NEW DELHI: The evaluation of rapid antibody testing kits supplied by two Chinese companies — Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics — in field conditions have shown wide variations in sensitivity and the Indian Council of Medical Research (ICMR) has asked states to stop using the kits.
In a fresh advisory issued to states on Monday, the ICMR said: “The results have shown wide variations in their sensitivity, despite early promise of good performance for surveillance purposes.” The decision ends the short-lived saga of the rapid tests that were intended to bolster surveillance and tracking of trends in hotspots and low-prevalence areas even as the RT-PCR test remains the sole means of confirming Covid-19 infection.
“States are advised to stop using these kits procured from the above-mentioned companies and return them to be sent back to the suppliers,” ICMR additional director general G S Toteja said in aletter to state chief secretaries. The ICMR also said it has not made any payment in respect of these supplies.
Because of the due process followed (not going for procurement with 100% advance amount), the government of India does not stand to lose asingle rupee,” the council said. The induction of rapid tests was also a response to criticism of a section of experts that India was not testing enough.
Though WHO has pointed to the limited utility of the blood-based tests, the government sought urgent supplies to add another string to its testing capacities. Advocating the use of RTPCR tests for diagnosis of Covid-19 suspects, Toteja said RTPCR detects the virus early and is the best strategy to identify and isolate the individual.
Several states procured rapid antibody test kits even as the ICMR made them available at the clear instruction that these were to be used only for surveillance. On April 16, the ICMR received a consignment of 5,50,000 of these test kits from the two Chinese companies. Various states, including Rajasthan which was the first to start using the kits on April 18, found patients already confirmed through RT-PCR tests being reported negative by the rapid test kits.
In a fresh advisory issued to states on Monday, the ICMR said: “The results have shown wide variations in their sensitivity, despite early promise of good performance for surveillance purposes.” The decision ends the short-lived saga of the rapid tests that were intended to bolster surveillance and tracking of trends in hotspots and low-prevalence areas even as the RT-PCR test remains the sole means of confirming Covid-19 infection.
“States are advised to stop using these kits procured from the above-mentioned companies and return them to be sent back to the suppliers,” ICMR additional director general G S Toteja said in aletter to state chief secretaries. The ICMR also said it has not made any payment in respect of these supplies.
Because of the due process followed (not going for procurement with 100% advance amount), the government of India does not stand to lose asingle rupee,” the council said. The induction of rapid tests was also a response to criticism of a section of experts that India was not testing enough.
Though WHO has pointed to the limited utility of the blood-based tests, the government sought urgent supplies to add another string to its testing capacities. Advocating the use of RTPCR tests for diagnosis of Covid-19 suspects, Toteja said RTPCR detects the virus early and is the best strategy to identify and isolate the individual.
Several states procured rapid antibody test kits even as the ICMR made them available at the clear instruction that these were to be used only for surveillance. On April 16, the ICMR received a consignment of 5,50,000 of these test kits from the two Chinese companies. Various states, including Rajasthan which was the first to start using the kits on April 18, found patients already confirmed through RT-PCR tests being reported negative by the rapid test kits.
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