STLS

Integrated patient-centred care and prevention are one of the pillars of the End TB strategy. This requires TB services to be made affordable and accessible by integrating them with the general health system. 

In 2005, the National Rural Health Mission (NRHM) was established and was merged with the National Urban Health Mission (NUHM) in 2013, to form the National Health Mission (NHM).The National TB Elimination Programme (NTEP) is a flagship programme under the NHM and fund allocation to NTEP occurs through the NHM.

• The public health system in India through the National Health Mission (NHM) visualises the attainment of Universal Health Coverage (UHC) for all its citizens, which provides access to equitable, affordable and quality health care services, which is also accountable and responsive to the needs of the people.

Overview of the organisational structure of the health system in relation to the National TB Elimination Programme (NTEP) is shown in the figure below.

All childhood TB patients’ sputum and other relevant samples (e.g. gastric aspirate, induced sputum, bronchoscopic lavage, lymph node aspiration, CSF, tissue biopsies etc.) should be subjected to genotypic or the phenotypic Drug Susceptibility Tests (DSTs). Based on the bacteriological confirmation, the child should be treated for DS/DR TB as required.

But in cases where the child’s DST is unknown, the source patient’s DST should be considered.

Drug-resistant TB (DR-TB) diagnosis is predominantly based on laboratory diagnosis. Presumptive-TB/ DR-TB is identified by the health facility doctor during passive screening or by health staff/ community volunteers during Active Case Finding (ACF). 

The vision of National TB Elimination Programme (NTEP) is to provide early diagnosis to all persons with any form of DR-TB through Universal Drug Susceptibility Testing (UDST).

When an HIV-positive person dies from TB, the underlying cause is classified as HIV with TB as a contributory cause. However, the milestones and targets for reductions in TB deaths set at the End TB Strategy are for the combined total of deaths in HIV-positive and HIV-negative people.

Monitoring of key quality indicators or performance indicators of Truenat is important to assess the functioning of the instrument, calibration/ service requirements of the instrument, competency of the technician performing the assays and inventory management. Overall quality indicators should assess:

1. Total tests done
2. Type of samples tested
3. Test failure
4. Availability of consumables
5. Turnaround time
6. Specimen rejected
7. External Quality Assurance (EQA) results
8. Instrument downtime

Need-based maintenance for Truenat instrument is done by lab personnel/ manufacturer while the manufacturer does annual maintenance.

The tasks included under annual maintenance are:

The sputum sample needs to be processed to liquefy and lyse the specimen before Truenat testing. This is because of the following reasons:

• Sputum samples contain Polymerase Chain Reaction (PCR) inhibitors but PCR amplification requires pure DNA from sputum samples.
• The sputum sample should be homogenized and pipettable before DNA extraction can begin.
• Pre-treatment also decontaminates specimen for storage/ transportation/ extraction.

The Truenat Assay Technology works on Real-time Polymerase Chain Reaction (PCR).

The key steps include: