Performance of cardiac troponins within the HEART score in predicting major adverse cardiac events at the emergency department.

BACKGROUND: This study compared the performance of a single blood draw of high-sensitivity troponin T (hsTnT), high-sensitivity troponin I (hsTnI) and conventional troponin I (cTnI) within a modified HEART score for predicting 30-day MACE at Emergency Department (ED) presentation, and established local reference norms for all three assays by determining the cut-off point which yielded the highest sensitivity and negative predictive value for acute myocardial infarction and 30-day MACE. METHODS: This single-center prospective cohort study recruited chest pain patients at the ED, whose hsTnT, hsTnI and cTnI were taken on admission. Subjects were classified into low and non-low risk group according to their modified HEART score, with MACE as the primary endpoint. Receiver-operating characteristic (ROC) curves were generated, area under the curves (AUCs) were calculated; the performance characteristics were determined. RESULTS: The performance of modified HEART scores was comparable among the three assays for 30-day MACE (84.9-87.0% sensitivity, 95.6-96.0% NPV, 95%CI) and none of these had very high AUC and specificity (AUC 0.70-0.71, 53.7-56.7% specificity, 95% CI). The modified HEART score using a single blood draw of either hsTnT (3.9ng/L), hsTnI (0.9ng/L) or cTnI (0.0ng/L) at presentation yielded a sensitivity of 100% for 30-day MACE. CONCLUSION: The modified HEART score using a single blood draw of either hsTnT, hsTnI or cTnI was equally effective in risk-stratifying chest pain patients for safe discharge. The theoretical cut-off points yielding 100% sensitivity are potentially useful (when achieved) for safely discharging low risk patients with undifferentiated chest pain in the ED.

Automation and productivity in the clinical laboratory: experience of a tertiary healthcare facility.

Clinical laboratories for in vitro diagnostics are facing pressure to preserve cost control while providing better services through new initiatives. Laboratory automation is a partial answer to this problem, having come a long way from the early days of clinical laboratory testing. The journey and implementation of automation in the Singapore General Hospital's Clinical Biochemistry Laboratory has allowed for sustained performance in the light of increasing workload and service commitments amid an evolving healthcare environment. Key to realising predicted outcomes is the optimisation of workflow processes, reduction of errors, and spatial placement of specimen reception and analytical areas. This paper gives an overview of our experience with automation in the clinical laboratory and its subsequent impact on service standards.

Thrombin-accelerated quick clotting serum tubes: an evaluation with 22 common biochemical analytes.

Clot activator serum tubes have significantly improved turnaround times for result reporting compared to plain tubes. With increasing workload and service performance expectations confronting clinical laboratories with high-volume testing and with particular emphasis on critical analytes, attention has focussed on preanalytical variables that can be improved. We carried out a field study on the test performance of BD vacutainer rapid serum tubes (RSTs) compared to current institutional issued BD vacutainer serum separator tubes (SSTs) in its test result comparability, clotting time, and stability on serum storage. Data from the study population (n = 160) of patients attending outpatient clinics and healthy subjects showed that results for renal, liver, lipids, cardiac, thyroid, and prostate biochemical markers were comparable between RSTs and SSTs. Clotting times of the RSTs were verified to be quick with a median time of 2.05 min. Analyte stability on serum storage at 4°C showed no statistically significant deterioration except for bicarbonate, electrolytes, and albumin over a period of 4 days. In conclusion, RSTs offered savings in the time required for the clotting process of serum specimens. This should translate to further trimming of the whole process from blood collection to result reporting without too much sacrifice on test accuracy and performance compared to the current widely used SSTs in most clinical laboratories.

Maltose interference-free test strips for blood glucose testing at point-of-care: a laboratory performance evaluation.

BACKGROUND: Maltose interference is a concern with blood glucose testing at point-of-care. We evaluated a maltose interference-free test strip (with a modified recombinant glucose dehydrogenase-pyrroloquinoline quinone system) for the Accu-Chek(®) Performa glucose meter (Roche Diagnostics, Mannheim, Germany). METHODS: Blood specimens (n = 120) sent for clinical laboratory glucose testing were used in assessing performance characteristics, including imprecision, linearity, clinical impact analysis, and method comparison, of the test strips. To evaluate sugar interference, two heparinized blood specimens were spiked with maltose, xylose, and galactose (up to 500 mg/dL) followed by testing with modified Performa, Accutrend(®) (Roche Diagnostics), and Advantage II (Roche Diagnostics) test strips and by the laboratory method. RESULTS: Test strips demonstrated total laboratory coefficients of variation of <7%; within-run coefficients of variation were 2.7-5.4% for blood glucose at 2.5-19.7 mmol/L. Clarke Error Grid analysis of the 120 results (0.8-27.6 mmol/L) showed all values to be within critical clinical limits. Comparison with laboratory results gave 0.960 correlation (Spearman's r(2)) with a Deming regression y (Performa) = 0.95x (laboratory) - 0.11 mmol/L (SEy|x0.06 mmol/L). A slight negative bias (-0.5 mmol/L) was demonstrated with the Bland-Altman difference plot. Maltose (up to 13.9 mmol/L) and xylose (33.3 mmol/L) had no effect, but galactose (2.2 mmol/L) showed interference. The sugars also affected test strips for Advantage II but not Accutrend glucose meters. With International Organization for Standardization ISO 15197:2003 criteria, 99% of the 120 results determined by the test strips were within the minimal acceptable performance; only one of 106 (5.9 mmol/L) was >20% from the laboratory result. CONCLUSIONS: The modified and improved Performa test strips were not affected by maltose and xylose. They meet ISO 15197:2003 requirements with a slight bias (-0.5 mmol/L) compared to the laboratory method.

Role of procalcitonin in infectious gastroenteritis and inflammatory bowel disease.

BACKGROUND AND AIM: We have evaluated procalcitonin (PCT) as a diagnostic marker for bacterial gastroenteritis (GE) and as a disease activity marker in inflammatory bowel disease (IBD) patients. METHODS: This was a prospective single-center study performed over a 1-year period. Venous blood samples were drawn from hospitalized patients with acute GE and tested for PCT, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and total white cell count (TWC); stools from the same patients were tested for standard pathogens. Venous blood samples from patients with IBD were tested for PCT, CRP, ESR, and platelet count. The PCT level was measured using an immunofluorescent assay, with normal being defined as <0.5 ng/ml. RESULTS: The GE arm of study consisted of 81 patients, 18.5% of whom were diagnosed with bacterial GE. The PCT and CRP levels were good diagnostic markers of bacterial GE, with an area under the curve (AUC) of 0.727 [95% confidence interval (CI) 0.580-0.874] and 0.786 (95% CI 0.627-0.946), respectively. An elevated PCT > or =0.5 ng/ml was associated with a 13-fold increased risk of renal impairment. The IBD arm of study consisted of 72 IBD patients. The PCT levels were not significantly different between active and inactive IBD in this patient cohort. CONCLUSION: Our results indicate that PCT and CRP are comparably good diagnostic markers of bacterial GE but that PCT is not useful as in monitoring disease activity in patients with IBD.

Evidence of autoantibodies to glutamic acid decarboxylase in oral fluid of type 1 diabetic patients.

Circulating antibodies to glutamic acid decarboxylase (GADab) are a major indicator for autoimmune destruction of pancreatic islet cells (type 1 diabetes). Previously reported detection of GADab in oral fluid, however, was assayed by enzyme-linked immunosorbent assay (ELISA) with low diagnostic sensitivity and high non-specific binding. We re-assessed oral fluid GADab detection using a different sampling technique and a more robust assay. Type 1 diabetic subjects (n = 32; mean age +/- SD: 13.9 +/- 3.7 years) provided Orasure oral fluid and venous blood samples. Orasure collections were assayed for total immunoglobulin G (IgG), then concentrated to 1/10 of their volume using mini-centrifugal protein concentrators. All samples were assayed by a GAD65 antibody radio-immunoprecipitation method. Oral fluid antibodies were detected ( > 99th percentile of radio-binding (%counts per min (%cpm)) for seronegatives) in 10/16 seropositive subjects, with %cpm (median: 6.4%; range: 4.6-25.8) significantly greater (P < 0.001) than for seronegatives (median: 4.7%; range: 3.4-5.7). A highly significant correlation (Spearman's rho: 0.85; P<0.001) was demonstrated between %cpm of concentrates and respective serum titres for seropositive diabetics. Median IgG concentration of Orasure collections was 22.8 mg/l (range: 9.4-168.0). GADab recovery from Orasure collectors was estimated at 90%. This is the first confirmatory detection of diabetes-specific autoimmune markers in oral fluid. Acceptable correlation between concentrated oral fluid radio-binding and serum titre was achieved. Improved antibody recovery and assay re-optimisation could provide a basis for more extensive studies that may lead to an alternative non-invasive screening method for pre-clinical autoimmune diabetes.