Biosynex CryptoPS隐球菌抗原半定量侧向流动分析法在晚期HIV疾病患者中的诊断准确性
Diagnostic Accuracy of the Biosynex CryptoPS Cryptococcal Antigen Semiquantitative Lateral Flow Assay in Patients with Advanced HIV Disease.
作者信息
Tenforde Mark W, Boyer-Chammard Timothée, Muthoga Charles, Tawe Leabaneng, Milton Thandi, Rulaganyang Ikanyeng, Lechiile Kwana, Rukasha Ivy, Leeme Tshepo B, Govender Nelesh P, Ngidi Julia, Mine Madisa, Molloy Síle F, Harrison Thomas S, Lortholary Olivier, Jarvis Joseph N
机构信息
Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington School of Medicine, Seattle, Washington, USA.
Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington, USA.
出版信息
J Clin Microbiol. 2020 Dec 17;59(1). doi: 10.1128/JCM.02307-20.
High cryptococcal antigen (CrAg) titers in blood are associated with subclinical meningitis and mortality in CrAg-positive individuals with advanced HIV disease (AHD). We evaluated a novel semiquantitative lateral flow assay (LFA), CryptoPS, that may be able to identify individuals with high CrAg titers in a cohort of AHD patients undergoing CrAg screening. In a prospective cohort of patients with AHD (CD4 cell count, ≤200/μl) receiving CD4 count testing, whole blood was tested for CrAg by CryptoPS and the IMMY LFA; the two assays were conducted by two different operators, each blind to the results of the other assay. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of CryptoPS were assessed against the IMMY LFA as a reference. CryptoPS low-titer (T1 band) and high-titer (T2 band) results were compared with IMMY LFA titers obtained through serial dilution. A total of 916 specimens were tested. The sensitivity of the CryptoPS assay was 61.0% (25/41) (95% confidence interval [95% CI], 44.5 to 75.8%), its specificity was 96.6% (845/875) (95% CI, 95.1 to 97.7%), its PPV was 45.5% (95% CI, 32.0 to 59.4%), and its NPV was 98.1% (95% CI, 97.0 to 98.9%). All (16/16) CryptoPS false-negative results were obtained for samples with IMMY titers of ≤1:160. Of 29 patients (30 specimens) who tested positive by CryptoPS but negative by the IMMY LFA, none developed cryptococcal meningitis over 3 months of follow-up without fluconazole. Median CrAg titers were 1:20 (interquartile range [IQR], 0 to 1:160) in CryptoPS T1-positive samples and 1:2,560 (IQR, 1:1,280 to 1:10,240) in T2-positive samples. We conclude that the diagnostic accuracy of the CryptoPS assay was suboptimal in the context of CrAg screening, with poor sensitivity at low CrAg titers. However, the CryptoPS assay reliably detected individuals with high titers, which are associated with poor outcomes.
血液中高滴度的隐球菌抗原（CrAg）与晚期HIV疾病（AHD）且CrAg呈阳性的个体发生亚临床脑膜炎及死亡相关。我们评估了一种新型的半定量侧向流动分析法（LFA），即CryptoPS，它或许能够在接受CrAg筛查的AHD患者队列中识别出CrAg滴度高的个体。在一个接受CD4细胞计数检测的AHD患者前瞻性队列（CD4细胞计数≤200/μl）中，采用CryptoPS和IMMY LFA对全血进行CrAg检测；这两种检测由两名不同的操作人员进行，彼此对对方的检测结果均不知情。以IMMY LFA作为参考，评估CryptoPS的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）。将CryptoPS低滴度（T1条带）和高滴度（T2条带）结果与通过系列稀释获得的IMMY LFA滴度进行比较。总共检测了916份标本。CryptoPS检测的敏感性为61.0%（25/41）（95%置信区间[95%CI]，44.5至75.8%），特异性为96.6%（845/875）（95%CI，95.1至97.7%），PPV为45.5%（95%CI，32.0至59.4%），NPV为98.1%（95%CI，97.0至98.9%）。所有（16/16）CryptoPS假阴性结果均来自IMMY滴度≤1:160的样本。在29例CryptoPS检测呈阳性但IMMY LFA检测呈阴性的患者（30份标本）中，在未使用氟康唑进行3个月随访期间，无人发生隐球菌性脑膜炎。CryptoPS T1阳性样本的CrAg滴度中位数为1:20（四分位间距[IQR]，0至1:160），T2阳性样本的CrAg滴度中位数为1:2560（IQR，1:1280至1:10240）。我们得出结论，在CrAg筛查背景下，CryptoPS检测的诊断准确性欠佳，在低CrAg滴度时敏感性较差。然而，CryptoPS检测能够可靠地检测出与不良预后相关的高滴度个体。
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