Department of Medicine, Faculty of Medicine, University of Malaya, Jalan University, Kuala Lumpur, Malaysia.
Community Health Unit, Department of Primary Care, Faculty of Medicine and Health Science, University Sains Islam Malaysia, Nilai, Negeri Sembilan, Malaysia.
Nephrology (Carlton). 2021 May;26(5):463-470. doi: 10.1111/nep.13862. Epub 2021 Feb 23.
In Malaysia, majority anti-HCV positive haemodialysis patients do not undergo hepatitis C confirmation due to the high cost of HCV RNA. HCV Core Antigen might be a cost-effective diagnostic test to identify HD patients who have active HCV infection eligible for Direct Acting Anti-viral therapy.
A cross-sectional study was conducted to assess the correlation between HCV Ag and HCV RNA and the cost implications of different diagnostic algorithms to diagnose active HCV infection using Anti-HCV, HCV Ag, and HCV RNA. Pre-dialysis blood was tested for both HCV Ag and HCV RNA. HCV Ag was tested with Abbott ARCHITECT HCV Ag test.
Two-hundred twenty-seven haemodialysis patients were recruited from 20 centres with mean age of 57.68 ± 12.48 years, and male constitutes 56.8% (129) of the study population. HCV Ag correlated well with HCV RNA (Spearman test coefficient 0.943, p < .001) with sensitivity of 93.9%, specificity 99.3%, and the accuracy was 97.36%. Cost analysis indicated that a sequential test involving Anti-HCV antibody as initial screening, followed by HCV Ag on Anti-HCV positive and HCV RNA on HCV Ag negative cases translated to a modest cost-saving algorithm compared to standard diagnostic algorithm.
HCV Ag correlated well with HCV RNA and can potentially be fused in an alternative diagnostic algorithm to generate cost savings methods to diagnose active HCV infection among haemodialysis patients. This alternative algorithm is especially relevant in low to middle-income countries such as Malaysia to optimize the use of the healthcare resource and gains in clinical outcomes.
在马来西亚,由于 HCV RNA 的费用较高,大多数抗 HCV 阳性血液透析患者并未进行 HCV 确认。HCV 核心抗原可能是一种具有成本效益的诊断测试,可以识别有活性 HCV 感染且适合直接作用抗病毒治疗的 HD 患者。
进行了一项横断面研究,以评估 HCV Ag 和 HCV RNA 之间的相关性,以及使用抗 HCV、HCV Ag 和 HCV RNA 诊断活动性 HCV 感染的不同诊断算法的成本影响。在透析前检测血液中的 HCV Ag 和 HCV RNA。使用 Abbott ARCHITECT HCV Ag 测试检测 HCV Ag。
从 20 个中心招募了 227 名血液透析患者,平均年龄为 57.68±12.48 岁,男性占研究人群的 56.8%(129 人)。HCV Ag 与 HCV RNA 相关性良好(Spearman 检验系数 0.943,p<0.001),其敏感性为 93.9%,特异性为 99.3%,准确性为 97.36%。成本分析表明,一种包括抗 HCV 抗体作为初始筛查的序贯检测,然后对抗 HCV 阳性患者进行 HCV Ag 检测,对 HCV Ag 阴性患者进行 HCV RNA 检测的方法与标准诊断算法相比,可以节省一定的成本。
HCV Ag 与 HCV RNA 相关性良好,可潜在地融合到替代诊断算法中,以节省诊断血液透析患者活动性 HCV 感染的成本。这种替代算法在马来西亚等中低收入国家尤其相关,可以优化医疗资源的利用并获得临床获益。