CBNAAT is mainly used for TB and is approved by US FDA for COVID-19 testing under emergency use authorization.
ICMR in its advisory stated that the specimen collection and transfer of sample for CBNAAT must be performed using appropriate PPE and following all applicable biosafety requirements.
"ICMR recommends that any testing with the Cepheid Xpert Xpress SARS CoV-2 is carried under Biosafety 2 level (BSL-2) conditions and with appropriate biosafety precautions," said ICMR.
Any laboratory which is already functional for SARS CoV2 testing by real-time PCR with the appropriate BSL-2 setup may initiate testing using Cepheid Xpert Xpress SARS-CoV 2 without any further approval from ICMR. The results of the testing need to be entered on OCMR COVID-19 portal, it added.
ICMR stated that any new Government laboratory seeking to initiate CBNAAT must satisfy the following minimum requirements: Availability of 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 requirements: Availability of following minimum staff--Medical Microbiologists-one or more with experience of work in Molecular Virology, Technicians-At least two to three with relevant experience of work in Molecular Voirology and Multi-Task Staff-one or more for washing and cleng," said ICMR.
Desired expertise of the staff: Good understanding of laboratory biosafety and biosecurity, trained for handling respiratory samples for viral diagnosis and experience of work in virology and handling clinical specimen, especially respiratory samples, it added.
Other requirements include, a robust institutional policy on biomedical waste management of human origin and well defined arrangement for segregation and discarding of biomedical waste.
Private laboratories which intend to initiate testing using CBNAAT should have NABL accredition for molecular detection of RNA viruses either by Real Time PCR or by CBNAAT, ICMR added.
( With inputs from ANI )