COVID Testing Private Labs capped at Rs 4500, Health Ministry spells out how to collect samples, testing and reporting guidelines

New Delhi: Soon after including the private sector for the purpose of testing of Coronavirus in the country, ICMR has updated the guidelines for COVID-19 testing in the private laboratories. The ICMR also put a price cap of Rs 4500 on the COVID-19 testing by the private sector.

"The national task force recommend that the maximum cost off testing sample should not exceed Rs 4500. This may include RS 1500 as a screening test for suspect cases, and an additional Rs 3000 for confirmation test. However, ICMR  encourages free or subsidized testing in this are of national public health emergency,", the guidelines stated

"Failure to comply with any of the above guidelines will result in legal action," it further added 

The guideline states the following

Whom to test

Laboratory test should be offered when prescribed by a qualified physician as per the ICMR guidelines for  COVID- 19 testing. 

Sample collection and Testing Guidelines.

• Appropriate bio safety and bio security precautions should be insured while collecting respiratory samples (oropharnygeal and nasal swab) from a suspect patient. Alternatively, a covid-19 specific 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 best assays are recommended. Conventional PCR, in-house real time PCR and anti body/antigen test are not recommended for COVID-19 testing.
• Commercial kids for real time PCR based diagnosis off covid -19 should be US FDA approved or European CE 35 certified or both for in vitro diagnosis off COVID 19 under emergency use under intimation to DCGI Ministry of Health and family welfare. nucleic acid extraction kits and other reagents should be of standard quality.
• All the laboratory staff involved in kovid 19 testing should be appropriately trained in good laboratory practices and performing real time PCR
• All the bio medical waste should be disposed off in accordance with national guideline.
• The sample should be opened only in bio safety cabinet class II A2. At the time all sample disposal, the viral transport medium (VTM) red swabs should be discarded in a biohazard bag containing 2% Lyzol or 5% freshly prepared hydrochloride solution. Bag should be then sealed using plastic tag  and disposed off in accordance with the national guidelines
• Government ID in support the current address and contact number of the suspect patient should be collected at the time of sample collection.

Reporting protocols.

• Before any laboratory ( private or public ) start their activities, they must ensure immediate/ real time reporting of the test results along with the contact details to the ICMR HQ database accessible at https://cvstatus.icmr.org.in. Login credentials to each lab for uploading the data will be given by ICMR.
• Each laboratory will be given a registration number by the ICMR. The registration number given by ICMR should be prominently exhibited in case any advertisement is made and also in the report.
• The access to specified data and analyisis to stakeholders like IDSP, MOHFE will be provided thorugh API for timely intimation of contact tracing and appropriate control measures.
• The request should be send at aggarwal.n@icmr.gov.in. indicating name, contact details and mobile number of nodal contact for the lab.

Policy for sample storage and destruction

• All COVID-19 positive samples will need to be transported to ICMR-NIV, Pune under suitable biosafety and biosecurity precautions as laid down by ICMR. The negative samples will be destroyed within one week of collection
• NO sample should be shared with any other organisation for any purpose

 For reading the guidelines, click on the following link

https://www.mohfw.gov.in/pdf/NotificationofICMguidelinesforCOVID19testinginprivatelaboratoriesiIndia.pdf