Commercial kits for nasal/throat swab-based diagnosis of COVID-19 in India
The Indian Council of Medical Research (ICMR) has established a fast-track mechanism for validation of non-US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) /CE (CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC) and that the device may be legally commercialized in the EU) In Vitro Diagnostic (IVD) approved kits at four of its constituent laboratories:
1. Pune-based National Institute of Virology (NIV)
2. National Aids Research Institute
3. National Institute of Pathology, New Delhi
4. National Institute of Cholera and Enteric Diseases (NICED), Kolkata
The approved laboratories can evaluate test kits for 100 per cent concordance among true positive and true negative samples and recommend it for commercial use in India.
The Indian Council for Medical Research on April 2, 2020 also issued guidelines for use of commercial kits for nasal/throat swab-based diagnosis of COVID-19 in India.
The test detects the genetic signature (RNA) of the SARS-CoV-2 virus, also known as novel coronavirus or COVID-19, in swab samples that a healthcare provider collects from the back of the patient's throat or nose.
The following guidelines were issued:
- Currently, RT-PCR probes for diagnosis of COVID-19 are procured from USA by ICMR-NIV and are distributed to the testing laboratories across the country
- ICMR welcomes use of commercial kits for diagnosis of COVID-19
- US FDA EUA/CE IVD approved kits can be used directly after due approval from DCGI and intimation to ICMR
- ICMR has established a fast-track mechanism for validation of non US FDA EUA/CE IVD approved kits at ICMR NIV. Test kits with 100% concordance among true positive and true negative samples will be approved for commercial use in India
- ICMR recommends these results and the Central Drugs Standard Control Organization (CDSCO) has been intimated.
- ICMR NIV has completed evaluation of 20 non- US FDA EUA/CE IVD kits. The results of the validation are summarized in the following table: