GK COVID-19 testing kit not effective: BSMMU

Bangabandhu Sheikh Mujib Medical University on Wednesday said that the COVID-19 Rapid Dot Blot Immunoassay Kit submitted by Gonoshasthaya Kendra could not successfully detect COVID-19-infected persons during their performance trial.

BSMMU vice-chancellor Kanak Kanti Barua at a press briefing at the university premises at 12:40pm also said that the Dot Blot antibody kit could identify only 11–40 per cent of the patients who were tested within two weeks of showing symptoms.

‘This kit is not effective to identify COVID-19 infection among the people who come with symptoms,’ he said at the press conference.

The BSMMU made three recommendations about using the GK kit.

It said that the antibody kit would come handy in making decisions about plasma collection, in ending the quarantine period and lockdowns as part of the pandemic control as it could identify 70 per cent cases when the kit is used to test those who have already recovered from the infection.

GK’s kit development programme coordinator Mohib Ullah Khondoker said that they would give reaction after officially getting the report.

He said that GK and BSMMU had a non-disclosure agreement but BSMMU did not discuss with them before they published the result.

‘We will reply to BSMMU after getting the report…now the Directorate General of  Drug Administration will decide whether they will approve the kit or not,’ he said.

BSMMU said that after trialling 509 samples with the kit within more than a month of time BSMMU sent the final report to the DGDA on Tuesday, a day before they held the briefing on the most waited issue.

BSMMU report also recommended that the kit might be used in those areas where people have no access to RT-PCR test and in testing those who had symptoms but were found negative in the PCR test.

Kanak Kanti in a written statement said that the kit could not separate IgM and IgG during the trial.

‘There was no pressure on BSMMU for any manipulation of the result,’ said Kanak Kanti.

Virology department professor and head of the six-member trial committee Shahina Tabassum, BSMMU pro-VCs Professor Shahana Akhter Rahman, Professor Muhammad Rafiqul Alam and Professor Mohd Zahid Hussain, among others, were present.

After the final report would be submitted the DGDA would decide the fate of the kit.

DGDA director general Major General Mahbubur Rahman and its director and spokesperson Md Ruhul Amin could not be contacted for comments despite repeated phone calls. They did not respond to the text messages sent either.

Gonoshasthaya Kendra’s Gonoshasthaya-RNA Biotech Limited’s researchers have developed two Rapid Dot Blot Kits — one for antibody test and the other for antigen test — and BSMMU trialled the performance of the antibody kit according to the government decision.

After 34 days of trial they submitted the antibody kit trial report and the antigen kit trial remained suspended for technical problems, as said by the authorities, when the country is in an acute crisis due to the COVID-19 pandemic.

On May 13, GK handed over specimens of Rapid Dot Blot Kit to the BSMMU authorities for performance trial as per the DGDA directives.

GK claimed that the kits were able to test a lot of people in a short time at a low cost while the PCR test was costly and time consuming.

Bijon Kumar Sil, the lead researcher and a medical teacher who has developed the COVID-19 testing kit, told New Age that he was confident about the performance of the kit.

He said that they saw a 100 per cent success in the GK clinical trial.

For example, he said, GK founder Dr Zarfullah Chowdhury was first tested by this kit at the both stages of his infection and recovery.

‘This kit gives the same result as the PCR test,’ he said.

News Courtesy: www.newagebd.net