Large-Scale Evaluation of the Immuno-Mycologics Lateral Flow and Enzyme-Linked Immunoassays for Detection of Cryptococcal Antigen in Serum and Cerebrospinal Fluid
Large-Scale Evaluation of the Immuno-Mycologics Lateral Flow and Enzyme-Linked Immunoassays for Detection of Cryptococcal Antigen in Serum and Cerebrospinal Fluid
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DOI：
10.1128/cvi.00536-12
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发表时间：
2013-01-01
影响因子：
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通讯作者：
Hanson, Kimberly E.
中科院分区：
文献类型：
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作者：
Hansen, Jessica;Slechta, E. Susan;Hanson, Kimberly E.
隐球菌病是由致病酵母菌、新生隐球菌属和加蒂隐球菌属引起的全身性感染。血清和脑脊液中隐球菌壳抗原(CRAG)的检测具有重要的诊断价值。我们前瞻性地将新的免疫真菌制剂公司(IMMY)的侧向流动试验(LFA)和酶免疫试验(EIA)与我们目前的CRAG试验(Premier EIA；Merdian Bioscience Inc.)进行了比较。不一致的标本用乳胶隐球菌抗原试验(IMMY)和血清型特异性单抗(MAb)重新检测。共平行检测了589份血清和411份脑脊液标本。各项检测的定性符合率为97.7%。总共有56份(41份血清和15份脑脊液)呈阳性，921份(527份血清和394份脑脊液)呈阴性。23份不同标本子午线EIA均为阴性。在23例不一致标本中，IMMY LFA和EIA同时阳性20例(87.0%)，LFA单独阳性2例，EIA单独阳性1例。11份有差异的标本有足够的容量进行乳胶凝集试验；8份乳胶凝集阳性，3份乳胶凝集阴性。LA阴性标本(2例脑脊液和1例血清)免疫LFA/EIA滴度较低(
Cryptococcosis is a systemic infection caused by the pathogenic yeasts Cryptococcus neoformans and C. gattii. Detection of cryptococcal capsular antigen (CrAg) in serum and cerebrospinal fluid (CSF) plays an important diagnostic role. We prospectively compared the new Immuno-Mycologics Inc. (IMMY) lateral flow assay (LFA) and enzyme immunoassay (EIA) to our current CrAg test (Premier EIA; Meridian Bioscience Inc.). Discordant samples were retested with the latex-Cryptococcus antigen test (IMMY) and using serotype-specific monoclonal antibodies (MAbs). A total of 589 serum and 411 CSF specimens were tested in parallel. Qualitative agreement across assays was 97.7%. In all, 56 (41 serum and 15 CSF) samples were positive and 921 (527 serum and 394 CSF) samples were negative by all three assays. The 23 discrepant specimens were all Meridian EIA negative. Of 23 discordant specimens, 20 (87.0%) were positive by both the IMMY LFA and EIA, 2 were LFA positive only, and 1 was EIA positive only. Eleven discrepant specimens had adequate volume for latex agglutination (LA) testing; 8 were LA positive, and 3 were LA negative. LA-negative samples (2 CSF samples and 1 serum) had low IMMY LFA/EIA titers (