ICMR issues advisory on use of CBNAAT for Coronavirus testing, details

It's a FDA approved testing system for use under the emergency use authorisation (EUA) only.

According to the advisory, any laboratory, already functional for SARS-CoV-2 testing by real-time PCR with appropriate BSL-2 setup, may start testing using Xpert Xpress SARS-CoV-2 without any further approval from the ICMR.

However, the test results will have to be uploaded on the ICMR Covid-19 portal.

The ICMR said any new government laboratory seeking to initiate the CBNAAT must meet the minimum ICMR requirements such as availability of a BSL-2 level laboratory facility, including a molecular biology setup for virological diagnosis and a functioning and calibrated biosafety cabinet type 2A/2B in the laboratory, staff having experience in molecular virology, a robust institutional policy on biomedical waste management of human origin and well-defined arrangement for segregation and discarding of biomedical waste.

Private laboratories that intended the CBNAAT should have the National Accreditation Board for Testing & Calibration Laboratories (NABL) accreditation for molecular detection of RNA viruses either by the real-time PCR or the CBNAAT, the apex medical research body added.

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