American Red Cross, Gaithersburg, Maryland 20877, USA.
Transfusion. 2011 Sep;51(9):2012-22. doi: 10.1111/j.1537-2995.2011.03140.x. Epub 2011 Apr 19.
There have been no comparisons of the relative sensitivity of the two Food and Drug Administration-licensed multiplex (MPX) nucleic acid test (NAT) systems (Procleix Ultrio [Gen-Probe], TIGRIS platform [Novartis]; and cobas TaqScreen MPX [Roche Molecular Systems], cobas s 201 platform [Roche Instrument Center]) for detecting hepatitis B virus (HBV)-infected donors in minipool sizes (MP) used in the United States.
Routine blood samples from Thailand were obtained from plasma units from 129 hepatitis B surface antigen (HBsAg)-negative, HBV NAT-yield donations. Blinded US testing included antibody to hepatitis B core antigen (anti-HBc), NAT using both manufacturers' systems (undiluted-individual donation [ID], in singlet and diluted 1:6 and 1:16 in triplicate), quantitative antibody to hepatitis B surface antigen, HBV DNA viral loads, and HBV genotyping. HBV yields in the United States were estimated using the incidence/window period (WP) model and compared to the calculated assay sensitivities.
Eighty samples were classified as occult HBV (anti-HBc reactive) and 49 as WP (anti-HBc nonreactive). For US pool sizes, MPX detected significantly more samples than Ultrio (MPX MP6 vs. Ultrio MP16; p < 0.0001 for occult and WP). Ultrio MP16 results were not statistically different from Ultrio MP6 (p = 0.68 for occult; p = 0.42 for WP). There was no difference between platforms for MP sizes used in most of the world (MPX MP6 vs. Ultrio ID; p = 0.70 for occult and p = 0.34 for WP). Viral loads were higher in WP samples. Modeled yield estimates were consistent with measured assay sensitivity on the Thai donor samples.
As used in the United States, MPX MP6 is more sensitive than Ultrio MP16, but the impact of this difference is mitigated by low numbers of HBV WP infections.
目前尚无比较两种美国食品和药物管理局批准的多重（MPX）核酸检测（NAT）系统（Procleix Ultrio [Gen-Probe]，TIGRIS 平台 [诺华]；以及 cobas TaqScreen MPX [罗氏分子系统]，cobas s 201 平台 [罗氏仪器中心]）检测用于检测美国使用的小池（MP）中乙型肝炎病毒（HBV）感染供体的相对敏感性的比较。
从泰国的血浆单位中获得了 129 份乙型肝炎表面抗原（HBsAg）阴性、HBV NAT 产量的常规血液样本。盲法美国检测包括乙型肝炎核心抗原抗体（抗-HBc）、使用两种制造商系统的 NAT（未稀释个体供体 [ID]、单独和稀释 1:6 和 1:16 一式三份）、乙型肝炎表面抗原定量抗体、HBV DNA 病毒载量和 HBV 基因分型。使用发生率/窗口期（WP）模型估计美国的 HBV 产量，并与计算的检测灵敏度进行比较。
80 个样本被归类为隐匿性 HBV（抗-HBc 反应性），49 个为 WP（抗-HBc 非反应性）。对于美国池大小，MPX 比 Ultrio 检测到更多的样本（MPX MP6 与 Ultrio MP16；隐匿性和 WP 均为 p < 0.0001）。Ultrio MP16 结果与 Ultrio MP6 无统计学差异（隐匿性为 p = 0.68；WP 为 p = 0.42）。在世界上大多数国家使用的池大小方面，两种平台之间没有差异（MPX MP6 与 Ultrio ID；隐匿性为 p = 0.70，WP 为 p = 0.34）。WP 样本中的病毒载量较高。模型产量估计与泰国供体样本的测定检测灵敏度一致。
在美国使用时，MPX MP6 比 Ultrio MP16 更敏感，但由于 WP 感染的 HBV 数量较少，这种差异的影响有所减轻。
