Comparison of Rapid Point-of-Care Tests for Detection of Antibodies to Hepatitis C Virus.
Comparison of Rapid Point-of-Care Tests for Detection of Antibodies to Hepatitis C Virus.
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DOI：
10.1093/ofid/ofv101
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发表时间：
2015-09
影响因子：
4.2
通讯作者：
Alonzo TA
中科院分区：
文献类型：
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作者：
Fisher DG;Hess KL;Erlyana E;Reynolds GL;Cummins CA;Alonzo TA
OraSure的灵敏度最高，为92.7%，其次是Chembio的三种血液检测。假结果与HIV和乙肝核心抗体相关。OraSure和Chembio血液测试具有良好的性能特点。背景。丙型肝炎是美国最普遍的血液传播疾病之一。尽管早期筛查有好处，但在320万感染丙型肝炎病毒（HCV）的美国人中，50%-70%不知道自己的感染状况。方法。数据收集于2011年至2014年，来自1048名客户，他们属于以下人群：(1)注射吸毒者，(2)有性风险的女性，(3)男同性恋和双性恋男性，(4)变性人。护理点检测的敏感性和特异性包括(1)MedMira人类免疫缺陷病毒(HIV)/HCV抗体快速检测，(2)MedMira乙型肝炎(HBV)/HIV/HCV抗体检测，(3)同时用于全血和(4)口腔标本的Chembio HCV筛选检测，(5)同时用于全血和(6)口腔标本的Chembio HIV-HCV检测，(7)Chembio HIV-HCV-梅毒检测，(8)OraSure全血HCV快速抗体检测。HCV检测的金标准是HCV酶免疫测定（EIA） 2.0。结果。OraSure的灵敏度最高，为92.7%(95%可信区间[CI] = 88.8%-96.5%)，其次是Chembio的3项血液检测，分别为92.1% （95% CI = 87.7%-96.4%）、91.5% （95% CI = 87.2%-95.7%）和92.3% （95% CI = 88.4%-96.2%）。MedMira HIV/HCV和MedMira HIV/HCV/HBV检测的敏感性最低，分别为79.1% （95% CI = 72.6% ~ 85.5%）和81.5% （95% CI = 75.2% ~ 87.8%）。OraSure的特异性为99.8% (95% CI = 99.4%-100%)；Chembio血液检测的特异性分别为99.2% （95% CI = 98.6%-99.9%）、99.4% （95% CI = 98.8%-99.9%）和99.3% (95% CI = 98.8%-99.9%)；而MedMira的特异性分别为100%和100%。假阴性结果与HIV和乙肝核心抗体血清状态有关。结论。OraSure和Chembio血液检测（包括HIV和梅毒的多重检测）表现出良好的性能特征。这项研究已经确定了在HIV和HBcAb检测呈阳性的人群中进行快速检测的潜在局限性。应该讨论对2013年CDC指南的更新。
OraSure had the highest sensitivity at 92.7% followed closely by Chembio's three blood tests. False results were associated with HIV, and hepatitis B core antibody. The OraSure and Chembio blood tests have good performance characteristics. Background. Hepatitis C is one of the most prevalent blood-borne diseases in the United States. Despite the benefits of early screening, among 3.2 million Americans who are infected with hepatitis C virus (HCV), 50%–70% are unaware of their infection status. Methods. Data were collected between 2011 and 2014, from 1048 clients who were in the following groups: (1) injection drug users, (2) women at sexual risk, (3) gay and bisexual men, and (4) transgender individuals. The sensitivity and specificity of point-of-care tests included (1) the MedMira rapid human immunodeficiency virus (HIV)/HCV antibody test, (2) MedMira hepatitis B (HBV)/HIV/HCV antibody test, (3) Chembio HCV Screen Assay used with both whole blood and (4) oral specimens, (5) Chembio HIV-HCV Assay also used with both whole blood and (6) oral specimens, (7) Chembio HIV-HCV-Syphilis Assay, and (8) OraSure HCV Rapid Antibody Test used with whole blood. The gold standard for the HCV tests were HCV enzyme immunoassay (EIA) 2.0. Results. OraSure had the highest sensitivity at 92.7% (95% confidence interval [CI] = 88.8%–96.5%) followed closely by Chembio's 3 blood tests at 92.1% (95% CI = 87.7%–96.4%), 91.5% (95% CI = 87.2%–95.7%), and 92.3% (95% CI = 88.4%–96.2%). The sensitivities of MedMira HIV/HCV and MedMira HIV/HCV/HBV tests were the lowest, at 79.1% (95% CI = 72.6%–85.5%), and 81.5% (95% CI = 75.2%–87.8%), respectively. Specificity for the OraSure was 99.8% (95% CI = 99.4%–100%); specificity for the Chembio blood tests was 99.2% (95% CI = 98.6%–99.9%), 99.4% (95% CI = 98.8%–99.9%), and 99.3% (95% CI = 98.8%–99.9%); and specificity for the MedMira was100% and 100%. False-negative results were associated with HIV and hepatitis B core antibody serostatus. Conclusions. The OraSure and Chembio blood tests (including those multiplexed with HIV and syphilis) appear to good performance characteristics. This study has identified potential limitations of rapid testing in those testing positive for HIV and HBcAb. There should be discussion of updates to the 2013 CDC guidance.