Indian Council of Medical Research has released guidance document for state nodal and testing virus research & diagnostic laboratories (VRDLs) for COVID-19. These laboratories are expected to ensure collection and transport of suspected coronavirus sample to ICMR-National Institute of Virology at Pune.
ICMR said shipment of all the positive respiratory samples and the first 10 negative respiratory samples to NIV, Pune will have to be on a real time basis. If these laboratories get any positive result by testing suspect coronavirus respiratory sample, they are not supposed to disclose the results to anyone. They will have to advise the treating clinician to isolate the patient in an appropriate facility and follow all biosafety precautions till further confirmation.
In such situations, these laboratories should immediately send an aliquot of sample to ICMR-NIC, Pune for coronavirus confirmation. A positive result (if any) would only be declared by NIV, Pune after reconfirmation.
In case of a negative respiratory sample, results will have to be reported as tentative clearly mentioning that confirmation is awaited from NIV, Pune. Blood samples should also be collected from all suspected cases and if they tested positive for coronavirus in that case those samples will have to shipped to NIV, Pune on a ral time basis.
For any positive cases, a convalescent serum sample needs to be collected after two week.
ICMR has asked these laboratories to ensure proper precautions to prevent cross contamination and ensure polymerase chain reaction (PCR) quality. The state nodal and VRDLs will have to strictly ensure uni directional workflow in the molecular biology laboratory and positive control should be added in a separate area that the extracted sample ribonucleic acid (RNA).
Further, these laboratories will have to ensure proper disinfection measures as well as avoiding cross contamination by cleaning all work surfaces in the molecular biology laboratory with bleach followed by 70% ethanol. They will have to strictly follow standard operating procedure shared by NIV Pune and include positive control and negative controls as per the instructions.
ICMR has clearly told to these laboratories that no results of coronavirus be reported on the National Institute of Epidemiology portal. However, other respiratory virus screening should be reported as usual.