Multicenter evaluation of the new Alinity s anti-HCV II assay for routine hepatitis C virus blood screening

IF 1.6 Q4 INFECTIOUS DISEASES Journal of clinical virology plus Pub Date : 2023-02-01 DOI:10.1016/j.jcvp.2023.100136

Wai-Chiu Tsoi , Catriona Simpson , Lisa Jarvis , Alan Smith , Ninette Robbins , Ramune Sepetiene , Sonu Bhatnagar

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Abstract

Background

Anti-HCV immunoassays remain the primary serologic test for HCV screening among blood donors. Since 1990s, Anti-HCV assays have evolved and those currently available detect infection earlier and have improved sensitivity and specificity compared with older generation assays. The new Alinity s Anti-HCV II assay, with its innovative design, has improved sensitivity, which shall further enhance safety of blood.

Methods

Alinity s Anti-HCV II assay was evaluated at 2 blood services (HKRCBTS & SNBTS). The overall sensitivity was evaluated using known positive samples (n = 5 at HKRCBTS; 50 at SNBTS) and 3 seroconversion panels (panel members =14 at each site). A total of 7,532 blood donor samples were tested to determine the clinical specificity.

Results

The clinical sensitivity of the new assay was found to be 100% at both sites. HCV seroconversion panel detection rates were 57.1% (8/14) and 14.3% (2/14) for the Alinity s Anti-HCV II and Anti-HCV assays respectively, resulting in an improvement in seroconversion sensitivity of 42.8% for the Anti-HCV II assay over the Anti-HCV assay. The specificity of the Anti-HCV II assay was 100% at HKRCBTS, and 99.95% at SNBTS.

Conclusions

The Anti-HCV II assay detected all known positive specimens and was able to detect samples in seroconversion panels earlier compared to the Anti-HCV assay. The assay showed excellent clinical specificity and generated fewer false-reactive results and was found to be suitable for routine blood donor screening.

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Alinity新的抗HCV II检测法用于丙型肝炎病毒血液常规筛查的多中心评价

背景抗-HCV免疫测定仍然是献血者中HCV筛查的主要血清学检测方法。自20世纪90年代以来，抗-HCV检测方法不断发展，目前可用的检测方法更早地检测感染，与旧一代检测方法相比，灵敏度和特异性有所提高。新的Alinity的抗-HCV II检测方法，其创新设计，提高了灵敏度，将进一步提高血液的安全性。方法在两个血液服务机构（HKRCBTS和SNBTS）进行Alinity的抗-HCV II检测。使用已知阳性样本（HKRCBTS n=5；SNBTS n=50）和3个血清转换小组（每个小组成员=14）评估总体敏感性。共检测了7532份献血者样本，以确定其临床特异性。结果新方法在两个部位的临床敏感性均为100%。Alinity的抗-HCV II和抗-HCV试验的HCV血清转换组检测率分别为57.1%（8/14）和14.3%（2/14），导致抗-HCVⅡ试验的血清转换敏感性比抗-HCV测定提高42.8%。抗-HCV II检测的特异性在HKRCBTS为100%，在SNBTS为99.95%。该检测显示出优异的临床特异性，产生较少的假反应结果，被发现适用于常规献血者筛查。

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