尿HIV筛查方法与血液检测方法的性能特点

M. Isichei, T. T. Selowo, D. Meshak, A. Ale, S. Peter, M. Misauno, A. Affi, O. Olaniru, C. Isichei
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引用次数: 1

摘要

人类免疫缺陷病毒(HIV)检测在撒哈拉以南非洲广泛分布,因为它主要是侵入性的,但也可以是非侵入性的和快速的,减少等待时间,特别是在需要进行外科手术时。本研究采用尿液筛查检测方法确定患者的HIV状态,并将其与血液检测方法进行比较。使用血液筛查方法对所有由提供者发起的艾滋病毒检测进行了常规艾滋病毒筛查前和后咨询。由于尿液检测试剂盒的成本和不可获得性,只有通过血液检测方法检测出HIV阳性并计划进行手术或外科手术的患者才被纳入该研究。获得知情同意。在同一次访问中,成对的尿液和血液样本被收集到干净的通用瓶中并立即进行分析。采用胶体金增强快速免疫层析检测试剂盒(Alliance Biomedical)快速定性检测尿液中人类免疫缺陷病毒(HIV) I和II抗体,并与EDTA抽真空器采集的标准爱滋病毒前静脉血进行比较,并使用确定(T) HIV 1和2体外定性免疫测定条、UNI gold快速检测试剂盒和Chembio HIV 1/2 STAT PAK测定条进行分析。共有7568名患者接受了由提供者发起的常规艾滋病毒检测,其中521人艾滋病毒检测呈阳性。男性105例(20.15%),女性416例(79.85%),年龄15 ~ 80岁。剖宫产93例(37%),疝55例(22%),肿块48例(19%),急性阑尾炎33例(13%),子宫肌瘤10例(4%),宫外孕破裂2例(1%),其他(肠梗阻、术后粘连、趾甲向内生长、乳腺脓肿、痔疮、肛裂等)10例(4%)。确定血液快速检测HIV方法:共检测HIV阳性样本521份,阳性502份(96.35%),阴性19份(3.65%)。这19名HIV阴性者与白锐康重新检测:19名(100%)HIV阳性。UNI GOLD血液HIV检测方法:共检测521份HIV阳性样本,521份(100%)HIV阳性。尿液检测方法:521例HIV阳性患者中有251例(48.18%)计划接受外科手术。采用尿检法重新检测,HIV阳性235例(93.63%),阴性16例(6.37%)。使用尿液检测方法检测为阴性的16人的血液样本使用Stat Pak进行确认检测,所有16人(100%)检测为HIV阳性。Unigold和Determine血液检测的特异性为100%。三种检测方法的阳性预测值(PPV)均为100%,阴性预测值(NPV)分别为100%和99.73%。与血液HIV检测方法相比,尿液HIV检测方法的使用效果较好,可以作为一种更好的非侵入性样本方法,用于人群中HIV/AIDS的筛查,特别是在外科医生的术前手术中。
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Performance Characteristics of Urine HIV Screening Methods against Blood-Based Methods for Surgeons Guide
Testing for Human Immunodeficiency Virus (HIV), widely distributed in sub-Saharan Africa since it is mainly invasive but, could be non-invasive and quick also, reducing waiting time especially when required for presurgical procedures. This study determined the HIV status of patients using Urine screening test method and to compare its performance to blood-based testing methods. The routine pre and post-test counselling for HIV screening were done for all provider-initiated HIV testing using blood-based screening methods. Due to the cost and unavailability of enough urine testing kits, only patients who tested positive for HIV with blood-based methods and were scheduled for surgery or a surgical procedure were enrolled in the study. Informed consent was obtained. Paired urine and blood samples were collected at the same visit into clean universal bottles and analyzed immediately. A colloidal gold enhanced rapid immuno-chromatographic assay (Alliance Biomedical) kit for the rapid qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) I and II in urine were used in comparison to the standard HIV testing of ante-cubital venous blood collected in EDTA vacutainer and analyzed using Determine (T) HIV 1 and 2 in vitro qualitative immunoassay strip, UNI GOLD rapid test kit and the Chembio HIV 1/2 STAT PAK assay strip. A total of 7568 patients were tested for routine provider-initiated HIV testing, 521 tested HIV positive. There were 105 (20.15%) males and 416 (79.85%) females, age ranged from 15 years to >80 years. Most of the surgeries performed were Caesarian section 93 (37%), Hernia 55 (22%), Lumps 48 (19%), Acute appendicitis 33 (13%), Uterine fibroids 10 (4%), Ruptured ectopic pregnancy 2 (1%) and others (Intestinal obstruction, Postoperative adhesions, Ingrown toe nails, Breast abscess, Hemorrhoids, Anal fissures etc.) 10 (4%). DETERMINE RAPID HIV TEST METHOD USING BLOOD: A total of 521 HIV positive samples were tested, 502 (96.35%) tested HIV positive and 19 (3.65%) tested HIV negative. These 19 HIV negatives were re-tested with Stak Pak: 19 (100%) tested HIV positive. UNI GOLD HIV TEST METHOD USING BLOOD: A total of 521 HIV positive samples were tested, 521 (100%) tested HIV positive. URINE TESTING METHOD: A total of 251 (48.18%) of the 521 HIV positive patients were scheduled to undergo a surgical procedure. These were re-tested using the Urine testing method, 235 (93.63%) tested HIV positive while 16 (6.37%) tested negative. The blood sample of the 16 who tested negative using the Urine testing method was subjected to confirmatory test using Stat Pak and all 16 (100%) tested HIV positive. The specificity for Unigold and Determine blood testing was 100%. All three tests had a Positive Predictive Value (PPV) of 100% while the Negative Predictive Values (NPV) were 100% and 99.73% for Unigold and Determine respectively. The use of Urine HIV testing method compared well to the blood HIV testing methods and could be a better non-invasive sample method for screening of HIV/AIDS in the population especially among surgeons’ pre-surgical procedures.
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