Abstract：
OBJECTIVE: To evaluate the diagnostic performance of urine HIV antibody rapid test kits in screening diverse populations and to analyse subjects\' willingness regarding reagent types, purchase channels, acceptable prices, and self-testing.
METHODS: Diagnostic accuracy studies PARTICIPANTS: A total of 2606 valid and eligible samples were collected in the study, including 202 samples from female sex workers (FSWs), 304 persons with injection drug use (IDU), 1000 pregnant women (PW), 100 subjects undergoing voluntary HIV counselling and testing (VCT) and 1000 students in higher education schools or colleges (STUs). Subjects should simultaneously meet the following inclusion criteria: (1) being at least 18 years old and in full civil capacity, (2) signing an informed consent form and (3) providing truthful identifying information to ensure that the subjects and their samples are unique.
RESULTS: The sensitivity, specificity and area under the curve (AUC) of the urine HIV-1 antibody rapid test kits were 92.16%, 99.92% and 0.960 (95% CI: 0.952 to 0.968, p<0.001), respectively, among 2606 samples collected during on-site screenings. The kits showed good diagnostic performance in persons with IDU (AUC, 1.000; 95% CI, 1.000 to 1.000, p<0.001), PW (AUC, 0.999; 95% CI, 0.999 to 1.000, p<0.001) and FSWs (AUC, 1.000; 95% CI, 1.000 to 1.000, p<0.001). The AUC of the urine reagent kits in subjects undergoing VCT was 0.941 (95% CI: 0.876 to 0.978, p<0.001). The \'acceptable price\' had the greatest influence on STUs (Pi=1.000) and PW (Pi=1.000), the \'purchase channel\' had the greatest influence on subjects undergoing VCT (Pi=1.000) and persons with IDU (Pi=1.000) and the \'reagent types\' had the greatest influence on FSWs (Pi=1.000).
CONCLUSIONS: The rapid urine test kits showed good diagnostic validity in practical applications, despite a few cases involving misdiagnosis and underdiagnosis.
METHODS: Diagnostic accuracy studies PARTICIPANTS: A total of 2606 valid and eligible samples were collected in the study, including 202 samples from female sex workers (FSWs), 304 persons with injection drug use (IDU), 1000 pregnant women (PW), 100 subjects undergoing voluntary HIV counselling and testing (VCT) and 1000 students in higher education schools or colleges (STUs). Subjects should simultaneously meet the following inclusion criteria: (1) being at least 18 years old and in full civil capacity, (2) signing an informed consent form and (3) providing truthful identifying information to ensure that the subjects and their samples are unique.
RESULTS: The sensitivity, specificity and area under the curve (AUC) of the urine HIV-1 antibody rapid test kits were 92.16%, 99.92% and 0.960 (95% CI: 0.952 to 0.968, p<0.001), respectively, among 2606 samples collected during on-site screenings. The kits showed good diagnostic performance in persons with IDU (AUC, 1.000; 95% CI, 1.000 to 1.000, p<0.001), PW (AUC, 0.999; 95% CI, 0.999 to 1.000, p<0.001) and FSWs (AUC, 1.000; 95% CI, 1.000 to 1.000, p<0.001). The AUC of the urine reagent kits in subjects undergoing VCT was 0.941 (95% CI: 0.876 to 0.978, p<0.001). The \'acceptable price\' had the greatest influence on STUs (Pi=1.000) and PW (Pi=1.000), the \'purchase channel\' had the greatest influence on subjects undergoing VCT (Pi=1.000) and persons with IDU (Pi=1.000) and the \'reagent types\' had the greatest influence on FSWs (Pi=1.000).
CONCLUSIONS: The rapid urine test kits showed good diagnostic validity in practical applications, despite a few cases involving misdiagnosis and underdiagnosis.
摘要：
目的：评估尿液HIV抗体快速检测试剂盒在筛查不同人群中的诊断性能，并分析受试者对试剂类型的意愿，购买渠道,可接受的价格,和自我测试。
方法：诊断准确性研究参与者：本研究共收集了2606份有效和合格样本，包括来自女性性工作者（FSW）的202份样本，304人注射毒品使用（IDU），1000名孕妇（PW），接受自愿艾滋病毒咨询和检测（VCT）的100名受试者和高等教育学校或学院（STU）的1000名学生。受试者应同时符合以下纳入标准:(1)年满18周岁,具有完全民事行为能力,（2）签署知情同意书；（3）提供真实的识别信息，以确保受试者及其样本是唯一的。
结果：灵敏度，尿HIV-1抗体快速检测试剂盒的特异性和曲线下面积(AUC)为92.16%,99.92%和0.960（95%CI：0.952至0.968，p<0.001），分别,在现场筛查期间收集的2606个样本中。试剂盒在患有IDU的人中显示出良好的诊断性能(AUC，1.000；95%CI，1.000至1.000，p<0.001)，PW(AUC,0.999；95%CI，0.999至1.000，p<0.001）和FSW（AUC，1.000；95%CI，1.000至1.000，p<0.001）。接受VCT的受试者的尿试剂盒的AUC为0.941（95％CI：0.876至0.978，p<0.001）。“可接受的价格”对STU（Pi=1.000）和PW（Pi=1.000）的影响最大，“购买渠道”对接受VCT的受试者的影响最大（Pi=1.000），患有IDU的人（Pi=1.000）和“试剂类型”对FSWs的影响最大（Pi=1.000）。
结论：快速尿液检测试剂盒在实际应用中显示出良好的诊断有效性，尽管少数病例涉及误诊和诊断不足。
方法：诊断准确性研究参与者：本研究共收集了2606份有效和合格样本，包括来自女性性工作者（FSW）的202份样本，304人注射毒品使用（IDU），1000名孕妇（PW），接受自愿艾滋病毒咨询和检测（VCT）的100名受试者和高等教育学校或学院（STU）的1000名学生。受试者应同时符合以下纳入标准:(1)年满18周岁,具有完全民事行为能力,（2）签署知情同意书；（3）提供真实的识别信息，以确保受试者及其样本是唯一的。
结果：灵敏度，尿HIV-1抗体快速检测试剂盒的特异性和曲线下面积(AUC)为92.16%,99.92%和0.960（95%CI：0.952至0.968，p<0.001），分别,在现场筛查期间收集的2606个样本中。试剂盒在患有IDU的人中显示出良好的诊断性能(AUC，1.000；95%CI，1.000至1.000，p<0.001)，PW(AUC,0.999；95%CI，0.999至1.000，p<0.001）和FSW（AUC，1.000；95%CI，1.000至1.000，p<0.001）。接受VCT的受试者的尿试剂盒的AUC为0.941（95％CI：0.876至0.978，p<0.001）。“可接受的价格”对STU（Pi=1.000）和PW（Pi=1.000）的影响最大，“购买渠道”对接受VCT的受试者的影响最大（Pi=1.000），患有IDU的人（Pi=1.000）和“试剂类型”对FSWs的影响最大（Pi=1.000）。
结论：快速尿液检测试剂盒在实际应用中显示出良好的诊断有效性，尽管少数病例涉及误诊和诊断不足。
