Frank A P, Wandell M G, Headings M D, Conant M A, Woody G E, Michel C
Department of Medicine, Illinois Masonic Medical Center, Chicago, USA.
Arch Intern Med. 1997 Feb 10;157(3):309-14.
Home human immunodeficiency virus (HIV) testing has been proposed as an alternative to conventional HIV testing. Despite debate over HIV type 1 (HIV-1) home test systems, these concerns have not to our knowledge been previously studied.
To evaluate the safety and efficacy of the Home Access Health Corp (Hoffman Estates, Ill) HIV-1 test system compared with traditional HIV-1 testing with venous blood.
A total of 1255 subjects were studied prospectively in a blinded, subject-as-control evaluation at 9 outpatient clinics using intent-to-treat analysis. Subjects were provided a home collection kit (Home Access Health Corp) to collect their own finger-stick blood spot samples for laboratory analysis. Subjects received pretest counseling by telephone and their comprehension was subsequently assessed. Subject-collected blood spot samples were compared with professionally drawn blood spot samples for adequacy (sufficient for completing the Food and Drug Administration-endorsed testing) and with venous samples for accuracy. Subjects called 3 days later for anonymous results and posttest counseling. Device safety was evaluated based on adverse events incidence. Subject comprehension of HIV information was measured.
Subject-collected blood spot sample results were in complete agreement with venous blood sample results, demonstrating 100% sensitivity and 100% specificity compared with venous controls. Ninety-eight percent of subjects obtained testable blood spot specimens compared with phlebotomists. Following pretest counseling, subjects answered 96% of HIV risk questions correctly. There were no significant adverse events.
Anonymous HIV-1 home collection kits with pretest and posttest telephone counseling can provide a safe and effective alternative to conventional venous HIV-1 antibody testing.
家庭人类免疫缺陷病毒（HIV）检测已被提议作为传统HIV检测的替代方法。尽管对1型HIV（HIV-1）家庭检测系统存在争议，但据我们所知，这些问题此前尚未得到研究。
评估家庭访问健康公司（伊利诺伊州霍夫曼庄园）的HIV-1检测系统与传统静脉血HIV-1检测相比的安全性和有效性。
在9家门诊诊所对1255名受试者进行前瞻性、双盲、以受试者为对照的评估，并采用意向性分析。为受试者提供家庭采集试剂盒（家庭访问健康公司），让他们自行采集指尖血斑样本进行实验室分析。通过电话为受试者提供检测前咨询，并随后评估他们的理解情况。将受试者采集的血斑样本与专业抽取的血斑样本进行充分性比较（足以完成美国食品药品监督管理局认可的检测），并与静脉样本进行准确性比较。受试者在3天后致电获取匿名检测结果和检测后咨询。根据不良事件发生率评估设备安全性。测量受试者对HIV信息的理解情况。
受试者采集的血斑样本结果与静脉血样本结果完全一致，与静脉对照相比，灵敏度和特异性均为100%。与采血技师相比，98%的受试者获得了可检测的血斑标本。在检测前咨询后，受试者对HIV风险问题的回答正确率为96%。未发生重大不良事件。
带有检测前和检测后电话咨询的匿名HIV-1家庭采集试剂盒可为传统静脉HIV-1抗体检测提供一种安全有效的替代方法。
