New DelhiL The Indian Council of Medical Research (ICMR), here on Monday, issued an advisory on use of cartridge-based nucleic acid amplification test (CBNAAT) using Cepheid's Xpert Xpress SARS-CoV-2 test.
It has invited applications from laboratories for use of this testing method. Any testing with the Cepheid's Xpert Xpress SARS-CoV-2 is done under the biosafety 2 level (BSL-2) conditions and with appropriate precautions.
The CBNAAT is a recently introduced polymerase chain raction-based (PCR) method for detection of mycobacterium tuberculosis.
The Xpert Xpress SARS-CoV-2 test is a rapid, real-time RT-PCR test aimed at the qualitative detection of nucleic acid from the SARS-CoV-2 in either nasopharyngeal, nasal, or mid-turbinate swab and/or nasal wash/aspirate specimens collected from individuals suspected of Covid-19 by their healthcare provider.
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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