Chronic kidney disease prevalence in Rivas, Nicaragua: Use of a field device for creatinine measurement
Chronic kidney disease prevalence in Rivas, Nicaragua: Use of a field device for creatinine measurement
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DOI：
10.1016/j.clinbiochem.2015.01.005
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发表时间：
2015-04-01
影响因子：
2.8
通讯作者：
Fiore, Louis
中科院分区：
文献类型：
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作者：
Minnings, Kailey;Kerns, Eric;Fiore, Louis
目标：中美洲太平洋沿岸地区已发现慢性肾病（CKD）流行，这些低收入国家的现场筛查在后勤方面仍然存在问题。我们测试了护理点肌酐分析仪与标准化血清肌酐测量结果的性能特征。方法：使用护理点分析仪（StatSensor Xpress，Nova Biomedical）和罗氏 Cobas Integra 400 分析仪通过 Jaffe 动力学方法对来自尼加拉瓜里瓦斯当地健康中心 (n = 34) 和医院 (n = 66) 的 100 名人员进行了测量。确定 StatSensor Xpress 的变异系数百分比、灵敏度和特异性。结果：血清肌酐的平均变异系数 (CV) 为 1.28%，StatSensor Xpress 分析仪的 CV 为 6.8%。使用 StatSensor Xpress 设备获得的个体内肌酐结果中位数比 Jaffe 动力学方法获得的血清肌酐结果高 0.32 mg/dL。 StatSensor Xpress 设备用于识别肌酐异常（定义为 >1.2 mg/dL）受试者的灵敏度和特异性分别为 100% 和 79%。 结论：肌酐即时检测显示出可接受的重复性、出色的灵敏度 (100%) 和中等的特异性 (79%)。使用护理点检测将允许在低收入国家进行现场普遍筛查；然而，确认升高水平 >1.2 mg/dL 将需要第二次实验室测试确认。 (C) 2015 年加拿大临床化学家协会。由爱思唯尔公司出版。保留所有权利。
Objective: An epidemic of chronic kidney disease (CKD) has been identified in Pacific coastal regions of Central America, and screening in the field in these low income countries remains logistically problematic. We tested the performance characteristics of a point of care creatinine analyzer compared to standardized serum creatinine measurements.Methods: Measurements were conducted in 100 persons from a local health center (n = 34) and hospital (n = 66) in Rivas, Nicaragua using both a point-of-care analyzer (StatSensor Xpress, Nova Biomedical) and serum creatinine by Jaffe kinetic method with a Roche Cobas Integra 400 analyzer. Percent coefficient of variation, sensitivity and specificity of the StatSensor Xpress were determined.Results: The average coefficient of variation (CV) was 1.28% for the serum creatinine and CV for the StatSensor Xpress analyzer was 6.8%. The median intra-individual creatinine results obtained with the StatSensor Xpress device were 0.32 mg/dL higher than those by serum creatinine by Jaffe kinetic method. The sensitivity and specificity of the StatSensor Xpress device for identifying subjects with abnormal creatinine (defined as >1.2 mg/dL) was 100% and 79%, respectively.Conclusions: Point of care testing for creatinine demonstrated acceptable repeatability, excellent sensitivity (100%) and modest specificity (79%). Using the point of care testing will allow for generalized screening in the field in low income countries; however, confirmation for elevated levels >1.2 mg/dL will require a second laboratory test confirmation. (C) 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.