Division of Infectious Diseases and International Health, Department of Medicine, Clinical Microbiology Laboratory, Duke University Medical Center, Durham, North Carolina 27710, USA.
J Clin Microbiol. 2010 Nov;48(11):4083-8. doi: 10.1128/JCM.01183-10. Epub 2010 Aug 18.
The Fungitell assay for (1,3)β-D-glucan (BG) detection in serum has been evaluated in patients with invasive fungal infections (IFIs) and healthy controls and for the early diagnosis of IFI in cancer patients. We evaluated the BG assay for the detection of IFI in lung transplant recipients. Serial serum samples were prospectively collected from patients undergoing lung transplants at Duke Hospital. Fungal infections were classified according to revised European Organization for Research and Treatment of Cancer/Mycoses Study Group criteria. A receiver operator characteristic (ROC) curve was generated; possible causes for false-positive and false-negative tests were investigated by linear regression analysis. Seven hundred fifty-six serum specimens from 59 subjects without IFI and 41 specimens from 14 patients with proven or probable IFI were tested. The area under the ROC curve was 0.69. Based on a 60-pg/ml positive cutoff, per-patient sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 64%, 9%, 14%, and 50%, respectively; per-test estimates were 71%, 59%, 9%, and 97%, respectively. The majority (92%) of patients not diagnosed with an IFI had at least one BG level of ≥60 pg/ml, and 90% had at least one BG level of ≥80 pg/ml. Respiratory colonization with mold and hemodialysis significantly affected mean BG levels. In conclusion, the accuracy of the BG test is marginal and its utility as a tool for the early diagnosis of IFI is questionable in the lung transplant population. Although the NPV of the BG test is high, the low PPV limits its utility as a screening tool for early diagnosis of IFI.
血清(1,3)β-D-葡聚糖(BG)检测真菌检测试剂盒(Fungitell assay)已在侵袭性真菌感染(IFI)患者和健康对照者中进行了评估,并且可用于癌症患者 IFI 的早期诊断。我们评估了该 BG 检测试剂盒在肺移植受者中用于 IFI 检测的性能。前瞻性地从杜克医院接受肺移植的患者中采集连续的血清样本。真菌感染根据修订后的欧洲癌症研究与治疗组织/霉菌病研究组(European Organization for Research and Treatment of Cancer/Mycoses Study Group)标准进行分类。生成了受试者工作特征(ROC)曲线;通过线性回归分析调查了假阳性和假阴性测试的可能原因。检测了 59 例无 IFI 患者的 756 份血清样本和 14 例确诊或可能 IFI 患者的 41 份血清样本。ROC 曲线下面积为 0.69。基于 60pg/ml 的阳性截断值,每位患者的敏感性、特异性、阳性预测值(PPV)和阴性预测值(NPV)分别为 64%、9%、14%和 50%;每次检测的估计值分别为 71%、59%、9%和 97%。大多数(92%)未诊断为 IFI 的患者至少有一个 BG 水平≥60pg/ml,90%的患者至少有一个 BG 水平≥80pg/ml。霉菌的呼吸道定植和血液透析显著影响平均 BG 水平。总之,BG 检测的准确性是边缘的,其在肺移植人群中作为 IFI 早期诊断工具的效用是有疑问的。尽管 BG 检测的阴性预测值较高,但较低的阳性预测值限制了其作为早期诊断 IFI 的筛查工具的效用。