The ICMR has written to all states and UTs saying all private laboratories in their areas which intend to initiate TrueNat/CBNAAT based tests for COVID-19 be encouraged to apply for NABL accreditation to ensure quality testing.

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In a letter to all chief secretaries, additional chief secretaries, secretaries, commissioners and principal secretaries (Health and Family Welfare), Additional Director General of ICMR Dr G S Toteja said many of the labs are doing this test for the first time and in view of this, it is prudent to comply with NABL norms and obtain accreditation of private labs.

The letter stated that ICMR, so far, has included a mandatory criterion for obtaining NABL accreditation for all COVID-19 testing private laboratories, including those with TrueNat/CBNAAT platform. "This is primarily to ensure quality testing and ensure correct interpretation of test results," the letter said.

The apex health research body had validated the usage of TrueNat, a diagnostic machine commonly used for detecting tuberculosis, for conducting coronavirus tests on April 10. Toteja emphasised that in the backdrop of COVID-19 crisis, the National Accreditation Board for Testing and Calibration Laboratories (NABL) has established expedited approval mechanism with fast-track approval being granted within seven days. "However, the need to augment testing for COVID-19 in the current situation is well understood. ICMR is committed to support all states in ramping up testing. In view of this, all private laboratories in your state who intend to initiate TrueNat / CBNAAT based testing for COVID-19 should be encouraged to apply for NABL accreditation," Toteja said in the letter.

All the labs which have applied can reach out to the ICMR with a copy of their NABL application. The ICMR will provide expedited approval for TrueNat /CBNAAT subject to NABL approval, which can be submitted within a maximum time span of four weeks from the date of approval. "I request you to direct the concerned private labs/hospitals in your state who intend to initiate COVID testing using TrueNat / CBNAAT, to adopt the above mechanism for obtaining approval for COVID testing from ICMR," the letter said.

The TrueNat and CBNAAT systems have been deployed for diagnosis of COVID-19 in view of availability of customised cartridges. These platforms have a quick turnaround time (30 -60 minutes) but only 1-4 samples can be tested in one run, limiting the maximum numbers that can be tested to 24-48 samples / day only, according to an advisory issued by the ICMR on June 23.

All COVID-19 tests conducted through RT-PCR, TrueNat and CBNAAT are reported on ICMR data entry portal which helps in drawing the national estimates on numbers of tests conducted, numbers of positives, tests conducted per million population, etc, it stated.