ICMR

Altona Diagnostics

Biosensor

Vadodara district

Gujarat-based CoSara Diagnostics has failed validation of their Made-In-India Covid-19 reagent test kits. CoSara Diagnostics' kit was among 15 others in India which failed the validation carried out by the Indian Council for Medical Research (). Only five of the companies passed the test.In a statement released on its website, ICMR declared that of the 20 reagent test kits sent for testing and validation to the National Institute of Virology in Pune, only five had been validated and been recommended for licensing and manufacture to the Central Drugs Standards Control Organization . The five companies whose tests showed 100% concordance among true positives as well as true negatives and were thus approved for use, included, My Lab, Kilpest (Blackbio), Seegene and SDUS test kit FDA/CEapproved, not Indian oneMirror had on March 19 reported that CoSara Diagnostics Pvt Ltd, registered in Ahmedabad and with its manufacturing plant in Ranoli, Vadodara, had received its licence on March 18. The company is a joint venture between Co-Diagnostics Inc of Utah, USA, and Ambalal Sarabhai Enterprises of India.ICMR had stated that test kits which had approval from either the USFDA or from European Union CE, could be used directly with approval from the Drugs Controller General of India (DCGI) or intimation to ICMR.Even as Co-Diagnostics had developed the test kit in the US and had exported the same to many countries in Europe, including Italy, France and Greece, since it had FDA as well as CE approval, CoSara Diagnostics had to submit its kits for validation in India since only the materials were coming for the US, and the kits were being manufactured at their plant in Ranoli, inof Gujarat.What the results say...In the test results dated April 2, the ICMR stated that under the fast-track system of validation of commercial Covid-19 test kits, the NIV had completed the testing of 20 such kits which did not have FDA or CE validation.According to the results, the SARAGENE Corona Virus (2019 NCV) test kit manufactured by CoSara Diagnostics, had shown 100% concordance among true positives and matched results with NIV's tests. However, it only showed 88% concordance with true negatives, thus making it ineligible to be put to commercial manufacture and sale, according to ICMR's rules.Mohal Sarabhai, CEO of CoSara Diagnostics, told Mirror, "This is a surprising and unexpected result. While our test has shown 100% concordance with true positive, there is only 88% concordance with true negative. This test is very sensitive and we will now get to work to study what happened and rectify the situation."Sarabhai said, "We tand by our test and will resubmit the test kit for validation as we have been given that option. Other companies have submitted other versions of their tests."