Buffart Beverly, Cherkaoui Sara, Dahma Hafid, Yin Nicolas, Martiny Delphine, Athanasopoulos Alexandre, Van den Wijngaert Sigi
Department of Microbiology, Laboratoire Hospitalier Universitaire de Bruxelles - Universitair Laboratorium Brussel (LHUB-ULB), Université Libre de Bruxelles (ULB, Bruxelles, Rue Haute, 322 - 1000, Belgium.
Faculty of Medicine and Pharmacy, University of Mons (UMONS), Mons, Belgium.
Eur J Clin Microbiol Infect Dis. 2025 Apr 10. doi: 10.1007/s10096-025-05123-7.
Viral hepatitis remains a leading cause of infectious mortality worldwide. This study aimed to improve the serological screening process by reducing unnecessary testing and healthcare costs by optimizing the assay threshold.
Three methods (Elecsys Anti-HCV II, Alinity s Anti-HCV and Ortho HCV 3.0) were compared against a composite gold standard on 260 samples. The best-performing was used to establish an optimal S/CO cut-off for our screening method (Elecsys Anti-HCV II), predictive of true-positivity. A confirmatory assay (Vidas anti-HCV) was used to differentiate true from false positives. A simulation of the use of this cut-off was conducted on a retrospective cohort to assess its effectiveness in terms of diagnosis and healthcare costs.
The Alinity s Anti-HCV II assay showed the highest sensitivity (100%) and specificity (98.2%). This assay was used to establish the cut-off threshold for our method. The best Youden's index was obtained with a value of 17.8 (sensitivity (95.6%), specificity (96.4%)). In a retrospective cohort of 667 patients with a positive initial HCV screening, 124 had an S/CO ratio of ≤ 17.8. Of these, Vidas anti-HCV confirmed 105 negative results (15.74% of the cohort), eliminating the need for PCR testing for these patients. The estimated theoretical savings for a 7-month assessment period is € 7186,2.
An S/CO cut-off of 17.8 was established for the Elecsys Anti-HCV II assay, accurately predicting true positives in 97% of cases and reduced the need for unnecessary PCR confirmatory testing, resulting in cost savings.
病毒性肝炎仍是全球感染性疾病致死的主要原因。本研究旨在通过优化检测阈值减少不必要的检测和医疗成本，从而改进血清学筛查流程。
将三种方法（罗氏电化学发光抗-HCV II检测法、雅培Alinity s抗-HCV检测法和奥森多HCV 3.0检测法）与基于260份样本的综合金标准进行比较。性能最佳的方法用于确定我们筛查方法（罗氏电化学发光抗-HCV II检测法）的最佳S/CO临界值，以预测真阳性。采用确证检测法（VIDAS抗-HCV检测法）区分真阳性和假阳性。对一个回顾性队列进行该临界值应用模拟，以评估其在诊断和医疗成本方面的有效性。
雅培Alinity s抗-HCV II检测法显示出最高的灵敏度（100%）和特异性（98.2%）。该检测法用于确定我们方法的临界阈值。最佳约登指数为17.8（灵敏度（95.6%），特异性（96.4%））。在一个667例初始HCV筛查呈阳性的患者回顾性队列中，124例的S/CO比值≤17.8。其中，VIDAS抗-HCV检测法确认105例结果为阴性（占队列的15.74%），这些患者无需进行PCR检测。7个月评估期的理论节约成本估计为7186.2欧元。
为罗氏电化学发光抗-HCV II检测法确定了S/CO临界值为17.8，能在97%的病例中准确预测真阳性，减少了不必要的PCR确证检测需求，从而节省了成本。
