Obriadina A, Meng J H, Ulanova T, Trinta K, Burkov A, Fields H A, Khudyakov Y E
Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
J Gastroenterol Hepatol. 2002 Dec;17 Suppl 3:S360-4. doi: 10.1046/j.1440-1746.17.s3.28.x.
The purpose of the present study was to develop enzyme immunoassay (EIA) for the detection of IgG anti-hepatitis E virus (HEV) activity using two new recombinant proteins as antigenic targets, and to evaluate these EIA with the aid of statistical methods.
Two proteins, a mosaic protein and pB166 containing region 452-617 aa of the ORF2 of the HEV Burma strain, were used to develop the new HEV EIA. This EIA was evaluated using several panels of serum specimens obtained from: (i) acutely HEV-infected patients; (ii) patients with non-A, non-C hepatitis; (iii) normal blood donors (NBD) from non-endemic countries; and (iv) experimentally infected chimpanzees.
A new HEV EIA was developed using two new recombinant proteins. This assay was able to detect anti-HEV activity in all specimens from acutely HEV-infected patients. When NBD were tested, more than 15% of specimens were found to be IgG anti-HEV positive. All NBD anti-HEV-positive specimens were tested with overlapping synthetic peptides spanning the entire HEV ORF2-encoded protein. More than 90% of the anti-HEV-positive NBD specimens immunoreacted with an average of 15 synthetic peptides derived from different regions of the HEV ORF2 protein. These data suggest that the HEV EIA is at least 90% specific in detecting remote HEV infections.
The new HEV EIA developed in the present study is a highly specific diagnostic assay for the detection of anti-HEV activity in serum specimens obtained from different epidemiologic settings.
本研究旨在开发一种酶免疫测定法（EIA），以两种新的重组蛋白作为抗原靶点检测抗戊型肝炎病毒（HEV）IgG活性，并借助统计学方法评估这些EIA。
使用一种嵌合蛋白和包含HEV缅甸株ORF2 452 - 617氨基酸区域的pB166这两种蛋白来开发新的HEV EIA。使用从以下几类人群获得的多组血清标本对该EIA进行评估：（i）急性HEV感染患者；（ii）非甲非丙型肝炎患者；（iii）非流行国家的正常献血者（NBD）；以及（iv）实验感染的黑猩猩。
利用两种新的重组蛋白开发出了一种新的HEV EIA。该检测方法能够在所有急性HEV感染患者的标本中检测到抗HEV活性。对NBD进行检测时，发现超过15%的标本抗HEV IgG呈阳性。所有抗HEV阳性的NBD标本都用覆盖整个HEV ORF2编码蛋白的重叠合成肽进行检测。超过90%的抗HEV阳性NBD标本与平均15种源自HEV ORF2蛋白不同区域的合成肽发生免疫反应。这些数据表明，HEV EIA在检测既往HEV感染时至少具有90%的特异性。
本研究中开发的新HEV EIA是一种高度特异性的诊断检测方法，用于检测从不同流行病学背景获得的血清标本中的抗HEV活性。
