Consolidated Guidelines

4.2.1. Justification and evidence

TB diagnosis in children relies on a thorough assessment of all evidence derived from a careful history of exposure, clinical examination and relevant investigations. While various algorithms and scoring systems for TB diagnosis in children exist, these have not been systematically evaluated. There is a need for evidence-based, practical treatment decision algorithm(s), ideally for different settings with varying access to diagnostic tests and CXR.

4.1.4. Monitoring and evaluation

Local monitoring of specimen collection by specimen type, diagnostic test, result and clinical diagnosis in a TB Laboratory Register (or equivalent) is recommended. Results should be recorded in a TB Register.

Routine recording and reporting of child and adolescent notifications in five-year age brackets (i.e. 0-4, 5-9, 10-14, 15-19 years) is recommended by WHO for countries with case-based electronic recording and reporting systems.

4.1.2. Subgroup considerations

Children with severe acute malnutrition (SAM): four studies (with 259 participants, of whom 9 had TB disease) were identified for children with SAM using Xpert Ultra on gastric aspirates and three studies (428 participants, 19 with TB) using Xpert Ultra on stool specimens. The meta-analysis on stool samples in children with SAM showed similar accuracy as in the overall analysis (sensitivity 63.2%, specificity 98.5%). A meta-analysis on gastric aspirates could not be performed due to insufficient data.

4.1.1. Justification and evidence

The development of the Xpert MTB/RIF assay (Cepheid, Sunnyvale, United States of America (United States)) was a significant step forward in improving the diagnosis of TB and the detection of rifampicin resistance globally. However, Xpert MTB/RIF sensitivity is suboptimal, particularly among people (including children) with smear-negative TB and people (including children) living with HIV. The Xpert MTB/RIF Ultra (Cepheid, Sunnyvale, United States), hereafter referred to as Xpert Ultra, was developed by Cepheid as the next-generation assay to overcome these limitations.

4.1. The use of the Xpert MTB/RIF Ultra assay in gastric aspirate and stool specimens for the diagnosis of pulmonary TB and rifampicin resistance

Recommendation:

In children with signs and symptoms of pulmonary TB, Xpert Ultra should be used as the initial diagnostic test for TB and detection of rifampicin resistance on sputum, nasopharyngeal aspirate, gastric aspirate or stool, rather than smear microscopy/culture and phenotypic drug susceptibility testing (DST).

4. Diagnostic approaches for TB in children and adolescents

Of the estimated 1.1 million children who developed TB annually, only 399 000 (36.5%) were notified to NTPs in 2020. Under-notification is worst among children below 5 years of age, with only 27.5% of children with TB being notified (1). These 'missing' children are not diagnosed and/or not reported. TB-related mortality among children below 15 years of age was estimated at 226 000 for 2020 (1). Modelling has shown that 80% of TB-related deaths are among children under 5 years of age, and that 96% of children who die of TB, did not access treatment (15).

3. Prevention of TB

This chapter includes current WHO recommendations that apply to children and adolescents on TB prevention. They have been consolidated from current WHO guidelines on TB infection, prevention and control, a BCG position paper and guidelines on TPT, namely the WHO guidelines on tuberculosis infection prevention and control, 2019 update (12), the BCG vaccines: WHO position paper (published in the Weekly Epidemiological Record) (13) and the WHO consolidated guidelines on tuberculosis. Module 1: prevention - tuberculosis preventive treatment (14).

2. TB screening and contact investigation

This chapter includes current WHO recommendations that apply to children and adolescents on TB screening and contact investigation. They have been consolidated from current WHO guidelines on systematic screening for TB disease and contact investigation, namely the WHO consolidated guidelines on tuberculosis. Module 2: screening - systematic screening for tuberculosis disease (11) and Guidance for national tuberculosis programmes on the management of tuberculosis in children (second edition) (8).