Mast E E, Alter M J, Holland P V, Purcell R H
Hepatitis Branch, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Hepatology. 1998 Mar;27(3):857-61. doi: 10.1002/hep.510270331.
Few data are available to evaluate the performance of existing assays for antibody to the hepatitis E virus (anti-HEV). A panel of 164 randomized and coded sera was tested for anti-HEV by 12 different assays. The panel included a dilution series of an early convalescent human serum, known-positive sera (undiluted human sera obtained 2 months to 13 years after acute hepatitis E, and postinoculation chimpanzee sera), known-negative sera (preinoculation chimpanzee sera; sera from chimpanzees with hepatitis A virus, hepatitis B virus, or hepatitis C virus infection; and normal human sera), and sera obtained from previously tested U.S. blood donors without a history of hepatitis. Six tests detected anti-HEV in > or =90% of undiluted known-positive sera. The sensitivity of all of the assays with known-positive sera ranged from 17% to 100%, and the limit of detection by endpoint dilution ranged from 1:5 to 1:160. Ten tests were nonreactive for all of the 22 known-negative sera, one test was reactive for one serum, and one test was reactive for 5 sera. In pairwise comparisons of different tests in blood donor sera, the overall concordance ranged from 49% to 94% (median, 69%) and the concordance among reactive sera ranged from 0% to 89% (median, 32%). Several of these tests performed well in detecting anti-HEV in known positive sera. However, highly discrepant results among U.S. blood donor sera indicate that anti-HEV seroprevalence data in non-HEV-endemic countries may be unreliable and should be interpreted with caution.
目前几乎没有数据可用于评估现有戊型肝炎病毒抗体（抗 - HEV）检测方法的性能。通过12种不同的检测方法对一组164份随机编码血清进行了抗 - HEV检测。该血清组包括一份早期恢复期人血清的稀释系列、已知阳性血清（急性戊型肝炎后2个月至13年获得的未稀释人血清以及接种后黑猩猩血清）、已知阴性血清（接种前黑猩猩血清；甲型肝炎病毒、乙型肝炎病毒或丙型肝炎病毒感染的黑猩猩血清；以及正常人血清），以及从之前检测过的无肝炎病史的美国献血者中获得的血清。六种检测方法在≥90%的未稀释已知阳性血清中检测到了抗 - HEV。所有使用已知阳性血清的检测方法的灵敏度范围为17%至100%，终点稀释法的检测限范围为1:5至1:160。对于所有22份已知阴性血清，有10种检测方法无反应，一种检测方法对一份血清有反应，一种检测方法对5份血清有反应。在对献血者血清中不同检测方法的两两比较中，总体一致性范围为49%至94%（中位数为69%），反应性血清之间的一致性范围为0%至89%（中位数为32%）。这些检测方法中的几种在检测已知阳性血清中的抗 - HEV方面表现良好。然而，美国献血者血清中存在高度不一致的结果，这表明在非戊型肝炎流行国家的抗 - HEV血清流行率数据可能不可靠，应谨慎解读。
