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Estudio primario

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Evaluation of Xpert C. difficile, BD MAX Cdiff, IMDx C. difficile for Abbott m2000, and Illumigene C. difficile Assays for Direct Detection of Toxigenic Clostridium difficile in Stool Specimens.

Autores Shin BM , Yoo SM , Shin WC
Revista Annals of laboratory medicine
Año 2016
Enlaces Pubmed DOI PubMed Central

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BACKGROUND: We evaluated the performance of four commercial nucleic acid amplification tests (NAATs: Xpert C. difficile, BD MAX Cdiff, IMDx C. difficile for Abbott m2000, and Illumigene C. difficile) for direct and rapid detection of Clostridium difficile toxin genes. METHODS: We compared four NAATs on the same set of 339 stool specimens (303 prospective and 36 retrospective specimens) with toxigenic culture (TC). RESULTS: Concordance rate among four NAATs was 90.3% (306/339). Based on TC results, the sensitivity and specificity were 90.0% and 92.9% for Xpert; 86.3% and 89.3% for Max; 84.3% and 94.4% for IMDx; and 82.4% and 93.7% for Illumigene, respectively. For 306 concordant cases, there were 11 TC-negative/NAATs co-positive cases and 6 TC-positive/NAATs co-negative cases. Among 33 discordant cases, 18 were only single positive in each NAAT (Xpert, 1; Max, 12; IMDx, 1; Illumigene, 4). Positivity rates of the four NAATs were associated with those of semi-quantitative cultures, which were maximized in grade 3 (>100 colony-forming unit [CFU]) compared with grade 1 (<10 CFU). CONCLUSIONS: Commercial NAATs may be rapid and reliable methods for direct detection of tcdA and/or tcdB in stool specimens compared with TC. Some differences in the sensitivity of the NAATs may partly depend on the number of toxigenic C. difficile in stool specimens.

Estudio primario

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A comparison of Clostridium difficile diagnostic methods for identification of local strains in a South African centre.

Revista Journal of medical microbiology
Año 2016
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Accurate diagnosis of Clostridium difficile infection is essential for disease management. A clinical and molecular analysis of C. difficile isolated from symptomatic patients at Groote Schuur Hospital, South Africa, was conducted to establish the most suitable clinical test for the diagnosis and characterization of locally prevalent strains. C. difficile was detected in stool samples using enzyme-based immunoassays (EIA) and nucleic acid amplification methods, and their performance was compared with that of C. difficile isolation using direct selective culture combined with specific PCR to detect the C. difficile tpi gene, toxin A and B genes and binary toxin genes. Toxigenic isolates were characterized further by ribotyping. Selective culture isolated 32 C. difficile strains from 145 patients (22 %). Of these, the most prevalent (50 %) were of ribotype 017 (toxin A- B+) while 15.6 % were ribotype 001 (toxin A+B+). No ribotype 027 strains or binary toxin genes (cdtA and cdtB) were detected. The test sensitivities and specificities, respectively, of four commercial clinical diagnostic methods were as follows: ImmunoCard Toxins A & B (40 % and 99.1 %), VIDAS C. difficile Toxin A & B (50 % and 99.1 %), GenoType CDiff (86.7 % and 88.3 %) and Xpert C. difficile (90 % and 97.3 %). Ribotype 001 and 017 strains had a 100 % detection rate by Xpert C. difficile, 100 % and 93.3 % by GenoType CDiff, 75 % and 53.3 % by ImmunoCard and 75 % and 60 % by VIDAS, respectively. The overall poor performance of EIA suggests that a change to PCR-based testing would assist diagnosis and ensure reliable detection of locally prevalent C. difficile 017 strains.

Estudio primario

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Comparison of Diagnostic Algorithms for Detecting Toxigenic Clostridium difficile in Routine Practice at a Tertiary Referral Hospital in Korea.

Autores Moon HW , Kim HN , Hur M , Shim HS , Kim H , Yun YM
Revista PloS one
Año 2016
Enlaces Pubmed DOI PubMed Central

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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. difficile were performed. We simulated two algorithms: screening by GDH ELFA and confirmation by Xpert C. difficile (GDH + Xpert) and combined algorithm of GDH ELFA, toxin ELFA, and Xpert C. difficile (GDH + Toxin + Xpert). The performance of each assay and algorithm was assessed. The agreement of Xpert C. difficile and two algorithms (GDH + Xpert and GDH+ Toxin + Xpert) with toxigenic culture were strong (Kappa, 0.848, 0.857, and 0.868, respectively). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of algorithms (GDH + Xpert and GDH + Toxin + Xpert) were 96.7%, 95.8%, 85.0%, 98.1%, and 94.5%, 95.8%, 82.3%, 98.5%, respectively. There were no significant differences between Xpert C. difficile and two algorithms in sensitivity, specificity, PPV and NPV. The performances of both algorithms for detecting toxigenic C. difficile were comparable to that of Xpert C. difficile. Either algorithm would be useful in clinical laboratories and can be optimized in the diagnostic workflow of C. difficile depending on costs, test volume, and clinical needs.

Estudio primario

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Evaluation of the Qiagen artus C. difficile QS-RGQ Kit for Detection of Clostridium difficile Toxins A and B in Clinical Stool Specimens.

Autores Jazmati N , Wiegel P , Ličanin B , Plum G
Revista Journal of clinical microbiology
Año 2015
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We compared the Qiagen artus C. difficile QS-RGQ kit, a new nucleic acid amplification test for the detection of Clostridium difficile toxins in stool specimens, with the Cepheid Xpert C. difficile test. The sensitivity, specificity, positive predictive value, and negative predictive value for the Qiagen artus C. difficile QS-RGQ test were 100%, 89.5%, 60.9%, and 100%, and those for the Cepheid Xpert C. difficile test were 100%, 90%, 62.2%, and 100%, respectively.

Estudio primario

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trasplante de microbiota intestinal, un tratamiento simple y eficaz para la infección grave y refractario Clostridium difficile.

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Revista Digestive diseases and sciences
Año 2015
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ANTECEDENTES: La restauración de la flora fecal normales a través del trasplante intestinal microbiota (IMT) fue un éxito en la curación de la infección por Clostridium difficile recurrente (CDI). Sin embargo, sólo se han descrito algunos casos de las IMT siendo utilizado para el tratamiento de CDI severa o fulminante. AIM: ¿Es IMT un tratamiento simple y eficaz para severa y recurrente CDI? MÉTODOS: En este estudio retrospectivo, se reportan 14 pacientes con CDI grave resistente al tratamiento médico convencional, que se sometió a las IMT. muestra de heces frescas de donantes se homogeneizó manualmente con agua caliente del grifo, se filtró a través de una gasa y luego inculcado a través de sonda nasogástrica (SNG). El resultado primario fue la curación clínica, definida como menos de 3 deposiciones sueltas al día en el día 7 después de la TGR y sin necesidad de tratamiento adicional CDI. Los resultados secundarios fueron la recurrencia de CDI dentro de los 100 días de IMT y mortalidad a 30 días después de la TGR. Se realizaron estadísticas descriptivas. RESULTADOS: Catorce pacientes con severa y refractaria CDI recibieron IMT. La edad media fue de 73,4 ± 11,9 años (rango 52-92). IMT se dio a través NGT en 13 de los 14 pacientes. Once pacientes (79%) alcanzaron la curación después de la TGR. No hubo recurrencia se observó en los pacientes que respondieron a las IMT y estaban vivos en el periodo de seguimiento de 100 días. IMT fue bien tolerado. El de 30 días por todas las causas de mortalidad fue del 29%, los 4 pacientes murieron como resultado de su cáncer subyacente. Ninguno de los pacientes murieron como resultado de la CDI o IMT. CONCLUSIONES: IMT lleva a cabo en la cabecera a través de NGT es eficaz y segura para el tratamiento de la severa y refractaria CDI y evita la recurrencia.

Estudio primario

No clasificado

Evaluation of 3 automated real-time PCR (Xpert C. difficile assay, BD MAX Cdiff, and IMDx C. difficile for Abbott m2000 assay) for detecting Clostridium difficile toxin gene compared to toxigenic culture in stool specimens.

Autores Yoo J , Lee H , Park KG , Lee GD , Park YG , Park YJ
Revista Diagnostic microbiology and infectious disease
Año 2015
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We evaluated the performance of the 3 automated systems (Cepheid Xpert, BD MAX, and IMDx C. difficile for Abbott m2000) detecting Clostridium difficile toxin gene compared to toxigenic culture. Of the 254 stool specimens tested, 87 (48 slight, 35 moderate, and 4 heavy growth) were toxigenic culture positive. The overall sensitivities and specificities were 82.8% and 98.8% for Xpert, 81.6% and 95.8% for BD MAX, and 62.1% and 99.4% for IMDx, respectively. The specificity was significantly higher in IMDx than BD MAX (P= 0.03). All stool samples underwent toxin A/B enzyme immunoassay testing, and of the 254 samples, only 29 samples were positive and 2 of them were toxigenic culture negative. Considering the rapidity and high specificity of the real-time PCR assays compared to the toxigenic culture, they can be used as the first test method for C. difficile infection/colonization.

Estudio primario

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Evaluation of the BD Max Cdiff assay for the detection of toxigenic Clostridium difficile in human stool specimens.

Revista Pathology
Año 2015
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The Becton Dickinson (BD) PCR-based GeneOhm Cdiff assay has demonstrated a high sensitivity and specificity for detecting Clostridium difficile. Recently, the BD Max platform, using the same principles as BD GeneOhm, has become available in Australia. This study aimed to investigate the sensitivity and specificity of BD Max Cdiff assay for the detection of toxigenic C. difficile in an Australian setting. Between December 2013 and January 2014, 406 stool specimens from 349 patients were analysed with the BD Max Cdiff assay. Direct and enrichment toxigenic culture were performed on bioMérieux ChromID C. difficile agar as a reference method. isolates from specimens with discrepant results were further analysed with an in-house PCR to detect the presence of toxin genes. The overall prevalence of toxigenic C. difficile was 7.2%. Concordance between the BD Max assay and enrichment culture was 98.5%. The sensitivity, specificity, positive predictive value and negative predictive value for the BD Max Cdiff assay were 95.5%, 99.0%, 87.5% and 99.7%, respectively, when compared to direct culture, and 91.7%, 99.0%, 88.0% and 99.4%, respectively, when compared to enrichment culture. The new BD Max Cdiff assay appeared to be an excellent platform for rapid and accurate detection of toxigenic C. difficile.

Estudio primario

No clasificado

Use of a daily disinfectant cleaner instead of a daily cleaner reduced hospital-acquired infection rates.

Revista American journal of infection control
Año 2015
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BACKGROUND: Documenting effective approaches to eliminate environmental reservoirs and reduce the spread of hospital-acquired infections (HAIs) has been difficult. This was a prospective study to determine if hospital-wide implementation of a disinfectant cleaner in a disposable wipe system to replace a cleaner alone could reduce HAIs over 1 year when housekeeping compliance was ≥80%. METHODS: In this interrupted time series study, a ready-to-use accelerated hydrogen peroxide disinfectant cleaner in a disposable wipe container system (DCW) was used once per day for all high-touch surfaces in patient care rooms (including isolation rooms) to replace a cleaner only. The HAI rates for methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and Clostridium difficile were stratified by housekeeping cleaning compliance (assessed using ultraviolet-visible marker monitoring). RESULTS: When cleaning compliance was ≥80%, there was a significant reduction in cases/10,000 patient days for MRSA (P = .0071), VRE (P < .0001), and C difficile (P = .0005). For any cleaning compliance level there was still a significant reduction in the cases/10,000 patient days for VRE (P = .0358). CONCLUSION: Our study data showed that daily use of the DCW applied to patient care high-touch environmental surfaces with a minimum of 80% cleaning compliance was superior to a cleaner alone because it resulted in significantly reduced rates of HAIs caused by C difficile, MRSA, and VRE.

Estudio primario

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Simple faecal preparation and efficacy of frozen inoculum in faecal microbiota transplantation for recurrent Clostridium difficile infection--an observational cohort study.

Revista Alimentary pharmacology & therapeutics
Año 2015
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BACKGROUND: Faecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridium difficile infection (rCDI). The finding of suitable donor, donor screening and preparation of faecal transplants are challenging in clinical work. AIM: To develop a practical protocol for preparing frozen transplants and to compare the efficacy of previously frozen and fresh faeces in treating rCDI. METHODS: Two healthy volunteers acted as universal donors for the frozen faecal preparations, which were prepared by suspending faeces into physiological saline, adding glycerol to a final concentration of 10% and storing at -80 °C. We compared the outcomes of patients with rCDI who had undergone FMT at colonoscopy and received infusion of previously prepared, freeze-stored faeces (n = 23) or fresh faeces from individual (n = 15) or universal donors (n = 11) (total n = 49). Clinical failure was defined as persistent or recurrent symptoms with a positive C. difficile toxin stool test, and a need for new therapy. RESULTS: At 12 weeks post-FMT, symptoms were resolved in 22 of 23 patients receiving previously frozen faeces, and in all 11 or 14 of 15 patients receiving fresh faeces from the universal or individual donors respectively (totally 25 of 26; P = ns, success rate 96%). Mild transient fever appeared for two patients receiving frozen faeces, but no other significant side effects were observed. 42 patients were followed up for a year post-FMT and the success rate was 88% in both fresh and frozen faeces groups. CONCLUSIONS: Preparation of frozen transplants simplifies the practical aspects of faecal microbiota transplantation without loss of efficacy or safety.

Estudio primario

No clasificado

La comparación de Genomera C. difficile y Xpert C. difficile como pruebas confirmatorias en un algoritmo de múltiples etapas para el diagnóstico de la infección por Clostridium difficile.

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Revista Journal of clinical microbiology
Año 2015
Enlaces Pubmed DOI PubMed Central

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Se compararon dos algoritmos de diagnóstico de varios pasos basado en C. Difficile Quik Chek completa y, como pruebas confirmatorias, Genomera C. difficile y Xpert C. difficile. La sensibilidad, especificidad, valor predictivo positivo y valor predictivo negativo fueron 87,2%, 99,7%, 97,1% y 98,3%, respectivamente, para el algoritmo basado en Genomera y 89.7%, 99.4%, 95.5% y 98.6%, respectivamente , para el algoritmo basado en Xpert. Genomera representa una alternativa a la Xpert como prueba confirmatoria de un algoritmo de múltiples pasos para la infección por Clostridium difficile diagnóstico (CDI).