Evaluation of the accuracy and ease of use of a rapid HIV-1 Antibody Test performed by untrained operators at the point of care
Evaluation of the accuracy and ease of use of a rapid HIV-1 Antibody Test performed by untrained operators at the point of care
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DOI：
10.1016/j.jcv.2013.08.024
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发表时间：
2013-12-01
影响因子：
8.8
通讯作者：
Shackleton, Christopher R.
中科院分区：
文献类型：
--
作者：
Galli, Richard A.;Green, Kevin F.;Shackleton, Christopher R.
背景资料：为了更广泛地利用快速HIV抗体检测在床旁护理（POC）设置，方法应该足够简单，由未经培训的测试提供者准确地执行，只使用测试制造商的书面说明。目的：为了证明，HIV-1抗体检测是简单和准确的，足以成功地运行由未经培训的操作员在POC设置。研究设计：进行了一项前瞻性研究，以比较FDA批准的HIV-1抗体检测试剂盒（美国FDA，bioLytical Laboratories Inc.，里士满，BC，Canada）与经过培训的实验室专业人员使用FDA批准的比较方法（CM）匹配静脉血获得的结果进行比较。在三个不同的美国POC研究中心共招募了1388例受试者。一个中心实验室用于CM检测。未经培训的操作人员和经验丰富的实验室专业人员也进行了研究准备的血浆标本，以比较检测限（LoD）的capabilities.Results：517 HIV阳性的主题（34个新的阳性和483已知阳性）之间的一致性由未经培训的操作人员和CM由受过培训的实验室专业人员进行的COMI是100%（95%CI = 99.3-100%）。HIV阴性结果（n=871）的一致性为99.8%（95% CI = 99.2-99.9%）。未经培训的操作员和实验室professionals.Conclusions：未经培训的操作员，没有实验室的背景下，能够执行和解释的结果，DEFI的手指针刺血液和LoD标本的检测限之间没有显着差异，只有按照制造商的书面说明，具有很高的准确度。(C)2013爱思唯尔有限公司版权所有。
Background: For broader utilization of rapid HIV antibody assays in point-of-care (POC) settings, methods should be simple enough to be performed with accuracy by untrained test providers, using only the test manufacturer's written instructions.Objective: To demonstrate that the INSTI HIV-1 Antibody Test is simple and accurate enough to be successfully run by untrained operators in a POC setting.Study design: A prospective study was conducted to compare the results of the FDA-cleared, INSTI HIV-1 Antibody Test (INSTI, bioLytical Laboratories Inc., Richmond, BC, Canada) used by untrained operators on finger-stick whole blood to results obtained by trained laboratory professionals using FDA-cleared comparator methods (CM) on matching venous blood. A total of 1388 subjects were recruited into the study in three diverse US POC sites. One central laboratory was used for CM testing. Untrained operators and experienced laboratory professionals also conducted a study on prepared plasma specimens to compare limit of detection (LoD) abilities.Results: Of the 517 HIV positive subjects (34 new positives and 483 known positives) the concordance between INSTI performed by untrained operators and CM performed by trained laboratory professionals was 100% (95% CI = 99.3-100%). Concordance for HIV negative results (n=871) was 99.8% (95% CI = 99.2-99.9%). There were no significant differences in INSTI limit of detection between untrained operators and laboratory professionals.Conclusions: Untrained operators with no laboratory background were able to perform and interpret the results of INSTI on finger-stick blood and LoD specimens with a high degree of accuracy by following only the manufacturer's written instructions. (C) 2013 Elsevier B.V. All rights reserved.