The evaluation of rapid antibody testing kits supplied by two Chinese companies- Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics in field conditions have shown wild variations in sensitivity and Indian Council Medical Research (ICMR) has asked states to stop using those kits.
In a new advisory issued to the states by ICMR, it stated that, “The results have shown wide variation in sensitivity, despite early promise of good performance for surveillance purposes,” ICMR said. The decision ends the era of short lived saga of 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.
“Several States have procured rapid antibody test kits and on their demand, ICMR has also provided these kits with clear instructions that they are to be used only for surveillance purposes. Later some States raised issues regarding their performance during the testing exercise that they have undertaken,’’ it observed.
ICMR, thereafter, evaluated the kits in field conditions and the results have shown wide variation in their sensitivity despite early promise of good performance for surveillance purposes. “States have now been told to not use these kits and return them to be sent back to the suppliers.’’