Chalifoux Nolan V, Rizzo Kaila, Stefanovski Darko, Weinstein Nicole M, Silverstein Deborah C
Department of Clinical Sciences and Advanced Medicine, University of Pennsylvania, School of Veterinary Medicine, Philadelphia, Pennsylvania, USA.
Veterinary Specialty Hospital Sorrento Valley, San Diego, California, USA.
Vet Clin Pathol. 2022 Dec;51(4):533-542. doi: 10.1111/vcp.13147. Epub 2022 Jun 21.
Creatinine is a universally important blood parameter used to detect and monitor acute and chronic kidney disease. Reliable measurements at the bedside remain a challenge in human and veterinary medicine. Despite its potential, a trustworthy point-of-care creatinine biosensor has yet to be established.
We aimed to determine the precision and accuracy of the StatSensor (SS) and StatSensor Xpress (SSX) handheld creatinine measurement devices in dogs.
Paired creatinine samples from dogs with normal (creatinine ≤159 μmol/L), moderate (159-354 μmol/L), and marked (>354 μmol/L) azotemia were compared with a commercial enzymatic analyzer. Within-day precision and linearity studies were performed prior to method comparison studies. Method comparison was evaluated using Bland-Altman, concordance correlation coefficient, Deming, and Passing-Bablok regression analysis.
Seventy-eight dogs were enrolled in the study, including 28 (35%), 25 (32%), and 26 (33%) with normal, moderate, and marked azotemia. Total error surpassed recommendations for all devices, and linearity deviated from identity for the SS1 and SS2. The concordance correlation coefficients of the SS1, SS2, SSXI, and SSX2, were 0.69, 0.59, 0.82, and 0.44, respectively. Bland-Altman analyses showed a high variation in the differences, and relationships showed high heteroskedasticity with negative systemic bias among high creatinine concentrations.
Neither the SS and SSX are considered acceptable for clinical applications in dogs. Further research is indicated for the development of a reliable, cost-effective, point-of-care creatinine analyzer to improve the rapid detection and monitoring human and veterinary patients.
肌酐是一种普遍重要的血液参数，用于检测和监测急慢性肾病。在人和兽医学中，床旁的可靠测量仍然是一项挑战。尽管有潜力，但一种值得信赖的即时检测肌酐生物传感器尚未建立。
我们旨在确定StatSensor（SS）和StatSensor Xpress（SSX）手持式肌酐测量设备在犬中的精密度和准确性。
将来自肌酐水平正常（肌酐≤159μmol/L）、中度（159 - 354μmol/L）和重度（>354μmol/L）氮质血症犬的配对肌酐样本与商用酶分析仪进行比较。在方法比较研究之前进行日内精密度和线性研究。使用Bland - Altman分析、一致性相关系数、Deming分析和Passing - Bablok回归分析评估方法比较。
78只犬纳入研究，其中28只（35%）肌酐水平正常，25只（32%）中度氮质血症，26只（33%）重度氮质血症。所有设备的总误差均超过推荐值，并且SS1和SS2的线性与恒等性存在偏差。SS1、SS2、SSXI和SSX2的一致性相关系数分别为0.69、0.59、0.82和0.44。Bland - Altman分析显示差异变化很大，并且关系显示在高肌酐浓度下具有高异方差性和负系统偏差。
SS和SSX均不被认为可接受用于犬的临床应用。需要进一步研究开发一种可靠、经济高效的即时检测肌酐分析仪，以改善对人和兽医患者的快速检测和监测。
