Comparison of the novel ARCHITECT procalcitonin assay with established procalcitonin assay systems.

AIMS: This study assessed the performance of a new fully automated immunoassay, ARCHITECT B.R.A.H.M.S procalcitonin (PCT), comparing the results with other commercial assays on routine clinical specimens. METHODS: At nine sites from eight countries, precision analysis was carried out on controls by ANOVA. Threshold and linearity were verified according to standard procedures. Comparison of ARCHITECT B.R.A.H.M.S PCT with the Cobas®, LIAISON®, VIDAS® and Kryptor® PCT assays was evaluated using Passing-Bablok and Deming regression analyses. RESULTS: The within-laboratory standard deviation and %CV across all sites ranged from 0.005 to 0.008 and 2.7 to 4.1; 0.040 to 0.212 and 2.1 to 11.7; 1.628 to 4.191 and 2.5-6.3 for the three control levels, respectively. The mean slope (linearity analysis) across all sites ranged from 0.85 to 1.03, with a mean y-intercept ranging from -6.15 to + 1.71 and a correlation coefficient ranging from 0.94 to 1.00. The LoB, LoD, and LoQ claims were verified. Deming regression analysis of 1116 plasma or serum samples with PCT results detected across a dynamic assay range of 0.02-100 µg/l using the ARCHITECT B.R.A.H.M.S PCT assay yielded results of r = 0.989 vs. Roche Cobas®, r = 0.986 vs Kryptor® B.R.A.H.M.S, r = 0.987 vs BioMèrieux VIDAS® and r = 0.972 vs. Diasorin LIAISON®, respectively. Concordance at cut-offs of 0.25 µg/l and 0.50 µg/l were 96.9% and 98.1% with Roche Cobas®, 95.4% and 96.1% with B.R.A.H.M.S Kryptor®, 93.8% and 98.4% with BioMèrieux VIDAS®, and 92.7% and 93.9% with Diasorin LIAISON®. CONCLUSIONS: Compared with other assays, ARCHITECT B.R.A.H.M.S PCT offers excellent precision and low-end sensitivity.

Percutaneous intramyocardial stem cell injection in patients with acute myocardial infarction: first-in-man study.

BACKGROUND: Clinical studies on intracoronary stem cell infusion in patients with acute myocardial infarction (AMI) have shown promising results for left ventricular ejection fraction (LVEF). However, preclinical studies have shown that intramyocardial cell injection is better than the intracoronary approach. OBJECTIVE: To test safety and feasibility of intramyocardial cell injection and left ventricular electromechanical mapping (EMM) early after AMI. DESIGN: On day 10.5 (5) (mean (SD)) after AMI and percutaneous coronary intervention with stent implantation (culprit lesion: 15 LAD, 3 circumflex and 2 right coronary arteries) 20 patients (mean (SD) 60.4 (11.4) years) received bone marrow derived mononuclear cells in the low-voltage area using EMM-guided percutaneous intramyocardial injection. EMM and coronary angiography were performed in 15 patients at 6-months' follow-up. Echocardiography, recording of laboratory data and clinical assessment (6-month and 12-month follow-up) were carried out in all 20 patients. RESULTS: None of the patients showed periprocedural complications. Three patients received an implantable cardioverter-defibrillator for primary prevention of sudden cardiac death and 6 (30%) patients showed in-stent restenosis. One patient underwent bypass surgery owing to chronic stent occlusion after 6 months. 2.0 (0.6)x10(8) cells, including 1.0 (0.3)x10(6) CD45(dim)/CD34(hi) stem cells, were injected in each patient. EMM showed a mean (SD) improvement from a baseline unipolar voltage of 45.5 (14.3)% to 59.3 (19.8)% of normal voltage (p = 0.002) and reduction of the low-voltage area from 28.7 (12.1)% to 20.3 (13.5)%; (p = 0.016). During the 12-month follow-up, the left ventricular ejection fraction (LVEF) improved from 40.8 (6.9)% to 47.1 (10.6)%; (p = 0.037). CONCLUSION: Left ventricular EMM and percutaneous intramyocardial cell injection in patients with AMI was shown to be a safe procedure. It is associated with improved LVEF and electromechanical parameters after 12-months' follow-up. TRIAL REGISTRATION NUMBER: Eudra-CT-No 2005-003629-19.

Identification of methicillin-resistant Staphylococcus aureus (MRSA): Comparison of a new molecular genetic test kit (GenoType MRSA) with standard diagnostic methods.

Results obtained from 188 isolates of staphylococci using standard diagnostic methods for identifying MRSA were compared with those achieved with a newly available molecular genetic test kit, the GenoType, Version 1, MRSA (Hain Lifescience GmbH, Nehren, Germany). The GenoType MRSA detects the mecA gene and, in addition, a highly specific sequence for Staphylococcus aureus (S. aureus) by polymerase chain reaction (PCR) and reverse hybridization. There was a 100% overall correlation between the results of conventional and molecular genetic testing. 143 isolates were tested positive for MRSA, 10 isolates were identified as oxacillin-sensitive Staphylococcus aureus strains (MSSA), and 35 isolates were coagulase-negative staphylococci of various species. However, five of the 143 MRSA strains yielded ambiguous results with the first line standard tests and therefore required additional testing leading to delay of definitive diagnosis. As expected, mecA could not only be detected in MRSA strains, but also in coagulase-negative staphylococci. The reliable identification as S. aureus from the same isolate is therefore an essential prerequisite for MRSA diagnosis. The GenoType MRSA fulfills this requirement by parallel detection of a S. aureus-specific sequence and the mecA gene. Molecular genetic testing with the GenoType MRSA kit needs much less time than conventional microbiological methods. Therefore genetic testing provides not only a considerable advantage with respect to reliability but also to speed.