Division of Infectious Disease, Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; Department of Medicine, National Taiwan University Cancer Center, Taipei, Taiwan.
Department of Pharmacy, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Clinical Pharmacy, National Taiwan University, Taipei, Taiwan.
Clin Microbiol Infect. 2020 Nov;26(11):1555.e9-1555.e14. doi: 10.1016/j.cmi.2020.02.002. Epub 2020 Feb 12.
Evidence of false-positive galactomannan enzyme immunoassay (GM-EIA) results associated with intravenous immunoglobulin (IVIG) administration is scarce. Here, we aimed to determine the false-positive rate of GM-EIA after IVIG administration and to identify the related factors.
Standard GM-EIA was performed using diluted and pure human IVIG samples with and without heat treatment. We also included adult patients who had at least one GM-EIA result within 1 week of IVIG administration for analysis. Those who had prior invasive aspergillosis within 1 year before IVIG therapy were excluded. The clinical characteristics and galactomannan index (GMI) kinetics between patients with false-positive and true-positive GMI were compared.
All diluted and pure IVIG samples tested positive for GM. Heat treatment resulted in the considerable elevation of GMI. Of 48 patients with positive GM-EIA results within 1 week of IVIG administration, 22 (45.8%) were considered to have false-positive antigenaemia (false-positive group, FPG). After the completion of IVIG administration, a decline in GMI was observed in all FPG patients but in only 18 out of 26 patients (69.2%) with true-positive results (true-positive group, TPG). By 7, 14, and 18 days of IVIG administration, GMI reverted to negative values in 7/15 (46.7%), 18/20 (90%) and 22/22 (100%) FPG patients, respectively, and 6/24 (25%), 14/24 (58.3%), and 16/26 (61.5%) of TPG patients, respectively. The TPG was more likely to have two or more consecutively positive GMIs after IVIG administration than the FPG (adjusted odds ratio, 9.01; 95% confidence interval, 1.99-40.9).
IVIG treatment may produce false-positive GM-EIA results. A positive GMI among patients receiving human IVIG should be interpreted with caution.
静脉注射免疫球蛋白（IVIG）治疗后出现半乳甘露聚糖酶免疫分析（GM-EIA）假阳性的证据很少。本研究旨在确定 IVIG 治疗后 GM-EIA 的假阳性率，并确定相关因素。
使用未经稀释和经稀释及热处理的纯人 IVIG 样本进行标准 GM-EIA。我们还纳入了至少有一次 GM-EIA 结果在 IVIG 治疗后 1 周内的成年患者进行分析。排除了在 IVIG 治疗前 1 年内有侵袭性曲霉菌病病史的患者。比较 GM-EIA 假阳性和 GM-EIA 真阳性患者的临床特征和半乳甘露聚糖指数（GMI）变化。
所有未经稀释和经稀释及热处理的纯 IVIG 样本 GM 均呈阳性。热处理导致 GMI 显著升高。在 IVIG 治疗后 1 周内 GM-EIA 阳性的 48 例患者中，有 22 例（45.8%）被认为 GM 抗原血症呈假阳性（假阳性组，FPG）。在 IVIG 治疗完成后，所有 FPG 患者的 GMI 均下降，但仅有 26 例真阳性结果（真阳性组，TPG）患者中的 18 例（69.2%）下降。在 IVIG 治疗后 7、14 和 18 天，FPG 患者中分别有 7/15（46.7%）、18/20（90%）和 22/22（100%）GMI 转为阴性，TPG 患者中分别有 6/24（25%）、14/24（58.3%）和 16/26（61.5%）GMI 转为阴性。与 FPG 相比，TPG 患者在 IVIG 治疗后更有可能连续两次或更多次 GM 阳性（调整后的优势比，9.01；95%置信区间，1.99-40.9）。
IVIG 治疗可能产生 GM-EIA 假阳性结果。在接受人 IVIG 治疗的患者中，GMI 阳性应谨慎解释。
