Gonoshasthaya Rapid Test Kit: BSMMU speaks at last, spurns it
The Gonoshasthaya Kendra-developed rapid test kit is not effective in detecting Covid-19, Bangabandhu Sheikh Mujib Medical University has concluded.
The kit can trace novel coronavirus only in 11 percent cases in the first week of infection and in 40 percent cases in the second week, BSMMU Vice-Chancellor Prof Kanak Kanti Barua told The Daily Star yesterday.
"Therefore, we cannot conclude that the kit is effective in detecting Covid-19," he said after a BSMMU committee, headed by Prof Shahina Tabassum of virology department, completed performance trial of the kit on 509 samples in over a month.
The report on the trial was submitted to the Directorate General of Drug Administration (DGDA), which will decide whether the kit will be approved for mass production and distribution, said Prof Barua.
The BSMMU committee said the GR Covid-19 Rapid Dot Blot Immunoassay Kit could not tell whether the person was currently infected with Covid-19, because it was unable to differentiate between the IgM, the antibody that develops at the start of infection, and IgG, the antibody that develops later on.
In its recommendations released to the media, the BSMMU, however, said the kit could be used for testing in places where the standard RT-PCR kits are not available. Besides, it could be used on those who did not test Covid-19 positive in the RT-PCR tests after showing symptoms.
"At least 70 percent of the cases can be detected when the kit is used to test those who have already recovered from the infection," the BSMMU said.
The BSMMU committee recommended that the antibody kit be used for seroprevalence or to assess the proportion of a population which was infected but recovered.
"Such information of population is useful in terms of plasma distribution, fixing the time for ending quarantine period and relaxing lockdown," it said.
Scientists say RT-PCR, in which samples from nose and throat are swabbed, is considered gold standard for Covid-19 tests, but it is expensive and time-consuming.
On the other hand, rapid test can give result in 15 minutes and is low cost. The tests can be done on a large scale. Many countries, including the US, UK, European Union and India, have approved antibody tests for coronavirus detection.
It takes five to seven days for antibody to develop in a human body after someone is infected. Antibody kits cannot diagnose the disease before the antibody appears, scientists say.
Gonoshasthaya also has antigen kits that can diagnose Covid-19 both in blood and saliva at the very initial stage. Scientists suggest combination of both tests can provide more than 90 percent accurate results.
Asked about the findings on the trial, Bijon Kumar Sil, leader of the Gonoshasthaya team of scientists which developed the kit, yesterday said they were yet to get the report from the BSMMU.
He said they would respond to its findings after receiving it.
He, however, told The Daily Star: "We are still confident that the kit is highly effective in detecting Covid-19. Our position is very clear about it."
Bijon said Gonoshasthaya Kendra Founder Dr Zafrullah tested positive both by rapid test and RT-PCR kits. Again, when he recovered, the test results came negative following both the tests.
"We have found similar results in several hundred tests. We have no doubt about the effectiveness of our kit," he said.
In a press statement yesterday, GR COVID-19 Rapid Dot Blot Project Coordinator Mohibullah Khondoker said Gonoshasthaya Kendra was yet to receive any official communication from the BSMMU and that there was no discussion on it.
"Once we receive the detailed report from the BSMMU, we will inform our decision to the BSMMU," he said.
On April 30, Gonoshasthaya decided to get the antibody kit's performance trial done at the BSMMU, situated in the capital's Shahbagh. After formal communication, the BSMMU formed a committee and on May 12 it wrote a formal letter asking Gonoshasthaya to supply the kit.
Since May 13, Gonoshasthaya supplied about 600 antibody and 500 antigen kits to the BSMMU, which was scheduled to submit the report on the performance to the DGDA on June 10.
The date was postponed thrice and the BSMMU has finally submitted the report.
About the antigen kit's performance trial, the BSMMU in its media statement said Gonoshasthaya had requested the BSMMU on June 2 to suspend the antigen test, saying that the result that was coming was not expected.
Mohibullah of Gonoshasthaya said clear saliva was necessary for testing antigen, but the monitoring team comprised of scientists of the BSMMU and Gonoshasthaya Kendra identified issues in sample collection procedures.
He said they have developed a new device to properly collect saliva for the antigen test kit, but they were waiting for the antibody trial to be completed first.
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