Abstract：
BACKGROUND: Accurate laboratory confirmation for Hepatitis B diagnosis and monitoring are crucial. Recently an ultrasensitive immunoassay test, the HBsAg Next (HBsAgNx), has been reported approximately eight times more sensitive than current HBsAg assays. The aim of our study was to assess the analytical performances of this new test.
METHODS: 253 clinical samples from Saint Louis University Hospital were analyzed, splitted into four panels: (1) routine prospectively screening serums (n = 196), (2) retrospective serum samples before HBV reactivation (HBV-R) (n = 18), (3) occult HBV infection (OBI) (n = 10) and (4) a selection of wild type HBV genotypes (n = 29) RESULTS: Panel 1, showed robust agreement with the HBsAg Qualitative II (HBsAgQII) assay (Cohen\'s kappa = 0.83). Despite this agreement, 7 false positive with the HBsAgQII assay were found negative with HBsAgNx. One OBI was detected only with HBsAgNx. Panel 2 showed potential time savings in diagnosing HBV-R using HBsAgNx among 4/18 HBsAg positives samples. Panel 3 highlighted the ability of HBsAgNx to detect HBsAg in OBI patients defined by negative for HBsAg with HBsAgQII assay and positive for HBV DNA. Furthermore, the HBsAgNx assay detected all different genotypes.
CONCLUSIONS: The study highlights the effectiveness of the HBsAgNx assay, showing its performance. It excels in detecting weakly positive samples and addressing challenging cases. HBsAgNx assay demonstrates promising analytical performances, with improved sensitivity and specificity compared to standard HBsAgQII assay, able to detect all genotypes. Its potential impact on early detecting and monitoring reactivations, and occult infections could be very useful in clinical practice.
METHODS: 253 clinical samples from Saint Louis University Hospital were analyzed, splitted into four panels: (1) routine prospectively screening serums (n = 196), (2) retrospective serum samples before HBV reactivation (HBV-R) (n = 18), (3) occult HBV infection (OBI) (n = 10) and (4) a selection of wild type HBV genotypes (n = 29) RESULTS: Panel 1, showed robust agreement with the HBsAg Qualitative II (HBsAgQII) assay (Cohen\'s kappa = 0.83). Despite this agreement, 7 false positive with the HBsAgQII assay were found negative with HBsAgNx. One OBI was detected only with HBsAgNx. Panel 2 showed potential time savings in diagnosing HBV-R using HBsAgNx among 4/18 HBsAg positives samples. Panel 3 highlighted the ability of HBsAgNx to detect HBsAg in OBI patients defined by negative for HBsAg with HBsAgQII assay and positive for HBV DNA. Furthermore, the HBsAgNx assay detected all different genotypes.
CONCLUSIONS: The study highlights the effectiveness of the HBsAgNx assay, showing its performance. It excels in detecting weakly positive samples and addressing challenging cases. HBsAgNx assay demonstrates promising analytical performances, with improved sensitivity and specificity compared to standard HBsAgQII assay, able to detect all genotypes. Its potential impact on early detecting and monitoring reactivations, and occult infections could be very useful in clinical practice.
摘要：
背景：乙型肝炎诊断和监测的准确实验室确认至关重要。最近一项超敏的免疫测定测试，HBsAg下一步（HBsAgNx），已报道比目前的HBsAg测定敏感约八倍。我们研究的目的是评估这种新测试的分析性能。
方法：对来自圣路易斯大学医院的253份临床样本进行分析，分为四个小组：（1）常规前瞻性筛查血清（n=196），（2）回顾性血清样本前HBV再激活（HBV-R）（n=18），（3）隐匿性HBV感染（OBI）（n=10）和（4）选择野生型HBV基因型（n=29）结果：第1组显示出与HBsAg定性II（HBsAgQII）测定（Cohen的kappa=0.83）的稳健一致性。尽管有这个协议,用HBsAgQII测定发现7个假阳性用HBsAgNx为阴性。仅用HBsAgNx检测到一个OBI。第2组显示在4/18HBsAg阳性样品中使用HBsAgNx诊断HBV-R的潜在时间节省。第3组强调了HBsAgNx在OBI患者中检测HBsAg的能力,所述OBI患者由HBsAgQII测定的HBsAg阴性和HBVDNA阳性定义。此外，HBsAgNx测定检测到所有不同的基因型。
结论：该研究突出了HBsAgNx测定的有效性，显示其性能。它擅长检测弱阳性样本和处理具有挑战性的案例。HBsAgNx测定显示有希望的分析性能，与标准HBsAgQII测定相比，具有改进的灵敏度和特异性，能够检测所有基因型。它对早期检测和监测重新激活的潜在影响，隐匿性感染在临床实践中可能非常有用。
方法：对来自圣路易斯大学医院的253份临床样本进行分析，分为四个小组：（1）常规前瞻性筛查血清（n=196），（2）回顾性血清样本前HBV再激活（HBV-R）（n=18），（3）隐匿性HBV感染（OBI）（n=10）和（4）选择野生型HBV基因型（n=29）结果：第1组显示出与HBsAg定性II（HBsAgQII）测定（Cohen的kappa=0.83）的稳健一致性。尽管有这个协议,用HBsAgQII测定发现7个假阳性用HBsAgNx为阴性。仅用HBsAgNx检测到一个OBI。第2组显示在4/18HBsAg阳性样品中使用HBsAgNx诊断HBV-R的潜在时间节省。第3组强调了HBsAgNx在OBI患者中检测HBsAg的能力,所述OBI患者由HBsAgQII测定的HBsAg阴性和HBVDNA阳性定义。此外，HBsAgNx测定检测到所有不同的基因型。
结论：该研究突出了HBsAgNx测定的有效性，显示其性能。它擅长检测弱阳性样本和处理具有挑战性的案例。HBsAgNx测定显示有希望的分析性能，与标准HBsAgQII测定相比，具有改进的灵敏度和特异性，能够检测所有基因型。它对早期检测和监测重新激活的潜在影响，隐匿性感染在临床实践中可能非常有用。
