Chen Dan, Kaplan Lawrence A
Department of Pathology, New York University, School of Medicine, Clinical Chemistry Laboratory of Bellevue Hospital, New York, NY 10016, USA.
Clin Chem. 2006 Aug;52(8):1592-8. doi: 10.1373/clinchem.2005.064063. Epub 2006 Jun 8.
The usual criteria for analysis of hepatitis B surface antigen (HBsAg) are detection of HBsAg and result confirmation by antibody neutralization. We observed that with the Immulite 2000 HBsAg assay [Diagnostics Product Corporation (DPC)] a relatively high percentage of weakly reactive (WR) samples did not pass the neutralization step.
For each of 3 lots of Immulite 2000 HBsAg reagent (DPC), we collected and analyzed HBsAg data from approximately 3000 to 4000 patient blood samples and compared these data with HBsAg data from 3393 samples tested with the Abbott Auszyme assay. For 127 samples with initially WR detection signals (relative signal/cutoff index of 1.00-2.5) on the Immulite 2000 HBsAg assay, we then measured hepatitis B (HB) viral load and/or other HB serologic markers.
The Immulite 2000 HBsAg assay produced more initially reactive results than the Abbott Auszyme method. Many of these reactive samples, however, were WR and did not meet the confirmation criteria in the neutralization test. Moreover, DNA PCR testing indicated that 22 of the 38 WR samples (58%) that did meet the confirmation criteria had no detectable HB viral DNA.
Immulite 2000 HBsAg assay results include a unique group of WR samples that are associated with both false-positive and false-negative results, regardless of neutralization status, and require careful interpretation. WR HBsAg samples should be reported as confirmed HBsAg reactive only if the samples not only meet the neutralization criteria but also are positive for other HB serologic markers such as anti-HB core total and anti-HB core IgM.
分析乙型肝炎表面抗原（HBsAg）的常用标准是检测HBsAg并通过抗体中和进行结果确认。我们观察到，使用Immulite 2000 HBsAg检测法[诊断产品公司（DPC）]时，相当高比例的弱反应性（WR）样本未通过中和步骤。
对于3批Immulite 2000 HBsAg试剂（DPC）中的每一批，我们收集并分析了约3000至4000份患者血样的HBsAg数据，并将这些数据与用雅培Auszyme检测法检测的3393份样本的HBsAg数据进行比较。对于在Immulite 2000 HBsAg检测中最初检测信号为WR（相对信号/临界值指数为1.00 - 2.5）的127份样本，我们随后检测了乙型肝炎（HB）病毒载量和/或其他HB血清学标志物。
Immulite 2000 HBsAg检测法产生的初始反应性结果比雅培Auszyme方法更多。然而，这些反应性样本中有许多是WR，并且在中和试验中不符合确认标准。此外，DNA聚合酶链反应检测表明，在38份符合确认标准的WR样本中，有22份（58%）未检测到HB病毒DNA。
Immulite 2000 HBsAg检测结果包括一组独特的WR样本，无论中和状态如何，这些样本都与假阳性和假阴性结果相关，需要仔细解读。只有当样本不仅符合中和标准，而且其他HB血清学标志物如抗HB核心总抗体和抗HB核心IgM呈阳性时，WR HBsAg样本才能报告为确认的HBsAg反应性。
