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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
 

  • Literatur

  • 1 Altman DG, Bland JM. Measurement in medicine: The analysis on method comparison studies. Statistician 1983; 32: 307-317.
    CrossrefPubMedGoogle Scholar
  • 2 Beall MJ, Cahill R, Pigeon K, Hanscon J, Huth SP. Performance validation and method comparison of an in-clinic enzyme-linked immunosorbent assay for the detection of canine pancreatic lipase. J Vet Diagn Invest 2011; 23, 1: 115-119.
    PubMedGoogle Scholar
  • 3 Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 01: 307-310.
    PubMedGoogle Scholar
  • 4 Breu D, Tress U, Aupperle H, Mueller E. Evaluation of the pancreatic lipase immunoreactivity-concentration (PLI) in sera from 1843 dogs. 23rd ECVIM-CA Congress, Liverpool, September 12–14, 2013 (abstract).
    PubMedGoogle Scholar
  • 5 De Cook HE, Foran MA, Farver TB, Marks SL. Prevalence and histopathologic characteristics of pancreatitis in cats. J Vet Pathol 2007; 44 (01) 39-49.
    PubMedGoogle Scholar
  • 6 Ekins R. Immunoassay standardization. Scan J Clin Lab Invest. 1991 51. Suppl. 205: 33–46.
    PubMedGoogle Scholar
  • 7 Ferreri JA, Hardam E, Kimmel SE, Saunders HM, Van Winkle TJ, Drobatz KJ, Washabau RJ. Clinical differentiation of acute necrotizing from chronic nonsuppurative pancreatitis in cats: 63 cases (1996–2001). J Am Vet Med Assoc 2003; 223 (04) 469-474.
    CrossrefPubMedGoogle Scholar
  • 8 Flatland B, Freeman KP, Friedrichs KR. et al. ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories. Vet Clin Pathol 2010; 39: 264-267.
    CrossrefPubMedGoogle Scholar
  • 9 Flatland B, Friedrichs KR, Klenner S. Differentiating between analytical and diagnostic performance evaluation with a focus on the method comparison study and identification of bias. Vet Clin Pathol 2014; 43 (04) 475-486.
    CrossrefPubMedGoogle Scholar
  • 10 Forman MA, Marks SL, De Cock HEV, Hergesell EJ, Wisner ER, Baker TW, Kass PH, Steiner JM, Williams DA. Evaluation of serum feline pancreatic lipase immunoreactivity and helical computed tomography versus conventional testing for the diagnosis of feline pancreatitis. J Vet Intern Med 2004; 18: 807-815.
    CrossrefPubMedGoogle Scholar
  • 11 Harr KE, Flatland B, Nabity M, Freeman KP. ASVCP guidelines: allowable total error guidelines for biochemistry. Vet Clin Pathol 2013; 42: 424-436.
    CrossrefPubMedGoogle Scholar
  • 12 Hänichen T, Minkus G. Retrospektive Studie zur Pathologie der Erkrankungen des exokrinen Pankreas bei Hund und Katze. Tierärztl Umsch 1990; 45: 363-368.
    PubMedGoogle Scholar
  • 13 Hess RS, Saunders HM, Van Winkle TJ, Shofer FS, Washabau RJ. Clinical, clinicopathologic, radiographic, and ultrasonographic abnormalities in dogs with fatal acute pancreatitis: 70 cases (1986–1995). J Am Vet Med Assoc 1998; 213 (05) 665-670.
    PubMedGoogle Scholar
  • 14 Hill RC, Van Winkle TJ. Acute necrotizing pancreatitis and acute suppurative pancreatitis in the cat. A retrospective study of 40 cases (1976–1989). J Vet Intern Med 1993; 07 (01) 25-33.
    CrossrefPubMedGoogle Scholar
  • 15 Huth SP, Relford R, Steiner JM, Strong-Townsend MI, Williams DA. Analytical validation of an ELISA for measurement of canine pancreas-specific lipase. Vet Clin Pathol 2010; 39: 346-353.
    CrossrefPubMedGoogle Scholar
  • 16 Jensen AL. Kjelgaard-Hansen Method comparison in the clinical laboratory. Vet Clin Pathol 2006; 35: 276-286.
    CrossrefPubMedGoogle Scholar
  • 17 Kalenyak K, Schadow A, Burgener IA. Diagnosis of canine pancreatitis dependent on snap CPLTM and spec CPLTM. Proceedings 22nd ECVIM-CA Congress, Maastricht, Netherland, September 6–8, 2012 (abstract).
    PubMedGoogle Scholar
  • 18 Lin LK. A concordance correlation coefficient to evaluate reproducibility. Biometrics 1989; 45: 255-268.
    CrossrefPubMedGoogle Scholar
  • 19 Linnet K. Evaluation of regression procedures for methods comparison studies. Clin Chem 1993; 39: 424-432.
    PubMedGoogle Scholar
  • 20 Mansfield CS, Jones BR. Plasma and urinary trypsinogen activation peptide in healthy dogs, dogs with pancreatitis and dogs with other systemic diseases. Aust Vet J 2000; 78: 416-422.
    CrossrefPubMedGoogle Scholar
  • 21 McCord K, Morley PS, Armstrong J, Simpson K, Rishniw M, Forman MA, Biller D, Parnell N, Arnell K, Hill S, Avgeris S, Gittelman H, Moore M, Hitt M, Oswald G, Marks S, Burney D, Twedt D. A multi-institutional study evaluating the diagnostic utility of the Spec cPLTM and SNAP cPLTM in clinical acute pancreatitis in 84 dogs. J Vet Intern Med 2012; 26: 888-896.
    CrossrefPubMedGoogle Scholar
  • 22 Neilson-Carley SA, Robertson JE, Newman SJ, Kutchmarick D, Relford R, Woosley K, Steiner JM. Specificity of a canine pancreas-specific lipase assay for diagnosing pancreatitis in dogs without clinical or histologic evidence of the disease. Am J Vet Res 2011; 72: 302-307.
    CrossrefPubMedGoogle Scholar
  • 23 Newman SJ, Steiner JM, Woosley K. et al. Localization of histologic pancreatitis lesions in dogs. J Vet Intern Med 2004; 18: 488-493.
    CrossrefPubMedGoogle Scholar
  • 24 Passing H. Bablok A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983; 21: 709-720.
    PubMedGoogle Scholar
  • 25 Petersen PH, Stockl D, Blaabjerg O, Pedersen B. et al. Graphical interpretation of analytical data from comparison of a field method with a reference method by use of difference plots. Clin Chem 1997; 43: 2039-2046.
    PubMedGoogle Scholar
  • 26 Sinclair HM, Fleeman LM, Rand JS. et al. Continuing pancreatic inflammation or reduced exocrine function are common in dogs after acute pancreatitis. J Vet Intern Med 2006; 20: 750.
    PubMedGoogle Scholar
  • 27 Steiner JM, Broussard J, Mansfield CS. et al. Serum canine pancreatic lipase immunoreactivity (cPL) concentrations in dogs with spontaneous pancreatitis. J Vet Intern Med 2001; 15: 274.
    PubMedGoogle Scholar
  • 28 Steiner JM, Rutz GM, Williams DA. Serum lipase activities and pancreatic lipase immunoreactivity concentrations in dogs with exocrine pancreatic insufficiency. Am J Vet Res 2006; 67: 84-87.
    CrossrefPubMedGoogle Scholar
  • 29 Steiner JM, Teague SR, Williams DA. Development and analytic validation of an enzyme-linked immunosorbent assay for the measurement of canine pancreatic lipase immunoreactivity in serum. Can J Vet Res 2003; 67: 175-182.
    PubMedGoogle Scholar
  • 30 Stockham SL, Scott MA. Introductory concepts. In: Fundamentals of Veterinary Clinical Pathology. 2nd edn.. Stockham SL, Scott MA. eds. Ames, IA:: Blackwell; 2008. 03 51.
    Google Scholar
  • 31 Strombeck DR, Farver T, Kaneko JJ. Serum amylase and lipase activities in the diagnosis of pancreatitis in dogs. Am J Vet Res 1981; 42: 1966-1970.
    PubMedGoogle Scholar
  • 32 Suchodolski JS, Ruaux CG, Steiner JM. et al. Serum α1-proteinase inhibitor/trypsin complex as a marker for canine pancreatitis. J Vet Intern Med 2001; 15: 273.
    PubMedGoogle Scholar
  • 33 Tress U, Müller S, Kahnt E, Müller E. Entwicklung und Validierung eines nicht invasiven Testes zur Diagnose der Pankreatitis beim Hund. Proceedings der 28. Jahrestagung der Vereinigung Österreichischer Kleintiermediziner (VÖK), 20.–22. September 2013 in Salzburg.
    PubMedGoogle Scholar
  • 34 Trivedi S, Marks SL, Kass PH, Luff JA, Keller SM, Johnson EG, Murphy B. Sensitivity and specificity of canine pancreas-specific lipase (cPL) and other markers for pancreatitis in 70 dogs with and without histopathologic evidence of pancreatitis. J Vet Intern Med 2011; 25: 1241-1247.
    CrossrefPubMedGoogle Scholar
  • 35 Westgard JO. Basic Method Validation. 3rd ed.. Madison, WI: Westgard QC, Inc; 2008
    Google Scholar
  • 36 Xenoulis P, Steiner JM. Canine and feline pancreatic lipase immunoreactivity. Vet Clin Pathol 2012; 41: 312-324.
    CrossrefPubMedGoogle Scholar