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Augsburg, Germany

von Eckardstein A.,Universitatsspital Zurich | Roth H.J.,Labor Dr Limbach und Kollegen | Jones G.,St Vincents Public Hospital | Preston S.,Huntsville Hospital | And 15 more authors.
Journal of Laboratory Automation

Clinical laboratories need to test patient samples precisely, accurately, and efficiently. The latest member of the Roche cobas modular platform family, the cobas 8000 modular analyzer series allows compact and convenient consolidation of clinical chemistry and immunochemistry assays in high-workload laboratories with a throughput of 3 to 15 million tests annually. Here we present the results of studies designed to test the overall system performance under routine-like conditions that were conducted at 14 laboratories over 2 y. Experiments that test analytical performance of the new module were integrated with overall system functionality testing of all modules in different configurations. More than two million results were generated and evaluated for ~100 applications using serum/plasma, urine, or EDTA blood samples. During the workflow studies, eight configurations of the possible 38 combinations were used, covering all available analytical modules. The versatility of the module combinations makes the system customizable to fit the needs of diverse laboratories, allowing precise and accurate analysis of a broad spectrum of clinical chemistry and immunochemistry parameters with short turnaround times. This new system will contribute to the ability of clinical laboratories to offer better service to their customers and support vital clinical decision making. © 2013 Society for Laboratory Automation and Screening. Source

Surucu G.,Charite - Medical University of Berlin | Mayer B.,Charite - Medical University of Berlin | Marzacker A.,Labor Schottdorf MVZ GmbH | Yurek S.,Charite - Medical University of Berlin | Salama A.,Charite - Medical University of Berlin
Transfusion Medicine and Hemotherapy

Background: There is little information concerning the development and significance of autoantibodies (aab) to red blood cells (RBCs) during pregnancy. Methods: Unselected pregnant women were routinely screened for the presence of unexpected antibodies to RBCs using standard techniques. Results: Between 2009 and 2013, 153,612 pregnant women were tested. The antibody screening test was positive in 1,721 women (1.12%). In 1,602 (1.04%) cases, immune and/or non-immune alloantibodies and cold-reactive aab were detected, whereas warm-reactive aab were found in 119 women (0.08%). In almost all cases, warm-reactive aab belonged to the IgG class. No evidence of the presence of significant haemolysis in affected women was observed. Conclusion: Pregnant women may rarely develop aab to RBCs, which do not appear to cause haemolytic anaemia. Further clarification is required on the reasons behind the development of these aab and their clinical insignificance. © 2015 S. Karger GmbH, Freiburg. Source

Enders M.,Infectious Diseases and Epidemiology e.V. | Hunjet A.,Infectious Diseases and Epidemiology e.V. | Gleich M.,Labor Schottdorf MVZ GmbH | Imdahl R.,Labor Schottdorf MVZ GmbH | And 12 more authors.
Clinical and Vaccine Immunology

Syphilis is a health problem of increasing incidence in recent years that may have severe complications if not diagnosed and treated at an early stage. There are many diagnostic tests available for syphilis, but there is no gold standard, and diagnosis therefore usually relies upon a combination of tests. In this multicenter study, we evaluated the treponemal Elecsys syphilis assay for use in the diagnosis of syphilis in routine samples, i.e., when syphilis is suspected or during antenatal or blood donation screening. The sensitivity and specificity of the Elecsys syphilis assay were compared head to head with those of other treponemal assays used in routine clinical practice and were assessed in potentially cross-reactive samples from patients with Epstein-Barr virus, HIV, and Lyme disease. In a total of 8,063 syphilis-negative samples collected from routine diagnostic requests and blood donations, the Elecsys syphilis assay had a specificity of 99.88%. In 928 samples previously identified as syphilis positive, the sensitivity was 99.57 to 100% (the result is presented as a range depending on whether four initially indeterminate samples are included in the assessment). The specificity of the Elecsys syphilis assay in patients with other infections was 100%; no false-positive samples were identified. © 2015, American Society for Microbiology. All Rights Reserved. Source

Wolters M.,University of Hamburg | Boyle E.C.,University of Hamburg | Lardong K.,University of Hamburg | Trulzsch K.,Max Von Pettenkofer Institute | And 5 more authors.
Journal of Biological Chemistry

Background: Pathogenic yersiniae translocate effectors into host cells to interfere with the immune defense. Results: Yersinia exotoxin CNF-Y enhances effector translocation by activating the GTP-binding protein Rac. Conclusion: A crucial role of Rac in translocation control and a potential virulence function of CNF-Y is revealed. Significance: Understanding the cross-talk between bacterial and host cell mechanisms in regulation of effector translocation. © 2013 by The American Society for Biochemistry and Molecular Biology, Inc. Source

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