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The Chinese companies, that are manufacturing the Covid-19 rapid antibody test kits that were reported as faulty by several Indian states, have claimed the problem is not with their kits but with the way they were being used by health care workers.

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India has imported five lakh rapid antibody testing kits from two Chinese companies - Wondfo Biotech and Livzon Diagnostics. These kits were distributed to several states reporting rising cases of coronavirus infection. However, the Rajasthan and West Bengal governments have said the kits were giving out inaccurate results.

Earlier, the Indian Council of Medical Research (ICMR) had asked all the states to put on hold the use of rapid testing kits for some time after inconsistencies were found in the test results. It had later said that these kits could be used only for surveillance.

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ICMR has put these kits under rigorous testing and has said that if the kits were found faulty then contracts of these companies will either be canceled or they will be asked to send a fresh batch of kits.

However, reacting to brewing controversy surrounding their kits, the two Chinese manufacturers claimed that the kits were fine and were being exported across the globe. The companies advised health care workers to follow the user manuals of the kits properly.

However, a senior infectious disease expert in India claimed that the Chinese companies seem to have launched the kits in a rush. "It seems that these Chinese companies have not conducted proper trial before launching it for commercial use globally. These companies did very little human testing because it seems that they were in a hurry to market their product in view of global demand," Dr Mubasheer Ali, senior infectious disease consultant, telemedicine Appolo Hospital said.

When asked about the kits, Union Health Minister Dr Harshvardhan said that the kits will be replaced if found faulty.

"We got lots of feedback from the states, which put a question mark over the use of these kits. The ICMR is holding a controlled test in their lab. Whatever the outcome, we'll inform you all. If we found faulty, whosoever is the company, we'll get the kits replaced by the vendor," Dr Harshvardhan said, adding that since the rapid antibody kits are only meant for surveillance, the states should create a hype around the issue.

What do the Chinese companies say:

In its clarification, Wondfo Biotech claimed that the company was fully cooperating with the ICMR. The company said that it received an import license from India on March 20, after its product was validated and approved by ICMR through NIV Pune.

Wondfo Biotech claimed that its Wondfo SARS-CoV-2 anti-body test (lateral flow method) has been exported to more than 70 countries with a total shipment volume of 18 million test kits.

The shipment to Brazil, Spain, Indonesia and Venezuela were over 1 million tests per country, the company said.

Livzon Diagnostics, in its statement, said that it was approved by China NMPA on March 14. The company said that its antibody test has been used in hundreds of hospitals in China and has received good feedback.

Livzon Diagnostics said that its rapid antibody test kit has been approved by India, EU, Brazil, Nigeria, Peru, Columbia and had been supplied to more than 10 countries.

The two companies claimed that the product must be stored and used as per the instructions given in the user manual for correct results. The instructions in their manuals include correct storage temperatures, the time limit to use the kit after opening it, storage guidelines and testing methods.

Rapid test kits not subsitutute to RT-PCR

Rapid antibody test is used as a tool for surveillance with respect to the formation of antibody in persons exposed to the virus. The government has recommended the use of rapid antibody tests in hotspot areas.

According to the ICMR protocol, only those showing symptoms of influenza-like illness such as fever, cough and cold for seven days or more in hotspot areas should be made to undergo a rapid antibody test.

Those who will be found positive must be quarantined at least for seven days and contract tracing should be initiated. Those who test negative should also remain under home quarantine for at least seven days.

The ICMR has said that the rapid antibody test kits should be used for surveillance purposes while stating that RT-PCR tests must be continued vigorously as the principal diagnostic test for Covid-19.

The RT-PCR test of the throat and/or nasal swab is the confirmatory test for the detection of Covid-19 at an early stage. As per ICMR guidelines, the RT-PCR test should be performed to confirm the diagnosis of Covid-19 if clinical suspicion is high.

Follow the government's latest guidance on safeguarding yourself during the coronavirus pandemic, including travel advice within and outside the country. The World Health Organization has also busted some myths surrounding coronavirus. The Ministry of Health's special helpline is available at +91-11-23978046, ncov2019@gmail.com and ncov2019@gov.in.