COVID-19 | Encourage pvt. labs using TrueNat/CBNAAT tests to get NABL accreditation, ICMR tells States

The ICMR had validated the usage of TrueNat, a diagnostic machine commonly used for detecting tuberculosis, for conducting coronavirus tests on April 10.

The TrueNat and CBNAAT systems, when used for COVID-19 testing, 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 per day only, according to an advisory issued by the ICMR on June 23.

The ICMR has written to all States and Union Territories asking them to encourage all private laboratories intending to initiate

TrueNat/CBNAAT-based tests for COVID-19 to apply for National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation to ensure quality testing.

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, since many of the private labs were conducting this test for the first time, it was prudent to comply with NABL norms and obtain accreditation.

The letter stated that ICMR, so far, had included a mandatory criterion for obtaining NABL accreditation for all private laboratories conducting COVID-19 tests, 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.

Mr. Toteja emphasised that in the backdrop of COVID-19 crisis, the 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,” Mr. 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 per 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.