Shu-Lian Li , Hui-Ling Lin , Hong-Fei Mi , Qing-Qi Meng , Ya Yan , Xiao-Luo Zhang , Wei-Ming Gu , Yao Xiao
{"title":"评估沙眼衣原体免疫层析检验的诊断性能","authors":"Shu-Lian Li , Hui-Ling Lin , Hong-Fei Mi , Qing-Qi Meng , Ya Yan , Xiao-Luo Zhang , Wei-Ming Gu , Yao Xiao","doi":"10.1016/j.plabm.2024.e00412","DOIUrl":null,"url":null,"abstract":"<div><h3>Objectives</h3><p>To evaluate the diagnostic performance of different brands of immunochromatographic test (ICT) reagents for <em>Chlamydia trachomatis</em> using homogenized samples to provide a reference for reagent quality control.</p></div><div><h3>Methods</h3><p>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 <em>C. trachomatis</em>, as well as clinical application validation using cervical epithelial cell samples acquired from the research subjects, were conducted. The concentration of <em>C. trachomatis</em> was quantified using a nucleic acid amplification test.</p></div><div><h3>Results</h3><p>The limit of detection (LOD) of different ICT reagents in the analytical performance evaluation varied from 9.5 × 10<sup>3</sup> to 1 × 10<sup>5</sup> 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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"40 ","pages":"Article e00412"},"PeriodicalIF":1.7000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000581/pdfft?md5=80e4a58215dd1f948a6dbedf49b565ca&pid=1-s2.0-S2352551724000581-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Evaluation of the diagnostic performance of an immunochromatographic test for Chlamydia trachomatis\",\"authors\":\"Shu-Lian Li , Hui-Ling Lin , Hong-Fei Mi , Qing-Qi Meng , Ya Yan , Xiao-Luo Zhang , Wei-Ming Gu , Yao Xiao\",\"doi\":\"10.1016/j.plabm.2024.e00412\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objectives</h3><p>To evaluate the diagnostic performance of different brands of immunochromatographic test (ICT) reagents for <em>Chlamydia trachomatis</em> using homogenized samples to provide a reference for reagent quality control.</p></div><div><h3>Methods</h3><p>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 <em>C. trachomatis</em>, as well as clinical application validation using cervical epithelial cell samples acquired from the research subjects, were conducted. The concentration of <em>C. trachomatis</em> was quantified using a nucleic acid amplification test.</p></div><div><h3>Results</h3><p>The limit of detection (LOD) of different ICT reagents in the analytical performance evaluation varied from 9.5 × 10<sup>3</sup> to 1 × 10<sup>5</sup> 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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>\",\"PeriodicalId\":20421,\"journal\":{\"name\":\"Practical Laboratory Medicine\",\"volume\":\"40 \",\"pages\":\"Article e00412\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2024-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2352551724000581/pdfft?md5=80e4a58215dd1f948a6dbedf49b565ca&pid=1-s2.0-S2352551724000581-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Practical Laboratory Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2352551724000581\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Practical Laboratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2352551724000581","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
Evaluation of the diagnostic performance of an immunochromatographic test for Chlamydia trachomatis
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.
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.
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