Johnson Cheryl C, Fonner Virginia, Sands Anita, Ford Nathan, Obermeyer Carla Mahklouf, Tsui Sharon, Wong Vincent, Baggaley Rachel
Department of HIV, World Health Organization, Geneva, Switzerland.
Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK.
J Int AIDS Soc. 2017 Aug 29;20(Suppl 6):21755. doi: 10.7448/IAS.20.7.21755.
In accordance with global testing and treatment targets, many countries are seeking ways to reach the "90-90-90" goals, starting with diagnosing 90% of all people with HIV. Quality HIV testing services are needed to enable people with HIV to be diagnosed and linked to treatment as early as possible. It is essential that opportunities to reach people with undiagnosed HIV are not missed, diagnoses are correct and HIV-negative individuals are not inadvertently initiated on life-long treatment. We conducted this systematic review to assess the magnitude of misdiagnosis and to describe poor HIV testing practices using rapid diagnostic tests.
We systematically searched peer-reviewed articles, abstracts and grey literature published from 1 January 1990 to 19 April 2017. Studies were included if they used at least two rapid diagnostic tests and reported on HIV misdiagnosis, factors related to potential misdiagnosis or described quality issues and errors related to HIV testing.
Sixty-four studies were included in this review. A small proportion of false positive (median 3.1%, interquartile range (IQR): 0.4-5.2%) and false negative (median: 0.4%, IQR: 0-3.9%) diagnoses were identified. Suboptimal testing strategies were the most common factor in studies reporting misdiagnoses, particularly false positive diagnoses due to using a "tiebreaker" test to resolve discrepant test results. A substantial proportion of false negative diagnoses were related to retesting among people on antiretroviral therapy. HIV testing errors and poor practices, particularly those resulting in false positive or false negative diagnoses, do occur but are preventable. Efforts to accelerate HIV diagnosis and linkage to treatment should be complemented by efforts to improve the quality of HIV testing services and strengthen the quality management systems, particularly the use of validated testing algorithms and strategies, retesting people diagnosed with HIV before initiating treatment and providing clear messages to people with HIV on treatment on the risk of a "false negative" test result.
按照全球检测与治疗目标，许多国家正在探寻实现“90-90-90”目标的方法，首先是诊断出90%的艾滋病毒感染者。需要高质量的艾滋病毒检测服务，以便艾滋病毒感染者能够尽早被诊断出来并接受治疗。绝不能错过发现未被诊断出的艾滋病毒感染者的机会，诊断必须准确无误，且不能让艾滋病毒阴性者在不知情的情况下开始接受终身治疗。我们进行了这项系统评价，以评估误诊的程度，并描述使用快速诊断检测时艾滋病毒检测的不良做法。
我们系统检索了1990年1月1日至2017年4月19日发表的同行评议文章、摘要和灰色文献。纳入的研究需至少使用两种快速诊断检测，并报告艾滋病毒误诊情况、与潜在误诊相关的因素，或描述与艾滋病毒检测相关的质量问题和错误。
本评价纳入了64项研究。发现了一小部分假阳性（中位数3.1%，四分位间距（IQR）：0.4-5.2%）和假阴性（中位数：0.4%，IQR：0-3.9%）诊断。在报告误诊情况的研究中，次优检测策略是最常见的因素，特别是由于使用“决胜”检测来解决不一致的检测结果而导致的假阳性诊断。相当一部分假阴性诊断与接受抗逆转录病毒治疗者的再次检测有关。艾滋病毒检测错误和不良做法确实存在，特别是那些导致假阳性或假阴性诊断的情况，但这些都是可以预防的。加快艾滋病毒诊断和治疗衔接的努力，应辅之以提高艾滋病毒检测服务质量和加强质量管理系统的努力，特别是使用经过验证的检测算法和策略，在开始治疗前对被诊断为艾滋病毒感染者进行再次检测，并向艾滋病毒感染者明确传达“假阴性”检测结果的风险信息。
