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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
Sikhulile Moyo, Terence Mohammed, Kathleen E Wirth, Melanie Prague, Kara Bennett, Molly Pretorius Holme, Lucy Mupfumi, Philemon Sebogodi, Natasha O Moraka, Corretah Boleo, Comfort N Maphorisa, Boitumelo Seraise, Simani Gaseitsiwe, Rosemary M Musonda, Erik van Widenfelt, Kathleen M Powis, Tendani Gaolathe, Eric J Tchetgen Tchetgen, Joseph M Makhema, Max Essex, Shahin Lockman, Vladimir Novitsky
BACKGROUND: Routine monitoring of HIV-1 RNA, or viral load (VL) in patients on antiretroviral therapy (ART) is important, but there are multiple impediments to VL testing in resource-constrained settings. An accurate point-of-care (POC) HIV-1 VL test could alleviate many of these challenges. METHODS: We compared the performance of the Cepheid Xpert® HIV-1 VL against the laboratory-based Abbott m2000sp/m2000rt assay (Abbot assay). ART-naïve individuals participating in the Botswana Combination Prevention Project in 20 communities provided EDTA blood specimens during household surveys...
October 12, 2016: Journal of Clinical Microbiology
Hae-Sun Chung, Miae Lee
Rapid and accurate diagnosis of Clostridium difficile infection (CDI) is crucial for patient care, infection control, and efficient surveillance. We evaluated C. DIFF QUIK CHEK COMPLETE (QCC; TechLab), which detects glutamate dehydrogenase (GDH) antigen (QCC-Ag) and toxin A/B (QCC-Tox) simultaneously, and compared it to the laboratory diagnostics for CDI currently in use in a tertiary hospital setting with a high prevalence of CDI. QCC, RIDASCREEN C. difficile toxin A/B assay (Toxin EIA; R-Biopharm AG), chromID C...
September 13, 2016: Journal of Investigative Medicine: the Official Publication of the American Federation for Clinical Research
Hee-Won Moon, Hyeong Nyeon Kim, Ji-Young Kim, Mina Hur, Heejung Kim, Yeo-Min Yun
OBJECTIVES: Nucleic acid amplification tests are commonly used for the direct detection of toxigenic Clostridium difficile. We evaluated the diagnostic performance of newly launched, artus C. difficile QS-RGQ Kit (artus C. difficile, QIAGEN, Hilden, Germany), in comparison with toxigenic culture (TC) and Xpert C. difficile (Cepheid, Sunnyvale, CA, USA). DESIGN AND METHODS: In prospectively collected 261 diarrheal specimens, the artus C. difficile and the Xpert C...
August 21, 2016: Clinical Biochemistry
Gareth Gerrard, Hui En Foong, Katherine Mudge, Mary Alikian, Jane F Apperley, Letizia Foroni
Molecular monitoring of BCR-ABL1 expression in chronic myeloid leukaemia (CML) is well established. As the International Scale (IS) normalised BCR-ABL1/ABL1 ratio at 3 months post-treatment is now an important milestone in patients' treatment schedule, the reliable and reproducible measurement of BCR-ABL1 levels is therefore paramount. IS conversion factors (CF) are established via sample exchange and yearly ratification with an external reference laboratory. Since any change to an established IS CF could lead to discontinuity in longitudinal results, we wished to add an internal verification step as an additional safeguard...
October 2016: Leukemia Research
R Geiger, D M Smith, S J Little, S R Mehta
OBJECTIVES: The GeneXpert(®) CT/NG (Cepheid, Sunnyvale, CA) assay is a point-of-care (POC) molecular diagnostic assay designed to rapidly test for the presence of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). However, the test is only approved for vaginal swabs, urine, and endocervical swabs. Here, we performed an evaluation of the GeneXpert(®) CT/NG assay to detect the presence of CT and GC on male pharyngeal and rectal swabs. METHODS: Men who have sex with men participating in an HIV and Sexually Transmitted Infection (STI) screening program providing consent were enrolled into the study...
2016: Austin J HIV AIDS Res
Hee-Won Moon, Hyeong Nyeon Kim, Mina Hur, Hee Sook Shim, Heejung Kim, Yeo-Min Yun
Since every single test has some limitations for detecting toxigenic Clostridium difficile, multistep algorithms are recommended. This study aimed to compare the current, representative diagnostic algorithms for detecting toxigenic C. difficile, using VIDAS C. difficile toxin A&B (toxin ELFA), VIDAS C. difficile GDH (GDH ELFA, bioMérieux, Marcy-l'Etoile, France), and Xpert C. difficile (Cepheid, Sunnyvale, California, USA). In 271 consecutive stool samples, toxigenic culture, toxin ELFA, GDH ELFA, and Xpert C...
2016: PloS One
Jonathan A Otter, Eleonora Dyakova, Karen N Bisnauthsing, Antonio Querol-Rubiera, Amita Patel, Chioma Ahanonu, Olga Tosas Auguet, Jonathan D Edgeworth, Simon D Goldenberg
BACKGROUND: Carbapenemase-producing Enterobacteriaceae (CPE) are an emerging threat for healthcare providers worldwide. OBJECTIVES: To determine CPE carriage rates and risk factors in an unselected hospital cohort at the time of admission. METHODS: We approached 4567 patients within 72 h of admission to provide a rectal swab and answer a questionnaire on risk factors for carriage. Rectal swabs were cultured for carbapenem-resistant organisms on chromogenic and non-chromogenic agar, and tested for carbapenemase production by PCR (Check-Direct CPE)...
August 11, 2016: Journal of Antimicrobial Chemotherapy
Rechel Geiger, David M Smith, Susan J Little, Sanjay R Mehta
The GeneXpert CT/NG (Cepheid, Sunnyvale, CA) is a point-of-care (POC) molecular diagnostic assay designed to detect Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). However, the test is only approved for urine, vaginal, and endocervical swabs. Here, we evaluated the GeneXpert CT/NG assay on male pharyngeal and rectal swabs. Men-who-have-sex-with-men participating in a sexually transmitted infection (STI) screening program collected two sets of paired pharyngeal and rectal swabs. One set was tested using GeneXpert and the other using the APTIMA (Hologic, San Diego, CA, USA)...
August 10, 2016: International Journal of STD & AIDS
Andrea Cortegiani, Vincenzo Russotto, Giorgio Graziano, Daniela Geraci, Laura Saporito, Gianfranco Cocorullo, Santi Maurizio Raineri, Caterina Mammina, Antonino Giarratano
Early institution of effective antibiotic therapy and source control are pivotal to improve survival of abdominal septic patients. Xpert® Carba-R is a real time polymerase chain reaction assay for rapid detection and differentiation of five genes (blaKPC, blaVIM, blaOXA-48, blaIMP-1, blaNDM) responsible for carbapenem resistance. We performed an observational study investigating the clinical usefulness and applicability of Xpert® Carba-R to detect carbapenem resistance in abdominal septic patients admitted to intensive care unit...
2016: PloS One
Marion Smith, Bram Diederen, Jelle Scharringa, Maurine Leversteijn-van Hall, Ad C Fluit, James Cohen Stuart
Rapid and accurate detection of carbapenemase-producing Enterobacteriaceae is pivotal for adequate antibiotic therapy and infection control. The Cepheid Xpert Carba-R assay detects and identifies the most prevalent carbapenemases (KPC, VIM, IMP, NDM and OXA-48), using automated real-time PCR. The test performance of the Xpert Carba-R was evaluated with 129 well-characterized non-repeat Enterobacteriaceae isolates, suspected for carbapenemase production, i.e. with meropenem MICs >0.25 mg l-1. The isolate collection contained 100 carbapenemase-producing isolates (36 KPC-2 or KPC-3, 20 VIM-1, 4 KPC-2 plus VIM-1, 5 NDM-1, 2 IMP-1, 1 IMP-28, 1 IMP-1 plus VIM-1 and 31 OXA-48 like) and 29 negative control isolates producing extended-spectrum β-lactamase and/or AmpC β-lactamases...
September 2016: Journal of Medical Microbiology
Heidi Albert, Ruvandhi R Nathavitharana, Chris Isaacs, Madhukar Pai, Claudia M Denkinger, Catharina C Boehme
The global roll-out of Xpert MTB/RIF (Cepheid Inc., Sunnyvale, CA, USA) has changed the diagnostic landscape of tuberculosis (TB). More than 16 million tests have been performed in 122 countries since 2011, and detection of multidrug-resistant TB has increased three- to eight-fold compared to conventional testing. The roll-out has galvanised stakeholders, from donors to civil society, and paved the way for universal drug susceptibility testing. It has attracted new product developers to TB, resulting in a robust molecular diagnostics pipeline...
August 2016: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
Sarah Edwards, Patricia Glynn, Miruna D David, Lavanya Kamesh
Diagnosing tuberculous peritonitis can be challenging, with mycobacterial culture potentially taking weeks for a positive result. This report describes 2 cases where a prompt diagnosis of tuberculous peritonitis was made employing the Xpert MTB/RIF assay (Cepheid Inc., Sunnyvale, CA, USA).
July 2016: Peritoneal Dialysis International: Journal of the International Society for Peritoneal Dialysis
Maria Isabel S Gouvea, Esau C Joao, Maria de Lourdes B Teixeira, Jennifer S Read, Sergio E L Fracalanzza, Claudia T V Souza, Maria José de Souza, Helio M Torres Filho, Cassiana C F Leite, Pedro E A A do Brasil
OBJECTIVE: There are limited data regarding Xpert performance to detect GBS in HIV-infected pregnant women. We evaluated the accuracy of a rapid real-time polymerase chain reaction test in a cohort of HIV-infected women. METHODS: At 35-37 weeks of pregnancy, a pair of combined rectovaginal swabs were collected for two GBS assays in a cohort of sequentially included HIV-infected women in Rio de Janeiro: 1) culture; and 2) real-time polymerase chain reaction assay [GeneXpert GBS (Cepheid, Sunnyvale, CA, US)]...
June 22, 2016: Journal of Maternal-fetal & Neonatal Medicine
Swati Jha, Nazir Ismail, David Clark, James J Lewis, Shaheed Omar, Andries Dreyer, Violet Chihota, Gavin Churchyard, David W Dowdy
BACKGROUND: Automated digital microscopy has the potential to improve the diagnosis of tuberculosis (TB), particularly in settings where molecular testing is too expensive to perform routinely. The cost-effectiveness of TB diagnostic algorithms using automated digital microscopy remains uncertain. METHODS: Using data from a demonstration study of an automated digital microscopy system (TBDx, Applied Visual Systems, Inc.), we performed an economic evaluation of TB diagnosis in South Africa from the health system perspective...
2016: PloS One
Guomei Wei, Jing Mu, Guirong Wang, Fengmin Huo, Lingling Dong, Yunxu Li, Hairong Huang
BACKGROUND: The Xpert MTB/RIF assay (Xpert; Cepheid, Sunnyvale, CA, USA) has been widely used for pulmonary and extra-pulmonary tuberculosis (TB) diagnosis. In clinical practice, specimen yielding smear-negative, culture-negative but Xpert-positive results is frequently confronted. Due to the notorious possibility of contamination that molecular tests always been thought of, Xpert-positive results without bacteriological supporting evidence arouse great confusions to clinicians. METHODS: A retrospective study was performed...
June 2016: Journal of Thoracic Disease
Steven G Badman, Lisa M Vallely, Pamela Toliman, Grace Kariwiga, Bomesina Lote, William Pomat, Caroline Holmer, Rebecca Guy, Stanley Luchters, Chris Morgan, Suzanne M Garland, Sepehr Tabrizi, David Whiley, Stephen J Rogerson, Glen Mola, Handan Wand, Basil Donovan, Louise Causer, John Kaldor, Andrew Vallely
BACKGROUND: Sexually transmitted and genital infections in pregnancy are associated with an increased risk of adverse maternal and neonatal health outcomes. High prevalences of sexually transmitted infections have been identified among antenatal attenders in Papua New Guinea. Papua New Guinea has amongst the highest neonatal mortality rates worldwide, with preterm birth and low birth weight major contributors to neonatal mortality. The overall aim of our study was to determine if a novel point-of-care testing and treatment strategy for the sexually transmitted and genital infections Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Bacterial vaginosis (BV) in pregnancy is feasible in the high-burden, low-income setting of Papua New Guinea...
2016: BMC Infectious Diseases
Francesca Rovida, Marta Premoli, Giulia Campanini, Antonella Sarasini, Fausto Baldanti
Xpert® Norovirus Assay (Cepheid, Sunnyvale, CA) was compared with a laboratory-developed real-time RT-PCR assay for the detection of Norovirus GI and GII in hospitalized patients with acute gastroenteritis. The two assays showed a high level of concordance but Xpert® Norovirus Assay allowed faster detection of Norovirus and a simpler sample handling.
August 2016: Diagnostic Microbiology and Infectious Disease
Dan Jang, Sam Ratnam, Jodi Gilchrist, Manuel Arias, Marek Smieja, Donna Mayne, Max A Chernesky
BACKGROUND: The 2015 Sexually Transmitted Diseases Treatment Guidelines from the Centers for Disease Control and Prevention recommend testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) using nucleic acid amplification tests, and prompt treatment of infected persons on site under direct observation. Faster time to results may enable treatment and management outcomes. METHODS: Workflow parameters for processing 1, 10, 48, 96, and 192 tests were determined in the GeneXpert Infinity 80 (Cepheid) and Panther (Hologic) instruments...
June 2016: Sexually Transmitted Diseases
Rrezarta Bajrami, Gjyle Mulliqi, Arsim Kurti, Greta Lila, Lul Raka
INTRODUCTION: Tuberculosis (TB) is a major public health problem worldwide, with the highest mortality occurring in developing countries. The burden of TB in Kosovo is among the highest in Europe. The aim of this study was to compare Cepheid GeneXpert MTB/RIF assay for direct detection of Mycobacterium tuberculosis complex (MTBC) and rifampin (RIF) resistance with conventional methods. METHODOLOGY: A cross-sectional design to evaluate diagnostic tests was carried out at the Department of Microbiology, National Institute of Public Health of Kosovo and Lung Clinic, from January to June 2014...
2016: Journal of Infection in Developing Countries
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