Hai T Pham1, Kathrin Arnhard2, Yasmin J Asad3, Lu Deng4, Thomas K Felder5, Lisa St John-Williams6, Volkhard Kaever7, Michael Leadley8, Nico Mitro9, Stephane Muccio10, Cornelia Prehn11, Manfred Rauh12, Ulrike Rolle-Kampczyk13, J Will Thompson6, Olaf Uhl14, Maria Ulaszewska15, Michael Vogeser16, David S Wishart4, Therese Koal1. 1. BIOCRATES Life Sciences AG, Innsbruck, Austria. 2. Institute of Legal Medicine and Core Facility Metabolomics, Medical University of Innsbruck, Innsbruck, Austria. 3. Division of Cancer Therapeutics, Institute of Cancer Research, London, UK. 4. Departments of Computing Science and Biological Sciences, University of Alberta, Edmonton, Alberta, Canada. 5. Department of Laboratory Medicine, Paracelsus Medical University, Salzburg, Austria. 6. Duke Proteomics and Metabolomics Core Facility, B02 Levine Science Research Center, Durham, NC. 7. ZFA Metabolomics, Medizinische Hochschule Hannover, Hannover, Germany. 8. Sick Kids, Analytical Facility for Bioactive Molecules (PGCRL), Toronto, Ontario, Canada. 9. Laboratory of Biochemistry and Molecular Biology of Metabolism and Mass Spectrometry "Giovanni Galli," Department of Pharmacological and Biomolecular Sciences, Università degli Studi di Milano, Milano, Italy. 10. Sanofi, Bioanalysis Laboratory, Montpellier, France. 11. Institute of Experimental Genetics, Genome Analysis Center, Helmholtz Zentrum München, Neuherberg, Germany. 12. Universitätsklinikum Erlangen, Kinder-und Jugendklinik, Erlangen, Germany. 13. Department Metabolomics, Helmholtz-Zentrum für Umweltforschung, Leipzig, Germany. 14. Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, University of Munich Medical Centre, Munich, Germany. 15. Fondazione Edmund Mach, Research and Innovation Centre, Food Quality and Nutrition Department, San Michele all'Adige (TN), Italy. 16. Institut für Laboratoriumsmedizin, Klinikum der Universität München, Munich, Germany.
Abstract
BACKGROUND: The increasing relevance of individual bile acids quantification in biological samples requires analytical standardization to guarantee robustness and reliability of laboratory results. We have organized the first international ring trial, carried out in 12 laboratories, to evaluate the newly developed LC-MS/MS-based test kit for bile acid analysis. METHODS: Each laboratory received a Biocrates® Bile Acids Kit including system suitability test (SST) protocol. The kit is designed to analyze 16 individual human and 19 mouse bile acids. A set of 9 human and mouse plasma samples was measured in replicates. Laboratories were first required to pass the acceptance criteria for the SST. Within the subset of laboratories passing SST criteria, we evaluated how many laboratories met the target criteria of 80% of reported values with a relative accuracy within the 70%-130% range and analytical precisions (%CV) below 30%. RESULTS: A total of 12 of 16 participating laboratories passed the SST as the prerequisite to enter the ring trial. All 12 laboratories were then able to successfully run the kit and ring trial samples. Of the overall reported values, 94% were within 70%-130% relative accuracy range. Mean precision was 8.3% CV. The condition of CV <30% was fulfilled by 99% of the reported values. CONCLUSIONS: The first publically available interlaboratory ring trial for standardized bile acids quantification in human and mouse plasma samples showed very good analytical performance, within acceptance criteria typically applied in the preclinical environment. The kit is therefore suitable for standardized quantitative bile acid analysis and the establishment of reference values.
BACKGROUND: The increasing relevance of individual bile acids quantification in biological samples requires analytical standardization to guarantee robustness and reliability of laboratory results. We have organized the first international ring trial, carried out in 12 laboratories, to evaluate the newly developed LC-MS/MS-based test kit for bile acid analysis. METHODS: Each laboratory received a Biocrates® Bile Acids Kit including system suitability test (SST) protocol. The kit is designed to analyze 16 individual human and 19 mousebile acids. A set of 9 human and mouse plasma samples was measured in replicates. Laboratories were first required to pass the acceptance criteria for the SST. Within the subset of laboratories passing SST criteria, we evaluated how many laboratories met the target criteria of 80% of reported values with a relative accuracy within the 70%-130% range and analytical precisions (%CV) below 30%. RESULTS: A total of 12 of 16 participating laboratories passed the SST as the prerequisite to enter the ring trial. All 12 laboratories were then able to successfully run the kit and ring trial samples. Of the overall reported values, 94% were within 70%-130% relative accuracy range. Mean precision was 8.3% CV. The condition of CV <30% was fulfilled by 99% of the reported values. CONCLUSIONS: The first publically available interlaboratory ring trial for standardized bile acids quantification in human and mouse plasma samples showed very good analytical performance, within acceptance criteria typically applied in the preclinical environment. The kit is therefore suitable for standardized quantitative bile acid analysis and the establishment of reference values.
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