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New antibody kits may have a China link, too

After initial hiccups over validating the efficacy of Covid-19 antibody testing kits made in China, the Indian Council of Medical Research (ICMR) has started the process of approving kits made by about 15 companies from Germany, the US, Israel and China.

, ET Bureau|
Last Updated: May 28, 2020, 08.40 AM IST
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Mumbai: After initial hiccups over validating the efficacy of Covid-19 antibody testing kits made in China, the Indian Council of Medical Research (ICMR) has started the process of approving kits made by about 15 companies from Germany, the US, Israel and China.

CPC Diagnostics, a manufacturer and distributor of medical devices backed by private equity firm Everstone, got approval for an antibody testing kit that it developed with Shanghai-based YHLO. The company said its tests are also useful to assess the suitability of plasma from individuals who have recovered from Covid-19 for therapy.

CPC, based in Chennai, has supplied 100,000 kits to the Andhra Pradesh government. Even after the bad press that Chinese-made kits faced in India, managing director R Kailasnath said it has not received complaints from buyers. “We are also hoping that as talks take off over immunity passports, such tests will gain importance,” Kailasnath said.

Siemens Healthineers of Germany said it has initiated the process for obtaining regulatory clearance from authorities in India for its kits. The company said it will ramp up production to more than 50 million antibody tests per month. “This will enable us to serve Indian markets against orders. However, we will follow the guidelines proposed by ICMR for antibody tests,” a spokesperson for Siemens Healthineers told ET.

The ICMR does not recommend antibody tests for diagnosing whether a person is infected. These tests are carried out for community screening or for population-based surveillance.
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