ICMR expands norms to enable rapid antibody, antigen testing
The Indian Council of Medical Research (ICMR) on Tuesday expanded the coronavirus disease (Covid-19) testing norms, advising that all hospitals, offices and public sector units be enabled to conduct rapid antibody tests, and recommending the deployment of rapid antigen tests in all containment zones, and hospitals and private labs across the state.
While the antibody-based test can be used as a surveillance method to check if a person was infected by the Sars-cov-2 virus at some point, tests through new “antigen” devices can be carried out on-site and provide results within 30 minutes. The rapid antigen tests were recently deployed in Delhi and have been hailed by experts for speeding up the testtrace-isolate process.
“It is advised to enable all government and private hospitals, offices, public sector units etc. to perform the antibody-based testing. This will help in allaying fear and anxiety of health care workers, office employees ..,” a statement by ICMR said.
“ICMR recommends deployment of the rapid antigen POC (point of care) test in the following settings: i) All containment zones identified by the State Governments, ii) All Central & State Government Medical Colleges and Government hospitals, iii) All private hospitals approved by National Accreditation Board for Hospitals & Healthcare (NABH), iv) All private labs accredited by National Accreditation Board for Laboratories (NABL) and approved by ICMR as COVID-19 testing labs,” India’s apex biomedical research body said.
The private sector welcomed the move. “We had raised the issue that we needed some clarity on whether we can perform antibody and antigen based tests. It’s good to know that government has come out with a revised advisory as it will be important to know how many have had exposure to the virus, especially in the health care sectors,” said Dr Anupam Sibal, group medical director, Apollo Hospitals.
Speaking about the efficacy of the rapid antigen test, Dr Navin Dang said: “Antigen testing is point of care testing for time is of essence in conducting an antigen based test. It has to be done within an hour so if offices or other places have been allowed which means booths will have to be set-up on site itself. It is doable but modalities will have to be worked out so as to not compromise the sanctity of a sample.”
An antigen is a molecule that induces an immune response within the body, especially the production of antibodies, and detecting its presence determines a present infection. Antigenbased tests ensure rapid diagnosis and they take about 30 minutes to present results, as opposed to nearly six hours taken by the RT-PCR test. It is a point-ofcare test and does not require laboratory facilities. It can be read through the naked eye without any specialised equipment.
The ICMR said all the positive results for any kind of Covid-19 test must be registered. “All data of testing needs to be entered into the ICMR portal on a real time basis…,” the advisory said.
The Union government has demanded clarification from Patanjali Ayurved, the company promoted by Baba Ramdev, over its claim of having developed a cure for the coronavirus disease (Covid-19), and asked it to stop advertising the product till the claim is verified.
The company announced its discovery in a press conference and Ramdev, a popular yoga guru, followed it up with a spate of interview to TV channels extolling the benefits of the cure, which, if it holds up to scientific scrutiny, will be the first of its kind in the world.
“Facts of the claim and details of the stated scientific study are not known to the Ministry… Patanjali Ayurved Ltd has been asked to provide at the earliest details of the name and composition of the medicines being claimed for COVID treatment; site(s)/hospital(s), where the research study was conducted for COVID-19…,” said the ministry of Ayush on Tuesday.
According to Patanjali, the products have been made in association with privately owned National Institute of Medical Science (NIMS), Jaipur. The company also claimed the medicines cleared a clinical trial in several cities including Delhi, Ahmedabad and Meerut and the RCT (Randomized Clinical Trial) controlled with placebo at NIMS. But, no clinical testing data was released by the company. NIMS was unavailable for comment.
The approvals for manufacturing and marketing of drugs, Coronil and Swasari, have likely come from the Uttarakhand government, the state licensing authority for Patanjali in Haridwar. The Centre has asked the Uttarakhand government for details and also ordered Patanjali to stop advertising the products.
In its response, Patanjali to the drug policy section of the Ayush ministry on Tuesday evening, giving details of its drugs trial.
“There was a 69% recovery at day 3 PCR in treatment group, and 100% recovery at day 7, which is 35% better recovery than the placebo group,” said the firm in its response that the Ayush ministry will be reviewing.
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