Meet the virologist who made India's first COVID-19 testing kit - while she was pregnant
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The company is confident of ramping up the capacity at its plant in Lonavala to deliver one lakh kits a week, Patole said.
He said the authorities are helping the company, including giving priority for shipping of the raw materials.
Mylab's Managing Director Hasmukh Rawal said that the kit is the first one to receive commercial approvals from Indian FDA/Central Drugs Standard Control Organisation (CDSCO) and called
'Mylab Patho Detect COVID-19 Qualitative PCR Kit'.
"Mylab is the only Indian company to have achieved 100 per cent sensitivity and 100 per cent specificity in the ICMR evaluation. It was developed and evaluated in record time. It has been
made as per WHO/CDC guidelines," said Rawal.
"Since this test is based on the sensitive PCR technology, even early-stage infection can be detected, with the highest accuracy as was seen during the ICMR tests, and makes the detection
faster," said Mylab Executive Director Shailendra Kawade.
India currently ranks lowest in terms of testing done per million populations — 6.8 — compared to other countries such as South Korea and Singapore which manage more and more testing.
So far, India has been importing millions of testing kits from Germany but supplies have been hit following the grounding of flights amid the national lockdown. The company said it can
manufacture upto 100,000 kits per week and scale it up further if required at its Pune facilities, and an average lab with automated PCR can test more than 1000 patients daily.
With the time reduction from seven-plus hours to barely 150 minutes, laboratories would be able to do twice the number of tests at the same time on a single machine.