Bangabandhu Sheikh Mujib Medical University (BSMMU) research team has found that the Gonoshasthaya Kendra kit is not suitable for identification of Covid-19 in patients with symptoms.
BSMMU Vice-Chancellor Prof Kanak Kanti Barua made the announcement at a press briefing on Wednesday.
Earlier on March 17, Gonoshasthaya announced that they had developed a testing kit (G-Rapid Dot Blot) that could examine samples to detect Covid-19 within 15 minutes, but they had yet to get approval for it from the concerned authorities.
Later on April 29, the Directorate General of Drug Administration (DGDA) appointed BSMMU as the Contract Research Organisation (CRO) by requesting them to conduct a scientific evaluation on the testing kit.
On May 2, BSMMU formed a six members research team led by Dr Shahina Tabassum, professor of virology of the university.
On May 13, they started the research titled "Evaluation of GRCovid-19 Rapid Antibody Dot Test and GR Covid-19 Rapid Antigen Dot Test for detection of Sars-Cov-2".
They completed the research within a month through 509 blood testing samples, and it took another week to complete statistical evaluation.
After the research, the team made the following recommendations:
Firstly, this kit is not effective for patients who have symptoms. It could only detect 11-40 percent of patients who showed symptoms in the first two weeks. However, in places where the RT-PCT test is unavailable or results came out negative even when the patients showed symptoms, the kit can be helpful in those cases.
Secondly, the kit could be used to see the seroprevalence in patients. In that case, the kit can be used to detect 70 per cent of patients who previously suffered from Covid-19. That information can be used for Covid-19 winner plasma distribution, duration of quarantine, and maps for lockdown.
Thirdly, this kit by the Gonoshasthaya Pharmaceuticals can detect antibodies but cannot separately detect IgM (which is created at the beginning of the infection) and IgG (which is created in the later phase of the infection).
Earlier, on May 12, Gonoshasthaya Pharmaceuticals gave 200 antibody testing kits to the research team. Initially, the aim was to carry out research based on blood tests, but on May 19 Gonoshasthaya Pharmaceuticals requested them to test saliva instead. The research team applied to IRB, BSMMU and on May 23, they granted the revised proposal. Later, Gonoshasthaya Pharmaceuticals again requested the BSMMU research team to temporarily stop the antigen test and continue research on the antibody test kit only. The research team says that these changes by Gonoshasthaya Pharmaceuticals delayed the research.
In the concluding remarks of the report, the research team mentioned that they did not take any remuneration for the month-long research. They also stated that they do not have any involvement or interest in Gonoshasthaya Pharmaceuticals.
However, in a press release, Gonoshasthaya Kendra said, "BSMMU signed a Non-Disclosure Agreement (NDA) with Gonoshasthaya Kendra. We haven't officially received any reports from BSMMU and there hasn't been any discussion following the NDA. After getting the report, we will talk to BSMMU according to the signed agreement."
The Directorate General of Drug Administration will take actions regarding the approval and marketing of the kit according to BSMMU, the press release read.