Yang Chia-Ju, Chen Ding-Ping, Wen Ying-Hao, Lai Nan-Chang, Ning Hsiao-Chen
Department of Laboratory Medicine, Taiwan, Republic of China.
Department of Laboratory Medicine, Taiwan, Republic of China; Medical Biotechnology and Laboratory Science, Taiwan, Republic of China; Graduate Institute of Biomedical Sciences, Taiwan, Republic of China.
Clin Chim Acta. 2020 Nov;510:177-180. doi: 10.1016/j.cca.2020.06.036. Epub 2020 Jun 25.
Taiwan has the highest end-stage renal disease prevalence in the world, and the costs on the maintenance of dialysis imposes a great financial burden on National Health Insurance. Routine urinalysis provides an opportunity for the early detection of microalbuminuria. We evaluated the accuracy of semi-quantitative chemical methods from Siemens Novus Pro12 dipstick for albumin-creatinine ratio (ACR).
We collected 1029 random urine samples and performed urinary analytic tests by Siemens Novus with Pro12 dipsticks and also calculated the urinary ACR. The reference method was performed by Hitachi LST008, a quantitative assay. The percentage of exact agreement in ACR was 81.9% between Siemens Novus and Hitachi LST008. The percentage of agreement within 1 level between the 2 methods was 98.5%. When ACR > 30 mg/g was defined as the threshold for positive results, the sensitivity, specificity, positive, and negative predictive values for microalbuminuria were 87.2%, 91.6%, 91.5%, and 87.3%, respectively. There were 778 cases with negative results of urinary protein, analyzed by conventional dipsticks. 149 of 778 (19.2%) cases were positive, measured by Pro12 dipsticks, and 111 of 149 (74.5%) cases were confirmed positive ACR by Hitachi LST008.
Urinary ACR measured by Siemens Novus with Pro12 dipsticks was shown to be a reliable test for detection of microalbuminuria.
台湾是世界上终末期肾病患病率最高的地区，维持透析的费用给国民健康保险带来了巨大的经济负担。常规尿液分析为早期检测微量白蛋白尿提供了机会。我们评估了西门子Novus Pro12试纸条半定量化学方法检测白蛋白-肌酐比值（ACR）的准确性。
我们收集了1029份随机尿液样本，使用西门子Novus Pro12试纸条进行尿液分析测试，并计算尿液ACR。参考方法采用日立LST008定量检测法。西门子Novus与日立LST008之间ACR的完全一致率为81.9%。两种方法在1个水平内的一致率为98.5%。当ACR>30mg/g被定义为阳性结果阈值时，微量白蛋白尿的灵敏度、特异度、阳性预测值和阴性预测值分别为87.2%、91.6%、91.5%和87.3%。对778例尿蛋白检测结果为阴性的病例，采用传统试纸条进行分析。在778例（19.2%）病例中，Pro12试纸条检测出149例为阳性，其中111例（74.5%）经日立LST008确认为ACR阳性。
西门子Novus Pro12试纸条检测尿液ACR是一种可靠的微量白蛋白尿检测方法。
