Abstract:
:Before a new method is used for clinical testing, it is essential that it is evaluated for suitability for its intended purpose. This document gives guidance for the performance of verification, validation and implementation processes required by regulatory and accreditation bodies. It covers the planning and execution of an evaluation of the commonly performed screening tests (prothrombin time, activated partial thromboplastin time, thrombin time and fibrinogen assay), and instrument-specific issues. Advice on selecting an appropriate haemostasis analyser, planning the evaluation, and assessing the reference, interval, precision, accuracy, and comparability of a haemostasis test system are also given. A second companion document will cover specialist haemostasis testing.
journal_name
Int J Lab Hematoljournal_title
International journal of laboratory hematologyauthors
Gardiner C,Coleman R,de Maat MPM,Dorgalaleh A,Echenagucia M,Gosselin RC,Ieko M,Kitchen Sdoi
10.1111/ijlh.13411subject
Has Abstractpub_date
2020-11-29 00:00:00eissn
1751-5521issn
1751-553Xpub_type
杂志文章,评审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:INTRODUCTION:Cellular analysis in body fluids (BFs) provides important diagnostic information in various pathological settings. This study was hence aimed at comparing automated cell count obtained with Mindray BC-6800 (BC-BF) vs Sysmex XN-series (XN-BF) and evaluating other quantitative and qualitative information pro...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12968
更新日期:2019-04-01 00:00:00
abstract::Nonvitamin K antagonist oral anticoagulants (NOACs) are being used with increasing frequency due to their safety profile, ease of use, and given that therapeutic monitoring is not required. As these agents have only recently been FDA approved, their effect on routine and specialty coagulation assays is not well apprec...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章,评审
doi:10.1111/ijlh.12350
更新日期:2015-05-01 00:00:00
abstract:INTRODUCTION:Lupus anticoagulant (LAC) testing is a multistep procedure including screening, mixing, and confirmation tests. STA Coag Expert is a software module for STA R Max and STA Compact Max analyzers which includes an on-demand LAC algorithm, based on ISTH guidelines, for automatic interpretation, calculation, an...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.13001
更新日期:2019-06-01 00:00:00
abstract::Molecular monitoring of the BCR-ABL1 transcript in chronic myelogenous leukemia (CML) using quantitative real-time PCR (RQ-PCR) can be performed using either bone marrow (BM) or peripheral blood (PB). However, a recent report by Stock et al. [International Journal of Oncology 28 (2006) 1099] questioned the reliability...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2009.01198.x
更新日期:2010-08-01 00:00:00
abstract::Platelets play a central role in physiological hemostasis and also in pathological thrombosis. It is well established that congenital or acquired abnormalities of platelet function are associated with a heightened risk of bleeding of variable severity and excessive hemorrhage after surgery or trauma. Several kinds of ...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12539
更新日期:2016-05-01 00:00:00
abstract:INTRODUCTION:The blood count provides qualitative and quantitative essential information on bloodlines. Reference hematologic parameters have been established in children and neonates, but few data are available regarding the premature population during the first month of life. The main objective of this study was to e...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12629
更新日期:2017-06-01 00:00:00
abstract::The paucity of clinical reports in the world literature suggests that, as a disease entity, haemoglobin SE compound heterozygosity is of negligible importance. In view of the significant community prevalence of this haemoglobinopathy in the Sultanate of Oman where it is the second most prevalent sickling disorder, a h...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2257.2006.00886.x
更新日期:2007-08-01 00:00:00
abstract::Blood coagulation factor XIII (FXIII) plays a key role in the protection of fibrin clot against fibrinolysis, in the cross-linking of fibrin and its mechanical strength. The role of the FXIII-A subunit Val34Leu polymorphism with fatal primary intracerebral hemorrhages (PICH) has not been studied. We evaluated retrospe...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2012.01465.x
更新日期:2013-02-01 00:00:00
abstract:INTRODUCTION:Monocytosis is a frequent trigger for blood smear review in a routine hematology laboratory whereas chronic myelomonocytic leukemia (CMML) is infrequent and arises mostly in elderly patients. In order to define the best workflow for monocytosis, we studied three diagnostic approaches: the classical morphol...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.13115
更新日期:2019-12-01 00:00:00
abstract:INTRODUCTION:Autoimmune haemolytic anaemia (AIHA) is defined as the increased destruction of red blood cells (RBCs) in the presence of anti-RBC autoantibodies and/or complement. Its pathogenesis is multifactorial and includes changes in mechanisms of cytokine production and functionality. A number of recent studies hav...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2012.01400.x
更新日期:2012-08-01 00:00:00
abstract:INTRODUCTION:While hyperparasitemia is considered an important indicator for the development of severe malaria, there is currently no consensus on the quantitative definition of hyperparasitemia. This study was conducted to establish a cutoff point for peripheral parasitemia among patients with Plasmodium falciparum ma...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2011.01398.x
更新日期:2012-06-01 00:00:00
abstract:INTRODUCTION:Mean platelet volume (MPV) and platelet (PLT) count are the two major parameters that reflect the functions and activities of PLTs. The associations of MPV and PLT count with the occurrence and prognosis of stroke have not been fully clarified. This study aimed to investigate the association of MPV and PLT...
journal_title:International journal of laboratory hematology
pub_type: 临床试验,杂志文章
doi:10.1111/ijlh.12474
更新日期:2016-06-01 00:00:00
abstract:BACKGROUND:White blood cell (WBC) counts are used to monitor bone marrow function and to screen for infections. The HemoCue WBC DIFF Point-Of-Care (POC) instrument classifies WBCs through cell image recognition. To evaluate its suitability for monitoring cancer patients, we examined its performance in samples from pati...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.13158
更新日期:2020-06-01 00:00:00
abstract::Though not very common, solid tumor involvement of the bone marrow (BM) may have serious consequences. Recent studies have shown that mean platelet volume (MPV) is a good indicator for BM disease in the differential diagnosis of thrombocytopenia. We investigated the significance of MPV in the diagnosis of BM metastasi...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2007.00947.x
更新日期:2008-06-01 00:00:00
abstract::B-lineage lymphoproliferative disorders (LPD) are rather frequent diseases, associated with specific clinical or biological features but also sometimes of fortuitous discovery. Multiparameter flow cytometry plays a major role for a rapid diagnostic indication, on peripheral blood or bone marrow samples in most instanc...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章,评审
doi:10.1111/ijlh.13170
更新日期:2020-06-01 00:00:00
abstract:INTRODUCTION:The workflow in clinical flow cytometry laboratories must constantly be reviewed to develop technical procedures that improve quality and productivity and reduce costs. Using the Beckman Coulter dry coating technology, we customized a ten-color tube with dried antibody reagents, designated the Duraclone sc...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12753
更新日期:2018-04-01 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::Flow cytometry (FCM) allows scientists to rapidly quantify up to 50 parameters for millions of cells per sample. The bottleneck in the application of the technology is data analysis, and the high number of parameters measured by the current generation of instruments requires the use of advanced computational algorithm...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章,评审
doi:10.1111/ijlh.13016
更新日期:2019-05-01 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:Point-of-care (POC) international normalized ratio (INR) values above an institutional cutoff are confirmed in the laboratory using a gold standard venous specimen. This can be problematic in a pediatric setting. METHOD:In this study, 449 consecutive POC INR results were compared to an INR performed in th...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12920
更新日期:2019-02-01 00:00:00
abstract::The consistent multi-ethnic migrations of the last decades have considerably changed the epidemiology of the hemoglobinopathies. Healthy carriers of these conditions are present today in many nonendemic parts of the world, and severely affected children are now born where these diseases were previously rare or unknown...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章,评审
doi:10.1111/ijlh.12037
更新日期:2013-10-01 00:00:00
abstract::Multiple myeloma (MM) is a malignant plasma cell disorder that involves multiple genetic abnormalities. Chimeric transcription factors, created by gene fusion as a result of chromosomal translocations, have been implicated in the pathogenesis of the disease. Here, we report the conventional cytogenetic analysis of a M...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2006.00837.x
更新日期:2007-06-01 00:00:00
abstract:INTRODUCTION:In the Janus kinase/signal transducer and activator of transcription (JAK/STAT) signaling pathway, STAT3 is one of the most prominent prognosis factors for cancer and leukemia. STAT3 activation might promote cellular transformation and therefore have an important role in human tumors. This study aimed to i...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2012.01406.x
更新日期:2012-08-01 00:00:00
abstract:INTRODUCTION:Capillary electrophoresis (CE) is a high-resolution method for detection of hemoglobin Constant Spring (Hb CS). METHODS:The levels of Hb CS quantified by CE were compared among three groups of samples including heterozygote and homozygote of Hb CS as well as Hb H-CS disease classified by DNA molecular dia...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2011.01371.x
更新日期:2012-04-01 00:00:00
abstract:BACKGROUND:Hematological patients, receiving intensive chemotherapy (predominantly acute leukemia patients), have repeated postchemotherapy periods with severe bone marrow suppression. As a result, these patients require regular monitoring of the complete blood counts (CBC) for optimal patient care. To reduce the strai...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.13330
更新日期:2021-02-01 00:00:00
abstract:INTRODUCTION:Venous blood (VB) sampling for complete blood count (CBC) via venipuncture is the basic method for the daily evaluation of hematological patients. However, several issues during this process, such as venipuncture difficulty and repetitive attempts, may cause pain, phlebitis, hematomas, inadequate sampling,...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.13237
更新日期:2020-10-01 00:00:00
abstract:INTRODUCTION:The complete blood count (CBC) with differential leukocyte count (DIFF) is an important part of clinical laboratory analyses and provides crucial data for clinicians. Delivery time after blood collection and conditions of storage is known to affect the reliability of results of some hematologic parameters....
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/j.1751-553X.2012.01452.x
更新日期:2012-12-01 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::The performance of factor VII (FVII) assays currently used by clinical laboratories was examined in North American Specialized Coagulation Laboratory Association (NASCOLA) proficiency tests. Data from 12 surveys conducted between 2008 and 2010, involving 20 unique specimens plus four repeat-tested specimens, were anal...
journal_title:International journal of laboratory hematology
pub_type: 杂志文章
doi:10.1111/ijlh.12083
更新日期:2013-06-01 00:00:00