Performance evaluation of a new Stago® automated haemostasis analyser: The STA R Max® 2.

INTRODUCTION: The STA R Max® 2 is a new coagulation analyser developed by Diagnostica Stago, able to perform clotting, chromogenic and immuno-turbidimetric tests. A pre-analytical module build into the cap-piercing needle performs the sample integrity verification (sample tube filling and measurement of haemolysis, icterus, lipaemia). The STA R Max® 2 analyser incorporates an accreditation program tools to assist technical validation of the analyser. We assessed the analytical performance of the STA R Max® 2. MATERIALS AND METHODS: The following tests were assessed: prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen, factor V (FV), antithrombin (AT), D-dimers (DDI) and von Willebrand factor antigen. The assay precisions were assessed using fresh plasma samples or internal quality controls. An inter-analyser comparison was performed with a STA-R Evolution® analyser or, for the FV, with a BCS® XP System. Haemolysis and icterus detection were also verified. RESULTS: For the intra-assay precision, the coefficients of variation (CV%) were all less than 5% and for DDI, the standard deviation (SD) was less than 0.1. For the inter-assay study, all CV% were less than 5%, with the exception of FV and AT (FV: 6.68% and 5.27%; AT: 7% and 12.14% for normal and pathological values, respectively). SD was less than 0.1 for DDI. The inter-analyser comparison demonstrated good results. Haemolysis and icterus were detected correctly for all our assessed samples. CONCLUSION: According to our methods validation's recommendations, the results demonstrated a good technical and analytical performance of the STA R Max® 2 analysers for the tests assessed.

[Large granular lymphocytic leukemia CD3-CD56-: a challenge for the biologist and the physician]. / Leucémie à grands lymphocytes granuleux CD3-CD56- : un défi pour le biologiste et le clinicien.

Large granular lymphocyte leukemia (LGL) are chronic lymphoproliferative disorders classified into three main groups: T-cell LGL leukemia (T-LGL), aggressive NK-cell leukemia and chronic lymphoproliferative disorder of NK cells (NK-LGL). Patients with LGL leukemia exhibit chronic (>3 months) and moderate (<1G/L) to substantial monoclonal expansion of large granular lymphocytes in the peripheral blood. Cytologically, large granular lymphocytes are medium to large cells which are further characterized by an eccentric nucleus and a slightly basophilic cytoplasm containing azurophilic granules. Typically, T-LGL (CD3-and mostly CD8+) can be differentiated from NK-LGL disorders (CD3-) based on flow cytometry analysis. However, distinction between LGL leukemias can be tricky. We report here the case of a 47-year-old woman patient diagnosed with large granular lymphocytes leukemia associated with atypical CD3-CD56- immunophenotyping and clinical manifestations of pseudo-Felty's syndrome.

Risk factors for infection and molecular typing in patients in the intensive care unit colonized with nosocomial Enterobacter aerogenes.

OBJECTIVES: To determine the frequency of colonization by Enterobacter aerogenes in patients in the intensive care unit (ICU) for more than 48 hours and to evaluate the risk factors for infection in patients colonized by this bacteria. DESIGN: An 8-month prospective study. SETTING: A 12-bed medical-surgical ICU in a 450-bed, university-affiliated, tertiary-care hospital in Belgium. METHOD: Pulsed-field gel electrophoresis was used to determine the genotypes of E. aerogenes isolates. RESULTS: We observed two major clones of E. aerogenes in the ICU. Interestingly, 87.5% of infected patients had the same genomic profile for colonization and infection. Risk factors for infection in this particular population included younger age, prolonged hospital stay, mechanical ventilation, and bronchoscopy. CONCLUSIONS: Colonization is a major prerequisite for infection. The identification of risk factors for infection in colonized patients can optimize the quality of treatment in the ICU.