National Reference Laboratory of HIV Molecular Biology, National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
Nam Tu Liem District Medical Center, Hanoi, Vietnam.
J Viral Hepat. 2020 May;27(5):514-519. doi: 10.1111/jvh.13263. Epub 2020 Feb 11.
Recently, treatment advances in direct-acting antivirals have radically changed the management of HCV patients. However, in resource-limited countries, identification of patients with active HCV infection is still challenging in remote settings due to the limited access to laboratories able to measure HCV viral load. This study evaluated whether dried blood spots (DBS) transferred to a central laboratory could overcome this challenge. A total of 315 HCV-infected patients, naïve to anti-HCV treatment, provided each three type of samples: plasma, DBS with calibrated quantities of venous blood and DBS with uncalibrated quantities of capillary blood. Qualitative comparison was conducted in terms of detection of HCV viral load on DBS as opposed to plasma to estimate sensitivity and specificity. Quantitative comparisons were conducted by means of correlation estimation. Of the 250 patients with detected plasma HCV viral load, 245 also had detectable DBS HCV viral load (capillary or venous) leading to a sensitivity of 98.0% (95% confidence interval (CI): 95.4%-99.3%); importantly, all measurements with a plasma HCV viral load >118 IU/mL were also detected in DBS. When HCV was not detected in plasma, it was also not detected in DBS resulting in 100% specificity (95% CI: 94.5%-100%). Quantitative HCV viral load results were very similar when utilizing plasma or DBS sample types as illustrated by correlations >0.99. In conclusion, DBS sample types, with either uncalibrated capillary blood or calibrated venous blood, performed well to distinguish patients with active HCV infection, and who therefore need treatment, from other patients.
最近,直接作用抗病毒药物的治疗进展极大地改变了 HCV 患者的治疗管理。然而,在资源有限的国家,由于能够测量 HCV 病毒载量的实验室数量有限,在偏远地区识别活动性 HCV 感染患者仍然具有挑战性。本研究评估了将干血斑(DBS)转移到中心实验室是否可以克服这一挑战。共有 315 名未经抗 HCV 治疗的 HCV 感染患者提供了三种类型的样本:血浆、定量静脉血的 DBS 和定量毛细血管血的 DBS。通过定性比较 DBS 与血浆中 HCV 病毒载量的检测,评估了敏感性和特异性。通过相关性估计进行了定量比较。在检测到血浆 HCV 病毒载量的 250 名患者中,245 名患者也有可检测到的 DBS HCV 病毒载量(毛细血管或静脉),敏感性为 98.0%(95%置信区间:95.4%-99.3%);重要的是,所有血浆 HCV 病毒载量 >118 IU/mL 的测量值也在 DBS 中检测到。当血浆中未检测到 HCV 时,DBS 中也未检测到 HCV,特异性为 100%(95%置信区间:94.5%-100%)。如相关性>0.99 所示,使用血浆或 DBS 样本类型时,HCV 病毒载量的定量结果非常相似。总之,未经校准的毛细血管血或校准的静脉血的 DBS 样本类型表现良好,可区分活动性 HCV 感染患者(因此需要治疗)与其他患者。