A Review of the Current Status of G6PD Deficiency Testing to Guide Radical Cure Treatment for Vivax Malaria.

Plasmodium vivax malaria continues to cause a significant burden of disease in the Asia-Pacific, the Horn of Africa, and the Americas. In addition to schizontocidal treatment, the 8-aminoquinoline drugs are crucial for the complete removal of the parasite from the human host (radical cure). While well tolerated in most recipients, 8-aminoquinolines can cause severe haemolysis in glucose-6-phosphate dehydrogenase (G6PD) deficient patients. G6PD deficiency is one of the most common enzymopathies worldwide; therefore, the WHO recommends routine testing to guide 8-aminoquinoline based treatment for vivax malaria whenever possible. In practice, this is not yet implemented in most malaria endemic countries. This review provides an update of the characteristics of the most used G6PD diagnostics. We describe the current state of policy and implementation of routine point-of-care G6PD testing in malaria endemic countries and highlight key knowledge gaps that hinder broader implementation. Identified challenges include optimal training of health facility staff on point-of-care diagnostics, quality control of novel G6PD diagnostics, and culturally appropriate information and communication with affected communities around G6PD deficiency and implications for treatment.

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.

Situating trade-offs: Stakeholder perspectives on overtreatment versus missed diagnosis in transition to Xpert MTB/RIF Ultra in Kenya and Swaziland.

Implementing new diagnostics in public health programs can involve difficult trade-off decisions between individual patient benefits and public health considerations. Such decision-making processes are often not documented and may not include engagement of affected communities. This paper examines the perspectives of stakeholders on the trade-off between over-treatment and missed diagnosis captured during decision-making workshops on the transition from use of Xpert MTB/RIF to diagnose tuberculosis to Xpert MTB/RIF Ultra in Kenya and Swaziland. Xpert MTB/RIF Ultra has an overall increase in sensitivity but a decrease in specificity when compared to its predecessor. We conducted a qualitative study using four focus group discussions with a total of 47 participants and non-participant observation. The analysis reveals how participants deemed Xpert MTB/RIF Ultra's reduced specificity vis-à-vis its increased sensitivity to be an acceptable trade-off. The way participants assessed this trade-off was shaped by their experiences with the general uncertainty of all diagnostic tests, alternative testing options, historical evolution of diagnostic practices, epidemiological factors and resource constraints. In assessing the trade-off community and individual benefit and harm was frequently discussed together. Qualitative research on stakeholder engagement activities for diagnostic development and implementation can identify everyday experiences and situate assessments and perspectives of key stakeholders and as such aid in decision-making, improving implementation as well as patient outcomes. Further research is needed on the intended and unintended consequences of such engagement activities, how findings are being incorporated by decision-makers, and the impact on programmatic implementation.