INDIAN COUNCIL OF MEDICAL RESEARCH DEPARTMENT OF HEALTH RESEARCH
Background:
WHO declared an outbreak of febrile respiratory illness of unknown etiology in December 2019 from Wuhan, Hubei province of China. Since its emergence, the disease has rapidly spread to neighboring provinces of China as well 151 other countries mainly through International travel. Infection is spread through droplets of an infected patient generated by coughing and sneezing or through prolonged contact with infected patients.
Currently, India has witnessed only imported cases of COVID19 and limited local transmission from imported cases to their immediate contacts. Community transmission of the disease has not been documented till now. If community transmission is documented, the above testing strategy will undergo changes to evolve into stage appropriate testing strategy.
Objectives:
- To contain the spread of infection / community transmission of COVID19 by improving access.
- To provide free of cost and reliable diagnosis to all individuals meeting the inclusion criteria of COVID19 testing.
- To avoid indiscriminate testing and reducing panic and optimally utilize the resources of the country and scale up facilities for testing.
Current scenario:
- All individuals requiring to be tested are being offered at no cost.
- Accessibility and availability of the test is being increased every day by adding optimum numbers of testing laboratories every week.
- Currently, the cost of the first step screening assay is INR 1500 and additional confirmatory assays is INR 3000.
- As a part of the laboratory expansion process, ICMR has engaged with non-ICMR / MOHFW Govt. laboratories to initiate testing facilities. This includes CSIR, DBT, DRDO, Govt. Medical Colleges etc.
- ICMR is also engaging with high-quality private laboratories that includes NABL accredited labs to understand the modalities of increasing access to the test while ensuring appropriate safeguards.
- ICMR is operationalizing already existing high throughput diagnostic systems (upto 1400 samples per day) to exponentially augment the testing capacity in heavily overloaded states. It is proposed to install high throughput systems in atleast 5 locations (with possibility of scale-up to 10 locations) on an urgent basis.
- ICMR-NIV, Pune has already placed orders to augment the existing stockpile of reagents to 1 million tests which would be available soon. WHO has also been requested to provide additional 1 million probes for testing.
- Advisory for testing are being reviewed and updated periodically (09/03/2020 and 16/03/2020). The testing strategy is reviewed by a high-level Expert Committee constituted by Secretary DHR & DG, ICMR and Chaired by Prof, Randeep Guleria, Director, All India Institute of Medical Sciences, Delhi.
Current testing strategy:
i. All asymptomatic people who have undertaken International travel:
- They should stay in home quarantine for 14 days.
- They should be tested only if they become symptomatic (fever, cough, difficulty in breathing etc.).
- If test result is positive, then they should be isolated and treated as per the standard protocol.
ii. All contacts of laboratory confirmed positive cases:
- They should stay in home quarantine for 14 days.
- They should be tested only if they become symptomatic (fever, cough, difficulty in breathing etc.).
- If test result is positive, then they should be isolated and treated as per the standard protocol.
Guidelines for private sector laboratories intending to initiate COVID19 testing:
Laboratory test should be only offered when prescribed by a qualified physician as per ICMR guidance for testing. Since the guidance evolves periodically, the latest revised version should be followed.
ICMR will share the SOPs for laboratory testing and provide positive controls for establishing the test as soon as the concerned private laboratory has procured the primers, probes and reagents as per SOPs. Adoption of commercial kits for testing should be based on validations conducted by ICMR-National Institute of Virology (NIV), Pune.
Appropriate biosafety and biosecurity precautions should be ensured while collecting samples from a suspect patient. Alternatively, a disease specific separate collection site may be created.
All the private testing laboratories ensure immediate/ real-time reporting to the State officials of IDSP (Integrated Disease Surveillance Program of Govt. of India)and ICMR Hq. for timely initiation of contact tracing and research activities.
ICMR strongly appeals that private laboratories should offer COVID19 diagnosis at no cost.
