Maine G T, Stricker R, Schuler M, Spesard J, Brojanac S, Iriarte B, Herwig K, Gramins T, Combs B, Wise J, Simmons H, Gram T, Lonze J, Ruzicki D, Byrne B, Clifton J D, Chovan L E, Wachta D, Holas C, Wang D, Wilson T, Tomazic-Allen S, Clements M A, Wright G L, Lazzarotto T, Ripalti A, Landini M P
Department of Congenital Infectious Disease Diagnostics, Abbott Laboratories, Abbott Park, IL 60064-6199, USA.
J Clin Microbiol. 2000 Apr;38(4):1476-81. doi: 10.1128/JCM.38.4.1476-1481.2000.
A new microparticle enzyme immunoassay (MEIA), the Cytomegalovirus (CMV) Immunoglobulin M (IgM) test, was developed on the Abbott AxSYM analyzer. This test uses recombinant CMV antigens derived from portions of four structural and nonstructural proteins of CMV: pUL32 (pp150), pUL44 (pp52), pUL83 (pp65), and pUL80a (pp38). A total of 1, 608 specimens from random volunteer blood donors (n = 300), pregnant women (n = 1,118), transplant recipients (n = 6), and patients with various clinical conditions and disease states (n = 184) were tested during development and evaluation of this new assay. In a preliminary clinical evaluation we tested specimens collected prospectively from pregnant women (n = 799) and selected CMV IgM-positive archived specimens from pregnant women (n = 39). The results from the new CMV IgM immunoassay were compared to the results of a consensus interpretation of the results obtained with three commercial CMV IgM immunoassays. The results for specimens with discordant results were resolved by a CMV IgM immunoblot assay. The relative sensitivity, specificity, and agreement for the AxSYM CMV IgM assay were 94.29, 96.28, and 96.19%, respectively, and the resolved sensitivity, specificity, and agreement were 95.83, 97.47, and 97.37%, respectively. We also tested serial specimens from women who experienced seroconversion or a recent CMV infection during gestation (n = 17) and potentially cross-reactive specimens negative for CMV IgM antibody by the consensus tests (n = 184). The AxSYM CMV IgM assay was very sensitive for the detection of CMV IgM during primary CMV infection, as shown by the detection of CMV IgM at the same time as or just prior to the detection of CMV IgG. Specimens from individuals with lupus (n = 16) or parvovirus B19 infection (n = 6) or specimens containing hyper IgM (n = 9), hyper IgG (n = 8), or rheumatoid factor (n = 55) did not cross-react with the AxSYM assay. One specimen each from individuals infected with Epstein-Barr virus (n = 26), measles virus (n = 10), herpes simplex virus (n = 12), or varicella-zoster virus (n = 13) infection, one specimen from an influenza vaccinee (n = 14), and one specimen containing antinuclear antibody cross-reacted with the assay. The overall rate of cross-reactivity of the specimens with the assay was 3.3% (6 of 184). The AxSYM CMV IgM assay is a sensitive and specific assay for the detection of CMV-specific IgM.
一种新型微粒酶免疫测定法（MEIA），即巨细胞病毒（CMV）免疫球蛋白M（IgM）检测法，已在雅培AxSYM分析仪上研发成功。该检测法使用的重组CMV抗原源自CMV四种结构蛋白和非结构蛋白的部分片段：pUL32（pp150）、pUL44（pp52）、pUL83（pp65）和pUL80a（pp38）。在该新检测法的研发和评估过程中，共对1608份来自随机自愿献血者（n = 300）、孕妇（n = 1118）、移植受者（n = 6）以及患有各种临床病症和疾病状态的患者（n = 184）的样本进行了检测。在一项初步临床评估中，我们对前瞻性收集的孕妇样本（n = 799）以及从孕妇中挑选出的CMV IgM阳性存档样本（n = 39）进行了检测。将新型CMV IgM免疫测定法的结果与三种商用CMV IgM免疫测定法所得结果的共识解读结果进行了比较。结果不一致的样本通过CMV IgM免疫印迹法进行判定。AxSYM CMV IgM检测法的相对灵敏度、特异性和一致性分别为94.29%、96.28%和96.19%，经判定后的灵敏度、特异性和一致性分别为95.83%、97.47%和97.37%。我们还对妊娠期间发生血清转化或近期感染CMV的女性的系列样本（n = 17）以及经共识检测CMV IgM抗体呈阴性的潜在交叉反应样本（n = 184）进行了检测。AxSYM CMV IgM检测法在原发性CMV感染期间对CMV IgM的检测非常灵敏，在检测到CMV IgG的同时或之前就能检测到CMV IgM。来自狼疮患者（n = 16）、细小病毒B19感染患者（n = 6）的样本，或含有高IgM（n = 9）、高IgG（n = 8）或类风湿因子（n = 55）的样本与AxSYM检测法无交叉反应。来自感染爱泼斯坦 - 巴尔病毒（n = 26）、麻疹病毒（n = 10）、单纯疱疹病毒（n = 12）或水痘 - 带状疱疹病毒（n = 13）的个体的各一份样本、一份来自流感疫苗接种者的样本（n = 14）以及一份含有抗核抗体的样本与该检测法发生了交叉反应。样本与该检测法的总体交叉反应率为3.3%（184份样本中有6份）。AxSYM CMV IgM检测法是一种检测CMV特异性IgM的灵敏且特异检测法。
