Laboratoire de Virologie, Département des Agents Infectieux, Pôle Biologie, Centre Hospitalier Universitaire Grenoble, BP 217, 38043 Grenoble Cedex 9, France.
J Clin Virol. 2012 Nov;55(3):220-5. doi: 10.1016/j.jcv.2012.07.016. Epub 2012 Aug 14.
Hepatitis C virus (HCV) is underdiagnosed and therefore increasing the opportunities for HCV testing without venipuncture may be useful.
We evaluated the analytical performance of a modified, commercially available, combined HCV antigen-antibody assay (cEIA) (Monolisa(®) HCV-Ag-Ab-ULTRA) and a commercially available point-of-care (POC) device (OraQuick(®) HCV) on fingerstick blood (FSB) and oral mucosal transudate (OMT).
FSB, OMT and serum samples were collected from 113 cases of HCV-antibody-positive patients and 88 HCV-antibody-negative controls. The HCV-antibody-positive group included 63 patients with quantifiable HCV-RNA (56%) and 17 HIV/HCV co-infected patients (15%). FSB and OMT specimens were collected as dried blood spots (DBSs) or with the OraSure collection system, before testing with cEIA.
With FSB specimens, the cEIA and the POC device exhibited 100% specificity and 98.2% and 97.4% sensitivity, respectively. The specificity of the cEIA in FSB sharply decreased if stored 3days at room temperature. With OMT specimens, the cEIA sensitivity (71.7%) and specificity (94.3%) were significantly lower than the performance of OraQuick(®) HCV (sensitivity, 94.6%; specificity, 100%). The optical densities obtained with the cEIA in FSB and OMT were lower in HIV/HCV co-infected patients compared with HCV monoinfected patients.
The cEIA using FSB specimens collected on DBSs preserved in appropriate storage conditions was a reliable alternative, equivalent to the POC assay, for HCV testing without venipuncture. The cEIA was not adapted for HCV testing on OMT.
丙型肝炎病毒（HCV）漏诊率高，因此增加无需静脉采血即可进行 HCV 检测的机会可能会有所帮助。
我们评估了一种改良的、市售的、联合 HCV 抗原-抗体检测（cEIA）（Monolisa(®) HCV-Ag-Ab-ULTRA）和一种市售的即时检测（POC）设备（OraQuick(®) HCV）在手指血（FSB）和口腔黏膜渗出液（OMT）中的分析性能。
采集了 113 例 HCV 抗体阳性患者和 88 例 HCV 抗体阴性对照者的 FSB、OMT 和血清样本。HCV 抗体阳性组包括 63 例可定量 HCV-RNA 的患者（56%）和 17 例 HIV/HCV 合并感染患者（15%）。FSB 和 OMT 标本采集为干血斑（DBS）或使用 OraSure 收集系统，在进行 cEIA 检测之前采集。
用 FSB 标本检测时，cEIA 和 POC 设备的特异性均为 100%，敏感性分别为 98.2%和 97.4%。如果在室温下储存 3 天，cEIA 在 FSB 中的特异性显著降低。用 OMT 标本检测时，cEIA 的敏感性（71.7%）和特异性（94.3%）明显低于 OraQuick(®) HCV 的检测性能（敏感性 94.6%，特异性 100%）。与 HCV 单感染患者相比，HIV/HCV 合并感染患者的 FSB 和 OMT 标本 cEIA 的光密度值较低。
使用 DBS 采集 FSB 标本并保存在适当的储存条件下的 cEIA 是一种可靠的替代方法，与 POC 检测一样，可用于无需静脉采血的 HCV 检测。cEIA 不适用于 OMT 上的 HCV 检测。
