Gonoshasthaya Kendra (GK) is set to start large scale clinical trials of their Covid-19 testing kit. The organization has already received ethical approval for conducting clinical trials from the Bangladesh Medical Research Council (BMRC).
Initially, GK will conduct internal clinical trials in two rooms that have been allocated for this purpose at their hospital.
Dr Jafrullah Chowdhury, founder of GK, told Dhaka Tribune: “There are many patients suffering from heart disease, kidney disease, people who need dialysis. Without dialysis, a patient can die. These kinds of patients are going from hospital to hospital, but no hospital is providing them with treatment because they do not have Covid-19 test results. People are dying. We cannot kill our fellow countrymen by refusing treatment.
“This is why we decided to do trials on a large scale, so that those kinds of patients can be admitted to hospitals and get treatment if they test negative for Covid-19. Those who test positive will be sent to Dhaka Medical College Hospital or other hospitals designated for Covid-19 treatment,” he added.
“A patient who needs treatment may conduct the test at GK by giving his consent to participating in the clinical trial. We are also telling them that our kit is not yet approved by the government, but you can do it,” Dr Jafrullah further said.
“An additional secretary of the government was refused treatment from different hospitals, because he did not have his Covid-19 test result. Anyone can imagine how tough it is to get treatment for a poor person. I want to bring a change to this situation,” he continued.
“I decided to start large scale trials of our kits. It is not for making profit, as we will take only tk200 for conducting the test. It is only for the betterment of the people of Bangladesh,” he added.
Dr Jafrullah also said: “The government is not appreciating or helping us. What is the problem if the people get some service from our kit?”
How accurate are GK’s kits?
Regarding the accuracy of the kits, Dr Jafrullah said: “At first we conducted trials on five Covid-19 positive patients who tested positive in the PCR test. We also tested them with our rapid test kit and the tests also came back positive. In this sense, the accuracy is 100%. On a large scale I can say the accuracy of our kit is 90%.”
He also expressed his hope that Bangabandhu Sheikh Mujib Medical University (BSMMU) will start clinical tests (External validation) of their kit soon.
When will BSMMU start external validation?
According to rules and regulations, ethical approval is needed to conduct external validation of any drug or medical device. GK had already applied for ethical approval from the BMRC.
Dr Jafrullah said: “We have already received ethical approval for conducting external clinical trials from BMRC. Now, we are waiting for external validation of our kit by BSMMU. BSMMU wanted to receive our kit sample today [on Saturday], but they could not take it due to obstacles as a result of the lockdown or some other reason. We hope they will start validation of our kit within a day or two.”