All private laboratories which have NABL accreditation for real-time PCR SA for RNA virus might be allowed to conduct COVID-19 tests, in accordance to the rules issued by the Indian Council of Medical Research (ICMR) for COVID-19 testing in private laboratories, which had been notified by the Union Health Ministry on Saturday evening.
The National Task Force recommends that the utmost cost for testing mustn’t exceed Rs 4,500. This could embody Rs 1,500 as a screening take a look at for suspect instances and an extra Rs 3,000 for affirmation take a look at, the rules mentioned.
“However, the ICMR encourages free or subsidised testing in this hour of national public health emergency,” the rules said.
An order issued by the Union Health ministry mentioned the failure to adjust to the rules will lead to authorized motion.
According to the rules on pattern assortment and testing, the ICMR has referred to as for making certain applicable biosafety and biosecurity precautions whereas amassing respiratory samples (oropharnygeal and nasal swab) from a affected person.
Alternatively, a COVID-19 particular separate pattern assortment website could also be created, it mentioned.
“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 said.
Commercial kits for real-time PCR-based analysis of COVID-19 must be US FDA permitted or European CE licensed or each for in vitro analysis of COVID-19 beneath emergency use, beneath intimation to the Drug Controller General of India, the rules added.
All the laboratory employees concerned in COVID-19 testing must be appropriately skilled in good laboratory practices and performing real-time PCR. All the biomedicial waste must be disposed off in accordance with nationwide tips.
Laboratory take a look at ought to solely be supplied when prescribed by a certified doctor as per the ICMR tips for COVID-19, the notification said.
As far because the reporting protocols are involved, the rules mentioned that any laboratory earlier than beginning its actions should guarantee rapid/real-time reporting of the take a look at outcomes together with the contact particulars to the ICMR headquarters information base.
Each laboratory might be given a registration quantity by the ICMR which must be prominently exhibited in case any commercial is made and likewise within the report, the notification said.
The tips could also be amended from time to time, the notification said.