With thousands of Truenat machines already installed across the public health system, the government requires compatible consumables to keep them operational<\/p>\n
The Union Health Ministry has said that its Rs 882-crore tender for tuberculosis (TB) diagnostic kits is meant to establish a rate contract for consumables for more than 9,000 Truenat machines already deployed across the public health system, and is not a fresh exercise to select Truenat over competing molecular diagnostic technologies.<\/p>\n
The clarification comes amid concerns over the tender for Truenat MTB chips under the National TB Elimination Programme (NTEP), which specifies Truenat by name rather than generic technical specifications that could allow other products meeting the required performance parameters to compete.<\/p>\n
The ministry said the procurement is driven by the existing diagnostic infrastructure and the need to ensure a steady supply of consumables for installed machines. Similar procurement exercises have been undertaken for other molecular diagnostic platforms deployed under the NTEP.<\/p>\n
It said that India began introducing nucleic acid amplification testing (NAAT) for TB about a decade ago, initially through CBNAAT, an imported technology. Truenat, an indigenous molecular diagnostic platform, was introduced in 2020 following recommendations from the Indian Council of Medical Research (ICMR). The machines were also widely used for COVID-19 testing during the pandemic.<\/p>\n
\u201cOver the years, the NTEP has expanded the use of molecular diagnostics and has progressively replaced traditional sputum microscopy with NAAT-based testing up to the Community Health Centre level,\u201d the ministry said.<\/p>\n
The ministry said NAAT platforms can detect TB and, in relevant tests, identify drug resistance at diagnosis. \u201cThis is important because drug-sensitive TB is generally treated with standard first-line drugs, while drug-resistant TB requires a different combination of medicines. Failure to identify resistance early can result in ineffective treatment and continued transmission,\u201d it said.\u00a0<\/p>\n
Of four molecular TB diagnostic technologies assessed by ICMR \u2014 GenXpert\/CBNAAT, Truenat, PathoDetect and Quantiplus \u2014 the first three are already being used at scale under the NTEP.<\/p>\n
The Quantiplus MTB FAST Detection Kit was validated in 2025 and recommended by ICMR and the Central Drugs Standard Control Organisation (CDSCO) for TB detection, particularly as a potential replacement for smear microscopy in areas with unmet diagnostic needs.<\/p>\n
However, in its currently approved form, Quantiplus detects Mycobacterium tuberculosis but does not provide drug-resistance testing. The ICMR assessment notes that Truenat and PathoDetect can detect MTB along with rifampicin resistance.<\/p>\n
The ministry\u00a0argued that Quantiplus cannot be considered a direct replacement for existing NTEP NAAT platforms when the objective includes identifying drug-resistant TB upfront.<\/p>\n
\u201cQuantiplus technology is currently approved for detection of TB and not drug resistance,\u201d officials said, adding that a direct cost comparison with existing NAAT platforms may therefore not be appropriate.<\/p>\n
The ministry has maintained that the tender was not designed to favour a particular manufacturer. However, it has acknowledged that the procurement is specifically intended to support the existing Truenat infrastructure.<\/p>\n
With thousands of Truenat machines already installed across the public health system, the government requires compatible consumables to keep them operational as TB screening is intensified under the TB Mukt Bharat Abhiyaan.<\/p>\n
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