TRUENAT- rapid molecular testing for TB It’s time to go global!

Price and implementation guide launched

IRL New Delhi Tuberculosis Centre, India National TB Elimination Program

08 April, Geneva, Switzerland Good news for all countries wanting to bring rapid molecular testing for tuberculosis (TB) and resistance to rifampicin to peripheral laboratories with minimal infrastructure. The Stop TB Partnership has negotiated global access pricing for TruenatTM tests, a battery-powered molecular technology that can diagnose TB in one hour as well as test for resistance to the drug rifampicin.

The cost per Truenat MTB test or the more sensitive Truenat MTB Plus test ordered through Global Drug Facility (GDF) is US $9. For every 100 MTB or MTB Plus tests ordered, 20 tests for rifampicin resistance (MTB-RIF Dx tests) will be included in the order at no extra cost to do reflex testing for rifampicin resistance as needed. An instrument kit (workstation) with an Uno analyzer able to test 1 sample at a time costs US $10,000, with a Duo analyzer to test 2 samples at a time costs US $14,000, and a Quattro analyzer to test 4 samples at a time costs US $18,000. GDF was able to negotiate decreased pricing for workstations as soon as procurement thresholds of 100, 500 and 1,000 workstations are met.

USAID has already committed to procuring over 100 Duo workstations through GDF, resulting in a price drop from $14,000 to $10,900 per Duo workstation for all buyers procuring through GDF in the coming year. Comprehensive service and maintenance packages are also available, including on-site visits for repair and replacement of equipment and parts. For complete details on Truenat pricing, see the GDF Diagnostics Catalog.

The pricing will be available for all TB programmes and non-profit organizations in low- and middle-income countries that order through Stop TB Partnership`s Global Drug Facility (GDF). 

To help countries in planning for adoption and scale-up of the tests, the Stop TB Partnership has also launched a Truenat Implementation Guide, developed jointly with the United States Agency for International Development (USAID) and the Global Laboratory Initiative (GLI).

The Stop TB/USAID/GLI Practical Guide to Implementation of Truenat includes a comprehensive background on the technology and procedures, guidance on selection of sites and planning steps required for a comprehensive roll-out, and sample standard operating procedures and preparedness checklists that countries can easily adapt to their settings.

“It is unacceptable for people especially from the most vulnerable and poorest populations to not have access to a reliable test for TB, and that they may only be offered an unreliable test like smear microscopy. Communities affected by TB have made it loud and clear that use of smear microscopy must be stopped; in fact this is a key demand in the Call to Action of their Deadly Divide report,” said Dr. Lucica Ditiu, Executive Director of the Stop TB Partnership. “With a test like Truenat suitable for deployment at point-of-care, countries finally now have the possibility to fill gaps in access to molecular testing. This of course will require additional funding, so governments and donors need to step up. Only by adding tests like Truenat to their armory will countries be able to meet the United Nations High Level Meeting (UNHLM) targets to test and treat 40 million with TB by 2022.”

The Truenat technology is manufactured by the Indian firm Molbio Diagnostics Pvt Ltd (Goa, India). Last year it became the first molecular test to be recommended by WHO for the detection of TB and rifampicin resistance that can be used at sites with minimal infrastructure. The equipment has built-in batteries and can be used at temperatures as high as 40°C. A suitcase for the Truenat Uno and Duo workstations allow for the system to be easily transported for active case finding activities. The system can also test for multiple diseases using disease-specific chips, including a test for COVID-19 that is currently undergoing WHO assessment for Emergency Use Listing.   

According to Molbio, over 4,000 Truenat systems have been deployed in India in 2,500 government facilities and 1,500 private laboratories and clinics, with over 4 million TB tests supplied so far. Following approval by its national regulatory authority, India is also using Truenat for decentralized COVID-19 testing, with over 9 million tests supplied so far.