Xpert negative means no TB: A mixed-methods study into early implementation of Xpert in Puducherry, India

Abstract

Introduction: Xpert MTB/RIF was implemented in 2016 as the initial diagnostic test for extrapulmonary, pediatric, and human immunodeficiency virus–associated tuberculosis (TB) and as an add-on test for sputum microscopy–negative patients under Revised National TB Control Programme, Puducherry, India. We intended to study the change in TB case notification rates (CNRs) after 2015 and explore the enablers and barriers for implementation of Xpert. Materials and Methods: Sequential mixed-methods study, quantitative phase followed by a descriptive qualitative phase (key informant interviews with healthcare providers in the program). Results: The TB (all forms) CNR increased in 2016 followed by a drop to 2015 levels in 2017. There was a reduction in patients notified as sputum-negative pulmonary TB and pediatric TB during 2016–2017. Healthcare providers used a negative Xpert result in ruling out TB among patients who would previously get diagnosed clinically. Perceived benefits of Xpert were efficiency, rapid results, and detecting resistance. Barriers included poor awareness among medical colleges and the private sector, difficulty in motivating sputum microscopy–negative patients for Xpert, and incompletely filled referral forms. Conclusion: Xpert-negative results should be interpreted cautiously after clinical assessment. Identified barriers should be addressed to ensure that all eligible undergo testing.

Implementation of GeneXpert for TB Testing in Low- and Middle-Income Countries: A Systematic Review

“…Among the studies included in this review, the huband-spoke implementation approach for Xpert was used more often (n=6) 15,[26][27][28][29][30] than the point-of-care model (n=5). [31][32][33][34][35] As part of the hub-and-spoke model, varying approaches to the transportation of samples between the laboratory and clinic were identified, which included transportation by a health care worker, 30 employed drivers, 26,28 and informal couriers.…”

“…The testing algorithm that determined eligibility for an Xpert test varied across all interventions. Although the majority used Xpert as an initial diagnostic for their targeted population (n=6), 15,28,29,[33][34][35] 3 studies implemented Xpert as a secondary diagnostic after smear-negative microscopy or a combination of both. 26,29,30 Across all studies, the broadest testing algorithm was defined as any person with presumptive TB (n=2).…”

“…However, the most cited barrier was a service coordination factor (n=8) involving the lack of communication/referral pathways between staff in laboratories and health centers. [27][28][29][30][32][33][34][35] The second most common barrier related to inadequate and/or inconsistent staff training, which was identified relatively equally by studies in both Africa (n=3) 26,28,34 and Asia (n=4). 29,30,32,35 Overall, the hub-and-spoke model generated the most commonly occurring barriers.…”

“…[27][28][29][30][32][33][34][35] The second most common barrier related to inadequate and/or inconsistent staff training, which was identified relatively equally by studies in both Africa (n=3) 26,28,34 and Asia (n=4). 29,30,32,35 Overall, the hub-and-spoke model generated the most commonly occurring barriers. Of the studies that implemented this approach, Cowan et al 26 was the only study that did not identify communication barriers between the testing laboratory and the clinic collecting patient samples.…”

Identifying barriers and facilitators to implementation of community-based tuberculosis active case finding with mobile X-ray units in Lima, Peru: a RE-AIM evaluation

“…In India, the willingness of providers to make clinical diagnoses decreased once Xpert was introduced, in part because Xpert was viewed as a 'gold standard' with perfect sensitivity. 29 Moreover, variable knowledge about Xpert among providers led to disagreements over the use of Xpert testing for TB diagnosis. 30 In other countries, treatment initiation delays for patients with positive Xpert results were observed because of confusion over guidelines for reporting Xpert-positive patients.…”