India is currently on high alert with almost a complete lockdown across all states.
The number of COVID-19 positive cases in India has crossed the 500 mark, with total death cases reaching 10.
To control the growing outbreak, the Health Ministry is already taking serious measures through quarantine and screening facilities across all states.
The government has been importing millions of testing kits from Germany for diagnosing COVID-19 cases across India.
Meanwhile, here comes an important update about the first ‘Made in India’ COVID-19 test kit!
PathoDetect COVID-19 Qualitative PCR kit, by Pune-based Mylab Discovery, has reportedly received commercial approval, emerging as the first one from India to have received Indian FDA nod.
Even Mylab also received 100 percent sensitivity and specificity in the ICMR approval.
“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. It was developed and evaluated in a record time,” Hasmukh Rawal, Managing Director, Mylab Discovery Solutions said in a statement.
The Indian Drugs Controller General of India (DCGI) approved Mylab’s product and the Indian Council of Medical Research (ICMR) has evaluated the new COVID-19 kit.
“Even early-stage infection can be detected, with highest accuracy as has been seen during tests at ICMR. The ICMR tested, CDSCO approved kit makes detection faster too,” says Shailendra Kawade, Executive Director at Mylab.
As per the data, India is currently reporting the lowest rate, at 6.8, for testing per million population.
Moreover, with the rising number of COVID-19 cases, the demand for test kits has also increased and getting the imported ones everytime is becoming a challenge for the authorities.
At this juncture, the new ‘Made in India’ test kit comes as a savior and Mylab promises of delivering 1 lakh such kits in a week and can beef up the supply on demand.
According to the company, a single kit can be used to test 100 patients and an average lab with PCR facility can test more than 1000 patients a day.
Moreover, the advent of new test kits will also cut down the procurement costs for the government by one-fourth of the current costs.
As per the existing protocols, it takes 7 hours to detect the infection. While, the new test kit promises to do so in just 2.5 hours, which will eventually cut down the time to detect and increase the number of tests in a day.
The Mylab manufacturing facility also complies with the MDR 2017 regulation for Manufacturing Medical Device of Class A, B, C and D and ISO 13485: 2016 certification.
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