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根据 HIV 感染状况评估干血斑和唾液样本中抗 HCV 检测的性能。

Performance of ANTI-HCV testing in dried blood spots and saliva according to HIV status.

机构信息

Viral Hepatitis Laboratory, Oswaldo Cruz Institute, Fiocruz, Rio de Janeiro, Brazil.

Clementino Fraga Filho Hospital, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.

出版信息

J Med Virol. 2017 Aug;89(8):1435-1441. doi: 10.1002/jmv.24777. Epub 2017 Mar 14.

Abstract

The use of saliva and dried blood spots (DBS) could increase access to HCV diagnosis for high-risk populations, such as HIV-infected individuals, but the performance of these assays has not been well established in this group. This study aims to evaluate HIV status, particularly TCD4 cell count and viral load, in the performance of anti-HCV testing using DBS and saliva. A total of 961 individuals classified as HCV+, HIV+, or HIV/HCV+, as well as negative controls, donated serum, DBS, and saliva samples for anti-HCV testing using a commercial enzyme immunoassay. Sample volume was modified for DBS and saliva, and an ROC curve was used for cut-off determination in saliva. Anti-HCV sensitivities were greater than 93% using DBS and saliva in the HCV+ group, while they were 83.3% and 95.6% for HCV/HIV+ individuals for DBS and saliva assays, respectively. Specificity varied from 91.7% to 100% using saliva and DBS in HIV monoinfected and control subjects. When only anti-HCV/HCV RNA+ serum samples, that is, true positives, were considered, the sensitivities were 98.3% and 100% for DBS and saliva, respectively, in the HCV+ group and 91.6% and 94.8% for DBS and saliva, respectively, in the HIV/HCV+ group. High absorbance values were observed among those presenting with HCV RNA in serum and low HIV viral load (less than 50 copies/mL). In conclusion, DBS and saliva samples could be used for anti-HCV detection, particularly to identify active HCV cases, but low sensitivity was observed for anti-HCV testing using DBS in the HIV/HCV+ group.

摘要

唾液和干血斑(DBS)的应用可以增加高危人群(如感染 HIV 的人群)对 HCV 诊断的机会,但这些检测方法在该人群中的性能尚未得到很好的确定。本研究旨在评估 HIV 状态,特别是 TCD4 细胞计数和病毒载量,用于使用 DBS 和唾液进行抗 HCV 检测。共有 961 名分类为 HCV+、HIV+或 HIV/HCV+的个体以及阴性对照者,为了使用商业酶免疫测定法进行抗 HCV 检测,他们捐献了血清、DBS 和唾液样本。DBS 和唾液的样本量进行了修改,并使用 ROC 曲线确定了唾液的截断值。在 HCV+组中,使用 DBS 和唾液进行抗 HCV 检测的灵敏度均大于 93%,而在 HCV/HIV+个体中,DBS 和唾液检测的灵敏度分别为 83.3%和 95.6%。在 HIV 单一感染和对照个体中,使用唾液和 DBS 的特异性从 91.7%到 100%不等。当仅考虑抗 HCV/HCV RNA+血清样本,即真正的阳性样本时,在 HCV+组中,DBS 和唾液的灵敏度分别为 98.3%和 100%,在 HIV/HCV+组中,DBS 和唾液的灵敏度分别为 91.6%和 94.8%。在血清中存在 HCV RNA 和低 HIV 病毒载量(小于 50 拷贝/ml)的个体中观察到高吸光度值。总之,DBS 和唾液样本可用于抗 HCV 检测,特别是用于识别活跃的 HCV 病例,但在 HIV/HCV+组中,使用 DBS 进行抗 HCV 检测的灵敏度较低。

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