The West Bengal government has alleged that the COVID-19 testing kits supplied by the National Institute of Cholera and Enteric Diseases, Indian Council of Medical Research's nodal agency in the state, a fortnight ago, are "apparently defective" as they show "inconclusive results" leading to repeated confirmatory tests and delaying diagnosis of the disease.
The ICMR-NICED authorities said it could be possibly because the kits "have not been standardized" and it is considering the matter "very seriously".
West Bengal has reported 12 deaths and 276 cases of COVID-19 affliction.
"The apparently defective test kits supplied by ICMR-NICED, Kolkata, have started to throw up a large number of inconclusive results, necessitating a repeat/confirmatory test run, thereby causing a delay in the generation of the final test report," the West Bengal department of health and family welfare has tweeted.
The "high number of repeat/ confirmatory tests are causing delays and other attendant problems at a time when we are battling a pandemic," it said, adding the Incian Council of Medical Research needs to look into it immediately.
The department claimed that the problem of defective kits has been faced not just by government labs in the state but other testing labs in the country.
The state health department had faced no such problem when the testing kits were supplied directly by the National Institute of Virology, Pune, it said.
Recently, the supplies to government laboratories in West Bengal have been routed through ICMR-NICED, Kolkata, the department tweeted.
When contacted, NICED director Shanta Dutta said,"It is unfortunate that test kits have not been standardised to yield appropriate results. It is difficult for each medical college to standardise them, because of which there were different and inconclusive results."
She said the matter was "very seriously considered" by the ICMR.
"Initial NIV kit was an assembled one where the NIV had procured the primer and probes from the US, standardised the kit in their laboratory with other reagents and controls, and distributed it directly to other VRDLs (Virus Research and Diagnostic Laboratory).
"When demand for the kit icreased, it was difficult for the NIV to cope up with it. Then ICMR started procuring readymade kits and supplied to VRDLs through 16 depots across the country," she said.
West Bengal on Sunday received 10,000 rapid antibody testing kits from ICMR and is expected to start using them soon in areas with a high number of COVID-19 patients.
The rapid tests will be conducted at the hotspots, clusters, containment zones or as a surveillance tool for epidemiological purposes in areas which have not reported any case so far.
