As India battles the COVID-19 outbreak, and testing as much as possible being the only way forward, a Pune-based diagnostic company has become the first Indian firm to receive commercial approval for its test kit. The test kit known as ‘Reverse transcription polymerase chain reaction tests’ from Mylab Discovery Solutions has been approved by the Drug Controller of India.
It was first approved by the National Institute of Virology that tested the kits. “With emphasis on ‘Make in India’ and support from local and central government, the COVID- 19 kit has been made as per WHO/CDC guidelines,” Mylab MD Hasmukh Rawa told Hindustan Times.
Speaking to the Economic Times, Dr Gautam Wankhde, Medical Director Mylab said that while the current lab-based test results are got after four hours, Mylab will reduce the time to around two-and-half hours.
Meanwhile, at least 22 private laboratory chains having around 15,500 collection centres spread all over the country have been registered with the Indian Council of Medical Research (ICMR) for COVID-19 testing. These labs are spread out in Maharashtra, Tamil Nadu, Haryana, Delhi, Gujarat and Karnataka
The Centre on Saturday issued guidelines recommending that maximum rate for coronavirus tests by private laboratories should not be more than Rs 4,500 while appealing for free or subsidised testing in this hour of national public health emergency.
The ICMR guidelines recommended that the maximum cost for testing sample should not exceed Rs 4,500. This may include Rs 1,500 as a screening test for suspect cases and an additional Rs 3,000 for confirmation test.
The order issued by the Union Health ministry stated that failure to comply with the guidelines will result in legal action.
According to the guidelines on sample collection and testing, the ICMR has called for ensuring appropriate biosafety and biosecurity precautions while collecting respiratory samples from a suspect patient. It also called for home collection of samples.
India’s confirmed cases of coronavirus crossed 560 on Wednesday, with death toll at 11.
With PTI inputs