Lactate dehydrogenase (LDH) in blood is measured using the Japanese Society of Clinical Chemistry (JSCC) method in Japan and the International Federation of Clinical Chemistry (IFCC) method in other countries. In human clinical practice, the IFCC method replaced the JSCC method due to international standardization. Moreover, veterinary LDH measurement will also eventually shift to the IFCC method. However, the relationship between the IFCC and JSCC methods for LDH in various animals and whether they can be equated or not have not yet been investigated. This study aimed to present the changes in measurements in canines and felines after switching to the IFCC method. The plasma LDH activity of canines (N=177) and felines (N=115), who visited a secondary care veterinary clinic, was measured using the JSCC and IFCC methods. The IFCC/JSCC ratio was <1.0 in 85% of canines and 88% of felines, indicating that the IFCC method tended to show lower values than the JSCC method, presumably because LDH5 is dominant among the LDH isozymes in canines and felines. The increase in the systematic errors of both assays was in the high value range, with some samples exceeding the error tolerance from near the upper end of the reference range. When switching to the IFCC method for LDH measurement in canines and felines, each institution should consider whether the reference range and clinical diagnostic values established by the JSCC method are appropriate for continued use.
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http://dx.doi.org/10.1292/jvms.22-0278 | DOI Listing |
Clin Chem Lab Med
January 2025
Canadian Microbiology Proficiency Testing Program (CMPT), Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada.
External quality assessment (EQA) enhances patient safety through the evaluation of the quality of laboratory-based and point of care testing. Regulatory agencies and accreditation organizations utilize the results and the laboratory's response to them as part of assessing the laboratory's fitness to practice. In addition, where EQA samples are commutable and the assigned value has been determined using reference measurement procedures (RMPs), EQA data contributes to the verification of metrological traceability of assays as part of the post-market surveillance of diagnostic (IVD) medical devices (IVD-MDs).
View Article and Find Full Text PDFPract Lab Med
November 2024
bioMérieux, Department of Research and Development for Immunoassays, Marcy-l'Étoile, France.
Introduction/objectives: Following the IFCC (The International Federation of Clinical Chemistry and Laboratory Medicine) guidelines concerning high-sensitivity cardiac troponin assays, we performed an assessment of the VIDAS® High-Sensitive Troponin I (TNHS) assay. The test was evaluated on its capacity to detect at least 50 % of healthy individuals and checked that the coefficient of variation was less than 10 % at the 99th percentile.
Methods: High-sensitivity performance was assessed by examining the limits of detection, the determination of the 99th percentile value, the evaluated imprecision at said value and the detectable results above limit of detection (LoD) in a cohort of healthy European individuals.
Clin Chim Acta
December 2024
EC, Joint Research Centre, Directorate F - Health and Food, Reference Materials Unit, Geel, Belgium.
The establishment of reference systems for the standardization of hemoglobin A (HbA) and fetal hemoglobin (HbF), both critical for improving diagnostic accuracy in conditions such as β-thalassemia and sickle cell disease, are described. Efforts were led by the IFCC and other groups to address and reduce the variability in laboratory measurements of these hemoglobins. This document outlines the production of certified reference materials (CRMs) for HbA and the development of a reference measurement procedure using isotope dilution mass spectrometry.
View Article and Find Full Text PDFJ Appl Lab Med
December 2024
Associate Professor, Chemistry/Physics (Ret.), Wentworth Institute of Technology, Boston, MA, United States.
Rev Med Inst Mex Seguro Soc
February 2024
Instituto de Seguridad Social para los Trabajadores del Estado, Hospital Fernando Quiroz Gutiérrez, Servicio de Cardiología. Ciudad de México, México.
Background: Errors in the pre-analytical phase of the microbiology laboratory reduce patient safety and generate additional expenses. In Mexico we do not have systems for evaluation and monitoring of the pre-analytical phase; quality indicators are proposed for continuous improvement.
Objective: Identify the main reasons for rejection of respiratory samples in the microbiology laboratory and evaluate the usefulness of preanalytical quality indicators.
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