Use Of Rapid Antibody Test Kits On Hold Due To Divergent Outcomes Of Sample Tests; Centre Tells Bombay HC [Read Order]

The Union Government informed the Bombay High Court's bench at Nagpur that the rapid antibody test kit recently procured by the centre is not being used for testing currently as there have been some divergent outcomes in a few sample tests. The same can be used for surveillance testing only and not for VRDL (Viral Research & Diagnostic Laboratory) Centres.

Justice NW Sambre was hearing a writ petition filed by CH Sharma tagged along with PIL by Subhash Zanwar seeking various directions and steps to combat coronavirus. In the previous hearing on April 20, Court has called upon ICMR and the State Government to clarify as to the period within which procedure will be completed in establishing the VRDL facilities at Yavatmal, Chandrapur, Gadchiroli and Gondia Government Hospitals.

Court was informed that VRDL Lab at Chandrapur and Yavatmal can be made operational by May 20.The machine required for VRDL Testing ie RT-PCR (Reverse Transcriptase Polymerase Chain Reaction) machine is made available by the Haffkine Institute which procures the same from Singapore and its shipment has been delayed. Hence, the labs are non-operational. Court asked the concerned authority to take appropriate steps to expedite the delivery of RT-PCR machines.

While blood samples are used for testing through Rapid Antibody Test kits, nasal or throat swab is collected and examined for testing through RT-PCR machines.

Court directed the Divisional Commissioner, Nagpur to take every day stock of number of pending samples in each of the laboratory and to pass all consequential orders of diversion of samples where the capacity of the VRDL Center is underutilized or the pendency is comparatively less.

Amicus Curiae Arun Gilda told the bench that there are Real-Time Polymerase Chain Reaction Machines (RT-PCR) available with NEERI, Nagpur, Department of Microbiology of Nagpur University and additional machines with MAFSU.

Justice Sambre noted that the Divisional Commissioner will be competent to take appropriate decisions in the matter of utilization of these RT-PCR machines in consultation with the Medical Superintendent of AIMS, Nagpur.

Furthermore, Court observed that similar testing facilities can be made operational at private Medical Colleges which are armed with proper academic staff, provided such staff is given training of testing and if contingency arises, samples can even be allocated to these private colleges. The only impediment in making VRDL Centers operational at Private Medical Colleges as informed by the Amicus is the non-grant of accreditation by the National Accreditation Board and Calibration for Laboratories (NABL) because of its stringent norms. Court noted that the Central Government should step in in order to expedite the accreditation of such VRDL centres at private medical colleges.

However, as far as the use of Rapid Antibody Test Kits is concerned, Additional Solicitor General of India UM Aurangabadkar told the Court that the procurement of the same at the Central Government level was completed in part, however, use of the same is put on hold in view of divergent outcome of the result of some sample tests.

"I am informed that these kits are used only for surveillance and the same cannot be used for VRDL Centers. Be that as it may, in response to the Court's query, the learned ASGI has placed on record a pursis intimating that the Rapid Antibody Kits,which are procured are at the disposal of the ICMR, will be distributed as per the demand made by the State Government", Justice Sambre said.

Court directed the State to raise the demand for rapid antibody kits if required with ICMR and asked ICMR to expeditiously deal with such demand. This matter will now be heard on April 30. 

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