ICMR issues advisory for rapid antibody-based blood tests for COVID-19

The move comes in the wake of the country reporting 3072 COVID-19 cases including 75 deaths so far.

Published: 04th April 2020 11:36 PM  |   Last Updated: 04th April 2020 11:51 PM   |  A+A-

Drones fitted with public addres systems deployed at Pudupettai on Saturday advising residents not to venture out from their houses. (Photo | Martin Louis/EPS)


NEW DELHI: The Indian Council of Medical Research (ICMR) on Saturday issued an advisory to start rapid antibody-based blood tests for COVID-19 in areas reporting clusters and in large migration gatherings or evacuee centres.

The decision for recommending these tests was taken at an emergency meeting of the National Task Force held recently.

The move comes in the wake of the country reporting 3072 COVID-19 cases including 75 deaths so far.

The results of antibody tests similar to blood tests are available in 15-30 minutes.

"Cases of influenza-like illness to be monitored in health facilities. Any surge in cases to be monitored and brought to the notice of surveillance officer/CMO for additional investigation," the advisory said.

As a matter of abundant precautions, all symptomatic persons with influenza-like illness should be advised home quarantine for 14 days.

At the facility level, symptomatic individuals with influenza-like illness to be tested using rapid antibody tests, the apex health research body said in its advisory.

If the antibody test comes out negative, then if warranted, it can be confirmed by real-time RT-PCR using throat/nasal swab.

At present, the government uses the RT-PCR (polymerase chain reaction) tests to detect the coronavirus from samples of the throat or a nasal swab of people with symptoms or high-risk individuals who might have come in contact with a positive patient.

RT-PCR negative indicates the likelihood of a non-COVID-19 influenza-like illness while RT-PCR positive means it is a confirmed case and action as per protocol should be initiated for isolation, treatment and contact tracing, the advisory stated.

If the antibody test comes out to be positive, there has to be a clinical assessment and treatment in hospital or isolation as per protocol.

Action as per protocol should be initiated for contact tracing.

"If symptoms worsen, refer to designated COVID-19 hospitals. When home quarantine is not feasible, consider facility-based quarantine," the advisory stated.

It also listed some general guidelines according to which healthcare workers doing the rapid antibody test should use gloves, mask, and headcovers.

Healthcare workers collecting throat/nasal swab should follow standard national infection control guidelines, it said.

The rapid antibody tests approved by US-FDA/CE-IVD or non-CE-IVD validated by ICMR-NIV with marketing approval by DCGI should be used.

In order to ensure that all such cases are monitored and necessary action is initiated with respect to infectious disease management, details of all test results shall be uploaded in ICMR portal.

"All such organisations are duty-bound to register themselves to ICMR portal and upload the data in real-time. Failure to do so, they will be held liable to action under the Disaster Management Act, 2005," the advisory stated.

In districts with no operational COVID-19 testing facility, setting up of a new centre will be considered if the number of suspected cases is more than 100 per day and the nearest testing laboratory is over 250 kms away in the plains and over 150 kms away in hilly regions, according to the ICMR.

Currently, the Indian Council of Medical Research (ICMR) has approved COVID-19 testing in more than 200 laboratories across the country.

Based on new requests from several districts for initiation of COVID-19 testing, the ICMR has come up with an advisory for setting up new laboratories.

According to the advisory, a testing laboratory can be made operational in a district in case the nearest one is at the above-mentioned distance and the existing laboratories are testing at least 100 samples each per day.

If the nearest testing laboratory is at the above-mentioned distance, not testing 100 samples per day and does not agree to test samples from the affected district, then it will be closed down and permission will be given to set up a new laboratory, it said.

To have a testing facility, the district should also have a BSL-2-level government laboratory, including a molecular biology setup for virological diagnosis and availability of staff with a good understanding of laboratory biosafety and biosecurity, and trained to handle respiratory samples for viral diagnosis among others.

"If a district has no government laboratory, but has a private laboratory which can apply for COVID-19 testing, the laboratory should have NABL accreditation and the scope of accreditation must include real-time PCR for respiratory viruses," the ICMR advisory stated.

Proofs of the mentioned requirements need to be submitted to the ICMR while applying for a new testing laboratory, including documents and photographs of the laboratory, it said.

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