在乌干达，一项针对 HIV 感染者青少年人群的横断面研究显示，即时白蛋白尿检测在慢性肾脏病筛查中的诊断性能。

Diagnostic performance of an albuminuria point-of-care test in screening for chronic kidney disease among young people living with HIV in Uganda: a cross-sectional study.

机构信息

Infectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda

Non-communicable Diseases Program, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.

出版信息

BMJ Open. 2024 Aug 17;14(8):e083221. doi: 10.1136/bmjopen-2023-083221.

DOI:10.1136/bmjopen-2023-083221

PMID:39153770

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11331864/

Abstract

OBJECTIVES

The main aim was to determine the diagnostic performance of an albuminuria point-of-care test (POC) for diagnosis of chronic kidney disease among young people living with HIV (YPLHIV) in Uganda.

DESIGN

We conducted a cross-sectional study comparing the diagnostic performance of MicroalbuPHAN (Erba Lachema, Czech Republic), an albuminuria POC test against the laboratory-measured albumin and creatinine as the reference standard.

SETTING

The study was set in seven HIV clinics in Kampala, Uganda that provide antiretroviral therapy to adults and children living with HIV. The study took place from April to August 2023.

PARTICIPANTS

497 YPLHIV aged 10-24 years who were diagnosed with HIV before 10 years of age were randomly selected from the HIV clinics. Pregnant YPLHIV were excluded.

PROCEDURES

Participants provided a spot urine sample that was tested for albumin and creatinine using the POC and in the laboratory and proteinuria using urine dipstick. The sensitivity, specificity, negative and positive predictive values (NPV, PPV) of the POC versus the laboratory test were calculated, and factors associated with having a positive POC test were estimated using logistic regression.

OUTCOME MEASURES

The primary outcome was a diagnosis of albuminuria defined as an albumin creatinine ratio above 30 mg/g.

RESULTS

Of the 497 participants enrolled, 278 (55.9%) were female and 331 (66.8%) were aged 10-17 years. The POC test had a sensitivity of 74.5% (95% CI 70.6% to 78.4%) and specificity of 68.1% (95% CI 63.9% to 72.3%). The PPV was 21.5% (95% CI 17.8% to 25.1%) and the NPV was 95.8% (95% CI 94.0% to 97.6%), with an accuracy of 68.8%. There was strong evidence that a positive POC test was associated with having proteinuria (OR 2.82; 95% CI 1.89 to 4.22, p<0.001); body mass index <19.5 (OR 1.69 95% CI 1.17 to 2.45, p=0.005) and being male (OR 1.48; 95% CI 1.02 to 2.14, p=0.04).

CONCLUSIONS

The albuminuria POC test had low sensitivity and specificity. However, it can be used to exclude kidney disease given its high NPV. It should be validated against the 24-hour urinary excretion rate to further determine its diagnostic performance.

摘要

目的

本研究旨在评估一种即时白蛋白检测（POC）在乌干达 HIV 阳性青年人群中诊断慢性肾脏病的诊断性能。

设计

本研究为一项横断面研究，比较了 MicroalbuPHAN（捷克的 Erba Lachema）即时白蛋白检测与实验室白蛋白和肌酐测量作为参考标准的诊断性能。

地点

本研究在乌干达坎帕拉的 7 家 HIV 诊所进行，这些诊所为成人和儿童 HIV 阳性患者提供抗逆转录病毒治疗。研究于 2023 年 4 月至 8 月进行。

参与者

497 名年龄在 10-24 岁之间的 HIV 阳性青年，他们在 10 岁之前被诊断为 HIV。排除孕妇 HIV 阳性青年。

程序

参与者提供了一份随机尿液样本，使用即时检测和实验室方法检测白蛋白和肌酐，使用尿试纸检测蛋白尿。计算了即时检测与实验室检测的敏感性、特异性、阴性和阳性预测值（NPV、PPV），并使用逻辑回归估计了与即时检测阳性相关的因素。

主要结局

主要结局是诊断为白蛋白尿，定义为白蛋白肌酐比大于 30mg/g。

结果

在纳入的 497 名参与者中，278 名（55.9%）为女性，331 名（66.8%）年龄在 10-17 岁之间。即时检测的敏感性为 74.5%（95%CI 70.6%至 78.4%），特异性为 68.1%（95%CI 63.9%至 72.3%）。PPV 为 21.5%（95%CI 17.8%至 25.1%），NPV 为 95.8%（95%CI 94.0%至 97.6%），准确性为 68.8%。有强有力的证据表明，即时检测阳性与蛋白尿（OR 2.82；95%CI 1.89 至 4.22，p<0.001）、体重指数<19.5（OR 1.69 95%CI 1.17 至 2.45，p=0.005）和男性（OR 1.48；95%CI 1.02 至 2.14，p=0.04）有关。