However, at places where they do not have the conventional RT PCR method or who get RT PCR negative despite Covid-19 symptoms, these kits can be somewhat helpful.”
Kanak said that the kits can be used to monitor the extent or seroprevalence of Covid-19 disease. In this case, it is possible to identify 70% of the patients who have had Covid-19 disease before, with this kit.
“This information can be used in our Covid-19 plasma distribution, quarantine completion time and lockdown lifting outlines,” he added.
Though the Gonoshasthya Pharmaceutical kits can detect antibodies, they cannot differentiate between Immunoglobulin M (IgM; which is formed early before infection) and IgG (which is formed in the late stage of infection), he further added.
The BSMMU VC also said that although the research team has worked tirelessly for one month, they will not receive any reward for this research.
Help identify past patients
According to Gonoshasthya, this antibody test kit would have helped identify whether people have been infected with coronavirus in the past, and the presence of antibodies or resistance power in their bodies.
Moreover, it would help collect plasma of those who have recovered.
On March 17, Gonoshasthya Kendra had announced that they developed a testing kit that can examine samples to detect Covid-19 within 15 minutes, but the kit was not approved right away by the authorities concerned.
The BSMMU VC said in a briefing that in this context, the Directorate General of Drug Administration (DGDA) of the Government had authorized BSMMU as the contract research organization (CRO) to conduct scientific evaluation of GR COVID-19 rapid dot blot immunoassay kits which were provided by Gonoshasthya Pharmaceutical on April 29.
To that end, the BSMMU authorities formed a six-member research team led by the virology department Prof Shahina Tabassum on May 2.
A research team started the research activities the project proposal titled "Evaluation of GR COVID-19 Rapid Antibody Dot Test and GR COVID-19 Rapid Antigen Dot Test for detection of SARS-CoV-2" after approval by the institutional review board (IRB) on May 13, he added.
It should be noted that the Directorate General of Drug Administration (DGDA) aims to provide one year to the BSMMU authorities to conduct research. But in view of the realities and the critical times of the country, the research team started their activities with the aim of conducting research within a month, the VC also said.
He also said that a total of 509 blood samples were tested and the research was completed within a month and another week was spent on the statistics.
He said Gonoshasthya Pharmaceutical had provided the first 200 antibody test kits to the research team on May 12. Although the initial goal was to conduct research only through blood tests, the Gonoshasthya Pharmaceutical requested that the patient's saliva be collected instead of blood on May 19.
The research team later applied to change the research proposal in response to that request and the IRB, BSMMU approved the amended proposal on May 23, he added.
Later, the test results with saliva were not as expected, and the Gonoshasthya Pharmaceutical requested the BSMMU research team to temporarily suspend the antigen test in saliva and to continue research on antibody kits only, he further added.
Research activities have been delayed due to repeated decision changes by Gonoshasthya Pharmaceuticals. However, the research team worked very diligently to complete their activities within a month and make a report.
And none of the members of the research team have any affiliation with Gonoshasthya Pharmaceutical, he said.