Roche says its kit will give results in 3 hrs

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‘Made in India’ kit by Mylab Discovery

The kits developed by the Pune-based firm are claimed to be completely made in India. “The kits will eliminate the requirement of two tests — screening and confirmatory testing. Rather, it will give the results within two-and-a-half hours of loading the samples on the machine,” Mylab Discovery managing director Hasmukh Rawal told ThePrint.

Dr Gautam Wankhede, director of medical affairs at Mylab, said, “Since the test is based on the sensitive PCR technology, even early stage infection can be detected with our kits. Per day, over 10,000 tests can be done and capacity can be increased.”
Mylab, in 2019, was recognised as India’s first FDA-approved molecular diagnostics company for the RT-PCR-based kits for testing HIV, Hepatitis B and C.
“With our expertise in the field of molecular diagnostics, the cost of testing will be much lesser with our kits in comparison to the foreign made kits. Their price of testing per sample is more than twice our price,” Wankhede said, without disclosing the price.
Mylab is the first company in Asia and second in the world to manufacture ID-NAT kits, which check blood samples to reduce risk of transfusion-transmitted infections in recipients.

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Trivitron can produce 7.5 lakh kits every day

Trivitron Healthcare also calls its diagnostic test kits for COVID-19 the country’s first indigenous kit.
“The kit can be used in all five sample types recommended by ICMR and WHO. The costs are still being worked out. We have allocated Rs 4 to 5 crore emergency funds to upgrade our R&D infrastructure for launching hand sanitisers and COVID-19 kits,” Dr G.S.K. Velu, Chairman & Managing Director, Trivitron Healthcare Group, told ThePrint.
“The standard turnaround time is normally 2-3 days, but Trivitron is trying to reduce (the time) to 3-5 hours for generating results.”
“The kits by our joint venture company in China, Labsystems Diagnostics Shandong, are approved and sold there. China and we are planning to use that expertise and components to make them in India,” he said.
The company is waiting for approvals from the National Institute of Virology for validation protocols and positive samples. “In the next two to three weeks, as long as we complete our validation in government-approved institutions, 500 to 750,000 test kits can be produced per day.”

Roche says its kit will give results in 3 hrs

Roche, Swiss diagnostic and pharma giant, has received emergency use authorisation from the United States’ regulator Food and Drug Administration (FDA) for its SARS-CoV-2 test.
“Roche Diagnostics India is keen to partner with the Government’s efforts in their drive to manage the COVID-19 infection situation. We have the potential to offer 3 types of test kits that can be used to screen and further diagnose COVID-19 infections on our existing systems that run other infectious disease panels. These systems are installed across India’s 15 major cities,” Dr Shravan Subramanyam, Managing Director, India and Neighbouring Markets, Roche Diagnostics India Private Limited, told ThePrint in an email.
According to the company’s media release, the test kits — Roche’s cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test — “provide test results in three and a half hours”.
The company also claims it provides up to 96 results in about three hours and a total of 384 results for the cobas 6800 System technology whereas 960 results are produced for the cobas 8800 System in eight hours.