Abstract:
INTRODUCTION:Monitoring of factor IX (FIX) replacement therapy in haemophilia B relies on accurate coagulation assays. However, considerable interlaboratory variability has been reported for one-stage clotting (OSC) assays. This study aimed to evaluate the real-world, interlaboratory variability of routine FIX activity assays used in clinical haemostasis laboratories for the measurement of recombinant FIX Fc fusion protein (rFIXFc) activity. METHODS:Human FIX-depleted plasma was spiked with rFIXFc at 0.80, 0.20 or 0.05 IU/mL based on label potency. Participating laboratories tested samples using their own routine OSC or chromogenic substrate (CS) assay protocols, reagents and FIX plasma standards. Laboratories could perform more than one measurement and method, and were not fully blinded to nominal activity values. RESULTS:A total of 142 laboratories contributed OSC results from 175 sample kits using 11 different activated partial thromboplastin time (aPTT) reagents. The median recovered FIX activity for the 0.80, 0.20 and 0.05 IU/mL samples was 0.72 IU/mL, 0.21 IU/mL and 0.060 IU/mL, respectively. Across all OSC reagents, interlaboratory variability (% CV) per aPTT reagent ranged from 9.4% to 32.1%, 8.2% to 32.6% and 12.2% to 42.0% at the 0.80, 0.20 and 0.05 IU/mL levels, respectively. CS results showed excellent median recoveries at all nominal levels (87.5% to 115.0%; n = 11) with low interlaboratory variability (CV 3.6% to 15.4%). CONCLUSION:This large, real-world data set indicates that rFIXFc activity in plasma samples can be accurately measured with the majority of routine OSC and CS assay methods. Given the variation in FIX assay procedures between sites, it is important that individual laboratories qualify their in-house methods for monitoring of rFIXFc activity.
journal_name
Int J Lab Hematoljournal_title
International journal of laboratory hematologyauthors
Sommer JM,Sadeghi-Khomami A,Barnowski C,Wikén M,Willemze AJdoi
10.1111/ijlh.13189subject
Has Abstractpub_date
2020-06-01 00:00:00pages
350-358issue
3eissn
1751-5521issn
1751-553Xjournal_volume
42pub_type
杂志文章,多中心研究abstract:INTRODUCTION:New methods for coagulation tests require careful assessment before routine use. We evaluated the analytical performance of five new coagulation assays for measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT). METHODS:PT Rec, PT Owren, aPTT, aPTT Lupus and aPTT Screen assays (R...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12897
更新日期:2018-12-01 00:00:00
abstract:INTRODUCTION:To measure direct factor Xa inhibitor (apixaban, edoxaban, rivaroxaban) concentrations, dedicated chromogenic anti-Xa assays are recommended as suitable methods to provide rapid drug quantification. Moreover, the high-performance liquid chromatography with ultraviolet detection (HPLC-UV) is reported as a r...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.13159
更新日期:2020-04-01 00:00:00
abstract::Advances in lab-on-a-chip technologies enabled programmable, reconfigurable, and scalable manipulation of a variety of laboratory procedures. Samples, reagents, and fluids can be precisely controlled; buffer temperature, pH, and concentration control systems as well as a variety of detection systems can be integrated ...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章,评审
doi:10.1111/ijlh.12054
更新日期:2013-10-01 00:00:00
abstract::Myelodysplastic syndrome (MDS) with hypocellular bone marrow (BM) is often difficult to distinguish from aplastic anemia (AA). Furthermore, the diagnosis of MDS with low blast counts and normal karyotype may be problematic. These issues highlight the need for a reliable marker for the diagnosis of MDS. This study was ...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2008.01056.x
更新日期:2009-06-01 00:00:00
abstract:INTRODUCTION:D-dimer (DD) assays are effective for the exclusion of deep-vein thrombosis (DVT), but point-of-care (POC) DD assays have not been fully evaluated. METHODS:We have compared five POC DD assays (Pathfast, Cardiac, Vidas, Stratus and NycoCard) with our routine DD method (Tinaquant), testing 60 samples from p...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2012.01421.x
更新日期:2012-10-01 00:00:00
abstract:INTRODUCTION:Iron-deficient erythropoiesis attributable to nutritional deficiency is the most common cause of anemia in early childhood. Beckman Coulter has proposed new parameters: red blood cell size factor (RSf) and low hemoglobin density (LHD%). [Formula: see text] The aims of the present communication were to esta...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12030
更新日期:2013-08-01 00:00:00
abstract::The DM is an automated microscope, which performs WBC differential counts and monitors red cell morphology. The user either validates the cell recognition if the DM has correctly identified the WBCs or reclassifies the WBCs in the good category in case of a DM mis-assignment. Morphological anomalies of leukocytes, red...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2009.01219.x
更新日期:2010-10-01 00:00:00
abstract:INTRODUCTION:In acute myeloid leukemia (AML), it has been shown that AML-derived cells often remain sensitive to autophagy-inducing stimuli, leading to the idea that harnessing the autophagy can be pertinent to AML cytotoxic therapy. Despite this promising notion, to date, there is no comprehensive study addressing aut...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12454
更新日期:2016-04-01 00:00:00
abstract::The ongoing COVID-19 pandemic has had a profound worldwide impact on the laboratory hematology community. Nevertheless, the pace of COVID-19 hematology-related research has continued to accelerate and has established the role of laboratory hematology data for many purposes including disease prognosis and outcome. The ...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章,评审
doi:10.1111/ijlh.13381
更新日期:2020-11-12 00:00:00
abstract:INTRODUCTION:It has been recently suggested that microparticles (MP) play a role in the pathogenesis of thrombotic complications. This study aimed to assess the contribution of procoagulant activity expressed by circulating MP in thrombotic events in MPN patients. METHODS:Seventy-four MPN patients were enrolled in a t...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12676
更新日期:2017-10-01 00:00:00
abstract::Using previously described procedures, this study quantified T-cell, T-cell subset, B-cell and NK-cell populations with the CD-Sapphire haematology analyser in a series of patients with mild to moderate lymphocytosis. Lymphocyte counts ranged from 6.0 to 14.9 x 10(9)/l, with 86/97 being <10.0 x 10(9)/l. Immunophenotyp...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2007.00934.x
更新日期:2007-12-01 00:00:00
abstract::Acquired haemophilia is a rare phenomenon and prompt diagnosis is essential for successful treatment. Early laboratory detection could minimize its potentially devastating consequences and reduce mortality but when a masking element such as anticoagulant therapy is present, delay in diagnosis is not uncommon. A prolon...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1365-2257.2006.00867.x
更新日期:2007-02-01 00:00:00
abstract:INTRODUCTION:Laboratory investigations for bleeding disorders are warranted when an individual has a personal and/or family history of bleeding, and/or laboratory findings that suggest the possibility of an inherited or acquired bleeding disorder. METHODS:This review summarizes author's experience with ordering and re...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章,评审
doi:10.1111/ijlh.12822
更新日期:2018-05-01 00:00:00
abstract:INTRODUCTION:Thrombotic thrombocytopenic purpura (TTP) is a rare life-threatening thrombotic microangiopathy (TMA) characterized by the severe deficiency of ADAMTS13 activity (<10%). Rapid ADAMTS13 testing is crucial for early diagnosis and optimal management of TTP patients and other TMAs. The objective of this study ...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.13414
更新日期:2020-12-02 00:00:00
abstract::Successful adoptive immunotherapy for leukemia depends on the generation of T cells that can specifically react with malignant cells. Dendritic cells (DCs) are important antigen-presenting cells in the development of antileukemia T-cell responses. Mononuclear cells (MNC) were isolated from peripheral blood or bone mar...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2007.00986.x
更新日期:2008-10-01 00:00:00
abstract:INTRODUCTION:Aberrant activation of Janus kinase (JAK)/signal transducer and activator of transcription (STAT) pathway leads to deregulated proliferation, differentiation, or apoptosis of normal cells. One of the members of this family, JAK2, plays a very important role in metabolizing carcinogens and medications. This...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2011.01386.x
更新日期:2012-06-01 00:00:00
abstract::Promoter hypermethylation plays an important role in the inactivation of cancer-related genes. This abnormality occurs early in leukemogenesis and seems to be associated with poor prognosis in myelodsplastic syndrome (MDS). The identification of more inactivated tumor suppressor genes contributing to the development o...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2008.01131.x
更新日期:2010-02-01 00:00:00
abstract:INTRODUCTION:Direct oral anticoagulants (DOAC) are commonly prescribed and measuring drug levels may be useful in a number of contexts. However, data on DOAC level measurement and their clinical utility in real-world studies are limited. METHODS:We carried out a 2-year retrospective cohort study of DOAC levels measure...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12944
更新日期:2019-04-01 00:00:00
abstract:INTRODUCTION:The investigation of platelet function by aggregometry requires specialist equipment and is labour intensive. We have developed an automated platelet aggregation method on a routine coagulation analyser. METHODS:We used a CS-2000i (Sysmex) with prototype software to perform aggregation in platelet-rich pl...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12161
更新日期:2014-08-01 00:00:00
abstract:BACKGROUND:Immediate reporting of critical values or test results significantly outside the normal range has a growing role in the management of patients, especially in life-threatening conditions. Due to the lack of international consensus, diverse approaches are used for determination of thresholds, reporting, docume...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.13109
更新日期:2019-12-01 00:00:00
abstract::Significant advances have been made in our understanding of the structural basis for altered cell function in various inherited red cell membrane disorders with reduced red cell survival and resulting hemolytic anemia. The current review summarizes these advances as they relate to defining the molecular and structural...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章,评审
doi:10.1111/ijlh.12657
更新日期:2017-05-01 00:00:00
abstract::Eosinophilia is typically secondary, that is, reactive, in nature and is associated with a wide variety of neoplastic and non-neoplastic disorders. Clonal eosinophilia is also seen in a wide variety of hematopoietic neoplasms, and sub-classification can be diagnostically challenging. A proper evaluation of persistent ...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章,评审
doi:10.1111/ijlh.12955
更新日期:2019-04-01 00:00:00
abstract:INTRODUCTION:Beta globin deletion/duplication analysis may serve as a useful adjunct to sequence analysis. Our purpose was to develop a robust assay for beta globin deletion/duplication analysis and determine its role in evaluating patients with beta thalassemia. METHODS:A single tube semi-quantitative fluorescent PCR...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2010.01287.x
更新日期:2011-06-01 00:00:00
abstract:INTRODUCTION:In the cytogenetically normal population of AML (CN-AML), FLT3-ITD-positive and wild-type NPM1 is correlated with a worse outcome, and FLT3-ITD-negative with NPM1-mut is correlated with a better outcome. This leaves a large subpopulation of CN-AML patients without NPM1 or FLT3-ITD mutations with heterogene...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12649
更新日期:2017-08-01 00:00:00
abstract:INTRODUCTION:Pathogen Inactivation allows to overcome microbial contamination and growth related to storage of platelets concentrates (PC) at room temperature. The aim of our study was to evaluate the platelet storage lesion extending the storage period of pathogen inactivated platelet concentrates over 7 days using an...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12102
更新日期:2013-12-01 00:00:00
abstract:INTRODUCTION:Paroxysmal nocturnal hemoglobinuria (PNH) is a hemolytic, clonal and acquired disorder of the hematopoietic stem cell with a deficiency of all glycophosphatidyl-inositol (GPI) linked proteins. The aim of this retrospective study was to analyse haematological and biochemical data from 152 patients referred ...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12156
更新日期:2014-04-01 00:00:00
abstract:INTRODUCTION:Atypical chronic lymphocytic leukemia (aCLL) is a morphologic variant found in approximately 25% of patients with chronic lymphocytic leukemia (CLL). Although aCLL has a more aggressive course compared to typical CLL (tCLL), it is not usually reported. This retrospective study used digital microscopy to mo...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12167
更新日期:2014-08-01 00:00:00
abstract::Diagnostic tests for von Willebrand disease (VWD) are important for the assessment of VWD, which is a commonly encountered bleeding disorder worldwide. Technical innovations have been applied to improve the precision and lower limit of detection of von Willebrand factor (VWF) assays, including the ristocetin cofactor ...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章,评审
doi:10.1111/ijlh.12220
更新日期:2014-06-01 00:00:00
abstract:INTRODUCTION:While the presence of disseminated intravascular coagulation (DIC) has been implicated in worse clinical outcome in acute leukemia, the relationship between different subtypes of acute leukemia and the clinicopathologic features of DIC has not been systematically well studied. METHODS:In this study, we re...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12636
更新日期:2017-08-01 00:00:00
abstract:INTRODUCTION:The Sysmex XP-300(®) (XP-300) is a new, fully automated hematology analyzer, designed to generate complete blood counts (CBC) with 3-part differential. In our study, the XP-300 was evaluated as a point-of-care (POC) analyzer in an oncology setting. In which blood samples from patients with different pathol...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章,随机对照试验
doi:10.1111/ijlh.12522
更新日期:2016-10-01 00:00:00