The matter is being seriously addressed by the ICMR, says official

Amid claims by the West Bengal Department of Health and Family Welfare that the testing kits being supplied by ICMR-NICED about two weeks ago have started to “throw up a large number of inconclusive results”, representatives of NICED (National Institute of Cholera and Enteric Disease) on Monday admitted of glitches in them.

“This has been noted by the ICMR as well..... It is unfortunate that the kits are not standardised by the manufacturer to give exact results... It is difficult for each of the medical college to standardise the kits... hence they are showing different and inconclusive results. The matter is being seriously addressed by the ICMR,” NICED director Shanta Dutta told The Hindu.

ICMR’s directive

Later in the day, Dr. Dutta said the IMCR had instructed the NICED not to “distribute the faulty kits and instead distribute kits assembled by NIV, Pune”.

On Sunday, the Health Department tweeted, “The apparently defective test kits supplied by ICMR-NICED, Kolkata are resulting in a high number of repeat/ confirmatory tests and causing delays and other attendant problems at a time when we are battling a pandemic. This is an issue that ICMR needs to look into immediately”. It said inconclusive results were “necessitating a repeat confirmatory test run, thereby causing a delay in generation of final test report”. There was no problem when testing kits were received directly from the National Institute of Virology (NIV), Pune, but recently, supplies to the government labs have been routed through ICMR- NICED, Kolkata, it added.

Dr. Dutta said the initial kits were assembled by the NIV, where it standardised them with other reagents and controls and distributed them directly to other Virus Reserach Diagnostic Laboratories (VRDLs). “When the numbers of kit supply increased, it was difficult for the NIV to cope up with the demand. Then, the ICMR started procuring ready-made kits and supplied them to the VRDLs through 16 depots across the country”.

State Chief Secretary Rajiva Sinha also highlighted the issue of faulty testing kits. The kits were throwing ambiguous tests, which was leading to delay in detection of COVID-19.

400 samples tested a day

The development comes at a time when questions are being raised if West Bengal, the fourth most populous State in the country, is doing enough tests. The State has seven testing tabs, which includes five State-run and two private ones, and the number of COVID-19 tests on a daily basis remains at 400. The Calcutta High Court on April 17 advised the State to increase testing on a “war footing”. The government on Monday started conducting rapid antibody tests as per the ICMR directives in “red zones areas where containment activities are going on” only upon receipt of prior clearance from Swasthya Bhawan. The State has about 245 active cases of viral infection and 12 deaths, according to an official bulletin of the Health Department on April 20.