Health experts warn against self-testing for Covid-19

Maitri Porecha New Delhi | Updated on April 05, 2020

Health experts have warned against ordering rapid antibody diagnostic testing kits online for self-testing for novel coronavirus (Covid-19) as the results may not be accurate.

Lav Agarwal, Joint Secretary, Ministry of Health and Family Welfare, has clarified that the tests can be done only in authorised health facilities.


Home screening kit

All India Drug Action Network (AIDAN) has written to the Central government to examine a Bengaluru-based private company Bione offering a “simple point-of-care home screening kit” directly to consumers through its website.

“These kits are available for screening online at between ₹2,000 and ₹3000. We have already sold out our first batch, and we are asking people to buy two of them, and retest themselves after seven days in case the first time around the result is negative,” said Ruchi Dana, founding investor.

Read also: ICMR approves TB machines for Covid-19 testing


ICMR unaware

Raman Gangakhedar, head, infectious diseases in ICMR, told Businessline, “I am not aware of such a company selling kits online. ICMR will look into the matter and will convey appropriate steps after discussing it.”

While Indian Council of Medical Research has allowed use of antibody kits which are either validated domestically or have been approved by European regulator CE-IVD for use by States for community screening, it has yet not released any guidance on whether individuals can be self-tested at home.

While Bione claims that it has received all regulatory approvals, its name is missing from ICMR’s list of kits that can be used for rapid screening. To this, Dana said, “Bione is importing kits from the ICMR approved vendors, but we cannot share their names.”

While ICMR has put out a list of all antibody kit suppliers, Drug Controller General of India has not made public the list of the suppliers allowed to conduct business in India. “In the absence of a public list of all Covid-19 test kits approved by DCGI, it is impossible for us to verify such claims,” said Malini Aisola, co-convenor, AIDAN.

Suresh Vazirani, founder chairman of Transasia, a leading medical equipment supplier to labs, warned against self- testing. “Accuracy of such kits is hardly 70 per cent. In 30 per cent of cases, you may get a false positive which may lead to worries. If you get a false negative result, the patient may miss the government scanner. In the absence of guidelines, selling kits online may be a violation of ICMR testing strategy,” he said.

Unknown provenance

“No details are available on the company website regarding the foreign manufacturers of the kits, approvals in India, or the test kit's performance. The kit is being sold online without the need for a physician's prescription. It is impossible to determine the efficacy of the test kit, which resembles a pregnancy test in appearance,” said Chinu Srinivasan, founder of Low Cost Standard Therapeutics and an expert on pharma policy.

Bione is also selling two more products for Covid-19 – a microbiome kit which claims to test faeces to check a person’s predisposition to the virus priced at ₹14,999, and a genetic susceptibility kit at ₹7,999 online. “We would like to know whether CDSCO has approved any of these kits being marketed by Bione,” Srinivasan said.

Read more: Cruise ship Karnika to serve as a floating quarantine facility




Published on April 05, 2020

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