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Tierarztl Prax Ausg K Kleintiere Heimtiere 2015; 43(06): 399-408
DOI: 10.15654/TPK-140821
Originalartikel
Schattauer GmbH

Messung kaniner und feliner PankreaslipaseImmunreaktivität – analytischer Vergleich neuer kommerzieller Tests mit etablierten Assays

Measurement of canine and feline pancreatic lipase immunoreactivity – analytical comparison of new commercial assays with established assays
E. Höfel
1   Kleintierklinik am Hochberg, Ravensburg
,
T. Rieker
1   Kleintierklinik am Hochberg, Ravensburg
,
J. S. Suchodolski
2   Gastrointestinal Laboratory, Department of Small Animal Clinical Sciences, Texas A&M University, College Station, TX, USA
,
J. M. Steiner
2   Gastrointestinal Laboratory, Department of Small Animal Clinical Sciences, Texas A&M University, College Station, TX, USA
,
K. Fetz Burke
2   Gastrointestinal Laboratory, Department of Small Animal Clinical Sciences, Texas A&M University, College Station, TX, USA
› Author Affiliations
Further Information

Publication History

Eingegangen: 29 October 2014

Akzeptiert nach Revision: 17 June 2015

Publication Date:
08 January 2018 (online)

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Zusammenfassung

Gegenstand und Ziel: Zur Messung der kaninen und felinen Pankreaslipase-Immunreaktivität gibt es seit mehreren Jahren kommerzielle Tests (Spec cPL®, Spec fPL®). Ziel der Studie war, neu verfügbare, bisher in der Literatur nicht validierte Assays mit den etablierten Assays zu vergleichen. Material und Methoden: Überschüssige Serumproben des GI-Labors der Texas A&M University wurden basierend auf verschiedenen Parametern (z. B. gute Probenqualität, hämolytische, lipämische, ikterische Proben) gesammelt und mit randomisierten ID-Nummern gekennzeichnet. Nach Durchführung der Tests Spec cPL® bzw. Spec fPL® wurden die Proben auf Trockeneis an die Kleintierklinik am Hochberg (Deutschland) versandt. Von dort ging ein Teil jeder Probe zur Untersuchung mit den neuen Assays verblindet an das Diagnostiklabor Laboklin (Deutschland). Ein weiterer Teil jeder Probe wurde zur erneuten Testung an das GI-Labor zurückgeschickt, um transportbedingte Veränderungen ausschließen zu können. Die Ergebnisse wurden mittels Wilcoxon-Vorzeichen-Rang-Tests, Rangkorrelationskoeffizienten, Bias Plots, Regressionsgleichung und Konkordanzkoeffizienten statistisch ausgewertet. Ergebnisse: Die Resultate des Spec cPL® und Spec fPL® im GI-Labor vor bzw. nach dem Transport differierten nicht signifikant (Wilcoxon-Rangsummentest: p = 0,581 bzw. 0,712). Zwischen den Ergebnissen der neuen Assays und der etablierten Assays bestanden signifikante Unterschiede (p = 0,0004 bzw. 0,025). Es zeigte sich zwar eine signifikante Assoziation zwischen den neuen und den etablierten Assays (Spearman r: 0,775 und 0,739), doch wurden signifikante systematische Abweichungen für die neuen Assays festgestellt. Konkordanzkoeffizienten der neuen Assays im Vergleich zu den etablierten Assays erwiesen sich als schwach (0,539 bzw. 0,465). Die klinische Interpretation der cPLund fPL-Ergebnisse stimmte in vielen Fällen nicht überein. Schlussfolgerung und klinische Relevanz: Die neuen Assays zur Bestimmung der cPL und fPL weisen statistisch signifikante Ungenauigkeiten auf und ergeben teilweise andere klinische Interpretationen. Deshalb sind weitere Studien zur Validierung der Tests nötig, bevor sie für den klinischen Gebrauch empfohlen werden können.

Summary

Objective: Commercial assays for the measurement of canine and feline pancreatic lipase immunoreactivity (Spec cPL® and Spec fPL®) have been available for a few years. The aim of this study was to compare new commercial assays that have not previously been validated in the literature to the established assays. Material and methods: Leftover serum samples from diagnostic submissions to the GI-lab of the Texas A&M University were collected based on certain parameters (e.g., good quality sample, hemolytic, lipemic, or icteric sample) and were assigned random sample ID numbers. The samples were evaluated by Spec cPL® or Spec fPL® and sent on dry ice to the Kleintierklinik am Hochberg (Germany). From here one aliquot of each sample was blindly submitted to the diagnostic laboratory Laboklin (Germany) for measurement of cPL and fPL by their newly released assay and also to the GI-Lab (Texas) for repeated analysis to exclude any effect of shipping. Results: There was no significant difference between serum cPL or fPL concentrations before or after shipping at the GI-Lab (Texas) (Wilcoxon paired sample signed rank tests p = 0.581 and 0.712, respectively). Significant differences were found between serum cPL or fPL concentrations of the newly released assays and the established assays (p < 0.0004 and p = 0.025, respectively). The newly released and the established assays showed some association (Spearman r: 0.775 and 0.739, respectively), however, there was a strong bias between the new assays and the established assays. The strength of agreement between the new and established canine and feline assays was poor (concordance coefficient 0.539 and 0.465, respectively). Also, the clinical interpretation for serum cPL and fPL results did not agree for many of the samples. Conclusion and clinical relevance: In conclusion, the newly released assays for the measurement of cPL and fPL show significant bias and poor concordance and provide different clinical interpretations when compared with validated assays. Thus, further research is needed before these newly released assays can be recommended for clinical use.

Schlüsselwörter

Pankreatitis - Methodenvergleich - cPL - fPL - Hund - Katze

Keywords

Pancreatitis - method comparison - cPL - fPL - canine - feline
 

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