Performance of ORTHO HCV core antigen and trak-C assays for detection of viraemia in pre-seroconversion plasma and whole blood donors.
Performance of ORTHO HCV core antigen and trak-C assays for detection of viraemia in pre-seroconversion plasma and whole blood donors.
复制标题
ORTHO HCV 核心抗原和 trak-C 检测用于检测血清转化前血浆和全血捐献者中的病毒血症。
DOI：
10.1111/j.1423-0410.2005.00687.x
复制
发表时间：
2005
期刊：
影响因子：
--
通讯作者：
Busch,MP
中科院分区：
文献类型：
--
作者：
Tobler,LH;Stramer,SL;Lee,SR;Baggett,D;Wright,D;Hirschkorn,D;Walsh,I;Busch,MP
核酸扩增检测（NAT）筛查的后勤和成本使其目前无法在许多发展中国家使用。丙型肝炎病毒（HCV）核心抗原检测的发展为NAT提供了一种替代方法。我们评价了两个样本群体，以评估HCV核心抗原（HCVcAg）ELISA相对于NAT的敏感性（酶联免疫吸附试验）检测系统和trak-C检测：（1）血浆供体HCV NAT-转换面板和（2）横截面全血供体NAT产量标本。（NGI; Chiron/Gen‐Probe）和HCVcAg检测试剂盒（Ortho‐Clinical Diagnostics，罗切斯特，纽约州）使用以下方法进行评价：（1）来自37个血浆供体NAT转换样本组的102份连续斜升阶段标本（Alpha Therapeutic/BioClinical Partners）和（2）42份横断面全血供体NAT标本（确认RNA阳性，抗体阴性）加54份NAT假阳性标本结果HCVcAg和trak‐C检测临界值时血浆供体NAT‐转换组中的病毒载量为32 000拷贝/ml（95%置信区间[CI] 8000-120 000）和8000拷贝/ml（95% CI：2200-28 000）。对于HCVcAg检测试剂盒，与常规微池NAT筛查（估计灵敏度100拷贝/ml）相比，窗口期缩短的平均（95% CI）差异延迟5.2天（2.2 - 7.6天），对于trak-C检测试剂盒，延迟3.8天（2.1 - 5.5天）。在42份NAT产量标本中，HCVcAg检测试剂盒检测到31份（74%）核心抗原阳性，而trak-C检测试剂盒检测到37份（88%）核心抗原阳性。trak‐C HCVcAg检测试剂盒未检出的5份标本的病毒载量范围为100 - 7770拷贝/ml。所有54份NAT假阳性标本在两种HCV核心抗原检测试剂盒上均无反应性。结论这些数据表明，trak‐C检测试剂盒在检测血清阴性HCV感染时的灵敏度接近常规微量池NAT筛查。在缺乏早期HCV感染的常规NAT筛查的情况下，应考虑使用HCV核心抗原检测。
ObjectiveLogistics and cost of nucleic acid amplification testing (NAT) screening preclude its current use in many developing countries. Development of hepatitis C virus (HCV) core antigen assays offer an alternative to NAT. We evaluated two specimen populations to assess the sensitivity, relative to NAT, of the HCV core antigen (HCVcAg) ELISA (enzyme‐linked immunosorbent assay) test system and the trak‐C assay: (1) plasma donor HCV NAT‐conversion panels and (2) cross‐sectional whole blood donor NAT yield specimens.MethodsDifferential sensitivities among NAT (NGI; Chiron/Gen‐Probe) and both HCVcAg assays (Ortho‐Clinical Diagnostics, Rochester, NY) were evaluated using: (1) 102 serial ramp‐up phase specimens from 37 plasma donor NAT‐conversion panels (Alpha Therapeutic/BioClinical Partners); and (2) 42 cross‐sectional whole blood donor NAT yield specimens (confirmed RNA positive, antibody negative) plus 54 NAT false‐positive specimens (American Red Cross).ResultsViral load among the plasma donor NAT‐conversion panels at the cutoffs for HCVcAg and trak‐C assays were 32 000 copies/ml (95% confidence interval [CI] 8000–120 000) and 8000 copies/ml (95% CI: 2200–28 000), respectively. The mean (95% CI) difference in window period reduction compared to routine mini‐pool NAT screening (estimated sensitivity 100 copies/ml) was delayed 5·2 days (2·2–7·6 days) for HCVcAg assay and 3·8 days (2·1–5·5 days) for the trak‐C assay. Among the 42 NAT yield specimens, the HCVcAg assay detected 31 (74%) as core antigen‐positive while the trak‐C assay detected 37 (88%) as core antigen‐positive. Viral loads for the five specimens not detected by the trak‐C HCVcAg assay ranged from 100 to 7770 copies/ml. All 54 NAT false‐positive specimens were non‐reactive on both HCV core antigen assays.ConclusionThese data indicate that the trak‐C assay has sensitivity approaching routine mini‐pool NAT screening for the detection of seronegative HCV infection. In the absence of routine NAT screening for early HCV infection, the use of an HCV core antigen assay should be considered.