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Alan M McGovern, Grace O Androga, Peter Moono, Deirdre A Collins, Niki F Foster, Barbara J Chang, Thomas V Riley
Strains of Clostridium difficile producing only binary toxin (CDT) are found commonly in animals but not humans. However, human diagnostic tests rarely look for CDT. The Cepheid Xpert C. difficile BT assay detects CDT with equal sensitivity (≥92%) in human and animal faecal samples.
March 10, 2018: Anaerobe
Zibusiso Ndlovu, Emmanuel Fajardo, Elton Mbofana, Tatenda Maparo, Daniela Garone, Carol Metcalf, Helen Bygrave, Kekeletso Kao, Sekesai Zinyowera
BACKGROUND: HIV Viral Load and Early Infant Diagnosis technologies in many high burden settings are restricted to centralized laboratory testing, leading to long result turnaround times and patient attrition. GeneXpert (Cepheid, CA, USA) is a polyvalent near point-of-care platform and is widely implemented for Xpert MTB/RIF diagnosis. This study sought to evaluate the operational feasibility of integrated HIV VL, EID and MTB/RIF testing in new GeneXpert platforms. METHODS: Whole blood samples were collected from consenting patients due for routine HIV VL testing and DBS samples from infants due for EID testing, at three rural health facilities in Zimbabwe...
2018: PloS One
Tracy McMillen, Shauna C Usiak, Liang Hua Chen, Luz Gomez, Peter Ntiamoah, Meera R Hameed, Indre Budvytiene, Niaz Banaei, Mini Kamboj, N Esther Babady
OBJECTIVES In this study, we sought to evaluate the performance of the Xpert MTB/RIF (Cepheid) assay for the detection of Mycobacterium tuberculosis (MTB) complex DNA on fresh and formalin-fixed, paraffin-embedded (FFPE) tissue specimens from oncology patients in an area with a low prevalence of tuberculosis. We also aimed to retrospectively assess the potential impact of Xpert MTB/RIF on the duration of airborne infection isolation (AII). SETTING A 473-bed, tertiary-care cancer center in New York City. DESIGN A total of 203 tissue samples (101 FFPE and 102 fresh) were tested using Xpert MTB/RIF, including 133 pulmonary tissue samples (65...
February 15, 2018: Infection Control and Hospital Epidemiology
Madlen Nash, Sophie Huddart, Sayema Badar, Shrikala Baliga, Kavitha Saravu, Madhukar Pai
Viral load (VL) is the preferred treatment monitoring approach for HIV-positive patients. However, more rapid, near-patient, and low-complexity assays are needed to scale-up VL testing. The Xpert HIV-1 VL assay (Cepheid, Sunnyvale) is a new, automated molecular test, and can leverage the GeneXpert systems that are being used widely for tuberculosis diagnosis. We systematically reviewed the evidence on the performance of this new tool in comparison to established reference standards. A total of twelve articles (thirteen studies) in which HIV patient VLs were compared between Xpert HIV VL assay and a reference standard VL assay were identified...
January 31, 2018: Journal of Clinical Microbiology
Rahul Pannala, Bruce Baldwin, Vijay Aluru, Thomas E Grys, Jordan Holmes, Laurence J Miller, M Edwyn Harrison, Cuong C Nguyen, Fred C Tenover, David Persing, Douglas O Faigel
Background/aims:  In an investigator-initiated, prospective study, we evaluated the feasibility of a five-gene sequence point-of-care (POC) testing strategy (Xpert CARBA-R Assay, Cepheid Inc., Sunnyvale, CA, USA), compared to reference laboratory PCR (48 - 72 hours turnaround time, two gene sequences), in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) and in a hospital outbreak investigation. Methods:  After informed consent, patients undergoing ERCP (September 2015 - April 2016, n = 191) at Mayo Clinic and potential hospital contacts (n = 9) of an index carbapenem-resistant organism (CRO)-positive inpatient were included...
January 2018: Endoscopy International Open
Ali A Rabaan, Ali M Bazzi, Sana A Alshaikh
OBJECTIVE: To compare two influenza polymerase chain reaction (PCR) methods. METHODS: A total of 749 suspected MERS-CoV patients presenting at Johns Hopkins Aramco Healthcare, Saudi Arabia, each submitted a clinical sample for influenza A reflex testing using the on-site Cepheid® Xpert Flu assay and at the Ministry of Health laboratory by the Roche PCR assay. RESULTS: There was 92.12% overall agreement between the two methods. Specificity of the Cepheid® Xpert Flu was 95...
December 16, 2017: Diagnostic Microbiology and Infectious Disease
Katheryn R Salow, Adam C Cohen, Claire C Bristow, Mark R McGrath, Jeffrey D Klausner
OBJECTIVES: To evaluate the concordance between clinic-collected extra-genital specimens and self-collected mailed-in extra-genital specimens among participants seeking sexually transmitted infection testing at a free clinic in Hollywood, CA. METHODS: A convenience sample of 210 men who have sex with men were enrolled between February 29, 2016 and December 21, 2016 and received mail-in testing kits for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). All testing was performed using the GeneXpert® CT/NG (Cepheid, Sunnyvale, CA)...
2017: PloS One
Laura Dize, Barbara Silver, Charlotte Gaydos
Self-collected rectal-swabs were tested for CT and NG on GeneXpert CT/NG as compared to APTIMA Combo2. Of 448 rectal-swabs, 22 were positive for CT; 7 for NG on both assays; two were discordant. Sensitivity and specificity of GeneXpert was 95.5% and 99.7% for chlamydia, respectively; for gonorrhea both were 100%.
February 2018: Diagnostic Microbiology and Infectious Disease
Jane R Schwebke, C A Gaydos, T Davis, J Marrazzo, D Furgerson, S N Taylor, B Smith, L H Bachmann, R Ackerman, T Spurrell, D Ferris, C A Burnham, H Reno, J Lebed, D Eisenberg, P Kerndt, S Philip, J Jordan, N Quigley
Trichomoniasis is the most prevalent curable sexually transmitted disease (STD). It has been associated with preterm birth and acquisition/transmission of HIV. Recently, nucleic acid amplification tests (NAAT) have been FDA-cleared in the United States for detection of Trichomonas vaginalis (TV) in specimens from both women and men. This current study reports the results of a multicenter study recently conducted using the Xpert TV Assay to test specimens from both men and women. On-demand results were available in as little as 40 minutes for positive specimens...
November 22, 2017: Journal of Clinical Microbiology
Daniel M Cohen, Jennifer Kline, Larissa S May, Glenn Eric Harnett, Jane Gibson, Stephen Y Liang, Zubaid Rafique, Carina A Rodriguez, Kevin M McGann, Charlotte A Gaydos, Donna Mayne, David Phillips, Jason Cohen
The Xpert Flu+RSV Xpress Assay is a fast, automated in vitro diagnostic test for qualitative detection and differentiation of influenza A, B, and RSV performed on the Cepheid GeneXpert Xpress System. The objective of this study was to establish performance characteristics of the Xpert Flu+RSV Xpress Assay compared to the Prodesse ProFlu+ real-time RT-PCR assay (ProFlu+) for the detection of influenza A and B as well as RSV in a CLIA-waived (CW) setting. Overall, the assay, using fresh and frozen nasopharyngeal (NP) swabs, demonstrated high concordance with ProFlu+ in the combined CW and non-CW settings with Positive Percent Agreements (PPA) (100%, 100%, 97...
November 15, 2017: Journal of Clinical Microbiology
Jan Heyckendorf, Sönke Andres, Claudio U Köser, Ioana D Olaru, Thomas Schön, Erik Sturegård, Patrick Beckert, Viola Schleusener, Thomas A Kohl, Doris Hillemann, Danesh Moradigaravand, Julian Parkhill, Sharon J Peacock, Stefan Niemann, Christoph Lange, Matthias Merker
Rapid and accurate drug-susceptibility testing (DST) is essential for the treatment of multi- and extensively drug-resistant tuberculosis (M/XDR-TB). We compared the utility of genotypic DST assays with phenotypic DST (pDST) using BACTEC 960 MGIT or Löwenstein-Jensen to construct M/XDR-TB treatment regimens for a cohort of 25 consecutive M/XDR-TB patients and 15 possible anti-TB drugs.Genotypic DST results from Cepheid GeneXpert MTB/RIF (Xpert) and line probe assays (LPAs: Hain GenoType MTBDRplus 2.0 and MTBDRsl 2...
November 13, 2017: Antimicrobial Agents and Chemotherapy
Yeliz Tanriverdi Cayci, Kemal Bilgin, Ahmet Yilmaz Coban, Asuman Birinci, Belma Durupınar
BACKGROUND: Mycobacterium tuberculosis (MTB) is one of the most significant causes of mortality and morbidity. Early diagnose is important especially in multiple drug resistant tuberculosis to avoid transmission. Traditional techniques requires at least one to three weeks for diagnosis of tuberculosis. Diagnostic delays with multiple drug resistant tuberculosis are associated with worse clinical outcomes and increased transmission The Xpert MTB/RIF assay is one of the new diagnostic device for the diagnosis of tuberculosis and rapid detection of rifampicin resistance...
November 2017: Memórias do Instituto Oswaldo Cruz
C Plainvert, F El Alaoui, A Tazi, C Joubrel, O Anselem, M Ballon, A Frigo, C Branger, L Mandelbrot, F Goffinet, C Poyart
Group B Streptococcus (GBS) is the leading cause of neonatal infections in industrialized countries. Intrapartum antibiotic prophylaxis (IAP) given to colonized parturients is a key step for the prevention of neonatal early-onset infection. We compared the performances of Xpert® GBS polymerase chain reaction (PCR) (Cepheid, Sunnyvale, CA, USA) as a point-of-care system in labor wards to standard culture for intrapartum GBS detection. Pregnant women with a GBS-positive antenatal screening were prospectively included...
October 29, 2017: European Journal of Clinical Microbiology & Infectious Diseases
Zizipho Z A Mbulawa, Timothy J Wilkin, Bridgette Goeieman, Avril Swarts, Sophie Williams, Simon Levin, Mark Faesen, Jennifer S Smith, Carla J Chibwesha, Anna-Lise Williamson, Cynthia Firnhaber
This study investigated the performance of Cepheid Xpert human papillomavirus (HPV) assay in South African human immunodeficiency virus (HIV)-infected women and compared its performance with that of hybrid capture-2 (hc2). METHODS: Stored cervical specimens from HIV-infected women that had previously been tested using hc2 were tested using Xpert. RESULTS: The overall HR-HPV prevalence was found to be 62.0% (720/1161) by Xpert and 61.2% (711/1161) by hc2. 13.6% (158/1161) were HPV16 positive, 18...
December 2016: Papillomavirus Research
Sean P Wilson, Taher Vohra, Jared Goldberg, Christopher Price, Sean Calo, Meredith Mahan, Joseph Miller
BACKGROUND: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are common sexually transmitted infections seen in the emergency department (ED). Due to an inability to reliably make accurate diagnosis by physical examination, concern for unreliable follow-up, and current delays in diagnostic nucleic acid amplification testing (NAAT), presumptive treatment active against CT and NG, as described by Centers for Disease Control clinical practice guidelines, is often performed. OBJECTIVES: The purpose of this study was to determine whether a rapid, urine NAAT performed in the ED is noninferior in its diagnostic sensitivity compared with a traditional, swab NAAT assay...
December 2017: Journal of Emergency Medicine
Rachel Shi-Lei Wong, Fion Yeo, Wai Theng Chia, Chun Kiat Lee, Mun Han Leong, Christopher Wai-Siong Ng, Kok Siong Poon, Gabriel Zherong Yan, Lily-Lily Chiu, Benedict Junrong Yan, Roland Jureen, Evelyn Siew-Chuan Koay, Hong Kai Lee
The Cepheid Xpert® Norovirus kit automates sample processing, nucleic acid extraction, and real-time reverse transcription polymerase chain reactions (RT-PCRs) to detect norovirus genogroups I (GI) and II (GII). Eighty-five stool samples collected between February 2015 and May 2017 were used to compare the performance of a user-modified Xpert assay against a clinically validated laboratory-developed test (LDT). Of the 85 samples, 54 were previously archived in -80°C freezer. The remaining 31 were fresh samples tested concurrently with the LDT...
October 26, 2017: Journal of Medical Virology
David John Speers, I-Ly Joanna Chua, Justin Manuel, Lewis Marshall
OBJECTIVES: Screening of men who have sex with men (MSM) for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) requires sampling from anorectal and pharyngeal sites in addition to urogenital sampling. Due to the cost of testing multiple anatomical sites individually testing of pooled specimens has potential merit. The Cepheid GeneXpert CT/NG assay (GeneXpert), which also has potential for point-of-care nucleic acid testing in the sexual health clinic, has not been assessed for pooled specimen testing...
October 24, 2017: Sexually Transmitted Infections
Ellen Wallace, Russell Higuchi, Malini Satya, Leena McCann, Mandy L Y Sin, Julia A Bridge, Huilin Wei, Jun Zhang, Edith Wong, Andrew Hiar, Kathleen E Mach, Douglas Scherr, R Blair Egerdie, Shoichiro Ohta, Wade J Sexton, Maxwell V Meng, Alon Z Weizer, Michael Woods, G Kenneth Jansz, Joseph Zadra, Yair Lotan, Bernard Goldfarb, Joseph C Liao
PURPOSE: Despite suboptimal sensitivity urine cytology is often performed as an adjunct to cystoscopy for bladder cancer diagnosis. We aimed to develop a noninvasive, fast molecular diagnostic test for bladder cancer detection with better sensitivity than urine cytology while maintaining adequate specificity. MATERIALS AND METHODS: Urine specimens were collected at 18 multinational sites from subjects prior to cystoscopy or tumor resection and from healthy and other control subjects without evidence of bladder cancer...
October 20, 2017: Journal of Urology
Sarah Fidler, Heather Lewis, Jodi Meyerowitz, Kristin Kuldanek, John Thornhill, David Muir, Alice Bonnissent, Georgina Timson, John Frater
There is a global need for HIV viral load point-of-care (PoC) assays to monitor patients receiving antiretroviral therapy. UNICORN was the first study of an off-label protocol using whole blood finger-prick samples tested with and without a simple three minute spin using a clinic-room microcentrifuge. Two PoC assays were evaluated in 40 HIV-positive participants, 20 with detectable and 20 with undetectable plasma viral load (pVL) (<20 copies/ml). Using 100 µl finger-prick blood samples, the Cepheid Xpert HIV-1 Viral Load and HIV-1 Qual cartridges were compared with laboratory pVL assessment (TaqMan, Roche)...
October 20, 2017: Scientific Reports
Hai Huang, Yanlin Zhang, Sheng Li, Jun Wang, Jun Chen, Zhiyun Pan, Hui Gan
BACKGROUND: The Xpert MTB/RIF test (Cepheid, Sunnyvale, CA) can simultaneously detect the Mycobacterium tuberculosis (MTB) complex DNA and rifampicin (RFP) resistance and can rapidly determine RFP resistance and predict multidrug-resistant tuberculosis (MDR-TB). In this study, we analyzed clinical examination results of a hospital specializing in TB treatment in Wuhan, Hubei, China, and examined the use of traditional culture and drug-sensitive test (DST) results as a gold standard to assess the diagnosis value of the Xpert MTB/RIF test in RFP resistance and MDR-TB...
October 20, 2017: Microbial Drug Resistance: MDR: Mechanisms, Epidemiology, and Disease
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