Cruz Helena Medina, Scalioni Leticia de Paula, de Paula Vanessa Salete, da Silva Elisangela Ferreira, do Ó Kycia Maria Rodrigues, Milagres Flavio Augusto Pádua, Cruz Marcelo Santos, Bastos Francisco Inácio, Pollo-Flores Priscila, Leal Erotildes, Motta-Castro Ana Rita Coimbra, Pilotto José Henrique, Lewis-Ximenez Lia Laura, Lampe Elisabeth, Villar Livia Melo
Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil.
Laboratory of Technological Development of Virology, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil.
BMC Infect Dis. 2015 Nov 30;15:548. doi: 10.1186/s12879-015-1249-5.
Rapid tests (RTs) might have several advantages over standard laboratory procedures, increasing access to diagnosis, especially among vulnerable populations and/or those living in remote areas. The aim of this study was to evaluate the performance of RTs for the detection of hepatitis B virus surface antigen (HBsAg) in samples from different populations/settings.
Three RTs for HBsAg detection (Vikia® HBsAg, HBsAg Teste Rápido®, and Imuno-Rápido HBsAg®) and different biological specimens (serum, whole blood, and saliva) were evaluated. Analyses comprised a reference panel and samples from field studies targeting suspected cases of hepatitis B virus (HBV) (G I), individuals living in deprived areas (G II), and highly vulnerable individuals (G III). Enzyme immunoassay (EIA) was defined as the gold standard in this study. Reproducibility, repeatability, and cross-reactivity with other infectious agents such as dengue, immunodeficiency (HIV), and hepatitis C (HCV) viruses and T. pallidum were determined.
For the reference panel, the sensitivity and specificity of all HBsAg RTs were higher than 93.00 %. G I presented the highest kappa values for all rapid assays using sera samples. When using serum, the sensitivity values were higher than 93.40 for G I, 60.00 % for G II and 66.77 % for G III, and the specificity values were higher than 99.50 for GI, 97.20 for G II and 99.10 % for G III for all tests. For whole blood samples & the Vikia® HBsAg assay, the best performance was achieved for GIII (k = 79.75 %). For saliva samples, the Imuno-Rápido HBsAg® assay showed the highest concordance values with EIA for G I (40.68 %) and G II (32.20 %). The reproducibility and repeatability of all RTs for serum and saliva were excellent, and the concordance between HBsAg EIAs and RTs using samples reactive with other infectious agents varied from 70.10 % to 100.00 %.
The overall performance of RTs for HBsAg in serum was high/moderately high for all groups, thereby promoting increased access to HBV diagnosis among vulnerable populations as well as samples from individuals in emergency settings or remote areas. Rapid tests for HBsAg using whole blood could be used in prevalence studies, though these assays should not be used for saliva samples.
快速检测（RTs）相对于标准实验室检测程序可能具有多个优势，能增加诊断的可及性，尤其是在弱势群体和/或居住在偏远地区的人群中。本研究的目的是评估RTs在不同人群/环境样本中检测乙型肝炎病毒表面抗原（HBsAg）的性能。
评估了三种用于检测HBsAg的RTs（Vikia® HBsAg、HBsAg Teste Rápido®和Imuno-Rápido HBsAg®）以及不同的生物样本（血清、全血和唾液）。分析包括一个参考面板以及来自针对乙型肝炎病毒（HBV）疑似病例（第一组）、生活在贫困地区的个体（第二组）和高度易感个体（第三组）的现场研究的样本。在本研究中，酶免疫测定（EIA）被定义为金标准。确定了与登革热、免疫缺陷（HIV）、丙型肝炎（HCV）病毒和梅毒螺旋体等其他传染原的再现性、重复性和交叉反应性。
对于参考面板，所有HBsAg RTs的敏感性和特异性均高于93.00%。在使用血清样本的所有快速检测中，第一组的kappa值最高。使用血清时，所有检测中第一组的敏感性值高于93.40%，第二组为60.00%，第三组为66.77%；第一组的特异性值高于99.50%，第二组为97.20%，第三组为99.10%。对于全血样本和Vikia® HBsAg检测，第三组的表现最佳（kappa = 79.75%）。对于唾液样本，Imuno-Rápido HBsAg®检测在第一组（40.68%）和第二组（32.20%）中与EIA的一致性值最高。所有血清和唾液RTs的再现性和重复性都很好，使用与其他传染原反应的样本时，HBsAg EIA和RTs之间的一致性在70.10%至100.00%之间。
所有组中血清HBsAg RTs的总体性能为高/中度高，从而有助于增加弱势群体以及紧急情况下或偏远地区个体样本中HBV诊断的可及性。使用全血进行HBsAg快速检测可用于患病率研究，不过这些检测不适用于唾液样本。
