Constructing confidence: User perspectives on AlereLAM testing for tuberculosis.

Background: Diagnosing tuberculosis (TB) in people living with HIV (PLHIV) is challenging due to atypical clinical and radiological presentation and higher rates of sputum-negative or extrapulmonary disease. Urine LAM is a promising diagnostic biomarker to address these challenges. Yet, AlereLAM, a World Health Organization-recommended point-of-care (POC) test of this kind, remains underutilized. This study aimed to understand perspectives and experiences of those using AlereLAM.

Methods: Fifteen semi-structured interviews were conducted with clinicians, nurses, program officers, laboratory staff, and patient advocates in Uganda, Kenya, and South Africa. Discussed topics included the approach to diagnosing TB, and experiences, perspectives, and country policy of AlereLAM testing.

Results: The POC-friendly characteristics of AlereLAM require more work to be realized. Although limited by relatively low sensitivity and specificity, AlereLAM has important value for identifying TB in people with advanced HIV disease, especially when the environment enables constructing confidence in the test. The initial communication about the low performance by global agencies, restrictive eligibility criteria, reliance on CD4+ testing, and lack of advocacy and awareness were noted as reasons for its slow uptake.

Conclusion: The work of operationalizing diagnostics, including constructing confidence, is important to consider for policymakers, implementers, and funders when assessing acceptability, feasibility, and scale-up of a diagnostic.