Karnataka, which had placed orders for rapid antibody blood-based test strips with two Chinese companies, has cancelled the orders following directions from the Indian Council of Medical Research (ICMR) to stop using the test strips.
In a letter to Chief Secretaries, ICMR Additional Director General G.S. Toteja said the scientific body has evaluated the performance of the kits, which were initially seen as crucial in efforts to speed up COVID-19 testing, and found wide variation in results.
“ICMR has tested 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,” the letter said. He said States should stop using kits procured from these companies and return them so that they could be sent back.
On April 16, ICMR received a consignment of 5,50,000 of these test kits from the two Chinese companies. Karnataka had been allotted 11,400 of these test strips and NIMHANS was entrusted with the task of validating the accuracy claims of these strips made by the manufacturers.
V. Ravi, Senior Professor and Head of Neurovirology at NIMHANS, said the validation process is still under way on negative samples. The process is likely to be completed by Tuesday.
C.N. Manjunath, Director of Sri Jayadeva Institute of Chest Diseases, who is the nodal officer for lab testing in the State’s COVID-19 task force, said the accuracy of the test strips on positive samples has not exceeded 47%. “Ideally, the accuracy should be at least 75 %. The validation results do not look promising,” he said.
“We have cancelled our order for one lakh strips that we placed with Zhuhai Livzon Diagnostics. A consignment of 50,000 strips from another order that we had placed with Guangzhou Wondfo Biotech had been sent to us three days ago through Blue Dart. However, we did not accept it,” he said.
Jawaid Akhtar, Additional Chief Secretary (Health and Family Welfare and Medical Education), said: “Only one of the two companies was given an advance amount and that has been taken back.”
With this, the State’s plans to take up random testing will now have to be done using reverse transcription polymerase chain reaction. The ICMR has approved 15 government labs and seven private labs to take up COVID-19 tests in Karnataka.
