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Title (Primary) Inter-laboratory robustness of next-generation bile acid study in mice and humans: international ring trial involving 12 laboratories
Author Pham, H.T.; Arnhard, K.; Asad, Y.J.; Deng, L.; Felder, T.K.; St. John-Williams, L.; Kaever, V.; Leadley, M.; Mitro, N.; Muccio, S.; Prehn, C.; Rauh, M.; Rolle-Kampczyk, U.; Thompson, J.W.; Uhl, O.; Ulaszewska, M.; Vogeser, M.; Wishart, D.S.; Koal, T.;
Journal Journal of Applied Laboratory Medicine
Year 2016
Department MOLSYB;
Volume 1
Issue 2
Language englisch;
POF III (all) F11; T42;
UFZ wide themes RU3;

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.

This article presents an effort toward standardization and harmonization in the analysis of
individual bile acids, which has an utmost importance not only in metabolomics studies across
different laboratories, but also in clinical diagnostics. For this purpose, the newly developed ultrahigh
pressure liquid chromatography (UHPLC) MS/MS–based kit was evaluated in terms of accuracy
and precision in a ring trial. Sixteen sites, including university, hospital, government, and
industry laboratories, were invited to participate. Twelve laboratories have met the system suitability
test protocol and carried out the measurements. Accuracy, precision, and other quality assurance
parameters, which are essential for the standardization, were all within expected ranges.
ID 17966
Persistent UFZ Identifier
Pham, H.T., Arnhard, K., Asad, Y.J., Deng, L., Felder, T.K., St. John-Williams, L., Kaever, V., Leadley, M., Mitro, N., Muccio, S., Prehn, C., Rauh, M., Rolle-Kampczyk, U., Thompson, J.W., Uhl, O., Ulaszewska, M., Vogeser, M., Wishart, D.S., Koal, T. (2016):
Inter-laboratory robustness of next-generation bile acid study in mice and humans: international ring trial involving 12 laboratories
J. Appl. Lab. Med. 1 (2), 129 - 142