Effectiveness of hepatitis B rapid tests toward linkage-to-care: results of a randomized, multicenter study
Effectiveness of hepatitis B rapid tests toward linkage-to-care: results of a randomized, multicenter study
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DOI：
10.1097/meg.0000000000000620
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发表时间：
2016-06-01
影响因子：
2.1
通讯作者：
Lacombe, Karine
中科院分区：
文献类型：
--
作者：
Bottero, Julie;Boyd, Anders;Lacombe, Karine
目的在世界范围内，许多感染者不知道自己的乙型肝炎病毒（HBV）状态。我们评估了HBV快速检测在促进与护理联系方面的有效性。方法2012年，从巴黎的五个中心招募志愿者。参与者以1:1的比例随机分配，接受标准血清学(S)或快速血清学（VIKIA-HBsAg/Quick Profile anti-HBsAb）验证血清学（R + S）。主要终点是与适当护理联系的个体的百分比（未接种疫苗的个体开始接种疫苗或hbsag阳性个体接受医疗评估）。次要结局是接受HBV检测结果的百分比和HBV快速检测的表现。结果共筛查995人。在主要终点纳入的hbv感染组（n=409）中，20例（4.9%）接受了适当的联系治疗，S组和R + S组之间无差异（5.7 vs. 4.1%， P=0.5）。8名hbsag阳性参与者中有2人进行了医疗访问（S组和R + S组分别为1/6和1/2），18/401（4.5%）未接种疫苗的参与者开始了hbv疫苗接种（11/205和7/196）。倾向于与连锁护理相关的因素是女性、HBV高流行的出生国和延长的医疗住院时间。4.7%的参与者未获得测试结果，S组显著高于S组（P=0.02）。VIKIA-HBsAg快速检测的敏感性和特异性均为100%，anti-HBsAb Quick Profile快速检测的敏感性和特异性分别为94.4%和80.8%。结论：尽管在R + S组中获得结果的参与者比例更高，抗hbsab快速检测的表现也比之前描述的更好，但我们没有发现证据表明最初基于快速检测的HBV筛查导致HBV疫苗接种率或医学评价的增加。应在更难接触到的人群中评估这一战略。版权所有2016威科集团有限公司版权所有。
Objectives Worldwide, many infected individuals are unaware of their hepatitis B virus (HBV) status. We evaluated the effectiveness of HBV rapid testing in promoting linkage-to-care.Methods In 2012, volunteers were recruited from five Parisian centers. Participants were randomized 1 : 1 to receive standard serology (S) or rapid testing (VIKIA-HBsAg/Quick Profile anti-HBsAb) with confirmatory serology (R + S). The primary endpoint was percentage of individuals with appropriate linkage-to-care (nonimmunized individuals starting vaccination or HBsAg-positive individuals receiving medical evaluation). The secondary outcomes were percentage receiving HBV-test results and performance of HBV rapid tests.Results In total, 995 individuals were screened. Among the HBV-infection groups included in the primary endpoint (n=409), 20 (4.9%) received appropriate linkage-to-care, with no difference between S and R + S groups (5.7 vs. 4.1%, P=0.5). Two of eight HBsAg-positive participants had a medical visit (1/6 and 1/2 in the S and R + S groups, respectively) and 18/401 (4.5%) nonimmunized participants initiated HBV-vaccination (11/205 and 7/196). Factors that tended to be associated with linkage-tocare were female sex, birth country of high HBV prevalence, and extended medical stay. Test results were not obtained in 4.7% of participants, which was significantly higher in the S arm (P=0.02). Both sensitivity and specificity were 100% for the VIKIA-HBsAg rapid test and 94.4 and 80.8%, respectively, for the anti-HBsAb Quick Profile rapid test.Conclusion Despite a higher proportion of participants obtaining their results in the R + S arm and better performance of anti-HBsAb rapid tests than described previously, we found no evidence that HBV screening based initially on rapid tests leads to increased HBV-vaccination rates or medical evaluation. This strategy should be evaluated in more hard-to-reach populations. Copyright (C) 2016 Wolters Kluwer Health, Inc. All rights reserved.