Tanzania is among the 30 countries with the highest tuberculosis (TB) burdens. Because TB has a long infectious period, early diagnosis is not only important for reducing transmission, but also for improving treatment outcomes. We assessed diagnostic delay and associated factors among infectious TB patients. We interviewed new smear-positive adult pulmonary TB patients enrolled in an ongoing TB cohort study in Dar es Salaam, Tanzania, between November 2013 and June 2015. TB patients were interviewed to collect information on socio-demographics, socio-economic status, health-seeking behaviour, and residential geocodes. We categorized diagnostic delay into ≤ 3 or > 3 weeks. We used logistic regression models to identify risk factors for diagnostic delay, presented as crude (OR) and adjusted Odds Ratios (aOR). We also assessed association between geographical distance (incremental increase of 500 meters between household and the nearest pharmacy) with binary outcomes. We analysed 513 patients with a median age of 34 years (interquartile range 27–41); 353 (69%) were men. Overall, 444 (87%) reported seeking care from health care providers prior to TB diagnosis, of whom 211 (48%) sought care > 2 times. Only six (1%) visited traditional healers before TB diagnosis. Diagnostic delay was positively associated with absence of chest pain (aOR = 7.97, 95% confidence intervals [CI]: 3.15–20.19; P < 0.001), and presence of hemoptysis (aOR = 25.37, 95% CI: 11.15–57.74; P < 0.001) and negatively associated with use of medication prior to TB diagnosis (aOR = 0.31, 95% CI: 0.14–0.71; P = 0.01). Age, sex, HIV status, education level, household income, and visiting health care facilities (HCFs) were not associated with diagnostic delay. Patients living far from pharmacies were less likely to visit a HCF (incremental increase of distance versus visit to any facility: OR = 0.51, 95% CI: 0.28–0.96; P = 0.037). TB diagnostic delay was common in Dar es Salaam, and was more likely among patients without prior use of medication and presenting with hemoptysis. Geographical distance to HCFs may have an impact on health-seeking behaviour. Increasing community awareness of TB signs and symptoms could further reduce diagnostic delays and interrupt TB transmission.

/pdf/diagnostic-delay-and-associated-factors-among-patients-with-398hy78992.pdf

Diagnostic delay and associated factors among patients with pulmonary tuberculosis in Dar es Salaam, Tanzania.

Molecular technology revolutionized the diagnosis of tuberculosis (TB) with a paradigm shift to faster, more sensitive, clinically relevant patient care. The most recent molecular leader is the GeneXpert MTB/RIF assay (Xpert) (Cepheid, Sunnyvale, CA), which was endorsed by the World Health Organization with unprecedented speed in December 2010 as the initial diagnostic for detection of HIV-associated TB and for where high rates of drug resistance are suspected. South Africa elected to take an aggressive smear replacement approach to facilitate earlier diagnosis and treatment through the decision to implement the Xpert assay nationally in March 2011, against the backdrop of approximately 6.3 million HIV-infected individuals, one of highest global TB and HIV coinfection rates, no available implementation models, uncertainties around field performance and program costs, and lack of guidance on how to operationalize the assay into existing complex clinical algorithms. South Africa's national implementation was conducted as a phased, forecasted, and managed approach (March 2011 to September 2013), through political will and both treasury-funded and donor-funded support. Today there are 314 GeneXperts across 207 microscopy centers; over 8 million assays have been conducted, and South Africa accounts for over half the global test cartridge usage. As with any implementation of new technology, challenges were encountered, both predicted and unexpected. This chapter discusses the challenges and consequences of such large-scale implementation efforts, the opportunities for new innovations, and the need to strengthen health systems, as well as the impact of the Xpert assay on rifampin-sensitive and multidrug-resistant TB patient care that translated into global TB control as we move toward the sustainable development goals.

Impact of the GeneXpert MTB/RIF Technology on Tuberculosis Control

In order to effectively combat Tuberculosis, resources to diagnose and treat TB should be allocated effectively to the areas and population that need them. Although a wealth of subnational data on TB is routinely collected to support local planning, it is often underutilized. Therefore, this study uses spatial analytical techniques and profiling to understand and identify factors underlying spatial variation in TB case notification rates (CNR) in Bangladesh, Nepal and Pakistan for better TB program planning. Spatial analytical techniques and profiling was used to identify subnational patterns of TB CNRs at the district level in Bangladesh (N = 64, 2015), Nepal (N = 75, 2014) and Pakistan (N = 142, 2015). A multivariable linear regression analysis was performed to assess the association between subnational CNR and demographic and health indicators associated with TB burden and indicators of TB programme efforts. To correct for spatial dependencies of the observations, the residuals of the multivariable models were tested for unexplained spatial autocorrelation. Spatial autocorrelation among the residuals was adjusted for by fitting a simultaneous autoregressive model (SAR). Spatial clustering of TB CNRs was observed in all three countries. In Bangladesh, TB CNR were found significantly associated with testing rate (0.06%, p < 0.001), test positivity rate (14.44%, p < 0.001), proportion of bacteriologically confirmed cases (− 1.33%, p < 0.001) and population density (4.5*10–3%, p < 0.01). In Nepal, TB CNR were associated with population sex ratio (1.54%, p < 0.01), facility density (− 0.19%, p < 0.05) and treatment success rate (− 3.68%, p < 0.001). Finally, TB CNR in Pakistan were found significantly associated with testing rate (0.08%, p < 0.001), positivity rate (4.29, p < 0.001), proportion of bacteriologically confirmed cases (− 1.45, p < 0.001), vaccination coverage (1.17%, p < 0.001) and facility density (20.41%, p < 0.001). Subnational TB CNRs are more likely reflective of TB programme efforts and access to healthcare than TB burden. TB CNRs are better used for monitoring and evaluation of TB control efforts than the TB epidemic. Using spatial analytical techniques and profiling can help identify areas where TB is underreported. Applying these techniques routinely in the surveillance facilitates the use of TB CNRs in program planning.

/pdf/finding-gaps-in-tb-notifications-spatial-analysis-of-hp300cjyvg.pdf

Finding gaps in TB notifications: spatial analysis of geographical patterns of TB notifications, associations with TB program efforts and social determinants of TB risk in Bangladesh, Nepal and Pakistan

Under-detection and -reporting in the private sector constitute a major barrier in Viet Nam’s fight to end tuberculosis (TB). Effective private-sector engagement requires innovative approaches. We established an intermediary agency that incentivized private providers in two districts of Ho Chi Minh City to refer persons with presumptive TB and share data of unreported TB treatment from July 2017 to March 2019. We subsidized chest x-ray screening and Xpert MTB/RIF testing, and supported test logistics, recording, and reporting. Among 393 participating private providers, 32.1% (126/393) referred at least one symptomatic person, and 3.6% (14/393) reported TB patients treated in their practice. In total, the study identified 1203 people with TB through private provider engagement. Of these, 7.6% (91/1203) were referred for treatment in government facilities. The referrals led to a post-intervention increase of +8.5% in All Forms TB notifications in the intervention districts. The remaining 92.4% (1112/1203) of identified people with TB elected private-sector treatment and were not notified to the NTP. Had this private TB treatment been included in official notifications, the increase in All Forms TB notifications would have been +68.3%. Our evaluation showed that an intermediary agency model can potentially engage private providers in Viet Nam to notify many people with TB who are not being captured by the current system. This could have a substantial impact on transparency into disease burden and contribute significantly to the progress towards ending TB.

https://www.mdpi.com/2414-6366/5/3/143/pdf

Enhanced Private Sector Engagement for Tuberculosis Diagnosis and Reporting through an Intermediary Agency in Ho Chi Minh City, Viet Nam.

Results from a roving, active case finding initiative to improve tuberculosis detection among older people in rural cambodia using the Xpert MTB/RIF assay and chest X-ray.

Setting The Xpert(®) MTB/RIF assay is a highly sensitive molecular test with the potential to improve tuberculosis (TB) case detection. However, evidence supporting this potential at a programme level is minimal. Methods Xpert testing following smear microscopy and chest X-ray was implemented as part of routine case finding in 16 districts of Eastern Nepal. Changes in TB case notification were evaluated based on a pre/post analysis, as were expected notifications based on linear trend. Results A total of 9723 Xpert tests were performed, resulting in the identification of 1662 Mycobacterium tuberculosis-positive patients. Despite a previous declining trend in notifications, annual bacteriologically positive TB notifications increased by 15.2% during the intervention, from 3390 to 3906. However, annual notifications of pulmonary TB dropped by 8.5% overall, from 5123 to 4688. Both observations were significantly different from expected notifications based on historical trends. Treatment initiation for drug-resistant TB almost doubled. Discussion Xpert testing significantly increased bacteriologically positive TB notifications, but large reductions in empiric treatment of smear-negative disease reduced the number of pulmonary TB notifications overall. While better diagnostics remain critical, focusing solely on superior test sensitivity may not increase TB case notifications. Additional interventions are required to reach the millions of people with TB who are missed by routine services.

Introducing new tuberculosis diagnostics: the impact of Xpert(®) MTB/RIF testing on case notifications in Nepal.

Tuberculosis (TB) is a leading cause of morbidity and mortality worldwide. Control of TB is lingering by the lack of diagnostic tests that are simple, rapid, yet accurate. Thus, smear-negative pulmonary TB often misses the diagnosis. The study evaluated the performance of GeneXpert MTB/RIF assay for the detection of Mycobacterium tuberculosis (MTB).The study was carried out from June to December 2016 in Nepal Tuberculosis Center, Bhaktapur, Nepal. A total of 173 sputum samples were collected and processed by microscopy [Auramine-O staining and Ziehl-Neelsen (ZN) staining], followed by GeneXpert MTB/RIF assay and culture in Lowenstein-Jensen (LJ) medium.Of 173 sputum samples, 162 (93.6%) were smear-negative. Of 162 smear-negative sputum samples, 35 (21.6%) were confirmed to have MTB by culture, and 31 (19.1%) by GeneXpert MTB/RIF assay. Of 31 GeneXpert-positive samples, 25 (80.6%) were susceptible, 4 (12.9%) were resistant, and 2 (6.45%) were intermediate to rifampicin. The sensitivity, specificity, positive predictive value, and negative predictive value of GeneXpert MTB/RIF assay for smear-negative sputum samples were 74.3%, 96.6%, 86.7%, and 92%, respectively. The GeneXpert MTB/RIF has a substantial diagnostic agreement of 90.91% with culture (Cohen's Kappa coefficient = 0.73).The diagnostic performance of GeneXpert MTB/RIF assay was almost on par with culture, and thus can be relied upon for MTB detection in smear-negative sputum samples. 

/pdf/diagnostic-performance-of-genexpert-mtb-rif-in-detecting-mtb-3v4f4rrm.pdf

Diagnostic performance of GeneXpert MTB/RIF in detecting MTB in smear-negative presumptive TB patients

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Introducing new tuberculosis diagnostics: the impact of Xpert(®) MTB/RIF testing on case notifications in Nepal.

Diagnostic performance of GeneXpert MTB/RIF in detecting MTB in smear-negative presumptive TB patients