Reimagining the status quo: How close are we to rapid sputum-free tuberculosis diagnostics for all?

Mycobacterium tuberculosis and other non-tuberculous mycobacteria are responsible for a variety of different infections affecting millions of patients worldwide. Their diagnosis is often problematic and delayed until late in the course of disease, requiring a high index of suspicion and the combined efforts of clinical and laboratory colleagues. Molecular methods, such as PCR platforms, are available, but expensive, and with limited sensitivity in the case of paucibacillary disease. Treatment of mycobacterial infections is also challenging, typically requiring months of multiple and combined antibiotics, with associated side effects and toxicities. The presence of innate and acquired drug resistance further complicates the picture, with dramatic cases without effective treatment options. Bacteriophages (viruses that infect bacteria) have been used for decades in Eastern Europe for the treatment of common bacterial infections, but there is limited clinical experience of their use in mycobacterial infections. More recently, bacteriophages’ clinical utility has been re-visited and their use has been successfully demonstrated both as diagnostic and treatment options. This review will focus specifically on how mycobacteriophages have been used recently in the diagnosis and treatment of different mycobacterial infections, as potential emerging technologies, and as an alternative treatment option.

Application of Bacteriophages for Mycobacterial Infections, from Diagnosis to Treatment

Molecular point-of-care (POC) tests offer high sensitivity, rapid turnaround times, relative ease of use, and the convenience of laboratory-grade testing in the absence of formal laboratory spaces and equipment, making them appealing options for infectious disease diagnosis in resource-limited settings. In this review, we discuss the role and potential of molecular POC tests in resource-limited settings and their associated logistical challenges. We discuss U.S. Food and Drug Administration approval, Clinical Laboratory Improvement Amendments complexity levels, and the REASSURED criteria as a starting point for assessing options currently available inside and outside of the United States. We then present POC tests currently in research and development phases that have potential for commercialization and implementation in limited-resource settings. Finally, we review published studies that have assessed the clinical impact of molecular POC testing in limited- and moderate-resource settings. 

Molecular point-of-care devices for the diagnosis of infectious diseases in resource-limited settings – A review of the current landscape, technical challenges, and clinical impact

A significant drop in tuberculosis (TB) case-finding has been widely reported during the period of the COVID-19 pandemic. To address a decrease in TB notification, Belarus introduced laboratory TB testing in patients with the laboratory-confirmed coronavirus disease 2019 (COVID-19). We conducted a secondary analysis of health records among 844 patients with laboratory-confirmed COVID-19 diagnosis who were admitted to repurposed departments at TB hospitals and who were tested by Xpert MTB/RIF (Cepheid Inc., Sunnyvale, CA, USA) in five Belarus regions between April and October 2021. Quantitative analysis followed by 13 individual interviews with health managers, physicians, and nurses participating in the intervention. Most patients were male (64%) and mean age was 43.5 ± 16 years. One in twenty (n = 47, 5.6%) patients were co-infected with active pulmonary TB, and over one-third of them (n = 18) had rifampicin resistance. In-hospital mortality was comparable in patients with and without TB co-infection (2.1% and 2.3% respectively, p > 0.99). Laboratory TB testing among patients with COVID-19 at repurposed departments of TB hospitals is feasible in Belarus and may improve TB case-finding.

/pdf/tuberculosis-co-infection-is-common-in-patients-requiring-1ifr9t2l.pdf

Tuberculosis Co-Infection Is Common in Patients Requiring Hospitalization for COVID-19 in Belarus: Mixed-Methods Study

Abstract Background Tuberculosis (TB) has been regarded as ‘a relentless scourge’, increasing morbidity and mortality and burdening vulnerable populations. Poor adherence to TB treatment and ineffective traditional interventions hinders TB control. A novel TB approach called ‘electronic monitors’, equipping medication boxes with daily audio or visual reminders for electronically monitoring medication intake, seems promising in improving adherence and health outcomes and overcoming the weaknesses of traditional interventions. However, no review has systematically examined and synthesized the influencing factors of implementing electronic monitors. Implementation research offers the means to analyse the influencing factors of the implementation and its process, fitting well with the aim of this review. Therefore, the widely recognized Consolidated Framework for Implementation Research (CFIR), which offers a common taxonomy for evaluating intervention implementation, will be adopted to systematically identify barriers and facilitators of the electronic monitors for improving adherence and health outcomes in patients with TB. Methods and analysis The systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Literature research will be conducted in five electronic databases (Ovid MEDLINE, CINAHL, EMBASE, Cochrane Library and Web of Science) to identify the barriers and facilitators of implementing electronic monitors in patients with TB. The CFIR will be used as a guide for categorizing and synthesizing the barriers and facilitators. Study screening, data extraction, quality appraisal and data analysis will be conducted by two independent reviewers. The use of additional reviewers will solve any disagreements between the two reviewers. Discussion Given the increased prominence of TB epidemiology and the adherence problem of electronic monitors, there is a solid rationale for synthesizing the existing studies via the CFIR. The findings and conclusion of this review will lay bare the achievements and effectiveness of implementing electronic monitors, as well as the attendant gaps and limitations. Further strategies for facilitating the implementation of electronic monitors will also be explored. This review will be of essential significance for research and practice, supporting future academic research initiatives centred on patients with TB and aiding electronic monitor design in lowering the morbidity and mortality associated with TB disease. Trial registration number: PROSPERO: CRD42023395747. 

Barriers and facilitators of implementing electronic monitors to improve adherence and health outcomes in tuberculosis patients: protocol for a systematic review based on the Consolidated Framework for Implementation Research

INTRODUCTION Current evidence indicates that the impact of GeneXpert for diagnosing TB in low- and middle-income countries (LMICs) has not demonstrated equivalent outcomes when compared to Xpert evaluations in upper-middle-income countries. Challenges associated with implementation are possible contributing factors preventing this innovative diagnostic technology from achieving more significant public health outcomes. This review aimed to assess the use of implementation science frameworks when reporting the enablers and barriers for the implementation of GeneXpert for diagnosing TB in LMICs. METHODS We conducted a qualitative systematic review of the peer-reviewed literature using PubMed, Medline, and Scopus. Eligible articles were those published between January 2010 and March 2020 that identified enablers and barriers to GeneXpert implementation, as well as the implementation approach delivered in an LMIC. RESULTS Eleven studies were included in the review. Implementation barriers were found to be relatively consistent across studies and included patient-level factors, human resources, material resources, service implementation, service coordination, and technical operations. Few studies (n=5) identified enabling factors in the implementation of Xpert for TB testing. Identified enablers included strategies such as active case finding, expanding diagnostic algorithms, and daily transport of samples. The public health impact of Xpert TB testing interventions was commonly influenced by implementation barriers (n=4). Of the 11 studies, only 3 reported against an implementation framework. CONCLUSION This review identified a commonality in implementation barriers and enablers that influenced the overall public health impact of GeneXpert. With greater transparency of these barriers and enablers, program planners can promote a more collaborative approach and adapt interventions. It is recommended that program planners use implementation science frameworks when conducting research and publishing. This will build an evidence base focused on implementation and thereby support programs to address implementation barriers and include enabling factors in program design.

Implementation of GeneXpert for TB Testing in Low-and middle-Income countries: A Systematic Review

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Implementation of GeneXpert for TB Testing in Low-and middle-Income countries: A Systematic Review