Volume 40, Issue 1

Hemostasis testing is conventionally referred to as performance of in vitro diagnostic tests for screening, diagnosis and therapeutic management of patients with either bleeding or thrombotic disorders. The ongoing revolution of diagnostic testing, squeezed between reduced funding and increasing volumes, carries notable implications in the way laboratory resources are organized and coagulation tests delivered. It is therefore predictable that the newer generation of hemostasis analyzers may be designed to face these emerging needs whilst maintaining a high degree in the quality of testing. In this opinion paper, we aim to discuss some concepts of redesigning coagulation analyzers in consideration of the most important aspects of the preanalytical, analytical and postanalytical phases in hemostasis testing.

Zusammenfassung: In dieser Übersicht werden Studien und evidenzbasierte Behandlungsempfehlungen zu Schilddrüsenerkrankungen zusammengefasst. Im Einzelnen handelt es sich um Diagnostik und Therapie des Morbus Basedow einschließlich der endokrinen Orbitopathie, die laborchemische und klinische Definition einer hypothyreoten Stoffwechsellage und Besonderheiten der Hypothyreosetherapie, sowie um Neuerungen zur Risikoeinschätzung bei Schilddrüsenknoten und zur Behandlung von Schilddrüsenkarzinomen.

Background: Screening for fetal trisomy 21 (T21) in the first trimester includes analysis of the serological markers pregnancy-associated plasma protein A (PAPP-A) and free β-choriogonadotropin (free βhCG). With the recent launch of these assays on the cobas e and Elecsys platforms, we investigated their clinical and analytical performance. Methods: We conducted a multicenter study in 5397 pregnancies including 108 cross-sectional collected repository cases with verified fetal T21 at 8–14 weeks of gestation. A technical validation of the Roche Elecsys ® free βhCG and PAPP-A assays were performed, including method comparisons with the Brahms Kryptor ® , PerkinElmer AutoDELFIA ® and Siemens IMMULITE ® assays. Furthermore a clinical validation including generation of assay specific medians from gestational age 8+0 to 14+0 weeks, and clinical test performance of risk assessment was performed. Results: The imprecision of the Elecsys free βhCG and PAPP-A assays was between 1.0% and 2.8%, and both assays showed correlation to Kryptor (free βhCG 0.981; PAPP-A 0.987), AutoDELFIA (free βhCG 0.995; PAPP-A 0.979) and IMMULITE assays (free βhCG 0.983; PAPP-A 0.983). With a cut off at 1:300 the overall sensitivity of the screening including nuchal translucency reached 94% for a 3% false positive rate. Conclusions: The Roche Elecsys free βhCG and PAPP-A are suitable and reliable assays for first trimester T21 risk assessment. Both assays were approved and recommended by the FMF.

Zusammenfassung Einleitung: Es werden pädiatrische Referenzintervalle zu eisenabhängigen Parametern kontinuierlich über das Alter unter Anwendung des, in der Laboratoriumsmedizin noch wenig bekannten, R-Pakets GAMLSS aus einer hoch standardisierten Probenpopulation ermittelt. Methoden: 2778 Blutproben von LIFE Child-Probanden im Alter von 2,5 bis 19 Jahren wurden mittels Sysmex XN-9000 für Hämoglobin und Retikulozyten, sowie mittels Roche cobas 8000 für Transferrin und Ferritin analysiert. Die Schätzung der Referenzintervalle erfolgte durch wiederholte Modellberechnungen unter Anwendung der LMS-Methode nach Cole mit spezifisch gewichteten Teilstichproben. Ergebnisse: Es wurden kontinuierliche und geschlechtsspezifische Referenzintervalle sowie geglättete Perzentilenkurven für Hämoglobin, Ferritin, Retikulozyten und Transferrin erstellt. Dabei konnten aufgrund der wiederholten Modellberechnungen Einzelkurven und durch Mittelung zusammengefasste Perzentilenkurven erstellt werden. Die Einzelkurven gaben einen Überblick über potentielle Schwankungen der einzelnen Parameterverläufe. Die gemittelten Kurven ermöglichten eine stabile Kurvenverlaufsbeurteilung der eisenabhängigen Parameter im Kindes- und Jugendalter. Schlussfolgerungen: Hiermit stehen erstmals mit dem GAMLSS-R-Paket und für die hier verwendeten Gerätetechniken eruierte aktuelle alters- und geschlechtsspezifische Referenzintervalle zur Verfügung. Verglichen zu bisherigen Studien können frühere Ergebnisse vervollständigt und Diskrepanzen, abhängig vom unterschiedlichen methodischen Vorgehen, verdeutlicht werden. Relevante Erkenntnisse für die Diagnostik der Eisenmangelanämie, wie eine geschlechtsabhängige Beurteilung des Hämoglobins ab dem 11. Lebensjahr statt wie bisher ab 15 Jahren (nach WHO), werden dargestellt.

Background: We investigated whether fetuin-A (a hepatic secretory protein that prevents arterial calcification) was related to revascularization in patients who had previously undergone coronary revascularization (percutaneous coronary intervention and/or coronary artery bypass grafting operation). Methods: This study included 71 patients who had previously undergone any revascularization procedure. All patients presented to the cardiology outpatient clinic with angina or angina equivalent and underwent coronary angiography upon findings of preliminary tests. The patients were grouped on the basis of the presence of restenosis on angiography: Group 1 consisted of 44 subjects with restenosis on angiography (30 male, 14 female; mean age 64.2±4.2 years) and group 2; 30 subjects without restenosis on angiography (20 male, 10 female; 61.2±13.1 years). In addition to routine biochemical tests and lipid panel, all patients underwent C-reactive protein, and fetuin-A measurements. Results: The groups were not significantly different with respect to age, sex, systolic and diastolic blood pressure. As compared to Group 2, Group 1 had a significantly lower fetuin-A level (383.8±76.2 vs. 416.3±49.3 ng/mL; p=0.029). There was a significantly negative correlation between fetuin-A and age; and a significantly positive correlation between fetuin-A and calcium. Conclusions: Fetuin-A levels were significantly lower in patients detected to have restenosis. Lower fetuin-A levels may contribute to restenosis by directly increasing calcium-phosphate precipitation.

Background: Hemolytic specimens are among the most challenging preanalytical issues in laboratory diagnostics. The type of blood collection tube in use is claimed to influence in vitro hemolysis. We aimed to examine this hypothesis and estimate the respective financial impact, evaluating routine blood samples from the past 4 years. Methods: A total of 47,820 hemolysis index (HI) values from five different time intervals (IV1–IV5) were compared against each other, representing the following tubes: IV1-Sarstedt Monovette; IV2-8 mL/16×100 mm Greiner BioOne (GBO) Vacuette; IV3/IV4-5 mL/16×100 mm GBO Vacuette; IV5-4.5 mL/13×75 mm GBO Vacuette. For estimation of the economic impact, material, personnel and analytical costs were calculated. Results: HI mean values in time interval IV2 were significantly higher than in all other intervals, while mean values amongst all other intervals were comparable. The number of moderately and severely hemolyzed samples increased with incrementing vacuum. Overall comparable costs between intervals IV1 and IV5 were €11,370, €14,045, €12,710, €11,213 and €8138 per 10,000 samples, respectively. Conclusions: Aspiration tubes and low vacuum tubes show comparable hemolysis rates. Increasing vacuum levels are associated with higher hemolysis rates. By decreasing in vitro hemolysis, financial savings up to €5907 per 10,000 samples could be gained.