New Delhi, March 22: The government has decided to allow private laboratories to test suspected cases of coronavirus only if they have COVID-19 testing kits approved by the US Food and Drug Administration (US FDA). A slew of guidelines has been issued by the Indian Council of Medical Research (ICMR) for private labs conducting coronavirus tests. The Ministry of Health and Family Welfare has notified those guidelines. Coronavirus Outbreak Live News Updates.

With the inclusion of private players, 111 labs will now conduct tests for diagnosis of novel coronavirus across the country. As per the ICMR guidelines, private labs can conduct coronavirus test when this is prescribed by a qualified physician. Labs must ensure real-time reporting of test results along with contact details to the ICMR database, said the guidelines. Each lab will be given a registration number by ICMR. Janata Curfew Over Coronavirus Outbreak: Streets Deserted, Shop Shuttered as Millions Stay Indoors.

"The access to specified data and analysis to stakeholders like IDSP, MoHFW will be provided through API for timely intimation of contact tracing and appropriate control measure," said the ministry. "The maximum cost for testing sample should not exceed Rs 45,000. This may include Rs 15,00 as a screening test for suspect cases, and an additional Rs 3,000 for a confirmation test," it added.

Sample Collection And Testing Guidelines:

  • Appropriate biosafety and biosecurity precaution should be ensured while collecting respiratory samples (oropharyngeal and nasal swab) from a suspect patient. Alternatively, a COVID-19 specific separate sample collection site may be created .

  • Preferably, home collection of samples may be done by all the private laboratories. This will help avoid the contact of people with the suspect case during local travel to reach the laboratory.

  • Only real-time PCR based assays are recommended. Conventional PCR in-house real-time PCR and antibody/antigen tests are not recommended for COV ID 1 9 testing.

  • Commercial kits for real-time PCR based diagnosis of COVID-19 should be US FDA approved or European CE Certified or both for in vitro diagnosis of COVID-19 under emergency use. under intimation to DCGI. MoH& FW. Nucleic acid extraction k its and other reagents should be of standard quality.

  • All the laboratory staff involved in COVlD- 19 testing should be appropriately trained in Good Laboratory Practices and perforn1ing real-time PCR.

  • All the biomedical waste should be disposed of in accordance with National guidelines.

  • The sample should be opened only in Biosafety Cabinet Class 11 A2. At the time of sample disposal, the Viral Transport Medium (VTM ) with swabs should be discarded in a biohazard bag containing 2% Lyzol or 5% freshly prepared hypochlorite solution. Bag should then be sealed using plastic tag and disposed of in accordance with the National guidelines.

  • Government ID to support the current address and contact number of the suspect patient should be collected at the time of sample collection.

Private labs have been allowed to conduct coronavirus tests to increase the scope and numbers of persons who are being tested. "People should not just come testing for fashion or confidence-building measure. It is very important to understand that testing should be done as per the protocol defined for testing," Joint Secretary of Health Ministry Lav Agarwal said.

(The above story first appeared on LatestLY on Mar 22, 2020 10:01 AM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).