Chinese companies refute India's claim of faulty rapid testing kits

Countering claims of defective rapid testing kits, two Chinese firms have come out in defence of their products. While Zhuhai Livzon Diagnostics blamed unfavourable storage and transport temperature conditions for the inaccurate results, Guangzhou Wondfo Biotech clarified that their test provides preliminary results and should not be used as the sole basis for treatment.

“Negative results do not preclude SARS-CoV-2 infection, and it is recommended to use nucleic acid detection identification methods for review and confirmation. For positive test results, it does not rule out co-infections with other pathogens,” said Guangzhou-based Wondfo Biotech in its response.

Livzon Diagnostics said it is very important to strictly follow the instructions for use in the package of our product and performed by trained professionals in qualified lab settings to ensure the test quality.

“The storage and transport temperature conditions are the first we need to emphasize, where we noticed in India recently temperature started to rise up to 3 degrees celsius. It will significantly impact the product stability when stored at over 30 degrees celsius and it should not be stored under 2 degrees celsius,” said the company.

Both the firms asserted that their kits were evaluated and approved by the Indian Council of Medical Research through National Institute of Virology, Pune.

The ICMR had last month asked state governments not to use the rapid antibody test kits procured from Wondfo Biotech and Livzon Diagnostics after it emerged that they were showing inaccurate results. The nodal medical research body had said these should be returned to the suppliers. According to reports, both these companies had exported close to 700,000 kits to India.