The Gonoshasthaya Kendra (GK) is likely to submit it’s newly produced coronavirus testing kits to the Directorate General of Drug Administration (DGDA) for approval on April 24-25.
Gonoshasthaya-RNA Biotech Limited has been developing the testing kit -- Rapid Dot Blot -- and is hopeful to get approval from the Directorate General of Drug Administration (DGDA) within a short time.
They are planning to produce 100,000 kits per month once approved, Gonoshasthaya Kendra founder Dr Zafrullah Chowdhury told the Dhaka Tribune on Monday.
He also said that they are expecting to handover some kits on April 24-25.
DGDA, Institute of Epidemiology, Disease Control and Research (IEDCR), International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Combined Military Hospital (CMH), World Health Organization (WHO), and Bangabandhu Sheikh Mujib Medical University (BSMMU) will also receive the kits for sampling, he continued.
"Then, they can compare our rapid test kits with Real time PCR kits."
Meanwhile, Dr Zafrullah said they obtained good results by their testing kits after analyzing five blood samples that had tested positive for Covid-19.
The IEDCR gave the samples to the GK earlier this month.
Raw materials are crucial
Gonoshasthaya Kendra is now struggling with raw materials to produce kits due to the lockdown across the world, the founder said.
"Everything is disrupted. Raw materials have to be imported as we do not produce those in the country. A lot of things are required in a manufacturing industry to produce this kit.
"Some raw materials are in Dubai and some are in China. We are trying to bring those here as soon as possible," he said.
Gonoshasthya Kendra asked for at least 3cc blood samples from 10 Covid-19 positive patients each for further testing, but they were yet to receive the samples till Monday afternoon, he said.
"We need approval from DGDA for mass production. So after the samples are provided, we are expecting to get approval from DGDA within a day or two," said Zafarullah.
He, however, said approval from WHO is not required in producing the rapid testing kits.
Gonoshasthaya-RNA Biotech earlier wanted to handover the kits to government and large medical institutions on April 11, but the attempt failed because of mechanical and electric disruptions.
On March 17, Gonoshasthaya Kendra declared that they had developed a cheap testing kit that can examine samples to detect Covid-19 in as little as 15 minutes.
A technical team of Gonoshasthaya-RNA Biotech Limited developed the testing kits and it cost about Tk2 crore.
After a two-month research, Prof Dr Bijon Kumar Sil, head of the Department of Microbiology at Gono Bishwabidyalay, and his four associates -- Dr Nihad Adnan, Dr Md Raed Jamiruddin, Dr Firoze Ahmed, and Dr Muhibullah Khandaker -- invented the kit.
The team received a green signal from the government in late March to import the raw materials for producing the testing kits.
Researchers say the testing kit can detect coronavirus infection in 15 minutes and is expected to cost around Tk300-350 each.
