Department of Chemical Pathology, Faculty of Health Sciences, University of Witwatersrand, 7 York Road, Parktown, Johannesburg, 2193, South Africa.
National Health Laboratory Service, Johannesburg, South Africa.
BMC Nephrol. 2021 Mar 20;22(1):103. doi: 10.1186/s12882-021-02290-5.
The prevalence of chronic kidney disease (CKD) is predicted to rise over the next few decades. In resource-limited settings access to central laboratory services is limited. Point-of-care (POC) urine dipstick testing offers the potential to detect markers of kidney damage (albuminuria) as well as markers of other disease processes. We evaluated the diagnostic accuracy of the semi-quantitative albumin-creatinine ratio (ACR) Sysmex UC-1000 POC urine dipstick system as well as the extent of other abnormal dipstick findings in urine.
700 participants from a rural area in South Africa were screened for albuminuria. A spot urine sample was used to measure POC and central laboratory ACR. We determined the sensitivity, specificity, positive predictive value and negative predictive value of the POC ACR, and recorded dipstick parameters.
The prevalence of albuminuria was 11.6% (95%CI; 9.3-14.2). Those with albuminuria had higher mean diastolic (82 vs 79 mmHg, p = 0.019) and systolic (133 vs 128 mmHg, p = 0.002) blood pressures and a higher proportion of diabetes mellitus (17.6 vs 4.9%, p < 0.001). The sensitivity of the POC ACR system was 0.79, specificity 0.84, positive predictive value 0.39 and negative predictive value 0.97. The sensitivity improved to 0.80, 0.85, 0.85 and 0.89 in those with elevated blood pressure, diabetes mellitus, HIV positive status, and those 65 years and older, respectively. Abnormalities other than albuminuria were detected in 240 (34.3%) of the samples; 88 (12.6%) were positive for haematuria, 113 (16.1%) for leucocytes, 66 (9.4%) for nitrites and 27 (3.9%) for glycosuria.
Our study shows that POC ACR has good negative predictive value and could be used to rule out albuminuria when screening for CKD. Additionally, a high proportion of participants had other urine abnormalities detected with dipsticks which may reflect kidney disease or co-morbid untreated genitourinary pathology such as urinary tract infections or endemic schistosomiasis with important implications for CKD.
在未来几十年,慢性肾脏病(CKD)的患病率预计将会上升。在资源有限的环境中,中心实验室服务的获取受到限制。即时检测(POC)尿液干化学试纸检测有潜力检测到肾脏损伤(蛋白尿)的标志物以及其他疾病过程的标志物。我们评估了半定量白蛋白-肌酐比值(ACR)Sysmex UC-1000 POC 尿液干化学试纸系统的诊断准确性,以及尿液中其他异常干化学试纸检测结果的程度。
从南非农村地区筛选了 700 名参与者,以检测蛋白尿。采集一份随机尿液样本,用于测量 POC 和中心实验室 ACR。我们确定了 POC ACR 的灵敏度、特异性、阳性预测值和阴性预测值,并记录了干化学试纸参数。
蛋白尿的患病率为 11.6%(95%CI;9.3-14.2)。蛋白尿患者的平均舒张压(82 与 79mmHg,p=0.019)和收缩压(133 与 128mmHg,p=0.002)更高,糖尿病(17.6%与 4.9%,p<0.001)的比例更高。POC ACR 系统的灵敏度为 0.79,特异性为 0.84,阳性预测值为 0.39,阴性预测值为 0.97。在血压升高、糖尿病、HIV 阳性和 65 岁及以上的人群中,灵敏度分别提高至 0.80、0.85、0.85 和 0.89。在 240 份(34.3%)样本中检测到除蛋白尿以外的其他异常;88 份(12.6%)尿液潜血阳性,113 份(16.1%)白细胞阳性,66 份(9.4%)亚硝酸盐阳性,27 份(3.9%)尿糖阳性。
我们的研究表明,POC ACR 具有良好的阴性预测值,可用于在 CKD 筛查中排除蛋白尿。此外,用干化学试纸检测到的尿液异常比例较高,这可能反映了肾脏疾病或合并未经治疗的泌尿生殖系统疾病,如尿路感染或地方性血吸虫病,这对 CKD 具有重要意义。