New Delhi: The Indian Council of Medical Research (ICMR) has approved two private companies from whom to source nasal and throat swab testing kits to detect Covid-19. From the current capacity of 5,000 tests per week, this move would potentially scale it up to 60,000 -70,000 tests a week.
With pressure mounting on government labs, ICMR has fast-tracked approvals to private labs to cary out Covid-19 tests. As of now 12 private lab chains with over 15,000 collection centres among them have registered their bids, out of which six have been approved.
The cost of the test is capped at Rs 4,500, inclusive of Rs 1,500 for screening and Rs 3,000 for confirmation, though the government has urged labs to conduct tests for free or at subsidised rates.
All tests have to be on done a real-time basis with home collection of samples to avoid contact of suspected cases with others. All positive samples are sent to ICMR-NIV Pune and the biomedical waste must be disposed of properly.
In addition, ICMR has said hydroxy-chloroquine has been found to be effective against the coronavirus in lab and in vivo studies. However, it has cautioned against random use of the drug as it is for use in prophylaxis for healthcare staff and household caregivers for Covid-19 patients. “Hydroxy-chloroquine is only for prevention,” said ICMR DH Dr Balram Bhargava, adding that the country has enough stock of it.
On the testing kits, Dr Bhargava said: “RT-PCR kits from Altona Diagnostics and My Lab have been approved for use.”
The name of the kit manufactrued by Altona Diagnostics is RealStar SARS-CoV-2 RT-PCR kit 1.0 while that of MY LAB is Patho Detect. They were approved following an evaluation of nine non-US FDA EUA/CE IVD kits. The testing kit produced by IIT-Delhi — called SYBR Green based one step QRT-PCR — failed to make the cut.
Currently, RT-PCR probes for diagnosis of Covid-19 are being procured from USA by ICMR-NIV and are distributed to testing laboratories across India.
While the US FDA EUA/CE IVD approved kits can be used directly after due approval from the Drug Controller General of India and intimation to ICMR, a fast-track mechanism has been established for validation of non US FDA EUA/CE IVD approved kits at ICMR NIV.
Testing must be done only with a doctor’s prescription. As for testing labs, ICMR has approved 12 private labs. Lal Path Labs (Rohini, Delhi) was approved; Unipath Specialty Laboratory Limited (Ahmedabad), Strand Life Sciences (Gurugram, Haryana) and SRL Limited (Gurugram); Neuberg Anand Reference Lab (Bengaluru); Department of Clinical Virology, CMC, Vellore and Department of Laboratory Services, Apollo Hospitals (Chennai).
Given the high number of positive cases in Maharashtra, five labs were approved: Thyrocare Technologies Limited (Navi Mumbai), Suburban Diagnostics (Andheri West, Mumbai), Metropolis Healthcare (Kohinoor Mall, Mumbai ), Sir H.N. Reliance Foundation Hospital and Research Centre, Molecular Medicine, Reliance Life Sciences (Navi Mumbai) and SRL Limited (Goregaon, Mumbai)....