Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.
Department of Hematology, University Hospitals Leuven, Leuven, Belgium.
Med Mycol. 2020 Jun 1;58(4):444-452. doi: 10.1093/mmy/myz079.
Fast diagnosis of invasive pulmonary aspergillosis (IPA) is essential as early adequate therapy improves survival. However, current microbiological methods suffer from a low sensitivity or a long turnaround time, often as a result of batching. Recently, two lateral flow assays for diagnosing IPA have been CE (Conformité Européenne)-marked and commercialized. These assays can be used for fast single sample testing. However, clinical validation and comparative studies are lacking. We therefore sought to evaluate and compare these assays in adult hematology patients. We retrospectively tested 235 bronchoalveolar lavage fluid (BALf) samples of adult hematology patients from four centers using the AspLFD (OLM Diagnostics) and the sōna Aspergillus galactomannan LFA (IMMY). Both tests were read out independently by two researchers and by a digital reader. We included 11 patients with proven IPA, 64 with probable IPA, 43 with possible fungal disease, and 117 controls with no signs of IPA. In cases of proven IPA, the performance of both assays was similar. In cases of proven and probable IPA, we found an identical specificity for both assays, but a higher sensitivity (0.83 vs 0.69, P = .008) and a better negative predictive value (0.89 vs 0.82, P = .009) for the LFA. Digital readout improved the diagnostic performance of both tests. In conclusion, both assays showed a good performance for the diagnosis of IPA in BALf from adult hematology patients. Results were further improved by using a digital reader, especially for weakly positive results.
快速诊断侵袭性肺曲霉病（IPA）至关重要，因为早期充分的治疗可以提高生存率。然而，目前的微生物学方法存在敏感性低或周转时间长的问题，这通常是由于分批处理造成的。最近，两种用于诊断 IPA 的侧向流动检测方法已经获得 CE（欧洲符合性）标记并商业化。这些检测方法可用于快速单一样本检测。然而，缺乏临床验证和比较研究。因此，我们试图评估和比较这些检测方法在成人血液病患者中的应用。我们回顾性地检测了来自四个中心的 235 例成人血液病患者的支气管肺泡灌洗液（BALf）样本，使用了 AspLFD（OLM Diagnostics）和 sōna 曲霉半乳甘露聚糖 LFA（IMMY）。两种检测方法均由两位研究人员和一位数字读取器独立读取。我们纳入了 11 例确诊 IPA 的患者、64 例可能 IPA 的患者、43 例可能真菌病的患者和 117 例无 IPA 迹象的对照患者。在确诊 IPA 的病例中，两种检测方法的性能相似。在确诊和可能 IPA 的病例中，我们发现两种检测方法的特异性相同，但 LFA 的敏感性更高（0.83 对 0.69，P =.008），阴性预测值更好（0.89 对 0.82，P =.009）。数字读取提高了两种检测方法的诊断性能。总之，两种检测方法在成人血液病患者的 BALf 中均显示出良好的 IPA 诊断性能。使用数字读取器可进一步提高检测结果，尤其是对于弱阳性结果。
