Two new Covid-19 detection kits approved for testing in India

New Delhi, 24 March 2020:
Both these kits had been validated by the Indian Council of Medical Research (ICMR) and National Institute of Virology(NIV) recently after the COVID-19 epidemic began. Based on their validation, CDSCO waived off the normal regulatory approval process and fast tracked commercial release in India.

Pune-based molecular diagnostics company Mylab Discovery Solutionshas received a commercial approval from the Central Drugs Standard Control Organisation (CDSCO)for its COVID-19test kit.

‘The test kit by the company is the first 'Made in India' kit to receive commercialapproval from CDSCO, and is named as MylabPathoDetect COVID-19 Qualitative PCR kit, the company said in a statement.

“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,” Mylab Discovery Solutions MD Hasmukh Rawal said. Local sourcing of test kits will be a major breakthrough for India as the testing kit by Mylab would cost nearly one-fourth of the current procurement cost, the company said.

Moreover, Mylab’s COVID-19 test kit screens and detects the infection within 2.5 hours as compared with over 7 hours taken by current protocols, it added.

We have been trying hard to make cutting edge technology available to our country at a reasonable and affordable price. Since this test is based on sensitive PCR technology, even early-stage infection can be detected, with the highest accuracy as has been seen during tests at ICMR. The ICMR tested, CDSCO approved kit makes detection faster too”, Mr. Shailendra Kawade, Executive Director at Mylab, was quoted by online publication BioVoice News.

First released in Germany by Altona Diagnostics on February 20,2020, the RealStar ® SARS-CoV-2 RT-PCR Kit 1.0*, a real-time RT-PCR based test for the qualitative detection and differentiation of lineage B-betacoronaviruses (B-βCoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA. 

SARS-CoV-2 (previously 2019-nCoV) is a member of the coronavirus family and the causative agent of coronavirus disease 2019 (COVID-19). First cases of a severe mystery respiratory disease were reported from Wuhan, China, end of December 2019. Since then, the number of COVID-19 cases has increased dramatically in China. Additionally, in more than 25 other countries, exported and locally transmitted COVID-19 cases have been confirmed.

“In recent weeks, we have received numerous inquiries from laboratories around the world for a test for SARS-CoV-2. We developed this kit to provide our customers with a reliable product of high quality so that they can respond to the current outbreak of coronavirus disease”, said Dr. Markus Hess, General Manager of altona Diagnostics.

Mr Tarun Jain, General Manager, altona Diagnostics India said Designed as a dual target assay and manufactured according to GMP guidelines the ready-to-use kit allows rapid detection of all lineage B-betacoronaviruses and confirms the presence of SARS-CoV-2 specific RNA in only one reaction. All RealStar ® (RT-) PCR kits consist of Master Reagents, Positive Control and an Internal Control. They can be used with a wide range of different real-time PCR instruments.

“In order to ensure that the test delivers highly reliable results we sent prototype kits to reference centers where the product was tested and where the functionality even with clinical samples was confirmed.” Dr. Leonie Hecht, the responsible R&D Project Manager, added. 

Altona Diagnostics has already developed molecular diagnostic test systems during previous global health crises and made them available very quickly. During the outbreaks of swine flu (H1N1) pdm09, MERS-CoV, Zaire ebolavirus and Zika virus, altona Diagnostics' tests have always been among the earliest available and most widely used in the world.

Altona Diagnostics GmbH is a diagnostics company with currently around 200 employees at its headquarters in Hamburg. Further subsidiaries are located in France, Great Britain, Italy, Canada, the USA, Brazil, Argentina and India. altona Diagnostics is focused on developing, manufacturing and marketing molecular diagnostic test systems for the reliable and specific detection of pathogens related to human infectious diseases. A particular focus of the company lies on the field of emerging diseases. altona Diagnostics is ISO 13485 certified and manufactures its high-quality CE-IVD medical devices according to GMP guidelines.

India’s drug regulator, CDSCO has allowed commercial use of two new COVID-19 test kits, one Made in India by Pune-based startup Mylab Discovery Solutions and a kit made by German company, altona Diagnostics.

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