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Xpert MTB

Amanda K Debes, Robert H Gilman, Carolyne Onyango-Makumbi, Andrea Ruff, Richard Oberhelman, David W Dowdy
BACKGROUND: The objective of this analysis was to assess the cost-effectiveness of TB diagnosis using Microscopic Observation Drug Susceptibility (MODS), Xpert MTB/RIF (Xpert), and empiric treatment for all patients, in addition to current clinical diagnostic practices in children less than 5 years of age in a national tuberculosis (TB) referral hospital in Uganda. METHODS: A decision analysis was conducted from the healthcare perspective, with a primary outcome of incremental cost effectiveness expressed as cost per year of life gained (YLG)...
October 3, 2016: Pediatric Infectious Disease Journal
Samuel G Schumacher, Maarten van Smeden, Nandini Dendukuri, Lawrence Joseph, Mark P Nicol, Madhukar Pai, Heather J Zar
Evaluation of tests for the diagnosis of childhood pulmonary tuberculosis (CPTB) is complicated by the absence of an accurate reference test. We present a Bayesian latent class analysis in which we evaluated the accuracy of 5 diagnostic tests for CPTB. We used data from a study of 749 hospitalized South African children suspected to have CPTB from 2009 to 2014. The following tests were used: mycobacterial culture, smear microscopy, Xpert MTB/RIF (Cepheid Inc.), tuberculin skin test (TST), and chest radiography...
October 13, 2016: American Journal of Epidemiology
A Jayakumar, R M Savic, C K Everett, D Benator, D Alland, C M Heilig, M Weiner, S O Friedrich, N A Martinson, A Kerrigan, C Zamudio, S V Goldberg, W C Whitworth, J L Davis, P Nahid
The Xpert® MTB/RIF assay is both sensitive and specific as a diagnostic test. Xpert also reports quantitative output in cycle thresholds (Ct), which may provide a dynamic measure of sputum bacillary burden when used longitudinally. We evaluated the relationship between Xpert Ct trajectory and drug exposure during TB treatment to evaluate the potential utility of Xpert Ct for treatment monitoring. We obtained serial sputum samples from patients with smear-positive pulmonary TB consecutively enrolled at ten international clinical trial sites participating in Study 29X, a CDC-sponsored TB Trials Consortium study evaluating the tolerability, safety, and antimicrobial activity of rifapentine at daily doses up to 20 mg/kg...
October 12, 2016: Journal of Clinical Microbiology
P Naidoo, R Dunbar, E du Toit, M van Niekerk, S B Squire, N Beyers, J Madan
SETTING: Cape Town, South Africa, where Xpert(®) MTB/RIF was introduced as a screening test for all presumptive tuberculosis (TB) cases. OBJECTIVE: To compare laboratory costs of smear/culture- and Xpert-based tuberculosis (TB) diagnostic algorithms in routine operational conditions. METHODS: Economic costing was undertaken from a laboratory perspective, using an ingredients-based costing approach. Cost allocation was based on reviews of standard operating procedures and laboratory records, timing of test procedures, measurement of laboratory areas and manager interviews...
October 2016: International Journal of Tuberculosis and Lung Disease
Simon Walusimbi, Brendan Kwesiga, Rashmi Rodrigues, Melles Haile, Ayesha de Costa, Lennart Bogg, Achilles Katamba
BACKGROUND: Microscopic Observation Drug Susceptibility (MODS) and Xpert MTB/Rif (Xpert) are highly sensitive tests for diagnosis of pulmonary tuberculosis (PTB). This study evaluated the cost effectiveness of utilizing MODS versus Xpert for diagnosis of active pulmonary TB in HIV infected patients in Uganda. METHODS: A decision analysis model comparing MODS versus Xpert for TB diagnosis was used. Costs were estimated by measuring and valuing relevant resources required to perform the MODS and Xpert tests...
October 10, 2016: BMC Health Services Research
George Sikalengo, Adria Ramirez, Diana Faini, Kim Mwamelo, Manuel Battegay, Levan Jugheli, Christoph Hatz, Klaus Reither, Emilio Letang
BACKGROUND: Extrapulmonary tuberculosis (EPTB) is associated with high rates of morbidity and mortality. Diagnosis of EPTB is challenging in resource-limited settings due to difficulties in obtaining samples, as well as the paucibacillarity of the specimens. Skeletal tuberculosis accounts for 10-35 % of EPTB cases, with vertebral osteomyelitis (Pott's disease) representing 50 % of the cases. We present two cases of suspected Pott's disease, diagnosed through GeneXpert MTB/RIF assay in urine at a rural Tanzanian hospital...
September 26, 2016: BMC Infectious Diseases
Guesly J Delva, Ingrid Francois, Cassidy W Claassen, Darwin Dorestan, Barbara Bastien, Sandra Medina-Moreno, Dumesle St Fort, Robert R Redfield, Ulrike K Buchwald
Background. Haiti has the highest tuberculosis (TB) prevalence in the Americas with 254 cases per 100,000 persons. Case detection relies on passive detection and TB services in many regions suffer from poor diagnostic and clinical resources. Methods. Mache Chache ("Go and Seek") was a TB REACH Wave 3 funded TB case finding project in Port-au-Prince between July 2013 and September 2014, targeting four intervention areas with insufficient TB diagnostic performance. Results. Based on a verbal symptom screen emphasizing the presence of cough, the project identified 11,150 (11...
2016: Tuberculosis Research and Treatment
Mei Yuan, Yan Lyu, Su Ting Chen, Chao Cai, Yuan Li, Zhi Guo Zhang, Yun Xu Li, Ling Ling Dong, Yu Hong Fu, Hai Rong Huang, Ji Min Gao, Wei Min Li
We evaluate the performance of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis (EPTB) in China. The performance of Xpert was evaluated compared to the composite reference standard (CRS), drug susceptibility testing (DST), and imaging examination. The overall sensitivity and specificity of Xpert were 64.1% (195/304) and 100% (24/24), respectively, using CRS as the gold standard. The sensitivity was significantly higher than that of culture for pus (P<0.05). The proportion of EPTB-positive cases diagnosed by imaging was two times more than that diagnosed using Xpert; however, 6 out of 19 cases may have been overdiagnosed by imaging...
August 2016: Biomedical and Environmental Sciences: BES
Ankur Gupta-Wright, Katherine L Fielding, Joep J van Oosterhout, Douglas K Wilson, Elizabeth L Corbett, Clare Flach, Krishna P Reddy, Rochelle P Walensky, Jurgens A Peters, Melanie Alufandika-Moyo, Stephen D Lawn
BACKGROUND: HIV-associated tuberculosis (TB) co-infection remains an enormous burden to international public health. Post-mortem studies have highlighted the high proportion of HIV-positive adults admitted to hospital with TB. Determine TB-LAM and Xpert MTB/RIF assays can substantially increase diagnostic yield of TB within one day of hospital admission. However, it remains unclear if this approach can impact clinical outcomes. The STAMP trial aims to test the hypothesis that the implementation a urine-based screening strategy for TB can reduce all cause-mortality among HIV-positive patients admitted to hospital when compared to current, sputum-based screening...
2016: BMC Infectious Diseases
Andrew F Auld, Katherine L Fielding, Ankur Gupta-Wright, Stephen D Lawn
Compared with smear microscopy, the Xpert MTB/RIF assay (Xpert), with superior accuracy and capacity to diagnose rifampicin resistance, has advanced TB diagnostic capability. However, recent trials of Xpert impact have not demonstrated reductions in patient morbidity and mortality. We conducted a narrative review of Xpert impact trials to summarize which patient-relevant outcomes Xpert has improved and explore reasons for no observed morbidity or mortality reductions. We searched PubMed, Google Scholar, Cochrane Library and Embase and identified eight trials meeting inclusion criteria: three individually randomized, three cluster-randomized, and two pre-post trials...
August 2016: Transactions of the Royal Society of Tropical Medicine and Hygiene
Adrián Peñata, Richard Salazar, Tatiana Castaño, Julián Bustamante, Sigifredo Ospina
INTRODUCTION: Tuberculosis continues to be a global public health problem, the extrapulmonary form being estimated to occur in 10-20% of immunocompetent individuals, increasing in patients who are carriers of the human immunodeficiency virus (HIV); its diagnosis is difficult with conventional methods due to the paucibacillary nature of samples. The Xpert® MTB/RIF test represents an important development in the molecular detection of Mycobacterium tuberculosis and has been used with a variety of non-respiratory clinical samples...
2016: Biomédica: Revista del Instituto Nacional de Salud
Willy Ssengooba, Durval Respeito, Edson Mambuque, Silvia Blanco, Helder Bulo, Inacio Mandomando, Bouke C de Jong, Frank G Cobelens, Alberto L García-Basteiro
INTRODUCTION: Early diagnosis and initiation to appropriate treatment is vital for tuberculosis (TB) control. The XpertMTB/RIF (Xpert) assay offers rapid TB diagnosis and quantitative estimation of bacterial burden through Cycle threshold (Ct) values. We assessed whether the Xpert Ct value is associated with delayed TB diagnosis as a potential monitoring tool for TB control programme performance. MATERIALS AND METHODS: This analysis was nested in a prospective study under the routine TB surveillance procedures of the National TB Control Program in Manhiça district, Maputo province, Mozambique...
2016: PloS One
Cassandra D Kelly-Cirino, Patricia S Curry, Jamie L Marola, Niels K Helstrom, Max Salfinger
OMNIgene®•SPUTUM (OM-S) is a sputum transport reagent designed to work with all tuberculosis diagnostics and eliminate the need for cold chain. The aim of this preliminary study was to assess the compatibility of OM-S-treated sputum with the Xpert® MTB/RIF assay. Fifty-five characterized sputa from the FIND TB Specimen Bank were used. Compatibility of OM-S was assessed for both Xpert sample preparation methods: H.1 protocol (sediment, n=25) and H.2 protocol (direct expectorate, n=30). All controls were prepared using the H...
November 2016: Diagnostic Microbiology and Infectious Disease
Ilaria Sauzullo, Donatella Maria Rodio, Samantha Facchinetti, Gianluca Puggioni, Massimiliano De Angelis, Paola Goldoni, Vincenzo Vullo, Fabio Mengoni, Maria Trancassini, Valeria Pietropaolo
Early diagnosis of tuberculosis (TB) is one the primary challenges in curtailing spread TB. This study aimed to determine the diagnostic accuracy of Xpert MTB/RIF for the identification of M. tuberculosis in clinical specimens, and compare this to a microscopist's diagnostic performance. Xpert MTB/RIF was positive in all specimens with culture-confirmed TB, giving a higher sensitivity than the smear microscopy (100% versus 63%).The use of Xpert MTB/RIF, as part of routine assay, permits rapid diagnosis of TB and enables clinicians to start an effective treatment...
August 23, 2016: New Microbiologica
Irfan Ullah, Aamer Ali Shah, Anila Basit, Mazhar Ali, Afsar Khan, Ubaid Ullah, Muhammad Ihtesham, Sumaira Mehreen, Anita Mughal, Arshad Javaid
BACKGROUND: Multi-drug resistant tuberculosis (MDR-TB) is a major public health problem especially in developing countries. World Health Organization (WHO) recommends use of Xpert MTB/RIF assay to simultaneously detecting Mycobacterium tuberculosis (MTB) and rifampicin (RIF) resistance. The primary objective of this study was to determine the frequency of MDR-TB in patients suspected to have drug resistance in Khyber Pakhtunkhwa. The frequency of probes for various rpoB gene mutations using Xpert MTB/RIF assay within 81 bp RRDR (Rifampicin Resistance Determining Region) was the secondary objective...
2016: BMC Infectious Diseases
E Hsiang, K M Little, P Haguma, C F Hanrahan, A Katamba, A Cattamanchi, J L Davis, A Vassall, D Dowdy
SETTING: Initial cost-effectiveness evaluations of Xpert(®) MTB/RIF for tuberculosis (TB) diagnosis have not fully accounted for the realities of implementation in peripheral settings. OBJECTIVE: To evaluate costs and diagnostic outcomes of Xpert testing implemented at various health care levels in Uganda. DESIGN: We collected empirical cost data from five health centers utilizing Xpert for TB diagnosis, using an ingredients approach. We reviewed laboratory and patient records to assess outcomes at these sites and10 sites without Xpert...
September 2016: International Journal of Tuberculosis and Lung Disease
Nesri Padayatchi, Naressa Naidu, Nonhlanhla Yende-Zuma, Max Roe OʼDonnell, Kogieleum Naidoo, Stanton Augustine, Alimuddin Zumla, Marian Loveday
BACKGROUND: The Xpert MTB/RIF assay has been widely implemented in South Africa for rapid tuberculosis (TB) screening. However, its usefulness in management and improving treatment outcomes in patients with multidrug-resistant TB (MDR-TB) remains undefined. The aim of this study was to evaluate the clinical impact of introduction of the Xpert MTB/RIF assay in patients with MDR-TB. METHODS: We enrolled 921 patients with MDR-TB, who presented to a specialist drug-resistant TB facility in KwaZulu-Natal, South Africa, pre- and post-rollout and implementation of the Xpert MTB/RIF assay...
September 1, 2016: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Shubhada Shenai, Katharina Ronacher, Stefanus Malherbe, Kim Stanley, Magdalena Kriel, Jill Winter, Thomas Peppard, Charles E Barry, Jing Wang, Lori E Dodd, Laura E Via, Clifton E Barry, Gerhard Walzl, David Alland
INTRODUCTION: Biomarkers are needed to monitor tuberculosis (TB) treatment and predict treatment outcomes. We evaluated the Xpert MTB/RIF (Xpert) assay as a biomarker for TB treatment during and at the end of the 24 weeks therapy. METHODS: Sputum from 108 HIV-negative, culture-positive pulmonary TB patients was analyzed using Xpert at time points before and during anti-TB therapy. Results were compared against culture. Direct Xpert cycle-threshold (Ct), a change in the Ct (delta Ct), or a novel "percent closing of baseline Ct deficit" (percent closing) were evaluated as classifiers of same-day and end-of-treatment culture and therapeutic outcomes...
2016: PloS One
Marilyn M Ninan, Mahasampath Gowri, D J Christopher, Priscilla Rupali, Joy S Michael
Owing to the burden of multidrug-resistant tuberculosis, molecular techniques have been approved by the WHO for the rapid diagnosis of the same. The objectives of this prospective, diagnostic study, conducted at Christian Medical College, a tertiary care center in South India, were to compare the performance of line probe assay (GenoTypeMTBDRplus) with culture, as well as the Xpert MTB/Rif assay on sputum samples. Ninety-one consecutive suspects of multidrug-resistant pulmonary tuberculosis patients from January 2013 to June 2013 were enrolled in this study and the results of line probe assay compared to culture and Xpert MTB/Rif...
June 2016: Pathogens and Global Health
Limakatso Lebina, Nigel Fuller, Tolu Osoba, Lesley Scott, Katlego Motlhaoleng, Modiehi Rakgokong, Pattamukkil Abraham, Ebrahim Variava, Neil Alexander Martinson
Introduction. Tuberculosis is a major cause of morbidity and mortality especially in high HIV burden settings. Active case finding is one strategy to potentially reduce TB disease burden. Xpert MTB/Rif has recently been recommended for diagnosis of TB. Methods. Pragmatic randomized trial to compare diagnosis rate and turnaround time for laboratory testing for Xpert MTB/Rif with TB microscopy and culture in household contacts of patients recently diagnosed with TB. Results. 2464 household contacts enrolled into the study from 768 active TB index cases...
2016: Tuberculosis Research and Treatment
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