India Issues Guidelines For Private Testing, Ropes In National Labs As Coronavirus Cases Increase
As the number of people getting infected by the novel coronavirus rises in India, the government has issued guidelines for testing by private labs in the country, set price caps for such tests, and roped in national laboratories.
All private laboratories that have National Accreditation Board for Testing and Calibration Laboratories accreditation for real-time polymerase chain reaction assay for RNA virus will only be allowed to conduct Covid-19 tests, according to the guidelines issued by the Indian Council of Medical Research on Saturday. The laboratory test can only be offered when prescribed by a qualified physician as per the ICMR guidelines for Covid-19 testing.
Private players, according to the guidelines, can only do home collection of samples to avoid the contact of people with the suspect case during local travel to reach the laboratory. Besides, the labs are advised to take appropriate bio-safety and bio-security precautions while collecting respiratory samples from a patient. And a separate sample collection site may be created for Covid-19.
The guidelines stipulate that all commercial kits for real time PCR-based diagnosis of Covid-19 should be either U.S. Food and Drug Administration approved or should meetEuropean certification standards, or both.
The national task force also recommended that the maximum cost of testing sample shouldn’t exceed Rs 4,500. This may include Rs 1,500 as a screening test for suspect cases and an additional Rs 3,000 for confirmation test.
The government also said that all Covid-19 positive samples will need to be transported to ICMR's National Institute for Virology, Pune under suitable biosafety and biosecurity precautions as laid down by ICMR, and the negative samples must be destroyed within one week of collection.
Failure to comply with any of the guidelines could lead to legal action, the guidelines said.
Reporting Protocol For Private Labs
- Before any lab starts their activities, they must ensure immediate or real-time reporting of the test results along with the contact details to the ICMR HQ database.
- Each lab will have a registration number by ICMR.
- Access to specified data and analysis to stakeholders like Ministry of Health and Family Welfare will be provided for timely initiation of contact tracing and appropriate control measures.
National Laboratories Roped In
Besides, the government has also allowed all of its national laboratories to carry out clinical testing of Covid-19, based on self-assessment. The decision was taken at the meeting of the Empowered Committee for Covid-19 response co-chaired by Vinod Paul, member of NITI Aayog; and Dr K Vijayraghavan, principal scientific adviser to the government; on Saturday.
Laboratories of Central Scientific and Industrial Research, Department of Science and Technology including others with BSL-3 (biosafety levels) and BSL-3+ facilities have been permitted to culture the virus and serve as additional testing and validation sites for research.
The committee also directed government hospitals to co-operate with these laboratories for collection of clinical samples, where this ethical approval in place.