The government has recommended that the maximum cost for testing samples for COVID-19 or novel coronavirus by private laboratories should not exceed 4,500 rupees. This may include 1,500 rupees as a screening test for suspect cases and additional 3,000 for confirmation test.
The Indian Council of Medical Research (ICMR) has issued guidelines in this regard which were notified by the Union Health Ministry. It said, all private laboratories which have NABL accreditation for real-time PCR assay for RNA virus will be allowed to conduct COVID-19 tests.
Laboratory test should only be offered when prescribed by a qualified physician
According to the guidelines on sample collection and testing, the ICMR has called for ensuring appropriate bio-safety and bio-security precautions while collecting respiratory samples – oropharnygeal and nasal swab from a patient.
Alternatively, a COVID-19 specific separate sample collection site may be created.It said, preferable home collection of samples may be done by all the private laboratories which will help avoid the contact of people with the suspect cases during local travel to reach the laboratory.
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 the Drug Controller General of India.
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 off in accordance with national guidelines.
Each laboratory will be given a registration number by the ICMR which should be prominently exhibited in case any advertisement is made and also in the report.
It said, all COVID-19 positive samples will need to be transported to ICMR-NIV, Pune under suitable bio-safety and bio-security precautions as laid down by ICMR. The negative samples will be destroyed within one week of collections. No sample should be shared with any other organisation for any purpose.