ICMR tells states not to deploy rapid kits of China firms

NEWDELHI: Six days after it decided to evaluate rapid test kits (RTKs) used to test for Covid-19 antibodies after states reported huge variations in results, the Indian Council of Medical Research (ICMR) on Monday asked all states to which it sent the kits, sourced from China, to return them — a move that comes even as one of the companies that supplied the kits revised prices sharply down following the Delhi high court’s observation on Sunday that there appeared to be significant profiteering going on.

“ICMR evaluated the kits of Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics in field conditions. The results have shown wide variation in their sensitivity, despite early promise of good performance for surveillance purposes. In view of this, states are advised to stop using these kits procured from the above mentioned companies and return them to be sent back to the suppliers,” said ICMR’s fresh advisory on rapid test kits issued on Monday.

Sensitivity is the ability of the test to identify a so-called truepositive -- it gives a positive result when someone is infected.

On April 16, the first batch of 5.5 lakh rapid testing kits arrived in Delhi from China, after missing two deadlines. The kits were part of ICMR’s plans and those of several states to aggressively expand testing. Of these, 300,000 were from Guangzhou Wondfo,

and 250,000 from Zhuhai Livzon. They were dispatched to the states over the following few days. But with states reporting variations between 6% and 71% in sensitivity, ICMR, on April 21, asked for the kits to not be used for two days.

“Since performance of these kits has been different in field settings from what the companies had submitted, these kits will be returned, and no money shall be paid. Rapid tests anyway have a limited role to play; the gold standard for identifying infection remains the polymerase chain reaction (RT-PCR) test,” Lav Agarwal, joint secretary, Union health ministry, said on Monday.

Meanwhile, importers of the RTKs have begun selling at revised rates after the Delhi high court capped the price of a test kit at ₹400 on Sunday. The court had observed there was heavy profiteering in the import and distribution of Covid-19 rapid testing kits with a kit costing ₹245 being sold for as high as ₹600. The court observed that 500,000 kits that were supplied to ICMR for ₹30 crore cost ₹12.25 crore.

Suresh K, proprietor, Matrix Labs, an importer of the Guangzhou Wondfo rapid test kits, said: “We have started selling the kits at ₹400 plus GST per unit. Whoever places an order will be given kits at this price from now on.” ICMR’s response on overpricing was that the price approved was based on the tender quotations received.

“Price range approved by ICMR is ₹740-1,150 for RT-PCR, and ₹528-795 for rapid test. Any Indian company wanting to supply at lower rates is welcome to contact ICMR…,” the body said in an official statement. It added that “…this was the first ever effort by any Indian agency to procure such kits and the rate quoted by the bidders was the only reference point.”

ICMR spokesperson Dr Rajnikant Srivastava said: “ICMR bought kits on pre-decided rates based on the tender quotation; now ICMR can’t keep a tab on who gets it for how much and how much profit or loss the companies are making. ICMR is not in the picture here.”

“These kits are not for early diagnosis as for that RT-PCR test is the gold standard; it can only be used for surveillance purposes, to periodically spot disease trends. To collect data on whether there is an old infection in a section of population or it is a recent infection; whether the spread is increasing or being successfully contained in places that are termed as hot spots, etc,” said Dr Raman R Gangakhedkar, head, epidemiology and communicable diseases, ICMR, in the briefing before deploying kits in the field.

Suresh however, refused to admit that the kits have problems. “The kit is not faulty. It was made very clear from the start that these rapid kits are not meant to do confirmatory tests to detect infection. The states have got it all wrong,” he said.

To be sure, researchers in the US too have found issues with first generation antibody test kits for Covid-19.