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In 2016, the World Health Organization (WHO) estimated that there were 147,000 cases and 12,500 deaths worldwide from tuberculosis, which is predominantly caused by Mycobacterium bovis. However, because of the [...]

Background: There is limited information on the performance of the Xpert® MTB/RIF test for diagnosis of smear-negative pulmonary tuberculosis (SNPT) and rifampicin resistance (RR) in the same-day diagnosis approach. The effects of sputum quality and other factors affecting the Xpert performance are also under-investigated. Objective: This study aimed to determine the performance of the Xpert® MTB/RIF test for detection of SNPT and RR in the same-day diagnosis strategy and the effect of sputum quality and other factors on its performance. Methods: A cross-sectional study was conducted from August 2017 to January 2018 across 16 health facilities in Addis Ababa, Ethiopia. Two spot sputum samples were collected from 418 presumptive SNPT patients, tested with Xpert® MTB/RIF, then compared to tuberculosis culture. Additionally, culture isolates were tested for RR by BACTEC MGIT™ 960 drug susceptibility testing (DST) and MTBDRplus version 2. Results: The Xpert® MTB/RIF test detected 24 (5.7%) SNPT cases, with a sensitivity of 92.3% (75.9% – 97.9%) and specificity of 99.2% (97.8% – 99.7%) compared with tuberculosis culture. Xpert® MTB/RIF also detected three (11.58%) RR strains with 100.0% concordance with BACTEC MGIT™ 960 DST and MTBDRplus results. Three blood-stained SNPT samples were positive by Xpert (30.0%), which was 6.9 times higher compared to salivary sputum (odds ratio: 6.9, 95% confidence interval: 1.36–34.96, p = 0.020). Conclusion: The performance of the Xpert® MTB/RIF to detect SNPT and RR in same-day diagnosis is high. However, SNPT positivity varies among sputum qualities, and good sample collection is necessary for better test performance. [ABSTRACT FROM AUTHOR]

Background: There is limited information on the performance of the Xpert ® MTB/RIF test for diagnosis of smear-negative pulmonary tuberculosis (SNPT) and rifampicin resistance (RR) in the same-day diagnosis approach. The effects of sputum quality and other factors affecting the Xpert performance are also under-investigated., Objective: This study aimed to determine the performance of the Xpert ® MTB/RIF test for detection of SNPT and RR in the same-day diagnosis strategy and the effect of sputum quality and other factors on its performance., Methods: A cross-sectional study was conducted from August 2017 to January 2018 across 16 health facilities in Addis Ababa, Ethiopia. Two spot sputum samples were collected from 418 presumptive SNPT patients, tested with Xpert® MTB/RIF, then compared to tuberculosis culture. Additionally, culture isolates were tested for RR by BACTEC MGIT™ 960 drug susceptibility testing (DST) and MTBDRplus version 2., Results: The Xpert ® MTB/RIF test detected 24 (5.7%) SNPT cases, with a sensitivity of 92.3% (75.9% - 97.9%) and specificity of 99.2% (97.8% - 99.7%) compared with tuberculosis culture. Xpert ® MTB/RIF also detected three (11.58%) RR strains with 100.0% concordance with BACTEC MGIT™ 960 DST and MTBDRplus results. Three blood-stained SNPT samples were positive by Xpert (30.0%), which was 6.9 times higher compared to salivary sputum (odds ratio: 6.9, 95% confidence interval: 1.36-34.96, p = 0.020)., Conclusion: The performance of the Xpert ® MTB/RIF to detect SNPT and RR in same-day diagnosis is high. However, SNPT positivity varies among sputum qualities, and good sample collection is necessary for better test performance., Competing Interests: The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article., (© 2022. The Authors.)

Background: Ethiopia is among high TB burden countries. The proportion of smear negative patients among pulmonary TB cases was 51%. Nevertheless, microscopy is still a primary tool for TB diagnosis. In the absence of sensitive diagnostic methods, clinicians often make the diagnosis of smear-negative pulmonary TB with information obtained through the clinical history, physical examination and chest X-ray. The treatment of smear negative TB patients with those criteria largely depends on the treating clinician. There is limited data on the utilization of clinical criteria commonly used to initiate TB treatment empirically when culture is used as the reference method. Beside this, there are a number of sensitive diagnostic methods that have a substantial contribution for the diagnosis of smear negative TB patients, but only few studies were conducted in Ethiopia to address this issue., Objective: To assess the contribution of conventional and molecular methods for smear-negative patients and describe the concordance rate of empiric TB treatment with culture assay., Methods: A cross-sectional study was designed on smear negative TB presumptive patients referred to St. Peter's TB Specialized Hospital from December 2014 to June 2015. Consecutive smear negative TB presumptive patients, aged greater or equal to 15 and willing to participate were included in the study. Socio-demographic and clinical data were collected using the data collection form designed for the study purpose. The data collection form was designed to capture patient demographic data, signs and symptoms, chest X-ray findings and empirical TB treatment initiations. Spot-Moring-spot sputum was collected using sterile falcon tubes for routine diagnostic purpose. Direct ZN examination was done on Spot-Moring-spot sputum at St. Peter's TB Specialized Hospital. The morning sputum was used for culture (LJ and MGIT), TB-LAMP, Xpert MTB/RIF assay and fluorescent microscopy examination. Data were captured and analyzed using SPSS., Results: This study enrolled 459 smear negative presumptive TB patients. Most (57%) of the study participants were female; with median age of 40 IQR (28-55) years. HIV test results were available for 41% of the study participants and the prevalence of HIV among the study participants was 30%. Three hundred eighty three cases were having both treatment and lab results. Forty six cases were treated empirically. The sensitivity and specificity of empiric TB treatment when compared to culture were 45.8% and 90% respectively. The overall culture positivity rate was 6.8% (30/439), of which 6.6% (26/391) was by MGIT and 5.3% (23/436) was by LJ method. Direct and concentrated fluorescent microscopy adds 0.9% and 1.3% detection rate compared to the direct ZN. The overall sensitivity and specificity of TB-LAMP was 61.5% (16/26) and 96.6% respectively. The overall sensitivity and specificity of Xpert MTB/RIF was 70.8% (17/24) and 97.2% respectively., Conclusion: TB-LAMP and Xpert MTB/RIFassaycan provide confirmatory results for at least two third of TB cases.