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Analytical Quality Specifications for Serum Lactate Dehydrogenase Isoenzyme 1 Based on Clinical Goals

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Published/Copyright: June 1, 2005
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Volume 37 Issue 5

Abstract

The aim of the study was to deduce analytical quality specifications for the determination of catalytic concentration of serum lactate dehydrogenase isoenzyme 1 (S-LD-1) according to clinical goals (the clinical utility model). We defined clinical goals for false positive and false negative S-LD-1 measurements in the monitoring of patients with testicular germ cell tumors (TGCT), clinical stage I, on a surveillance only program. The absolute S-LD-1 catalytic concentrations were routinely corrected for contamination from preanalytical hemolysis. A reference group of 37 men had a near ln-Gaussian distribution for the absolute S-LD-1 catalytic concentration. The geometric mean was 76 U/l and an S-LD-1 > 128 U/l (99.72 percentile, the decision limit) indicated a high risk of a relapse of TGCT. We have previously shown that an S-LD-1 > 160 U/l (treatment limit) was associated with a suboptimal outcome from the treatment of metastatic TGCT. The maximum allowable analytical positive bias was 5 U/l, and the maximum allowable analytical negative bias was −32 U/l. The maximum allowable analytical coefficient of variation, CVA, was 11 % (≈14 U/l) at a bias = −5 U/l. For S-LD-1 measurements not corrected for hemolysis, the decision limit was 145 U/l, the maximum allowable negative bias −19 U/l, and CVA 8 % (≈12 U/l). A routine correction for hemolysis had a large impact on the analytical quality specifications.

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Published Online: 2005-06-01
Published in Print: 1999-05-01

Copyright (c)1999 by Walter de Gruyter GmbH & Co. KG

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  12. Analytical Quality Specifications for Serum Lactate Dehydrogenase Isoenzyme 1 Based on Clinical Goals
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  14. Towards Common Reference Intervals in Clinical Chemistry
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https://doi.org/10.1515/CCLM.1999.089

Articles in the same Issue

  1. Metrological Support of the Institute for Reference Materials and Measurements (IRMM) to Clinical Chemistry
  2. Web Applications for Total Quality Management
  3. Inflammation, the Acute Phase Response and Atherosclerosis
  4. Characterization of Two Distinct Mechanisms for Induction of Apoptosis in Human Vascular Endothelial Cells
  5. Lipid Peroxidation and Antioxidant Defenses in Cystic Fibrosis Patients
  6. Autoantibodies against Oxidised Low-Density Lipoprotein in Patients with Obstructive Sleep Apnoea
  7. Inter-α-Inhibitor (IαI) Concentration in Pig Plasma Is Independent of Acute-Phase Protein Response
  8. Advances in Reverse Transcription Polymerase Chain Reaction Analysis of Cellular mRNA Levels of Transforming Growth Factor-β1 by Capillary Electrophoresis with Laser-Induced Fluorescence Detection
  9. Determination of Ascorbic Acid in Plasma and Urine by High Performance Liquid Chromatography with Ultraviolet Detection
  10. A New Liquid Homogeneous Assay for the Determination of HDL-Cholesterol
  11. On the Standardization of Total Prostate-Specific Antigen: an Exercise with Two Reference Preparations
  12. Analytical Quality Specifications for Serum Lactate Dehydrogenase Isoenzyme 1 Based on Clinical Goals
  13. Physiological HEPES Buffer Proposed as a Calibrator for pH Measurement in Human Blood
  14. Towards Common Reference Intervals in Clinical Chemistry
  15. Evaluation of an Automated Method for Cytokine Measurement Using the Immulite® Immunoassay System
  16. Handbook of Interpretation of Diagnostic Tests by Jacques Wallach
  17. Assessment of a Major Academic Development Programme Linking European Union with Central and Eastern Europe
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