Coronavirus | Rapid test kits were cleared by ICMR, say Chinese manufacturers

ICMR had advised all States to refrain from using rapid test kits for two days, after huge variations in the accuracy of results were noticed across regions. A scene on antibody-based rapid test kits in Chennai.   | Photo Credit: B. Jothi Ramalingam

Two leading Chinese companies on April 23 expressed shock and surprise at reports of malfunctioning of rapid testing kits that they had supplied to India saying the products had been approved by the Indian Council of Medical Research (ICMR) and the National Institute of Virology.

Also read | Acting on ICMR’s advice, State halts rapid testing

“Wondfo received import license from India for Wondfo SARS-CoV-2 Antibody Test [Lateral Flow Method] on March 20, 2020. And the product was validated and approved by the ICMR through National Institute of Virology [NIV], Pune,” said a statement from Wondfo, one of the major global suppliers of rapid testing kits for COVID-19 viral infection.

A similar statement was issued by Livzon Diagnostics Inc., the other Chinese supplier that also supplied a bulk of the rapid testing kits.

The statements from the Chinese medical device companies came a day after ICMR halted surveillance testing for two days, largely due to complaints of faulty Chinese test kits. The explanations from Wondfo and Livzon clarified that the tests had to be conducted within laid down procedures and violation of the laid down procedures could disturb the test results.

Also read | NICED admits testing kits have problem in West Bengal

They promised to cooperate with Indian authorities to investigate the reported malfunctioning and said the products met the ISO 9001 standard.

The companies said they are among the most reputed global suppliers of rapid testing kits for COVID-19 and have supplied the same to the United States, and many other European and Latin American countries.

The communications from the two suppliers sent to the media by the Chinese Embassy in India insisted that users should follow the “Storage & Stability” guidelines specified in the package.

India imported 6.5 lakh test kits from China last week and more such test kits were expected to reach India from China in the coming days.

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Printable version | Sep 22, 2021 5:54:01 AM |

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