Analytical validation of cardiac troponin I assays in horses.
Abstract: Human cardiac troponin I (cTnI) assays have been used in equine medicine, often without prior analytical validation for equine use. In the absence of appropriate validation, the clinical significance of assay results is uncertain and can lead to misdiagnosis. We followed the American Society for Veterinary Clinical Pathology guidelines and investigated linearity, precision, limit of quantification (LoQ), and comparative recovery for 6 commercial cTnI assays developed for use in human medicine. Clinically acceptable linearity was observed in assays A-D, whereas assay E did not detect equine cTnI in any sample. Comparative recovery revealed 1-3-fold differences between assay results, and low analyte recoveries (2.2-3.4%) were observed in assay F. Precision was investigated in assays A and B, and found to be within acceptable limits. The LoQ was 1.53 ng/L for assay A, and 0.031 µg/L for assay B. Assays A and B performed within clinically acceptable limits and were deemed suitable for use in equine medicine. Assays C and D did not undergo full validation but had acceptable linearity, which demonstrates their potential for use in equine medicine. Assays E and F are unsuitable for use in horses given issues with detection of equine cTnI. The variability in results between assays indicates that reference intervals and cutoffs for diagnostic decision-making are assay specific and should be established prior to adoption by diagnostic laboratories.
Publication Date: 2017-12-10 PubMed ID: 29224512PubMed Central: PMC6505877DOI: 10.1177/1040638717747070Google Scholar: Lookup
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- Journal Article
- Validation Study
- Analytical Methods
- Biomarkers
- Cardiac Arrhythmias
- Clinical Findings
- Clinical Pathology
- Clinical Study
- Comparative Study
- Diagnosis
- Diagnostic Technique
- Disease Diagnosis
- Disease Management
- Disease Treatment
- Equine Diseases
- Equine Health
- Equine Medicine
- Heart
- Horses
- Laboratory Methods
- Veterinary Medicine
- Veterinary Practice
- Veterinary Research
Summary
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The research assessed the accuracy and reliability of six human cardiac troponin I (cTnI) assays when used in horses. The tests were evaluated for linearity, precision, limit of quantification, and comparative recovery. Two of the assays were found to be reliable and suitable for use in horses, while two showed potential for use, and two were deemed unsuitable.
Methodology
- The researchers employed the American Society for Veterinary Clinical Pathology guidelines to validly assess six commercial cTnI assays originally designed for human medical use.
- The study examined the linearity which verifies whether the test results are straightforwardly proportional to the sample concentration for each assay.
- Precision, which tells us how consistently a test measures the same sample, was also examined in two assays, A and B.
- The lowest amount of cTnI that can be distinguished and reliably quantified, known as the limit of quantification (LoQ), was evaluated for the two assays.
- Comparative recovery was observed which checks if a test correctly reports the amount of analyte in a sample.
Findings
- Out of the six assays tested, assays A to D showed clinically acceptable linearity, meaning the tests results of these assays have a direct relationship with the sample concentrations.
- Assays A and B presented acceptable levels of precision and their LoQ was found to be 1.53 ng/L and 0.031 µg/L respectively.
- However, assay E failed to detect any equine cTnI in samples, rendering it unfit for use in equine medicine.
- Assay F also was found to be unsuitable due to its low recovery rates, that is, it failed to accurately detect the quantity of analyte present in a sample.
Implications
- Based on these findings, assays A and B are appropriate for use in equine medicine as they met clinically acceptable standards for linearity, precision, and limit of quantification.
- While assays C and D didn’t undergo full validation, their acceptable linearity gives them potential for use in equine medicine.
- Assays E and F, due to their failure to detect or accurately measure cTnI, are not suitable for use in equine medicine.
- The study also highlighted the importance of establishing reference intervals and cutoffs specific to each assay for diagnostic decision-making prior to their use in diagnostic laboratories.
Cite This Article
APA
Rossi TM, Kavsak PA, Maxie MG, Pearl DL, Pyle WG, Physick-Sheard PW.
(2017).
Analytical validation of cardiac troponin I assays in horses.
J Vet Diagn Invest, 30(2), 226-232.
https://doi.org/10.1177/1040638717747070 Publication
Researcher Affiliations
- Departments of Population Medicine (Rossi, Pearl, Physick-Sheard) and Biomedical Sciences (Pyle), Laboratory Services Division, University of Guelph, Guelph, Ontario, Canada.
- Ontario Veterinary College, Animal Health Laboratory (Maxie), Laboratory Services Division, University of Guelph, Guelph, Ontario, Canada.
- Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada (Kavsak).
- Departments of Population Medicine (Rossi, Pearl, Physick-Sheard) and Biomedical Sciences (Pyle), Laboratory Services Division, University of Guelph, Guelph, Ontario, Canada.
- Ontario Veterinary College, Animal Health Laboratory (Maxie), Laboratory Services Division, University of Guelph, Guelph, Ontario, Canada.
- Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada (Kavsak).
- Departments of Population Medicine (Rossi, Pearl, Physick-Sheard) and Biomedical Sciences (Pyle), Laboratory Services Division, University of Guelph, Guelph, Ontario, Canada.
- Ontario Veterinary College, Animal Health Laboratory (Maxie), Laboratory Services Division, University of Guelph, Guelph, Ontario, Canada.
- Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada (Kavsak).
- Departments of Population Medicine (Rossi, Pearl, Physick-Sheard) and Biomedical Sciences (Pyle), Laboratory Services Division, University of Guelph, Guelph, Ontario, Canada.
- Ontario Veterinary College, Animal Health Laboratory (Maxie), Laboratory Services Division, University of Guelph, Guelph, Ontario, Canada.
- Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada (Kavsak).
- Departments of Population Medicine (Rossi, Pearl, Physick-Sheard) and Biomedical Sciences (Pyle), Laboratory Services Division, University of Guelph, Guelph, Ontario, Canada.
- Ontario Veterinary College, Animal Health Laboratory (Maxie), Laboratory Services Division, University of Guelph, Guelph, Ontario, Canada.
- Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada (Kavsak).
- Departments of Population Medicine (Rossi, Pearl, Physick-Sheard) and Biomedical Sciences (Pyle), Laboratory Services Division, University of Guelph, Guelph, Ontario, Canada.
- Ontario Veterinary College, Animal Health Laboratory (Maxie), Laboratory Services Division, University of Guelph, Guelph, Ontario, Canada.
- Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada (Kavsak).
MeSH Terms
- Animals
- Biological Assay / methods
- Biological Assay / veterinary
- Horses / blood
- Reference Values
- Reproducibility of Results
- Troponin I / blood
Conflict of Interest Statement
PA Kavsak has received grants/ honoraria/consultant/advisor fees from Abbott
Laboratories, Abbott Point of Care, Beckman Coulter, Ortho Clinical Diagnostics,
Randox Laboratories, Roche Diagnostics, and the Canadian Agency for Drugs and
Technologies in Health. He is listed as an inventor on patents filed by McMaster
University related to laboratory testing in acute cardiac care. The other
authors declared no potential conflicts of interest with respect to the
research, authorship, and/or publication of this article.
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Citations
This article has been cited 5 times.- Garcia Filho SG, de Andrade FSRM, Dos Santos RST, Gonçalves LA, Pereira MAA, de Souza AF, Ambrósio AM, Fantoni DT. Comparison of Hemodynamic Effects of Dobutamine and Ephedrine Infusions in Isoflurane-Anesthetized Horses. Vet Sci 2023 Apr 6;10(4).
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