The organization will decide next course of action after receiving a full validation report from BSMMU as well as comment on the validation report
Antibody detection accuracy of Gonoshasthaya Kendra’s (GK) rapid testing kit can reach up to 70% but the accuracy of antigen detection of this kit is yet to be tested, which has created uncertainty for its approval.
Antibodies are molecules of protein manufactured by the body that help fight against foreign substances called antigens.
Antigens are any substance that stimulates the immune system to produce antibodies.
A virus infection can be detected using either antibody or antigen, or both.
Following this principle, Gonoshasthaya Kendra on March 17 declared that they had developed a cheap testing kit that can examine samples to detect Covid-19 in as little as 15 minutes.
The kit had been invented after a two-month research by Prof Dr Bijon Kumar Sil, head of the Microbiology Department at Gono University, and his four associates — Dr Nihad Adnan, Dr Md Raed Jamiruddin, Dr Firoze Ahmed, and Dr Muhibullah Khandaker.
GK first wrote a letter to the Directorate General of Drug Administration (DGDA) on March 15 describing their invention, while also obtaining ethical approval from Bangladesh Medical Research Council (BMRC) to conduct a validation report or performance study.
According to the rules, this kind of kit needs to be validated by a third party.
After receiving the validation report from the third party, the DGDA will take the decision of the kit’s approval based on the report.
The third party in this case is Bangabandhu Sheikh Mujib Medical University (BSMMU), which has already submitted the performance study report of the rapid testing kit to the DGDA.
GK officials say there was a non-disclosure agreement between Gonoshasthaya and BSMMU which means no party will disclose the result and other issues to the public or any other organization to keep it confidential.
However, BSMMU disclosed the validation result to the public by arranging a press conference last week while it also sent the report to DGDA and GK.
Results of the performance study
At the press briefing at BSMMU campus, Vice-Chancellor Prof Kanak Kanti Barua said: “Only 11% of patients could get accurate results of antibody against coronavirus using GK kits if they are tested within one week of virus infection, while 40% patients could get accurate results within two weeks of infection.
“The detection result was 70% successful on those who tested three weeks after their symptoms emerged.”
He added: “However, at places where there are no conventional RT PCR tests available or for those who get a negative result in a RT PCR test despite Covid-19 symptoms, this kit can be somewhat helpful.”
“It is possible to identify 70% of the patients who have been previously infected by Covid-19 using this kit. This information can be used in our Covid-19 plasma distribution, quarantine completion time and lockdown lifting outlines,” Prof Kanak added.
Is it effective or not? Will Gonoshasthaya Kendra finally seek permission for the approval of their kit only as an antibody testing kit or both antigen and antibody testing kit? Or, will they seek permission for both purposes gradually? Will the kit be approved or not?
The organization wants to wait to answer these questions.
When contacted, Dr Nihad Adnan, technical director of Gonoshasthaya-RNA Biotech, declined to comment on the result published by the mass media.
Dr Nihad said: “We had an agreement with BSMMU not to disclose anything before the validation process is completed and we did not receive any report from BSMMU. After receiving the report from BSMMU, we will decide what the next step will be."
"The result obtained through media reports is for antibody test, not for antigen,” she clarified.
Sources said GK requested to halt antigen tests as BSMMU was struggling to take samples (saliva) from the patients. GK is developing a device that will help facilitate the process and make it more reliable.
The disclosure of the results to the media came before the new and more reliable process could be initiated.
According to Prof Kanak, Gonoshasthaya Pharmaceuticals Ltd provided the first 200 antibody testing kits to the research team on May 12. Although the initial goal was to conduct research only through blood tests, Gonoshasthaya Pharmaceuticals requested that patient 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 institutional review board of BSMMU approved the amended proposal on May 23.
Later, the test results with saliva were unsatisfactory, and Gonoshasthaya Pharmaceuticals requested the BSMMU research team to temporarily suspend the antigen test using saliva and continue research on antibody kits only.