Evaluation of a new hepatitis B virus surface antigen rapid test with improved sensitivity
Evaluation of a new hepatitis B virus surface antigen rapid test with improved sensitivity
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DOI：
10.1128/jcm.00498-08
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发表时间：
2008-10-01
影响因子：
9.4
通讯作者：
Lee, Helen H.
中科院分区：
文献类型：
--
作者：
Lin, Yu-Huei;Wang, Yi;Lee, Helen H.
真实世界诊断(欧洲)有限公司建立了一种基于信号放大系统(SAS)的新的快速免疫层析法，用于检测血浆或血清标本中的乙肝病毒表面抗原(HBs)。由于检测器分子的结合价增加，SAS格式具有增强的灵敏度。现在，我们已经通过与成熟的商业快速检测方法(确定乙肝表面抗原；以前来自雅培实验室；现在来自因弗内斯医疗创新公司)以及以CE标记的酶免疫分析(EIA)(Hepanostika HBs Ag Ultra；BioMerieux)作为金标准，评估了新的HBs Ag快速检测(DRW-HBs Ag)的性能。对连续稀释的内部乙肝表面抗原阳性样本、世界卫生组织标准以及敏感性和参照板的测试表明，不同乙肝表面抗原血清型的DRW测试的分析敏感性为0.2至0.8IU/ml。对8个商业血清转换板的评估表明，DRW-HBs Ag检测方法比测定方法平均提前6.1d(范围为3-8d)(P=0.0078)。北京的中国用两个低滴度的乙肝表面抗原EIA阳性小组检测了试验的敏感性。而用DRW-HBs Ag检测这些样本的阳性率为100%，而用Del-HBs Ag检测的阳性率分别为15.0%(P<；0.0001)和87.3%(P&t；0.0001)。对几内亚科纳克里和北京中国经环评确定为乙肝表面抗原阳性或阴性的样本，进一步评估了DRW-HBs Ag检测的性能。与来自几内亚(96.7%对94.4%)或中国(99.46%对98.92%)的乙肝表面抗原EIA反应样本相比，DRW和DIRE试验之间的敏感性没有明显差异。对中国地区EIA阴性献血员的检测，其特异性略高于DRW-HBs检测(分别为100%和99.2%)。综上所述，新的DRW-HBs-Ag快速检测方法比测定-HBs-Ag检测更敏感，适合在资源有限的环境中进行诊断和血液筛查。
A new rapid immunochromatographic assay based on the signal amplification system (SAS) has been developed by Diagnostics for the Real World (Europe) Ltd. for the detection of hepatitis B virus surface antigen (HBsAg) in plasma or serum specimens. The SAS format features enhanced sensitivity as a result of an increased binding valence of the detector molecules. We have now evaluated the performance of the new HBsAg rapid test (DRW-HBsAg) in comparison with a well-established commercial rapid test (Determine HBsAg; previously from Abbott Laboratories; now from Inverness Medical Innovations) and with a CE-marked enzyme immunoassay (EIA) (Hepanostika HBsAg Ultra; BioMerieux) as the gold standard. Testing of serially diluted in-house HBsAg-positive samples, the World Health Organization standard, and sensitivity and reference panels yielded an analytical sensitivity for the DRW test of 0.2 to 0.8 IU/ml across HBsAg serotypes. Evaluation with eight commercially available seroconversion panels showed that the DRW-HBsAg test detected HBsAg an average of 6.1 days (range, 3 to 8 days) earlier than the Determine assay (P = 0.0078). Test sensitivity was also examined with two low-titer HBsAg EIA-positive panels in Beijing, China. Whereas 100% of these samples were detected by the DRW-HBsAg test, only 15.0% (P < 0.0001) and 87.3% (P < 0.0001), respectively, were detected by the Determine HBsAg test. The performance of the DRW-HBsAg test was further evaluated with samples determined to be HBsAg positive or negative by the EIA in Conakry, Guinea, and Beijing, China. No significant difference in sensitivity between the DRW and Determine tests was apparent with the HBsAg EIA-reactive samples from Guinea (96.7% versus 94.4%, respectively) or China (99.46 versus 98.92%, respectively). The specificity of the Determine HBsAg test was slightly higher than that of DRW-HBsAg test (100 versus 99.2%, respectively) with samples from EIA-negative blood donors in China. In conclusion, the new DRW HBsAg rapid test is more sensitive than the Determine HBsAg test and is suitable for diagnostic and blood screening in resource-limited settings.