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手指采血与口腔液快速 HIV 检测的可接受性:来自急诊室普遍 HIV 感染筛查(USHER 二期)随机对照试验的结果。

Acceptability of fingerstick versus oral fluid rapid HIV testing: results from the universal screening for HIV infection in the emergency room (USHER Phase II) randomized controlled trial.

机构信息

Division of Infectious Disease, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, USA.

出版信息

J Acquir Immune Defic Syndr. 2012 Dec 15;61(5):588-92. doi: 10.1097/QAI.0b013e31826a6d67..

Abstract

BACKGROUND

Oral rapid HIV testing has been reported to have a lower sensitivity and specificity than rapid HIV testing with whole blood and has been associated with clusters of false-positive results. Patient preference for oral rapid HIV testing compared with more invasive whole blood fingerstick may influence the acceptance of rapid HIV testing.

OBJECTIVE

To compare HIV test acceptance rates among patients routinely offered fingerstick compared with those routinely offered oral fluid screening in an urban hospital emergency department.

METHODS

The Universal Screening for HIV Infection in the Emergency Room Phase II was a single-center, prospective, randomized controlled trial that randomized subjects to either fingerstick or oral rapid HIV screening in an urban academic emergency department. From May 5, 2009, to January 4, 2010, eligible patients aged 18-75 years were invited to participate in the trial. The primary outcome measure was HIV test acceptance rate.

RESULTS

: 2012 eligible patients were approached, of whom 1651 (82%) consented to trial participation and enrolled. Among those enrolled, 830 and 821 were randomized to the fingerstick and oral fluid arms, respectively. Acceptance of rapid HIV testing was similar in both arms; 67% (553 of 830) of subjects accepted fingerstick testing compared with 69% (565 of 821) who accepted oral (P = 0.34).

CONCLUSIONS

Although fingerstick rapid HIV testing is more invasive than oral fluid testing, test acceptance rates did not differ. Given the option, preference should therefore be given to fingerstick testing because of its slightly superior test characteristics. System factors such as ease of staff use, necessary Clinical Laboratory Improvement Amendments waivers, laboratory capacity, and HIV prevalence should also be considered.

摘要

背景

口腔快速 HIV 检测的敏感性和特异性低于全血快速 HIV 检测,并且与假阳性结果群集相关。与更具侵入性的全血指刺相比,患者对口腔快速 HIV 检测的偏好可能会影响快速 HIV 检测的接受程度。

目的

比较常规提供指刺与常规提供口腔液筛查的患者中 HIV 检测的接受率,在城市医院急诊部。

方法

“急诊室普遍筛查 HIV 感染二期”是一项单中心、前瞻性、随机对照试验,该试验将受试者随机分配到城市学术急诊部的指刺或口腔快速 HIV 筛查组。从 2009 年 5 月 5 日至 2010 年 1 月 4 日,符合条件的 18-75 岁患者受邀参加该试验。主要结局测量指标是 HIV 检测接受率。

结果

2012 名符合条件的患者被邀请参加试验,其中 1651 名(82%)同意参加试验并入组。在入组的患者中,830 名和 821 名患者分别被随机分配到指刺和口腔液组。两组中快速 HIV 检测的接受率相似;67%(553 名/830 名)的受试者接受指刺检测,而 69%(565 名/821 名)接受口腔(P=0.34)。

结论

尽管指刺快速 HIV 检测比口腔液检测更具侵入性,但检测接受率没有差异。鉴于这种选择,应该优先考虑指刺检测,因为其具有略优的检测特性。系统因素,如工作人员使用的便利性、必要的临床实验室改进修正案豁免、实验室能力和 HIV 流行率,也应考虑在内。

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