Mumbai: Amid the threat of community transmission of coronavirus, the centre has issued fresh guidelines for testing in private laboratories in the country, making it amply clear that laboratory tests should only be offered when prescribed by a qualified physician as per the Indian Council of Medical Research (ICMR) advisory. Appropriate biosafety and biosecurity precautions should be ensured while collecting respiratory samples from a suspected patient. Alternatively, a specific and separate COVID-19 sample collection site may be created.
The ministry said, preferably, home collection of samples may be done by all the private laboratories to avoid people coming in contact with suspected cases on their way to the laboratory. Only real time polymerase chain reaction (PCR)-based assays are recommended, while the conventional in-house real time PCR and antibody/antigen tests are not recommended for COVID-19.
It will be mandatory for private laboratories to use US FDA approved or European CE certified or both commercial kits for real time PCR-based diagnosis. All the laboratory staff engaged in COVID-19 testing should be appropriately trained in good laboratory practices and performing real time PCR. All the biomedical wastes should be disposed off in accordance with the national guidelines issued in 2016.
All COVID-19 positive samples will need to be transported to ICMR- National Institute of Virology (NIC), Pune, under suitable biosafety and biosecurity precautions as laid down by ICMR. The negative samples will have to be destroyed within one week of collection. No sample should be shared with any other organisation for any purpose.
The centre, in its guidelines, said the maximum cost for testing samples should not exceed Rs 4,500, which may include Rs 1,500 as a screening test for suspected cases and an additional Rs 3,000 for confirmation. These charges should be as per the recommendations of the National Task Force. However, ICMR encourages free or subsidised testing in the present hour of an national public health emergency.
The centre has warned that if private laboratories fail to comply with these guidelines, then it may face legal action.