Evaluation of the diagnostic performance of an immunochromatographic test for Chlamydia trachomatis

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine Pub Date : 2024-05-01 DOI:10.1016/j.plabm.2024.e00412

Shu-Lian Li , Hui-Ling Lin , Hong-Fei Mi , Qing-Qi Meng , Ya Yan , Xiao-Luo Zhang , Wei-Ming Gu , Yao Xiao

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引用次数: 0

Abstract

Objectives

To evaluate the diagnostic performance of different brands of immunochromatographic test (ICT) reagents for Chlamydia trachomatis using homogenized samples to provide a reference for reagent quality control.

Methods

Eight commercially available ICT reagents were evaluated, of which three used the latex method and five used the colloidal gold method. Analytical performance evaluation using a pure culture broth of C. trachomatis, as well as clinical application validation using cervical epithelial cell samples acquired from the research subjects, were conducted. The concentration of C. trachomatis was quantified using a nucleic acid amplification test.

Results

The limit of detection (LOD) of different ICT reagents in the analytical performance evaluation varied from 9.5 × 10³ to 1 × 10⁵ IFU/mL, and only one reagent met the LOD specified in the manufacturer's instructions. Likewise, only one reagent in the clinical application validation achieved the analytical LOD, four reagents were 2.1–4.2-fold of the analytical LODs, and three reagents failed to detect positive results in clinical samples.

Conclusions

The diagnostic performance of different methods and different brands of ICT reagents in clinical practice was different from the manufacturer's instructions and the results of laboratory evaluation. The diagnostic performance of reagents should be evaluated before they are actually used in clinical practice.

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评估沙眼衣原体免疫层析检验的诊断性能

方法评估了八种市售的沙眼衣原体免疫层析试剂，其中三种采用乳胶法，五种采用胶体金法。使用沙眼衣原体纯培养液进行了分析性能评估，并使用研究对象的宫颈上皮细胞样本进行了临床应用验证。结果在分析性能评估中，不同 ICT 试剂的检测限（LOD）从 9.5 × 103 到 1 × 105 IFU/mL 不等，只有一种试剂达到了制造商说明书中规定的检测限。同样，在临床应用验证中，只有一种试剂达到了分析LOD，4种试剂是分析LOD的2.1-4.2倍，3种试剂未能在临床样本中检测出阳性结果。结论不同方法和不同品牌的ICT试剂在临床实践中的诊断性能与制造商的说明书和实验室评估结果不同。试剂的诊断性能应在临床实际使用前进行评估。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.