First WHO/IFCC International Reference Reagent for Lipoprotein(a) for Immunoassay – Lp(a) SRM 2B
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Francesco Dati
Abstract
Lipoprotein(a) is an important predictor of cardiovascular disease risk. The lack of internationally accepted standardization has impeded the broad application of this lipoprotein in laboratory medicine. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), through its Working Group on Lipoprotein(a) and together with research institutions and several diagnostic companies, have succeeded in developing an international reference material that is intended for the transfer of a lipoprotein(a) concentration to manufacturers' master calibrators. IFCC SRM 2B has recently been accepted by the WHO Expert Committee on Biological Standardization as the ‘First WHO/IFCC International Reference Reagent for Lipoprotein(a) for Immunoassay’. The assigned unitage of 0.1071 nanomoles of lipoprotein(a) per vial is traceable to the consensus reference method for lipoprotein( a) and will enable conformity by diagnostic companies to the European Union's Directive on In vitro Diagnostic Medical Devices for the metrological traceability of calibrator materials.
Copyright © 2004 by Walter de Gruyter GmbH & Co. KG
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Articles in the same Issue
- Publishers note
- Towards quality specifications in extra-analytical phases of laboratory activity
- Quality indicators and specifications for the extra-analytical phases in clinical laboratory management
- Pitfalls and drawbacks in screening of congenital disorders of glycosylation
- Activity of eosinophils and immunoglobulin E concentration in the peritoneal fluid of women with endometriosis
- Rapid generation of detailed loss of heterozygosity profiles for routine diagnosis of gliomas
- Presence of secretory group IIa and V phospholipase A2 and cytosolic group IVα phospholipase A2 in chondrocytes from patients with rheumatoid arthritis
- Neurokinin B levels in maternal circulation during early pregnancy
- Cl- regulates cryoglobulin structure: a new hypothesis for the physiopathological mechanism of temperature non-dependent cryoprecipitation
- Urine labeling with orally applied marker substances in drug substitution therapy
- Cardiac natriuretic hormones, neuro-hormones, thyroid hormones and cytokines in normal subjects and patients with heart failure
- Clinical utility of serum holotranscobalamin as a marker of cobalamin status in elderly patients with neuropsychiatric symptoms
- Comparison of serum creatinine, uric acid, albumin and glucose in male professional endurance athletes compared with healthy controls
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- Reference ranges for two automated chemiluminescent assays for serum insulin-like growth factor I (IGF-I) and IGF-binding protein 3 (IGFBP-3)
- The influence of freezer storage of urine samples on the BONN-Risk-Index for calcium oxalate crystallization
- First WHO/IFCC International Reference Reagent for Lipoprotein(a) for Immunoassay – Lp(a) SRM 2B
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- Intra-laboratory analytical variability of biochemical markers of fibrosis (Fibrotest) and activity (Actitest) and reference ranges in healthy blood donors
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