Clostridioides difficile in Outpatients: Application of a Diagnostic Algorithm Recommended by the European Society of Clinical Microbiology and Infectious Diseases.

This study aimed at evaluating in outpatients an algorithm for the laboratory diagnosis of Clostridioides (Clostridium) difficile infection (CDI), i.e., enzyme immunoassays (EIAs) detecting bacterial glutamate dehydrogenase (GDH) and toxin A/B, followed by polymerase chain reaction (PCR) analyses of samples with discordant EIA results. In total, 9802 examinations of stool samples by GDH and toxin EIAs performed in 7263 outpatients and 488 inpatients were analyzed retrospectively. Samples with discordant EIA results had been tested by a commercially available PCR assay detecting genes of the C. difficile-specific triose phosphate isomerase (tpi) and toxin B (tcdB). Concordant EIA results (686 C. difficile-positive, 8121 negative) were observed for 8807 (89.8%; 95% CI, 89.2-90.4%) samples. Of 958 samples with discordant EIA results, 895 were analyzed using PCR and 580 of 854 GDH-positive/borderline, toxin-negative samples (67.9%; 95% CI, 64.7-71.0%) were positive for tpi and tcdB, while 274 samples (32.1%; 95% CI, 29.0-35.3%) were tcdB-negative. In contrast, 35 of 41 GDH-negative, toxin-positive/borderline samples (85.4%; 95% CI, 71.2-93.5%) were tcdB-negative. Still, 6 samples (14.6%; 95% CI, 6.5-28.8%) yielded positive PCR results for both genes. In conclusion, around 90% of the samples were analyzed appropriately by only applying EIAs. Approximately one third of the PCR-analyzed samples were tcdB-negative; thus, patients most likely did not require CDI treatment.

Accurate Detection of Helicobacter pylori Antigen in Human Stool Specimens by Two Novel Immunoassays.

Stool antigen tests are recommended for the diagnosis of Helicobacter pylori infection. Here, we compared two novel assays, i.e., one enzyme immunoassay (EIA) and one immunochromatography assay (ICA), with a chemiluminescence immunoassay (CLIA) that had previously been compared with rapid urease test, histology, and urea breath test. Two hundred sixty-six frozen stool samples with defined CLIA results (42 positives, 219 negatives, and 5 samples with borderline results) collected between January and May 2018 were thawed and immediately tested by EIA, ICA, and CLIA. In 248 samples with repeatedly positive/negative CLIA results, EIA and ICA were positive for 40 and 37 of 41 CLIA-positive samples and yielded negative results for 206 and 201 of 207 CLIA-negative samples, respectively. There was a high positive percent agreement (EIA, 97.6%; 95% confidence interval (95% CI), 86.3-100%; ICA, 90.2%; 95% CI, 76.9-96.7%), as well as a negative percent agreement between the assays (EIA, 99.5%; 95% CI, 97.0-100%; ICA, 97.1%; 95% CI, 93.7-98.8%). This was further supported by kappa values indicating very good agreement (CLIA vs. EIA, 0.971; CLIA vs. ICA, 0.857). In conclusion, both EIA and ICA comprise valuable assays for the detection of H. pylori antigen in stool samples.

Detection of Enterobius vermicularis in greater Berlin, 2007-2017: seasonality and increased frequency of detection.

The pinworm (Enterobius vermicularis) causes mostly mild infections characterised by nocturnal anal pruritus, mainly in children. Still, the infection is stigmatising and sleep disturbances may lead to lack of concentration. For Germany, no epidemiological data are available. Laboratory data of all patients for whom detection of E. vermicularis by cellulose tape test had been requested between 2007 and November 2017 were analysed retrospectively. E. vermicularis was detected in 971/5578 (17.4%) samples collected from 3991 patients. The detection rate increased significantly within the period of investigation. It was higher in male than in female patients (20.0 vs. 15.4%). Children 4 to 10 years old and, if also examined, their relatives were most frequently affected. Control investigations at an interval of at least 1 month, which could indicate insufficient therapy or re-infection, were performed in 90/714 patients (12.6%). While parasite detection in children < 6 years was evenly distributed throughout the year, in older patients, it peaked between October and December. In conclusion, in the area of investigation, the frequency of E. vermicularis is higher in males than in females and is subject to a hitherto undescribed seasonality. The causes of the increased frequency of parasite detection warrant further investigations.

Multicenter Evaluation of Two Next-Generation HIV-1 Quantitation Assays, Aptima Quant Dx and Cobas 6800, in Comparison to the RealTime HIV-1 Reference Assay.

High accuracy and precision at the lower end of quantification are crucial requirements of a modern HIV viral load (VL) assay, since some clinically relevant thresholds are located at 50 and 200 copies/ml. In this study, we compared the performance of two new fully automated HIV-1 VL assays, Aptima HIV-1 Quant Dx and Cobas HIV-1 (Cobas 6800), with the established RealTime m2000 assay. Assay precision and accuracy were evaluated in a retrospective evaluation out of excess plasma material from four HIV-1+ individuals (subtypes B, C, CRF01_AE, and CRF02_AG). Native plasma samples were diluted to nominal concentrations at 50 and 200 copies/ml (according to the RealTime m2000 assay). All dilutions were tested in triplicate in five independent runs over 5 days and in three labs per system. Assay concordance was determined using 1,011 surplus clinical routine samples, as well as selected retrospective longitudinal samples from 7 patients on treatment. The three assays yielded highly concordant results for individual clinical samples (R2 > 0.98; average difference, ≤0.2 log copies/ml) and retrospective longitudinal samples from patients on treatment. The Aptima and RealTime assays showed similar high precision, meeting the 5σ criterion for the majority of samples across all labs and subtypes. The Cobas assay was less precise, missing the 5σ criterion for the majority of samples at low concentrations. In this analysis, results from the Cobas assay appeared less reliable near the clinically relevant cutoff and should be interpreted with more caution in this context. Due to high precision, full automation, and high concordance with the RealTime assay, the Aptima assay represents a good alternative in routine VL monitoring.

Gender differences in patients with cardiogenic shock complicating myocardial infarction: a substudy of the IABP-SHOCK II-trial.

BACKGROUND: Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) is associated with high mortality. Previous studies regarding gender-specific differences in CS are conflicting and there are insufficient data for the presence of gender-associated differences in the contemporary percutaneous coronary intervention era. Aim of this study was therefore to investigate gender-specific differences in a large cohort of AMI patients with CS undergoing contemporary treatment. METHODS: In the randomized Intra-aortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial, 600 patients with CS complicating AMI undergoing early revascularization were assigned to therapy with or without intra-aortic balloon pump. We compared sex-specific differences in these patients with regard to baseline and procedural characteristics as well as short- and long-term clinical outcome. RESULTS: Of 600 patients 187 (31%) were female. Women were significantly older than men and had a significantly lower systolic and diastolic blood pressure at presentation (p < 0.05 for all). Diabetes mellitus and hypertension were more frequent in women, whereas smoking was more frequent in men (p < 0.05 for all). Women showed a higher mortality within the first day after randomization (p = 0.004). However, after multivariable adjustment this numerical difference was no longer statistically significant. No gender-related differences in clinical outcome were observed after 1, 6 and 12 months of follow-up. CONCLUSION: In this large-scale multicenter study in patients with CS complicating AMI, women had a worse-risk profile in comparison to men. No significant gender-related differences in treatment as well as short- and long-term outcome were observed.

Intraaortic balloon support for myocardial infarction with cardiogenic shock.

BACKGROUND: In current international guidelines, intraaortic balloon counterpulsation is considered to be a class I treatment for cardiogenic shock complicating acute myocardial infarction. However, evidence is based mainly on registry data, and there is a paucity of randomized clinical trials. METHODS: In this randomized, prospective, open-label, multicenter trial, we randomly assigned 600 patients with cardiogenic shock complicating acute myocardial infarction to intraaortic balloon counterpulsation (IABP group, 301 patients) or no intraaortic balloon counterpulsation (control group, 299 patients). All patients were expected to undergo early revascularization (by means of percutaneous coronary intervention or bypass surgery) and to receive the best available medical therapy. The primary efficacy end point was 30-day all-cause mortality. Safety assessments included major bleeding, peripheral ischemic complications, sepsis, and stroke. RESULTS: A total of 300 patients in the IABP group and 298 in the control group were included in the analysis of the primary end point. At 30 days, 119 patients in the IABP group (39.7%) and 123 patients in the control group (41.3%) had died (relative risk with IABP, 0.96; 95% confidence interval, 0.79 to 1.17; P=0.69). There were no significant differences in secondary end points or in process-of-care measures, including the time to hemodynamic stabilization, the length of stay in the intensive care unit, serum lactate levels, the dose and duration of catecholamine therapy, and renal function. The IABP group and the control group did not differ significantly with respect to the rates of major bleeding (3.3% and 4.4%, respectively; P=0.51), peripheral ischemic complications (4.3% and 3.4%, P=0.53), sepsis (15.7% and 20.5%, P=0.15), and stroke (0.7% and 1.7%, P=0.28). CONCLUSIONS: The use of intraaortic balloon counterpulsation did not significantly reduce 30-day mortality in patients with cardiogenic shock complicating acute myocardial infarction for whom an early revascularization strategy was planned. (Funded by the German Research Foundation and others; IABP-SHOCK II ClinicalTrials.gov number, NCT00491036.).

Incidence and predictors of ventricular arrhythmias after ST-segment elevation myocardial infarction.

BACKGROUND: Sustained ventricular arrhythmias (VA) complicate 7% to 20% of acute myocardial infarctions. We hypothesized that primary angioplasty (percutaneous coronary intervention [PCI]) and contemporary medical treatment will result in a lower incidence of VA and shorten the time frame of their occurrence. Thus, an electrocardiographic monitoring period of 24 hours should be sufficient to detect more than 95% of all malignant VA. METHODS: We continuously monitored all patients with ST-segment elevation myocardial infarction (STEMI) for 48 hours. RESULTS: Of the 510 patients who underwent PCI for STEMI, 24 (4.7%) developed sustained VA. Sixty percent of sustained VA occurred during the first 24 hours; and 92%, during the first 48 hours. In univariate analysis, heart rate greater than 100 beats per minute, Thrombolysis in Myocardial Infarction flow grade less than 3, elevated creatinine (≥1 mg/dL), elevated C-reactive protein (≥0.8 mg/dL), higher white blood cell count (≥12 × 10(3)/µL), use of diuretics, and lower hematocrit (≤39%) were associated with an increased risk of VA. Symptom-onset-to-balloon time of 4 hours or more in patients with postprocedural Thrombolysis in Myocardial Infarction 3 flow, treatment with ß-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and statins were associated with a reduced risk of VA. After multivariate adjustment, independent predictors of sustained VA included total white blood cell count of 12 × 10(3)/µL or more, hematocrit of 39% or less, and lack of ß-blocker medication. CONCLUSIONS: In this study, we could demonstrate that primary PCI results in a lower incidence of VA compared with data from the literature but did not shorten the time frame of VA occurrence. Thus, an electrocardiographic monitoring period for VA of 48 hours should be performed in patients with STEMI.

Prevalence and spectrum of coronary artery anomalies in patients with an isolated congenital left ventricular aneurysm or diverticulum.

BACKGROUND: Congenital left ventricular aneurysm (LVA) and diverticulum (LVD) are rare cardiac anomalies and frequently associated with other cardiac anomalies. The objective of our study was to investigate the prevalence and the spectrum of coronary anomalies in such patients. HYPOTHESIS: The incidence of coronary anomalies is increased in patients with LVA or LVD. METHODS: We assessed 117 patients with isolated LVA or LVD for the prevalence of coronary anomalies and compared the findings with an age- and sex-matched control group (n = 117) without the diagnosis of LVA or LVD. RESULTS: Coronary anomalies were present in 58.1% of the study population (68 of 117). The median age of affected patients was 64 years, and 45 (38.5%) were male. Coronary anomalies were more prevalent in patients with LVA or LVD (58.1% vs 6.8%, P < 0.001), male patients (89% vs 57%, P = 0.0002), and in patients with nonapical location of LVA or LVD (24% vs 45%, P = 0.02) compared with control, whereas age and type (LVA vs LVD) had no influence (57% vs 57.6%, P = 0.4; and 58.8% vs 57.6%, P = 0.87, respectively). The number of adverse cardiac events was similar in both groups during a 4.2-year follow-up period (29% vs 19%, P = 0.09). None of the patients in our series had major coronary anomalies with potential lethal consequences. CONCLUSIONS: This large single-center study suggests that the prevalence of abnormal coronary-artery anatomy in patients with isolated LVA or LVD is as high as 58.1%. However, we did not identify major coronary anomalies with potential lethal consequences, and the clinical course during follow-up was not influenced by the presence or absence of coronary anomalies.