Clinical performance of a new point-of-care cardiac troponin I test.

BACKGROUND: We evaluated the clinical performance of the Minicare cardiac troponin-I (cTnI), a new point-of-care (POC) cTnI test for the diagnosis of acute myocardial infarction (AMI) in a prospective, multicentre study (ISRCTN77371338). METHODS: Of 474 patients (≥18 years) admitted to an emergency department (ED) or chest pain unit (CPU) with symptoms suggestive of acute coronary syndrome (ACS; ≤12 h from symptom onset), 465 were eligible. Minicare cTnI was tested immediately, 3 h and 6 h after presentation. AMI diagnoses were adjudicated independently based on current guidelines. RESULTS: The diagnostic performance of the Minicare cTnI test at 3 h was similar for whole blood and in plasma: sensitivity 0.92 vs. 0.90; specificity 0.91 vs. 0.90; positive predictive value (PPV) 0.68 vs. 0.66; negative predictive value (NPV) 0.98 vs. 0.98; positive likelihood ratio (LR+) 10.18 vs. 9.41; negative likelihood ratio (LR-) 0.09 vs. 0.11. The optimal diagnostic performance was obtained at 3 h using cut-offs cTnI >43 ng/L plus cTnI change from admission ≥18.5 ng/L: sensitivity 0.90, specificity 0.96, PPV 0.81, NPV 0.98, and LR+ 21.54. The area under the receiver operating characteristics (ROC) curve for cTnI whole blood baseline value and absolute change after 3 h curve was 0.93. CONCLUSIONS: These data support the clinical usefulness of Minicare cTnI within a 0 h/3 h-blood sampling protocol supported by current guidelines for the evaluation of suspected ACS.

Equal clinical performance of a novel point-of-care cardiac troponin I (cTnI) assay with a commonly used high-sensitivity cTnI assay.

BACKGROUND: Efficient rule-out of acute myocardial infarction (MI) facilitates early disposition of chest pain patients in emergency departments (ED). Point-of-care (POC) cardiac troponin (cTn) may improve patient throughput. We compared the diagnostic accuracy of a novel cTnI test (Minicare cTnI, Philips), with current POC cTnI (I-Stat, Abbott) and high-sensitivity central laboratory cTnI (hs-cTnI; Architect, Abbott) assays. METHODS: The clinical performance of the assays were compared in samples from 450 patients from a previous clinical evaluation of Minicare cTnI. RESULTS: Minicare cTnI correlated with Architect hs-cTnI (r2=0.85, p<0.0001) and I-Stat cTnI (r2=0.93, p<0.0001). Areas under the receiver operating characteristics curves were 0.87-0.91 at admission (p=ns) and 0.96-0.97 3h after admission (p=ns). The negative predictive values (NPV) at admission were 95% ((92-97%, 95% CI) for Minicare cTnI and increased to 99% (97-100%) at 2-4h, and similar to Architect hs-cTnI (98%, 96-100%), but higher than I-Stat cTnI (95%, 92-97%; p<0.01). Negative likelihood ratios (LR-) after 2-4h were 0.06 (0.02-0.17, 95% CI) for Minicare cTnI, 0.11 (0.05-0.24) for Architect hs-cTnI (p=0.02) and 0.28 (0.18-0.43) for I-Stat cTnI (p<0.0001). The clinical concordances between Minicare cTnI and Architect hs-cTnI were 92% (admission) and 95% (2-4h), with lower concordances between Minicare cTnI and I-Stat cTnI (83% and 78%, respectively; p=0.007). CONCLUSIONS: The Minicare cTnI POC assay may become useful for prompt and safe ruling-out of AMI in ED patients with suspected AMI using a guideline supported 0/3h sampling protocol.

Analytical evaluation of a new point of care system for measuring cardiac Troponin I.

OBJECTIVES: Point-of-care cardiac troponin testing with adequate analytical performances has the potential to improve chest pain patients flow in the emergency department. We present the analytical evaluation of the newly developed Philips Minicare cTnI point-of-care immunoassay. DESIGN & METHODS: Li-heparin whole blood and plasma were used to perform analytical studies. The sample type comparison study was performed at 4 different hospitals. The 99th percentile upper reference limit (URL) study was performed using Li-heparin plasma, Li-heparin whole blood and capillary blood samples from 750 healthy adults, aging from 18 to 86years. RESULTS: Limit of the blank, limit of detection and limit of quantitation at 20% coefficient of variation (CV) were determined to be 8.5ng/L, 18ng/L and 38ng/L respectively without significant differences between whole blood and plasma for LoQ. Cross-reactivity and interferences were minimal and no high-dose hook was observed. Total CV was found to be from 7.3% to 12% for cTnI concentrations between 109.6 and 6135.4ng/L. CV at the 99th percentile URL was 18.6%. The sample type comparison study between capillary blood, Li-heparin whole blood and Li-heparin plasma samples demonstrated correlation coefficients between 0.99 and 1.00 with slopes between 1.03 and 1.08. The method comparison between Minicare cTnI and Beckman Coulter Access, AccuTnI+3 demonstrated a correlation coefficient of 0.973 with a slope of 1.09. The 99th percentile URL of a healthy population was calculated to be 43ng/L with no significant difference between genders or sample types. CONCLUSIONS: The Minicare cTnI assay is a sensitive and precise, clinical usable test for determination of cTnI concentration that can be used in a near-patient setting as an aid in the diagnosis of acute myocardial infarction.

[Sepsis in Emergency Medicine]. / Diagnostik und Management der Sepsis außerhalb der Intensivstation.

Sepsis is defined as "life-threatening organ dysfunction caused by a dysregulated host-response to infection". Presence of organ dysfunction is associated with a mortality of 10% and higher in hospitalized sepsis patients.Introduction of standards in diagnosis and treatment of sepsis in intensive care units has not considerably reduced sepsis mortality. About 80% of patients with sepsis are transferred to intensive care units from usual care wards and emergency departments. Thus, it is tempting to speculate whether opportunities for further improvement of sepsis management exist outside of intensive care units. Performing a "quick sequential organ assessment" (qSOFA; two of following criteria have to be present: respiratory rate >22/min; sytolic blood pressure <100mmHg; altered mental status) supports to identify patients with suspicion of an infection and an increased risk of death within the hospital. Subsequent treatment according to current guidelines on sepsis management will reduce in-hospital mortality of sepsis patients. Indeed, we were able to show a substantial decrease of in-hospital mortality of about 20% in patients presenting with community acquired pneumonia to the emergency department.In summary, decision of further management of sepsis patients has to be done outside intensive care units at the time of initial presentation to professional care givers. Sepsis management in acute care settings should include a structured and standardized protocol to further improve survival in affected patients with even mild organ dysfunction.

Diagnostic and prognostic value of high-sensitivity cardiac troponin T in patients with syncope.

OBJECTIVE: We examined the diagnostic and predictive value of high-sensitivity cardiac troponin T (cTnThs) in patients with syncope. METHODS: We performed an analysis of consecutive patients with syncope presenting to the emergency department. The primary end point was the accuracy to diagnose a cardiac syncope. In addition, the study explored the prognostic relevance of cTnThs in patients with cardiac and noncardiac syncope. RESULTS: A total of 360 patients were enrolled (median age, 70.5 years; male, 55.8%; 23.9% aged >80 years). Cardiac syncope was present in 22% of patients, reflex syncope was present in 40% of patients, syncope due to orthostatic hypotension was present in 20% of patients, and unexplained syncope was present in 17.5% of patients. A total of 148 patients (41%) had cTnThs levels above the 99% confidence interval (CI) (cutoff point). The diagnostic accuracy for cTnThs levels to determine the diagnosis of cardiac syncope was quantified by the area under the curve (0.77; CI, 0.72-0.83; P < .001). A comparable area under the curve (0.78; CI, 0.73-0.83; P < .001) was obtained for the predictive value of cTnThs levels within 30 days: Patients with increased cTnThs levels had a 52% likelihood for adverse events, patients with cTnThs levels below the cutoff point had a low risk (negative predictive value, 83.5%). Increased cTnThs levels indicate adverse prognosis in patients with noncardiac causes of syncope, but not in patients with cardiac syncope being a risk factor for adverse outcome by itself. CONCLUSIONS: Patients with syncope presenting to the emergency department have a high proportion of life-threatening conditions. cTnThs levels show a limited diagnostic and predictive accuracy for the identification of patients with syncope at high risk.

The prevalence and prognostic significance of near syncope and syncope: a prospective study of 395 cases in an emergency department (the SPEED study).

BACKGROUND: The prognostic significance of near-syncope has not yet been adequately characterized. METHOD: We collected prospective data on a consecutive series of patients seen in an emergency department with syncope (brief loss of consciousness, usually with loss of muscle tone) or near-syncope (a feeling that syncope is about to occur, but without actual loss of consciousness or muscle tone). We report on the prevalence, etiology, and prognosis of such events (the SPEED study). Patients were followed up at 30 days and at 6 months after the event. RESULTS: From 17 July to 31 October 2011, 395 patients were seen in the emergency department for a chief complaint of syncope or near-syncope (3% of all emergency patients). Their median age was 70 years, and 55% were men. 62% had experienced syncope, and 38% near-syncope. The patients with near-syncope were younger than those with syncope ( 63 vs. 72 years, p < 0.014) and were also more commonly male (63% vs. 49%, p = 0.006). The two patient groups did not differ significantly with respect to their measured laboratory values and vital parameters or their accompanying medical conditions. Hospitalizations were more common for syncope than for near-syncope (86% vs. 70%, p < 0.001). Etiologies were similarly distributed in the two patient groups, with the main ones being reflex syncope, orthostatic syncope, cardiac syncope, and syncope of uncertain origin. In all, 123 of 379 patients (32%) had further undesired events within 30 days of the event. Multivariable logistic regression revealed that age, heart rate, and renal dysfunction were independent predictors of undesired events, while the type of syncope was not. CONCLUSION: Patients with near-syncope do not differ to any large extent from patients with syncope with respect to the features studied. The diagnostic evaluation should be similar for patients in the two groups.

Severity illness scoring systems for early identification and prediction of in-hospital mortality in patients with suspected sepsis presenting to the emergency department.

The in-hospital mortality of patients with severe sepsis and septic shock (SSSS) is high. In this study we examined the diagnostic and prognostic accuracy of the emergency severity index (ESI), the modified early warning score (MEWS), and the mortality in emergency department (ED) sepsis (MEDS) score. This is a single-centre, prospective and observational study of 151 consecutive patients presenting to the ED of the Nuremberg Hospital with suspected sepsis (age 68.3 ± 18 years, 54.3 % men, 45 % with SSSS, in-hospital mortality of SSSS: 27.8 %). In this study, 37.7 % of the studied patients had a urinary tract infection (n = 57/151), 33.8 % a pneumonia (n = 51/151), 8.6 % an acute abdominal infection (n = 13/151), and in 12.6 % the focus of infection was not further specified or identifiable (n = 19/151). The diagnostic and prognostic accuracy was analyzed by means of the receiver operating characteristic (ROC) curve. The areas under curve (AUC) in terms of diagnostic accuracy were 0.609, 0.641, and 0.778 for the ESI, MEWS, and MEDS score respectively. The AUCs concerning prognostic accuracy were 0.617, 0.642, and 0.871 for ESI, MEWS, and MEDS score respectively.By using the MEDS score systematically, critically ill patients with sepsis could be detected in the ED. Finally, the MEDS score provides the basis for a risk adjusted disposition management that follows objective criteria.