【半乳甘露聚糖曲霉单抗检测作为Platelia™曲霉EIA试剂盒替代品的评价】。

Pub Date : 2022-06-01 DOI:10.4067/s0716-10182022000200248
Rubi Troncoso C, Claudia Sepúlveda F, Evelyn Sepúlveda P, Camila Guzmán U, Marcela Morales G, Cecilia Tapia P
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引用次数: 0

摘要

背景:半乳甘露聚糖Aspergillus Galactomannan Ag Virclia®(GMVClia)检测是一种基于化学发光免疫分析(CLIA)的半乳甘露聚糖单检测和自动化技术。目的:评价GM-VClia试验在先前用Platelia™Aspergillus EIA试剂盒(GM-Plat)处理的血清和细支气管肺泡灌洗(BAL)样品中的性能。方法:对56份bal40患者血清(部分两份血清均有半乳球蛋白检测)、肺部疾病、血液病、SLE、Covid-19和肿瘤等患者的血清进行研究。13例有侵袭性曲霉病(1例确诊,12例可能)。结果:两种方法血清与BAL的相关性分别为r = 0.8861 p < 0.0001和r = 0.6368 p < 0.001。全球一致性为67.7%(65/96),血清为85.7% (48/56),BAL为42.5.0%(14/49)。通过GM-VClia提高LBA的分界点,该协议增加到85.7%。结论:血清的相关性和一致性高于BAL。GM-VClia试剂盒比GM-Plat试剂盒具有更高的灵敏度和NPV。GM-VClia的缺点是“可疑”类别,这使得解释困难,并且在LBA中目前的截止点与GM-Plat的相关性较低。其优点是灵敏度高,处理方便,出结果快。
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[Evaluation of the Aspergillus Galactomannan ag VircliaR Monotest test as an alternative to Platelia™ Aspergillus EIA kit].

Background: The Aspergillus Galactomannan Ag Virclia® (GMVClia) test is a monotest and automated galactomannan technique based on chemiluminescent immunoassay (CLIA).

Aim: To evaluate the performance of the GM-VClia test in serum and bronchioalveolar lavage (BAL) samples previously processed with the Platelia ™ Aspergillus EIA kit (GM-Plat).

Methods: 56 samples of serum 40 from BAL (some of them with galactomaman determination in both samples), from patients with pulmonary diseases, hematological diseases, SLE, Covid-19 and tumors, among others, were studied. Thirteen patients had invasive aspergillosis (1 proven and 12 probable).

Results: The correlation between both methods for serum and BAL was r = 0.8861 p < 0.0001 and r = 0.6368 p < 0.001, respectively. There was a global concordance of 67.7% (65/96), being 85.7% (48/56) in sera and 42.5.0% (14/49) in BAL. By raising the cut-off point in LBA by GM-VClia, the agreement increased to 85.7%.

Conclusion: A greater correlation and concordance was observed in sera than in BAL. The GM-VClia kit had a higher sensitivity and NPV than the GM-Plat kit. The disadvantages of GM-VClia are the "doubtful" category, which makes interpretation difficult and that with the current cut-off points in LBA the correlation with GM-Plat is lower. The advantages are its greater sensitivity, ease of processing and faster results.

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