Coronavirus COVID-19 test in private labs could cost up to Rs 4500

ICMR also released the guidelines for COVID-19 testing in private laboratories.

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New Delhi: The Indian Council of Medical Research (ICMR) on Saturday (March 21, 2020) said in a press release that the National Task Force recommends the maximum cost for the testing sample should not exceed Rs 4,500. This may include Rs 1,500 as a screening test for suspect cases, and an additional Rs 3,000 for a confirmation test. However, ICMR encourages free or subsidized testing in this hour of a national public health emergency. 

ICMR also released the following guidelines for COVID-19 testing in private laboratories:

1. The test to be conducted by a laboratory which has NABL accreditation for real-time PCR assay for an RNA virus. 

2. A laboratory test should only be offered when prescribed by a qualified physician as per the ICMR guidelines for COVID-19 testing. Since the guidance evolves periodically, the latest revised version should be followed (link below). (https://icmr.nic.in/sites/default/files/upload documents/2020-03-20 сovid19 test v3.pdf)/www. mohfw.gov.in. 

3. Appropriate biosafety and biosecurity precautions 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, the 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 COVID-19 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 kits and other reagents should be of standard quality. All the laboratory staff involved in COVID-19 testing should be appropriately trained in Good Laboratory Practices and performing real-time PCR. All the biomedical waste should be disposed of in accordance with National guidelines (https://dhr.gov.in/sites/default/files/Bio-medical_Waste_Management_Rules_2016.pdf). The sample should be opened only in Biosafety Cabinet Class II 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. The bag should then be sealed using a plastic tag and disposed of in accordance with the National guidelines. 

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

5. 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. 

6. Each laboratory will be given a registration number by 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 analysis to stakeholders like IDSP, MOHFW will be provided through API for timely initiation of contact tracing and appropriate control measures. The request should be sent at aggarwal.n@icmr.gov.in indicating name, contact details and mobile number of nodal contact for the lab. 

7. 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.