Marshal A Covin, Robynne R Gomez, Jan S Suchodolski, Jörg M Steiner, Jonathan A Lidbury
{"title":"分析验证点护理测试和自动免疫比浊法测定血清中犬c反应蛋白。","authors":"Marshal A Covin, Robynne R Gomez, Jan S Suchodolski, Jörg M Steiner, Jonathan A Lidbury","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>C-reactive protein (CRP) is an acute phase protein, which is used to evaluate and monitor the response of the innate immune system to a variety of inflammatory processes in the dog. The purpose of this study was to analytically validate a point-of-care assay (IDEXX Catalyst CRP Test) and an immunoturbidimetric assay (Gentian Canine CRP Immunoassay) for the measurement of serum CRP concentrations in dogs. These 2 assays (Catalyst, Gentian) were compared to a previously validated enzyme-linked immunosorbent assay (Tridelta Development EIA Canine CRP Assay). Linearity, precision, reproducibility, and accuracy were assessed using leftover serum samples. Agreement between assays was assessed using leftover serum samples and serum from clinically healthy dogs. Observed to expected ratios (O/E) for dilutional parallelism were 83.9 to 163.1% and 108.3 to 160.6% for the Catalyst and the Gentian assays, respectively. Coefficients of variation for intra-assay variability ranged from 6.4 to 9.5% for the Catalyst assay and 1.5 to 2.6% for the Gentian assay. Coefficients of variation for inter-assay variability ranged from 3.8 to 18.2% for the Catalyst assay and 4.5 to 5.8% for the Gentian assay. The mean O/E for recovery were 97.9% and 98.5% for the Catalyst and Gentian assays, respectively. Correlations between assays were as follows: Catalyst and Tridelta (<i>R</i> <i><sup>2</sup></i> = 0.76), Gentian and Tridelta (<i>R</i> <i><sup>2</sup></i> = 0.79), and Catalyst and Gentian (<i>R</i> <i><sup>2</sup></i> = 0.98). The Catalyst and Gentian assays are both acceptable for measuring CRP in dog serum, but their results are not directly comparable with the Tridelta assay.</p>","PeriodicalId":9550,"journal":{"name":"Canadian journal of veterinary research = Revue canadienne de recherche veterinaire","volume":null,"pages":null},"PeriodicalIF":1.1000,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8451710/pdf/cjvr_04_285.pdf","citationCount":"0","resultStr":"{\"title\":\"Analytical validation of a point-of-care test and an automated immunoturbidimetric assay for the measurement of canine C-reactive protein in serum.\",\"authors\":\"Marshal A Covin, Robynne R Gomez, Jan S Suchodolski, Jörg M Steiner, Jonathan A Lidbury\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>C-reactive protein (CRP) is an acute phase protein, which is used to evaluate and monitor the response of the innate immune system to a variety of inflammatory processes in the dog. The purpose of this study was to analytically validate a point-of-care assay (IDEXX Catalyst CRP Test) and an immunoturbidimetric assay (Gentian Canine CRP Immunoassay) for the measurement of serum CRP concentrations in dogs. These 2 assays (Catalyst, Gentian) were compared to a previously validated enzyme-linked immunosorbent assay (Tridelta Development EIA Canine CRP Assay). Linearity, precision, reproducibility, and accuracy were assessed using leftover serum samples. Agreement between assays was assessed using leftover serum samples and serum from clinically healthy dogs. Observed to expected ratios (O/E) for dilutional parallelism were 83.9 to 163.1% and 108.3 to 160.6% for the Catalyst and the Gentian assays, respectively. Coefficients of variation for intra-assay variability ranged from 6.4 to 9.5% for the Catalyst assay and 1.5 to 2.6% for the Gentian assay. Coefficients of variation for inter-assay variability ranged from 3.8 to 18.2% for the Catalyst assay and 4.5 to 5.8% for the Gentian assay. The mean O/E for recovery were 97.9% and 98.5% for the Catalyst and Gentian assays, respectively. Correlations between assays were as follows: Catalyst and Tridelta (<i>R</i> <i><sup>2</sup></i> = 0.76), Gentian and Tridelta (<i>R</i> <i><sup>2</sup></i> = 0.79), and Catalyst and Gentian (<i>R</i> <i><sup>2</sup></i> = 0.98). The Catalyst and Gentian assays are both acceptable for measuring CRP in dog serum, but their results are not directly comparable with the Tridelta assay.</p>\",\"PeriodicalId\":9550,\"journal\":{\"name\":\"Canadian journal of veterinary research = Revue canadienne de recherche veterinaire\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2021-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8451710/pdf/cjvr_04_285.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Canadian journal of veterinary research = Revue canadienne de recherche veterinaire\",\"FirstCategoryId\":\"97\",\"ListUrlMain\":\"\",\"RegionNum\":4,\"RegionCategory\":\"农林科学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Veterinary\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Canadian journal of veterinary research = Revue canadienne de recherche veterinaire","FirstCategoryId":"97","ListUrlMain":"","RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Veterinary","Score":null,"Total":0}
Analytical validation of a point-of-care test and an automated immunoturbidimetric assay for the measurement of canine C-reactive protein in serum.
C-reactive protein (CRP) is an acute phase protein, which is used to evaluate and monitor the response of the innate immune system to a variety of inflammatory processes in the dog. The purpose of this study was to analytically validate a point-of-care assay (IDEXX Catalyst CRP Test) and an immunoturbidimetric assay (Gentian Canine CRP Immunoassay) for the measurement of serum CRP concentrations in dogs. These 2 assays (Catalyst, Gentian) were compared to a previously validated enzyme-linked immunosorbent assay (Tridelta Development EIA Canine CRP Assay). Linearity, precision, reproducibility, and accuracy were assessed using leftover serum samples. Agreement between assays was assessed using leftover serum samples and serum from clinically healthy dogs. Observed to expected ratios (O/E) for dilutional parallelism were 83.9 to 163.1% and 108.3 to 160.6% for the Catalyst and the Gentian assays, respectively. Coefficients of variation for intra-assay variability ranged from 6.4 to 9.5% for the Catalyst assay and 1.5 to 2.6% for the Gentian assay. Coefficients of variation for inter-assay variability ranged from 3.8 to 18.2% for the Catalyst assay and 4.5 to 5.8% for the Gentian assay. The mean O/E for recovery were 97.9% and 98.5% for the Catalyst and Gentian assays, respectively. Correlations between assays were as follows: Catalyst and Tridelta (R2 = 0.76), Gentian and Tridelta (R2 = 0.79), and Catalyst and Gentian (R2 = 0.98). The Catalyst and Gentian assays are both acceptable for measuring CRP in dog serum, but their results are not directly comparable with the Tridelta assay.
期刊介绍:
The Canadian Journal of Veterinary Research, published by the Canadian Veterinary Medical Association, is Canada''s only veterinary research publication. This quarterly peer-reviewed online-only journal has earned a wide international readership through the publishing of high quality scientific papers in the field of veterinary medicine. The Journal publishes the results of original research in veterinary and comparative medicine.