Consolidated Guidelines

The following technologies were included in the evaluation:

2.2.1. Justification

Testing for TB infection increases the certainty that individuals targeted for treatment will benefit from it. However, there is no gold-standard test to diagnose TB infection. Both currently available tests – the TST and IGRAs – are indirect and require a competent immune response to identify people infected with TB. A positive test result by either method is not by itself a reliable indicator of the risk of progression to active disease. This section discusses the evidence and the recommendations for TB infection testing

Research priorities are as follows:

Factors that will require monitoring and evaluation are as follows:

• adverse event monitoring is a gap with the current TST use; thus, recording and reporting systems for results and adverse events need to be introduced when implementing the new tests; and
• there is a need to monitor the linkage between results of the new class of the tests and number of people placed on TPT.

Considerations for implementation were as follows:

User perspectives on the value, feasibility, usability and acceptability of diagnostic technologies are important in the implementation of such technologies. If the perspectives of laboratory personnel, clinicians, patients and TB programme personnel are not considered, the technologies risk being inaccessible to and underused by those for whom they are intended.

To address questions related to user perspective, the following activities were undertaken:

Two reviews following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were carried out to look at costs and cost–effectiveness of: