Médecins Sans Frontières - France, Phnom Penh, Cambodia.
Médecins Sans Frontières - France, Phnom Penh, Cambodia; Epicentre, Paris, France.
J Clin Virol. 2019 Feb;111:39-41. doi: 10.1016/j.jcv.2018.12.008. Epub 2018 Dec 31.
Simplifying hepatitis C virus (HCV) screening is a key step in achieving the elimination of HCV as a global public health threat by 2030.
The objective of this study was to demonstrate the agreement of capillary blood and venipuncture specimens when using SD Bioline HCV, a low-cost rapid diagnostic test (RDT), prequalified by WHO in 2016 on venous blood samples.
Recruitment was conducted prospectively among adult patients presenting for HCV testing at the Médecins Sans Frontières (MSF) clinic of Preah Kossamak Hospital (Phnom Penh, Cambodia) between October and November 2017. Capillary and venous blood samples were collected from consenting patients and tested with SD Bioline HCV. Two independent, blinded readers, and in the case of disagreement, a third reader, interpreted the results of each blood sample. Concordance between results was compared using Cohen's Kappa interrater reliability statistic. Discrepant sample pairs were tested with an enzyme immunoassay, the reference standard, at the Institute Pasteur of Cambodia.
Among 421 pairs of samples collected, reader disagreement occurred for 0.7% (n = 3) of the participants. Sixty-four percent of capillary and venous blood sample pairs tested positive for HCV, with a Kappa statistic of 0.985 between the two methods. Three participants with discrepant sample pair results tested positive with EIA.
Capillary and venous blood samples were concordant when tested with HCV SD Bioline in a clinical context. This simplified testing approach is essential to the scale-up of HCV screening and useful in resource-limited settings or among populations for whom venipuncture is problematic.
简化丙型肝炎病毒（HCV）筛查是到 2030 年实现消除 HCV 这一全球公共卫生威胁目标的关键步骤。
本研究旨在展示 2016 年世卫组织预认证的低成本快速诊断检测试剂（RDT）SD Bioline HCV 在静脉血样本上的检测结果与毛细血管血和静脉血标本的一致性。
2017 年 10 月至 11 月，前瞻性地招募了在柬埔寨金边 Preah Kossamak 医院无国界医生组织（MSF）诊所就诊并接受 HCV 检测的成年患者。采集同意的患者的毛细血管血和静脉血样本，并用 SD Bioline HCV 进行检测。两名独立的、盲法的读者进行解读，如结果不一致，则由第三名读者进行解读。使用 Cohen's Kappa 一致性检验统计比较两种血样的结果一致性。使用酶免疫测定法（参考标准）对不一致的样本对进行了检测，该方法在柬埔寨巴斯德研究所进行。
在收集的 421 对样本中，有 0.7%（n=3）的样本出现了读者间的不一致。64%的毛细血管血和静脉血样本对 HCV 检测呈阳性，两种方法之间的 Kappa 统计值为 0.985。3 名样本对结果不一致的患者经 EIA 检测均为阳性。
在临床环境中，HCV SD Bioline 可用于检测毛细血管血和静脉血样本，且结果一致。这种简化的检测方法对于 HCV 筛查的推广至关重要，在资源有限的环境中或在静脉采血有问题的人群中非常有用。
