Low specificity of Aspergillus spp. ELITe MGB assay, and potential risks in management of invasive aspergillosis

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Practical Laboratory Medicine Pub Date : 2024-02-21 DOI:10.1016/j.plabm.2024.e00378

Violaine Bothy , Maria A. Argudín , Nathalie Olive , Cindy Barbée , Benoît Kabamba-Mukadi , Hector Rodriguez-Villalobos

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Abstract

Objectives

In recent years, commercial molecular tools for diagnosis of invasive aspergillosis have emerged, requiring evaluation to ensure quality. Here we assessed the specificity of Aspergillus spp.-ELITe MGB Assay a commercial assay tergeting 18S gene of Aspergillus spp.

Design and methods

As part of a method validation, we evaluate the specificity of the Aspergillus spp.-ELITe MGB Assay by testing fourteen culture based samples of sequenced non-Aspergillus fungal species. The benefits of a pre-lysis treatment was evaluated in parallel on serial dilutions of an Aspergillus fumigatus strain.

Results

Our findings revealed cross-reactivity in five strains using the 50 copies/mL cut-off recommended by the manufacturer, suggesting potential diagnostic errors and inappropriate management of patients. Pre-lysis treatment does not affect the limit of detection at serial dilution.

Conclusions

In conclusion, the Aspergillus spp. ELITe MGB Assay exhibits limited specificity in culture-based samples, underscoring the importance of careful utilization in laboratories. Further studies are warranted to better comprehend of the impact of this cross-reactivity on clinical samples.

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侵袭性曲霉菌病 ELITe MGB 检测的低特异性和潜在风险

目的近年来，用于诊断侵袭性曲霉菌病的商业分子工具不断涌现，需要对其进行评估以确保质量。设计与方法作为方法验证的一部分，我们通过检测 14 个基于培养基的非曲霉菌种测序样本来评估曲霉菌属-ELITe MGB 检测法的特异性。结果我们的研究结果表明，使用制造商推荐的 50 拷贝/毫升临界值，有五种菌株存在交叉反应，这表明可能存在诊断错误和对患者的不当管理。结论总之，曲霉菌属 ELITe MGB 检测试剂盒在基于培养基的样本中表现出有限的特异性，强调了实验室谨慎使用的重要性。为了更好地了解这种交叉反应对临床样本的影响，还需要进一步的研究。

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来源期刊

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.