Central Haematology Laboratory

Luzern, Switzerland

Central Haematology Laboratory

Luzern, Switzerland
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Fontana P.,University of Geneva | Alberio L.,University of Lausanne | Angelillo-Scherrer A.,University of Bern | Asmis L.M.,Unilabs Zurich | And 9 more authors.
Thrombosis Research | Year: 2017

Background Point-of-care testing (POCT) is regularly used to assess haemostasis in various clinical settings. The impact of rivaroxaban on those POCT is still elusive. We aimed to study the effects of rivaroxaban on most commonly used POCT assays. Methods Blood samples were taken before, 3 h, and 24 h after administration of 20 mg rivaroxaban to 20 healthy volunteers as part of a prospective, multicenter validation study (clinicaltrials.gov NCT01710267). Blood samples were analysed with thromboelastometry (ROTEM®), two platelet function assays (INNOVANCE® PFA-200 and Multiplate®), and the CoaguChek® XS. Rivaroxaban plasma levels were determined using liquid chromatography-mass spectrometry. Results Rivaroxaban significantly modified some thromboelastometry parameters (CT INTEM: mean difference 56.1 s, 95% CI: 41.8, 70.3; CT EXTEM: 47.5 s, 95% CI: 37.8, 57.1; CT HEPTEM: 50.1 s, 95% CI: 34.7, 65.6), and CoaguChek® XS parameters (prothrombin time: mean difference 3.8 s, 95% CI: 3.3, 4.2; INR: 0.32, 95% CI: 0.27, 0.38; prothrombin ratio: − 36.1%, 95% CI: − 32.3, − 39.9). CT EXTEM and INR showed a moderate correlation with rivaroxaban plasma levels (r = 0.83; 95% CI 0.69, 0.9 and r = 0.83; 95% CI 0.70, 0.91, respectively) and a high sensitivity to detect rivaroxaban treatment at peak levels (0.95; 95% CI: 0.76, 1.0 and 0.90, 95% CI 0.70, 0.99, respectively). Conclusions Rivaroxaban 20 mg treatment significantly alters ROTEM® and CoaguChek® XS parameters. Even though POCT do not allow precise quantification of rivaroxaban plasma concentration, CT EXTEM and CoaguChek XS detect the presence of rivaroxaban at peak level with a high sensitivity. © 2017 Elsevier Ltd

Bankova A.,Central Haematology Laboratory | Andres Y.,Kreisspital fur das Freiamt | Horn M.P.,University of Bern | Alberio L.,University of Lausanne | Nagler M.,University of Bern
PLoS ONE | Year: 2017

Background: Immunoassays are crucial in the work-up of patients with suspected heparin-induced thrombocytopenia (HIT) and rapid tests have been recently developed. However, comparative data on diagnostic accuracy, reproducibility, and analytical costs of different immunoassays in clinical practice are limited. Methods: Samples of 179 consecutive patients evaluated for suspected HIT in clinical practice using a polyspecific enzyme-linked immunoabsorbent assay (GTI diagnostics; ELISA) and a rapid particle gel immunoassay (PaGIA), were additionally analysed with a IgG-specific chemiluminescent immunoassay (AcuStar HIT-IgG). Presence of HIT was defined as a positive functional heparin-induced platelet aggregation test. Diagnostic accuracy was determined for low, intermediate and high thresholds as previously established (ELISA: optical density 0.4, 1.3, and 2.0 respectively; PaGIA: positive/negative, titre of 4, titre of 32; AcuStar HIT-IgG: 1.0 U/ml, 2.8, 9.4) and reproducibility was assessed by repeated measurements. Costs of test determination were calculated taking reagents, controls, and working time of technicians according to Swiss health care system into account. Results: Data on PaGIA results were available for 171 patients (95.5%), ELISA for 144 patients (80.4%), and AcuStar HIT-IgG for 179 patients (100%). Sensitivity was above 95% for all assays at low and intermediate thresholds. Specificity increased with higher thresholds and was above 90% for all assays with intermediate and high thresholds. Specificity of AcuStar HIT-IgG (92.8%; 95% CI 87.7, 96.2) was significantly higher than PaGIA (83.0%; 95% CI 76.3, 88.5) and higher than ELISA (81.8%, 95% CI 74.2, 88.0) at low threshold (p<0.05). Reproducibility was adequate for all assays. Total costs per test were CHF 51.02 for ELISA, 117.70 for AcuStar HIT-IgG, and 83.13 for PaGIA. Conclusions: We observed favourable diagnostic accuracy measures and a high reproducibility for PaGIA and AcuStar HIT-IgG. Implementation into 24-hours-service might improve patient care but the results must be confirmed in other settings and larger populations as well. © 2017 Bankova et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Nagler M.,Maastricht University | Nagler M.,Central Haematology Laboratory | Nagler M.,University of Bern | Bachmann L.M.,Medignition Inc. | And 2 more authors.
Blood | Year: 2016

Immunoassays are essential in the workup of patients with suspected heparin-induced thrombocytopenia. However, the diagnostic accuracy is uncertain with regard to different classes of assays, antibody specificities, thresholds, test variations, and manufacturers. We aimed to assess diagnostic accuracy measures of available immunoassays and to explore sources of heterogeneity. We performed comprehensive literature searches and applied strict inclusion criteria. Finally, 49 publications comprising 128 test evaluations in 15 199 patients were included in the analysis. Methodological quality according to the revised tool for quality assessment of diagnostic accuracy studies was moderate. Diagnostic accuracy measures were calculated with the unified model (comprising a bivariate random-effects model and a hierarchical summary receiver operating characteristics model). Important differences were observed between classes of immunoassays, type of antibody specificity, thresholds, application of confirmation step, and manufacturers. Combination of high sensitivity (>95%) and high specificity (>90%) was found in 5 tests only: polyspecific enzyme-linked immunosorbent assay (ELISA) with intermediate threshold (Genetic Testing Institute, Asserachrom), particle gel immunoassay, lateral flow immunoassay, polyspecific chemiluminescent immunoassay (CLIA) with a high threshold,andimmunoglobulinG(IgG)-specific CLIA with low threshold. Borderline results (sensitivity, 99.6%; specificity, 89.9%) were observed for IgG-specific Genetic Testing Institute-ELISA with low threshold. Diagnostic accuracy appears to be inadequate in tests with high thresholds (ELISA; IgG-specific CLIA), combination of IgG specificity and intermediate thresholds (ELISA, CLIA), high-dose heparin confirmation step (ELISA), and particle immunofiltration assay. When making treatment decisions, clinicians should be a aware of diagnostic characteristics of the tests used and it is recommended they estimate posttest probabilities according to likelihood ratios as well as pretest probabilities using clinical scoring tools. © 2016 by The American Society of Hematology.

Nagler M.,Central Haematology Laboratory | Nagler M.,Central University of Costa Rica | Bachmann L.M.,Medignition Inc. | Schmid P.,Central Haematology Laboratory | And 3 more authors.
PLoS ONE | Year: 2014

Patient self-management (PSM) of oral anticoagulation is under discussion, because evidence from real-life settings is missing. Using data from a nationwide, prospective cohort study in Switzerland, we assessed overall long-term efficacy and safety of PSM and examined subgroups. Data of 1140 patients (5818.9 patient-years) were analysed and no patient were lost to follow-up. Median follow-up was 4.3 years (range 0.2-12.8 years). Median age at the time of training was 54.2 years (range 18.2-85.2) and 34.6% were women. All-cause mortality was 1.4 per 100 patient-years (95% CI 1.1-1.7) with a higher rate in patients with atrial fibrillation (2.5; 1.6-3.7; p<0.001), patients>50 years of age (2.0; 1.6-2.6; p<0.001), and men (1.6; 1.2-2.1; p = 0.036). The rate of thromboembolic events was 0.4 (0.2-0.6) and independent from indications, sex and age. Major bleeding were observed in 1.1 (0.9-1.5) per 100 patient-years. Efficacy was comparable to standard care and new oral anticoagulants in a network meta-analysis. PSM of properly trained patients is effective and safe in a long-term real-life setting and robust across clinical subgroups. Adoption in various clinical settings, including those with limited access to medical care or rural areas is warranted. © 2014 Nagler et al.

Nagler M.,Central Haematology Laboratory | Nagler M.,University of Bern | Kathriner S.,Central Haematology Laboratory | Bachmann L.M.,Medignition Inc. | And 2 more authors.
Thrombosis Research | Year: 2013

Introduction To what extent haematocrit levels (Hct) and platelet counts (PLT) influence the measurement of parameters of thromboelastometry when assessed with the ROTEM® device is unclear. We investigated to what extent thromboelastometry measurements depend on Hct and PLT. Materials and Methods Whole blood samples were taken for in-vitro preparations of mixtures with three different levels of PLT and a varying Hct. Maximum clot firmness (MCF), clotting time (CT), clot formation time (CFT) and alpha angle (α) for INTEM, EXTEM, FIBTEM and APTEM was recorded. Results Measurements depended substantially on Hct and PLT. MCF readings were systematically lower with increasing Hct (0.2 vs. 0.4: - 7.8 (- 8.3 to - 7.2); p < 0.001, 0.2 vs. 0.55: - 14.5 (- 17.3 to - 14.3); p < 0.001) but higher with increasing PLT (50 vs. 125 × 109/l: 8.2 (4.2 to 12.3); p = 0.005, 50 vs. 250 × 109/l: 12.0 (7.2 to 16.8); p = 0.002). CT readings were systematically higher with increasing Hct (0.2 vs. 0.4: 9.2 (6.2 to 12.1); p = 0.001, 0.2 vs. 0.55: 38.2 (21.5 to 54.9); p = 0.003) while increasing PLT had no influence. CFT readings were also systematically higher with increasing Hct (0.2 vs. 0.4: 83.8 (40.2 to 127.6); p = 0.006, 0.2 vs. 0.55: 226.2 (110.7 to 341.7); p = 0.006) but systematically lower with increasing PLT (50 vs. 125 × 109/l: - 144.0 (- 272.3 to - 15.6); p = 0.036, 50 vs. 250 × 109/l: - 189.2 (- 330.4 to - 48.0); p = 0.02); readings of the alpha angle showed a similar pattern. Conclusions Our results suggest that readings of thromboelastometry parameters need to be adjusted by Hct and PLT to avoid potential confounding and miss-interpretations in clinical practice. © 2013 Elsevier Ltd.

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