Expedite approval process for rapid antigen, RTPCR testing: HC to ICMR, NABL

New Delhi, July 16

The Delhi High Court on Thursday directed the ICMR and healthcare accreditation body NABL to expedite the process of granting approvals to private labs and hospitals for conducting Rapid Antigen and RTPCR tests in view of the increasing number of COVID-19 cases in the city, which have gone past 1.16 lakh.

A direction was also issued by the high court to the National Centre of Disease Control (NCDC) to place before it by July 27 the preliminary report of the “sero surveillance” carried out in the city from June 27 to July 5, during which 21,387 blood samples were collected from the 11 districts in Delhi and tested for the presence of antibodies to assess the prevalence of COVID-19 infection at the community level.

The directions were issued by a bench of Justices Hima Kohli and Subramonium Prasad after perusing the affidavits filed by the Indian Council of Medical Research (ICMR) and NCDC in response to its queries on the last date regarding how many labs and private hospitals in Delhi have been allowed to conduct the Rapid Antigen and RTPCR tests as well as the status of the sero survey carried out in the national capital.

The ICMR said it had been granting approvals to private hospitals and labs to conduct the Rapid Antigen and RTPCR tests. and it has given one month’s time to them apply for the same after getting accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL).

RT/PCR, short for Reverse Transcription Polymerase Chain Reaction, is a laboratory technique widely used in the diagnosis of genetic diseases and to measure gene expression in research.

The bench was of the view that the one-month time given to private labs and hospitals was too long as it could lead to complacency and directed the ICMR to shorten the window so that the general public was not inconvenienced in finding a lab or hospital for testing during the prevailing pandemic.

The court also directed the NABL, represented by Central Government standing counsel Anurag Ahluwalia, not to drag its feet when it receives applications for accreditation and to immediately carry out the inspections.

“The NABL has to hasten the procedure,” the court said to Ahluwalia.

Regarding the sero surveillance, the NCDC in its affidavit said the study was done “to assess the prevalence of infection at the community level and is primarily used for evidence-based public health response”.

It said after testing the collected blood samples for antibodies, the “results are then further collated based on epidemiological data and are then analysed for their stratification across different parameters which requires time and expertise”.

“The data is further analysed for its validity, variation and confirmation vis-a-vis similar such studies across the world,” it said.

The NCDC said this exercise had to be done methodically and was a time-consuming process and therefore, imposing timelines for declaration of result of these studies “will lead to a compromise in the quality of the analysis and can have a detrimental impact on the evidence-based results so expected to be obtained through such sero survey studies”.

It said that once preliminary findings were obtained, the same would be made available in the public domain.

It told the court that minimum one more week would be required for the preliminary results to be ready and the bench asked it to file the same before the next date of hearing on July 27.

During the hearing, conducted via video-conference, the Delhi government informed the court that from June 18 to July 15, it had carried out 2,81,555 Rapid Antigen Detection Tests, and of these, 19,480 were positive and therefore, they were recommended/referred to necessary treatment.

Of the remaining 2,62,075 who tested negative, those who were symptomatic — which numbered 1,365 — were sent for RTPCR test, and of them, 243 were found to be positive, Delhi government additional standing counsel Satyakam told the court.

The bench, thereafter, directed Satyakam to file an updated status report by the next date of hearing on July 27.

The directions came on the plea by advocate Rakesh Malhotra seeking increasing of the testing numbers in the national capital and getting speedy results. PTI

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