比较抗肝炎 D 病毒（HDV） ETI-AB-DELTAK-2 检测和新型 LIAISON® XL MUREX 抗 HDV 检测在 HDV 感染诊断中的应用。

Comparison of anti-hepatitis D virus (HDV) ETI-AB-DELTAK-2 assay and the novel LIAISON® XL MUREX anti-HDV assay in the diagnosis of HDV infection.

机构信息

Dipartimento di Scienze Mediche Traslazionali, Università Federico II, U.O.S.D. Virologia A.O.U. Federico II, Napoli, Italy.

出版信息

Diagn Microbiol Infect Dis. 2019 Dec;95(4):114873. doi: 10.1016/j.diagmicrobio.2019.114873. Epub 2019 Jul 26.

DOI:10.1016/j.diagmicrobio.2019.114873

PMID:31473034

Abstract

Hepatitis B/D virus infection leads to severe liver disease. HDV infection is not routinely investigated since the diagnosis is based on enzyme immunoassays (EIAs), which are not available in all laboratories. This study investigates the performance of new automated assay for anti HDV Ab detection: LIAISON® XL Murex anti-HDV. HBsAg-positive samples were evaluated for HDV serology using the ETI-AB-DELTAK-2 and the new LIAISON® XL Murex with a concordance of 97.5% and 2.42% discordant results. The discordant specimens reacted negatively with EIA and positively with the new test. Dilutions of HDV-purified antibodies and HDV-positive samples were tested with both assays, showing a lower detection limit for the new assay. In conclusion, LIAISON® XL Murex showed a good concordance with the reference method and allowed a more rapid HDV detection. This new diagnostic tool may be useful for a more efficient approach to the HDV diagnosis and evaluation of HDV epidemiology.

摘要

乙型肝炎/丁型肝炎病毒感染可导致严重的肝脏疾病。由于丁型肝炎的诊断基于酶免疫测定法（EIAs），而并非所有实验室都能进行这项检测，因此通常不会对其进行常规检测。本研究旨在评估新型自动化抗 HDV Ab 检测试剂盒 LIAISON® XL Murex 的性能：抗-HDV。对 HBsAg 阳性样本进行了 ETI-AB-DELTAK-2 和新型 LIAISON® XL Murex 两种方法的 HDV 血清学检测，结果显示，两种方法的一致性为 97.5%，2.42%的结果不一致。不一致的标本经 EIA 检测呈阴性，而经新检测方法检测呈阳性。两种方法均对 HDV 纯化抗体和 HDV 阳性样本进行了稀释检测，结果显示新检测方法的检测下限更低。总之，LIAISON® XL Murex 与参考方法具有良好的一致性，并可更快地检测到 HDV。这种新的诊断工具可能有助于更有效地诊断 HDV 并评估 HDV 的流行病学。