采用血清样本多重免疫层析快速检测同时检测 HIV-1、HIV-2 和丙型肝炎特异性抗体及乙型肝炎表面抗原（HBsAg）的分析性能：一项横断面研究。
Analytical performances of simultaneous detection of HIV-1, HIV-2 and hepatitis C- specific antibodies and hepatitis B surface antigen (HBsAg) by multiplex immunochromatographic rapid test with serum samples: A cross-sectional study.
机构信息
Laboratoire de virologie, hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.
Laboratoire de virologie, hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France; Ecole Doctorale Régionale d'Infectiologie Tropicale de Franceville, Gabon.
出版信息
J Virol Methods. 2018 Mar;253:1-4. doi: 10.1016/j.jviromet.2017.12.001. Epub 2017 Dec 5.
BACKGROUND
The HIV/HCV/HBsAg Triplex consists in manually performed, visually interpreted, lateral flow, immunochromatographic rapid diagnostic test simultaneously detecting in 15min human immunodeficiency virus (HIV)-1 and HIV-2 and hepatitis C virus (HCV)- specific antibodies (Ab) (IgG and IgM) and hepatitis B virus (HBV) surface antigen (HBsAg) in serum, plasma and whole blood.
METHODS
A hospital-based cross-sectional study was conducted on a prospective panel of serum samples from adult inpatients included from routine analysis irrespectively of age and sex, including 250 sera positive for HIV-1-specific Ab, 250 for HCV-specific Ab, 250 for HBsAg and 250 sera negative for HIV- and HCV- Ab and HBsAg, and from 110 HIV-2-infected patients living in Ivory Coast, according to the results obtained by the reference chemiluminiscent microparticle immunoassay (CMIA) Abbott Architect i2000SR analyzer (Abbott Diagnostic, Chicago, IL, USA). Among HCV-seropositive sera, 187 were positive for HCV RNA (chronic infection), whereas 63 were negative (resolved infection), respectively. Serum samples were further tested blindly by HIV/HCV/HBsAg Triplex according to manufacturers' recommendations.
RESULTS
HIV/HCV/HBsAg Triplex showed very high sensitivity and specificity, as well as excellent concordance with CMIA Abbott results, as shown in the Table. Lower sensitivity was observed only in individuals who had cleared their HCV infection (presence of HCV-specific Ab in absence of HCV RNA). The mean lower limit of HBsAg detection was 2.38±0.63 IU/ml. Erythrocytes-spiked serum samples gave similar results than serum samples.
CONCLUSIONS
Advantages of HIV/HCV/HBsAg Triplex for HIV-1, HIV-2, HCV and HBV include the requirement for less overall specimen volume, fewer finger-sticks if capillary whole blood is used, cost savings through lower cost per virus tested, improved patient flow with results for multiple viruses available at the same time, overall service delivery efficiencies with less time required per infected patient; and patient benefits from fewer visits and lower cost associated with each clinic attendance. The screening of chronic HIV, HCV and HBV by multiplex HIV-1/HIV-2/HCV/HBsAg Triplex may improve the "cascade of screening" and quite possibly linkage-to-care with reduced cost.
背景
HIV/HCV/HBsAg 三联检测试剂是一种手动操作、目视判读的侧向层析免疫层析快速诊断试剂，可在 15 分钟内同时检测血清、血浆和全血中人类免疫缺陷病毒（HIV）-1 和 HIV-2 以及丙型肝炎病毒（HCV）特异性抗体（Ab）（IgG 和 IgM）和乙型肝炎病毒（HBV）表面抗原（HBsAg）。
方法
对来自成年住院患者的前瞻性血清样本进行了一项基于医院的横断面研究，这些样本是根据参考化学发光微粒子免疫分析（CMIA）Abbott Architect i2000SR 分析仪（雅培诊断，芝加哥，IL，USA）的结果，不分年龄和性别，从常规分析中随机选择的。该研究包括 250 例 HIV-1 特异性 Ab 阳性血清、250 例 HCV 特异性 Ab 阳性血清、250 例 HBsAg 阳性血清和 250 例 HIV 和 HCV Ab 及 HBsAg 阴性血清，以及 110 例居住在科特迪瓦的 HIV-2 感染患者。在 HCV 血清阳性的患者中，187 例 HCV RNA 阳性（慢性感染），63 例 HCV RNA 阴性（已清除感染）。根据制造商的建议，血清样本进一步用 HIV/HCV/HBsAg 三联检测试剂进行盲法检测。
结果
HIV/HCV/HBsAg 三联检测试剂具有很高的灵敏度和特异性，与 CMIA Abbott 的结果高度一致，如表所示。在已清除 HCV 感染的个体中（存在 HCV 特异性 Ab，但不存在 HCV RNA），观察到的灵敏度较低。HBsAg 检测的平均下限为 2.38±0.63IU/ml。红细胞混入血清样本与血清样本的结果相似。
结论
HIV/HCV/HBsAg 三联检测试剂在 HIV-1、HIV-2、HCV 和 HBV 检测方面的优势包括需要的标本量较少，如果使用毛细血管全血，手指采血次数较少，每个病毒检测成本降低，通过同时获得多种病毒的结果，提高了患者的就诊流程效率，感染患者所需的时间减少；减少就诊次数和每次就诊费用，使患者受益。通过多重 HIV-1/HIV-2/HCV/HBsAg 三联检测试剂筛查慢性 HIV、HCV 和 HBV，可能会提高“筛查级联”，并通过降低成本，很有可能实现与护理的关联。
Zotero 插件