Abstract
In childhood tuberculosis (TB), with an estimated 69% of missed cases in children under 5 years of age, the case detection gap is larger than in other age groups, mainly due to its paucibacillary nature and children’s difficulties in delivering sputum specimens. Accurate and accessible point-of-care tests (POCTs) are needed to detect TB disease in children and, in turn, reduce TB-related morbidity and mortality in this vulnerable population. In recent years, several POCTs for TB have been developed. These include new tools to improve the detection of TB in respiratory and gastric samples, such as molecular detection of Mycobacterium tuberculosis using loop-mediated isothermal amplification (LAMP) and portable polymerase chain reaction (PCR)-based GeneXpert. In addition, the urine-based detection of lipoarabinomannan (LAM), as well as imaging modalities through point-of-care ultrasonography (POCUS), are currently the POCTs in use. Further to this, artificial intelligence-based interpretation of ultrasound imaging and radiography is now integrated into computer-aided detection products. In the future, portable radiography may become more widely available, and robotics-supported ultrasound imaging is currently being trialed. Finally, novel blood-based tests evaluating the immune response using “omic-“techniques are underway. This approach, including transcriptomics, metabolomic, proteomics, lipidomics and genomics, is still distant from being translated into POCT formats, but the digital development may rapidly enhance innovation in this field. Despite these significant advances, TB-POCT development and implementation remains challenged by the lack of standard ways to access non-sputum-based samples, the need to differentiate TB infection from disease and to gain acceptance for novel testing strategies specific to the conditions and settings of use.
Highlights
In recent years, it was estimated that approximately 10 million individuals had tuberculosis (TB) each year, of which almost one-third were not diagnosed or reported.This detection gap has further increased in 2020 as reported cases fell from 7.1 million to5.8 million, with an estimated 4.1 million cases thought to be unreported [1]
As the sensitivity of the AlereLAM is limited, the World Health Organization (WHO), recommends its use mostly in inpatient settings [8]. It is only recommended as a rule-in test for TB disease in individuals living with human immunodeficiency virus (HIV) infection including adults, adolescents, and children who are seriously ill, defined as having fever above 39 ◦ C, being tachypneic and tachycardic and “unable to walk unaided” [8]
In contrast to Xpert MTB/RIF, the assay has only been validated for use in sputum samples, so that it cannot be used for gastric aspirate specimen, which are more commonly obtained in younger children
Summary
It was estimated that approximately 10 million individuals had tuberculosis (TB) each year, of which almost one-third were not diagnosed or reported. This detection gap has further increased in 2020 as reported cases fell from 7.1 million to. Accurate point-of-care tests (POCT) suitable for children represent an unmet but urgent clinical need. The need for child-friendly sampling has been advocated for in recent years. One such example is the use of stool samples for the molecular diagnosis of TB, suboptimal sensitivity remains a challenge
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