The central government on Saturday recommended that the maximum charge for each COVID-19 test by private laboratories should not exceed Rs 4,500.
All private laboratories which have NABL accreditation for real-time PCR SA for RNA virus will be allowed to conduct COVID-19 tests, according to the guidelines issued by the Indian Council of Medical Research for COVID-19 testing in private laboratories, which were notified by the Union health ministry on Saturday night.
The National Task Force recommends that the maximum cost for testing 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 confirmation test, the guidelines said.
"However, the ICMR encourages free or subsidised testing in this hour of national public health emergency," the guidelines stated.
An order issued by the Union health ministry said the failure to comply with the guidelines will result in legal action.
According to the guidelines on sample collection and testing, the ICMR has called for ensuring appropriate biosafety and biosecurity 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," the notification stated.
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, the guidelines added.
All the laboratory staff involved in COVID-19 testing should be appropriately trained in good laboratory practices and performing real-time PCR. All the biomedicial waste should be disposed off in accordance with national guidelines.
Laboratory test should only be offered when prescribed by a qualified physician as per the ICMR guidelines for COVID-19, the notification stated.
As far as the reporting protocols are concerned, the guidelines said that any laboratory before starting its activities must ensure immediate/real-time reporting of the test results along with the contact details to the ICMR headquarters data base.
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, the notification stated.
The guidelines may be amended from time to time, the notification stated.
