Luis Cuevas and colleagues report findings from a multicenter diagnostic clinical trial in tuberculosis, showing that the sensitivity and specificity of a “front-loaded” diagnostic scheme is not inferior to that of a standard diagnostic scheme.

This study, nested within a clinical trial, by Luis Cuevas and colleagues finds that LED-FM microscopy has higher sensitivity but lower specificity than Zn microscopy for detecting tuberculosis in sputum samples.

Objectives and BackgroundObtaining a diagnosis of tuberculosis (TB) is a prerequisite for accessing specific treatment, yet one third of estimated new cases are missed worldwide by National Programmes. This study investigated economic, geographical, socio-cultural and health system factors hindering adults' attendance and completion of the TB diagnostic process in Yemen, to inform interventions designed to improve patient access to services.MethodologyThe study employed a mixed methods design comprising a cross-sectional survey and In-Depth-Interviews (IDIs) and Focus Group Discussions (FGDs) among patients abandoning the diagnosis or registering for treatment. Adults with cough of ≥2 weeks attending a large governmental referral centre in Sana'a, Yemen, between 2009 and 2010, were eligible to participate.Results497 and 446 (89.7%) participants were surveyed the first and second day of attending the services and 48 IDIs and 12 FGDs were also conducted. The majority of patients were disadvantaged and had poor literacy (61% illiterate), had travelled from rural areas (47%) and attended with companions (84%). Key barriers for attendance identified were clinic and transport costs (augmented by companions), distance from home, a preference for private services, strong social stigma and a lack of understanding of the diagnostic process. There were discrepancies between patient- and doctor-reported diagnosis and 46% of patients were unaware that TB treatment is free. Females faced more difficulties to attend than men. The laboratory practice of providing first-day negative smear results and making referrals to the private sector also discouraged patients from returning. Strategies to bring TB diagnostic services closer to communities and address the multiple barriers patients face to attend, will be important to increase access to TB diagnosis and care.

BackgroundA major impediment to the treatment of TB is a diagnostic process that requires multiple visits. Descriptions of patient costs associated with diagnosis use different protocols and are not comparable.MethodsWe aimed to describe the direct costs incurred by adults attending TB diagnostic centres in four countries and factors associated with expenditure for diagnosis. Surveys of 2225 adults attending smear-microscopy centres in Nigeria, Nepal, Ethiopia and Yemen. Adults >18 years with cough >2 weeks were enrolled prospectively. Direct costs were quantified using structured questionnaires. Patients with costs >75th quartile were considered to have high expenditure (cases) and compared with patients with costs <75th quartile to identify factors associated with high expenditure.ResultsThe most significant expenses were due to clinic fees and transport. Most participants attended the centres with companions. High expenditure was associated with attending with company, residing in rural areas/other towns and illiteracy.ConclusionsThe costs incurred by patients are substantial and share common patterns across countries. Removing user fees, transparent charging policies and reimbursing clinic expenses would reduce the poverty-inducing effects of direct diagnostic costs. In locations with limited resources, support could be prioritised for those most at risk of high expenditure; those who are illiterate, attend the service with company and rural residents.Electronic supplementary materialThe online version of this article (doi:10.1186/s40249-016-0117-x) contains supplementary material, which is available to authorized users.

Background There are an abundance of commercially available lateral flow assays (LFAs) that detect antibodies to SARS-CoV-2. Whilst these are usually evaluated by the manufacturer, externally performed diagnostic accuracy studies to assess performance are essential. Herein we present an evaluation of 12 LFAs. Methods Sera from 100 SARS-CoV-2 reverse-transcriptase polymerase chain reaction (RT-PCR) positive participants were recruited through the FASTER study. A total of 105 pre-pandemic sera from participants with other infections were included as negative samples. Results At presentation sensitivity against RT-PCR ranged from 37.4-79% for IgM/IgG, 30.3-74% for IgG, and 21.2-67% for IgM. Sensitivity for IgM/IgG improved ≥21 days post symptom onset for 10/12 tests. Specificity ranged from 74.3-99.1% for IgM/IgG, 82.9-100% for IgG, and 75.2-98% for IgM. Compared to the EuroImmun IgG enzyme-linked immunosorbent assay (ELISA), sensitivity and specificity ranged from 44.6-95.4% and 85.4-100%, respectively. Conclusion There are many LFAs available with varied sensitivity and specificity. Understanding the diagnostic accuracy of these tests will be vital as we come to rely more on the antibody status of a person moving forward, and as such manufacturer-independent evaluations are crucial.

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Introduction:Tuberculosis (TB) remains a leading infectious cause of morbidity and mortality worldwide. A key contributor to this burden is poor diagnosis as only 60% of new pulmonary tuberculosis (TB) cases in Africa are ever detected. Therefore, this study aimed to assess the feasibility of Xpert MTB/RIF test implementation in the region, and the performance of the assay to increase case detection on the selected rural health care setting. Objective:To assess the feasibility of Xpert MTB/RIF test implementation in the rural health care setting in Southern Ethiopia. Methods:Two Xpert MTB/RIF machines were brought in 2012 through TB REACH project. It was placed at Yirgalem hospital and at Aletawondo health centre. The instruments were installed after formal training was provided to laboratory technologists for three days. We collected sputum sample from participants who repeatedly had negative smear microscopy and those who had not responded to first-line anti-TB drugs. Result:Of the total participants tested, 1828 have valid result (MTB-, MTB+/RIF-, MTB+/RIF+, MTB+/RIF Indeterminate). From the participants with valid results, 217 (11.9%) were Xpert-positive of which were 165 (9.0%) RIF-negative, 6 (0.3%) RIF-indeterminate and 46 (2.5%) RIF-positive. Among TB suspects with previous treatment history and positive by Xpert, RIF resistance was detected in 10 (2.2%). From the new TB suspects with positive Xpert, RIF resistance was detected in 29 (2.7%). All cases identified were linked with TB/MDR-TB treatment centers. Conclusion:Xpert provides an additional tool for the diagnosis of TB and drug resistance, with almost 12% of new and retreatment cases obtaining information that is useful for clinical management. To enhance its efficient utilisation, operational challenges should be minimized particularly in relation to availing robust alternative power source.

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