Amid doubts over its coronavirus kits, Chinese firm says fast tests more reliable only after incubation period

India to soon decide if it should keep importing rapid COVID-19 test kits from China

The Government said it would soon take a call on future imports of COVID-19 rapid test kits from China, as Indian Council of Medical Research already suspended the use of the ones it imported from the communist country last week.

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The ICMR acted on the complaints from state governments about variations and inaccuracies in the rapid test kits procured from the two Chinese companies.

One of the companies, Guangzhou Wondfo Biotech Company Limited, however, defended its product, arguing that the rapid test to detect presence of Covid-19 antibodies in the blood of infected people was expected to give accurate results only after the “incubation period”. It also underlined that the rapid tests, designed to detect the antibodies to the virus, should be used “as a supplement to nucleic acid detection testing or virus culture identification methods to increase the likelihood of an accurate result”

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The test kits of the Guangzhou Wondfo Biotech Company Limited earlier this month came under scanner for allegedly inaccurate results in the United Kingdom too.

New Delhi is in touch with Beijing as it is weighing its options to decide whether it should still continue importing the diagnostic equipment from the neighbouring country, a senior official told DH on Wednesday.

The State Government of Haryana, however, already dropped its plan to import 1.1 lakh rapid test kits from China and instead opted to procure it from SD Biosensor Inc of South Korea.

The South Korean company started producing the diagnostic equipment at its facility at Manesar in Haryana and the first batch was rolled out last Sunday.

India started importing rapid Covid-19 diagnostic kits from China on April 16. The first consignment to arrive in New Delhi had 300,000 kits from Guangzhou Wondfo Biotech Company Limited and 250,000 kits from Zhuhai Livzon Diagnostics Inc. The kits were later distributed among the states.

A second consignment of about 300,000 came on April 18 for Rajasthan and Tamil Nadu.

The Indian embassy in Beijing played a key role in procuring the kits from the two companies.

New Delhi apparently had plans to procure more rapid test kits from China, but the complaints about inaccurate results triggered the higher echelons of the Union Government to rethink their decision, which is also looking for alternate sources to procure the diagnostic equipment. The ICMR asked the State Governments to suspend the use of the equipment for two days.

The Guangzhou Wondfo Biotech Company Limited on Tuesday issued a statement, refuting media reports about inaccurate diagnosis caused by its kits in the United Kingdom.

“There is an incubation period after infection by the virus which causes Covid-19. During the incubation period, the virus could be detected through Polymerase Chain Reaction (PCR) testing and antigen testing,” it said, adding: “We know that the incubation period varies from person to person, and that sometime after the incubation period, the immune system creates specific antibodies to the coronavirus.”

The company argued that its rapid tests would be “more sensitive and reliable” after the creation of the antibodies to the Covid-19 virus following the “incubation period”. It also underlined that the antigen tests, designed to detect the presence of a live virus, would be less reliable after the “incubation period”, because of the presence of the antibodies.”

It said that its “SARS-CoV-2 Antibody Test (Lateral Flow Method)” obtained the certification from National Medical Products Administration (NMPA) of China on February 22 and was also approved by the European Union.

The ICMR too cleared the kit produced by the Guangzhou Wondfo Biotech Company Limited and Zhuhai Livzon Diagnostics Inc. for import to India in the first week of April.

“Noticed reports concerning rapid testing kits,” Ji Rong, a spokesperson of the Chinese Embassy in New Delhi, posted on Twitter, shortly after the ICMR suspended the use of the test kits imported from the communist country. “#China attaches great importance to the quality of exported medical products. Will keep close communication with #Indian concerned agency and provide necessary assistance,” she added in her post late on Tuesday.