ICMR Asks States Not to Use Covid-19 Rapid Test Kits for 2 Days after Variations Reported in Results

New Delhi: Amid complaints from Rajasthan and some other states about faulty rapid test kits, the Indian Council of Medical Research (ICMR) on Tuesday advised states not to use them for the next two days, saying it will issue an advisory after their teams carry out field validation of these equipment.

The Rajasthan government earlier in the day told ICMR that the rapid antibody test kits were not accurate enough and showed a high degree of variation in results.

A committee at Jaipur's Sawai Man Singh Hospital, comprising members from the department of medicine and microbiology, examined the accuracy of these kits and said they were unhappy with the results. They then informed the ICMR. Sources from the hospital confirmed this to News18.com.

“The sensitivity of the test is showing variations and the results are not as per what we are expecting in particular patients, based on scientific literature,” said a hospital source.

“One state complained of low detection and then we asked three other states too. We learnt that the variation in detection with respect to samples that tested positive with RT-PCR test is from 6% to 71%. This is not a good thing and we have to investigate it," said ICMR's head of epidemiology Dr Raman R Gangakhedkar at the daily press briefing on the coronavirus situation in the country. "We cannot overlook these findings and we can ask for replacement of those batches of kits.”

"These kits will be tested and validated in the field by our teams. We will issue a clear-cut advisory in two day. If problems are detected in batches, we will tell the companies for replacement," he said.

The ICMR had ordered rapid antibody testing kits earlier this month and the shipment was delayed by almost a fortnight. These kits have been ordered from China and South Korea and the Rajasthan government was reportedly using those procured from China. The kits are meant for surveillance to find out the prevalence of the infection in the community. It is not used for diagnosing the presence of the SARS-CoV-2 virus in the swab samples of a suspected patient.

Rapid test is a blood serum-based test and checks for antibodies that might be present in the body of a person. Depending on what kind of test it is, it may reflect whether there are IgM (Immunoglobulin M) antibodies or IgG (Immunoglobulin G) antibodies, or both. For this test, one drop of serum is dropped in the control bank and it will reflect whether antibodies are present.

IgM antibodies are produced in the first 4-7 days after pathogens enter the body while IgG antibodies can be detected 12-14 days after the pathogens have entered the body.

Gangakhedkar said a total of 4,49,810 samples for COVID-19 infection have been tested till Tuesday of which 35,852 were done on Monday. As many as 29,776 samples have been tested in 201 labs under the ICMR network, and 6,076 at 86 private laboratories, he said.

Lav Agrawal, Joint Secretary in the Health Ministry, said 18,601 positive cases have been reported across the country so far. As many as 3,252 people have been cured till now, he said, adding 705 of them recovered on Monday.

"This takes our recovery percentage to 17.48," he said.

(With inputs from PTI)