A-359 基于聚合酶链式反应（PCR）的 cobas CT/NG/MG 检测试剂盒在临床实验室和护理点 (POC) 环境中用于 cobas liat 系统的临床性能评估

IF 7.1 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry Pub Date : 2024-10-02 DOI:10.1093/clinchem/hvae106.353

B Van Der Pol, R Arcenas, C Boraas, S Chavoustie, L L Crane, N d'Empaire, A C Ermel, G Harnett, F Hinestrosa, S House, R Lillis, J Miller, A Mills, R Poblete, S A Young

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Methods This non-interventional, non-observational study used prospective clinician-collected and self-collected specimens (urine, and vaginal swabs, all in cobas® PCR Media) from symptomatic/asymptomatic patients ≥14 years old from 13 POC sites across the US. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of cobas liat CT/NG/MG were calculated with respect to patient infected status (PIS), as determined using results from three FDA-approved NAATs and one laboratory-developed test. Due to insufficient positive NG samples during the trial period, further testing used archived samples. Results The median (range) age of the study population (N=4,800) was 35.0 (15.0-81.0) years; 40.4% (n=1,941) were symptomatic and 51.9% (n=2,489) were assigned female at birth. The cobas CT/NG/MG nucleic acid test demonstrated good clinical performance (Table 1). Across all specimen types, specificity was &gt;97% for each analyte. 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引用次数: 0

摘要

背景 cobas® CT/NG/MG 检测试剂盒可快速（约 20 分钟）筛查沙眼衣原体 (CT)、淋病奈瑟菌 (NG) 和生殖支原体 (MG)（该检测试剂盒未经美国 FDA 批准。目前正在审查中，可能会根据卫生部门的反馈意见进行修改）。这种基于实时 PCR 的自动定性核酸扩增检验（NAAT）可在 cobas® liat® 系统上使用。本研究使用有症状和无症状患者的泌尿生殖系统样本对该检验的临床性能进行了评估。方法这项非干预、非观察性研究使用了前瞻性临床医生采集和自采标本（尿液和阴道拭子，均使用 cobas® PCR 培养基），样本来自美国 13 个 POC 站点的年龄≥14 岁的有症状/无症状患者。计算了 cobas liat CT/NG/MG 的灵敏度、特异性、阳性预测值 (PPV) 和阴性预测值 (NPV)，以及患者感染状态 (PIS)，患者感染状态是使用三种 FDA 批准的 NAAT 和一种实验室开发的检测结果确定的。由于试验期间 NG 阳性样本不足，进一步检测使用了存档样本。结果研究对象（样本数=4,800）的年龄中位数（范围）为 35.0（15.0-81.0）岁；40.4%（样本数=1,941）有症状，51.9%（样本数=2,489）出生时被指定为女性。cobas CT/NG/MG 核酸检测的临床表现良好（表 1）。在所有标本类型中，每种分析物的特异性均为 >97% 。灵敏度≥95%，女性尿液除外（CT 87.0%，NG 93.1%，MG 78.9%）。无论标本类型如何，CT 和 NG 的 PPV 和 NPV 均≥95%；男性尿液中 MG 的 PPV 最高（92.7%），各种分析物的 NPV 均为 >97.5%。结论在临床环境中，cobas CT/NG/MG 核酸检测试剂盒在检测泌尿系统样本中的 CT、NG 和 MG 方面表现出良好的临床性能，此外，它还能在 POC 上为自取和临床医生采集的样本提供较短的周转时间和集中检测实验室质量。

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A-359 Clinical Performance Evaluation of the Polymerase Chain Reaction (PCR)-Based cobas CT/NG/MG Test for Use on the cobas liat System in a Clinical Laboratory Setting and Point-of-Care (POC) Location

Background Screening for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) can be achieved rapidly (in approximately 20 minutes) with the cobas® CT/NG/MG test (assay not cleared by US FDA. Submission currently under review and subject to change per health authority feedback). This automated, qualitative, real-time PCR-based nucleic acid amplification test (NAAT) is for use on the cobas® liat® system. This study evaluated the test’s clinical performance using urogenital samples from symptomatic and asymptomatic patients. Methods This non-interventional, non-observational study used prospective clinician-collected and self-collected specimens (urine, and vaginal swabs, all in cobas® PCR Media) from symptomatic/asymptomatic patients ≥14 years old from 13 POC sites across the US. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of cobas liat CT/NG/MG were calculated with respect to patient infected status (PIS), as determined using results from three FDA-approved NAATs and one laboratory-developed test. Due to insufficient positive NG samples during the trial period, further testing used archived samples. Results The median (range) age of the study population (N=4,800) was 35.0 (15.0-81.0) years; 40.4% (n=1,941) were symptomatic and 51.9% (n=2,489) were assigned female at birth. The cobas CT/NG/MG nucleic acid test demonstrated good clinical performance (Table 1). Across all specimen types, specificity was >97% for each analyte. Sensitivity was ≥95%, except in female urine (CT 87.0%, NG 93.1%, MG 78.9%). Regardless of specimen type, PPV and NPV were ≥95% for CT and NG; PPV for MG was highest in male urine (92.7%) and NPV was >97.5% across analytes. Conclusions In a clinical setting, the cobas CT/NG/MG nucleic acid test showed good clinical performance for the detection of CT, NG, and MG in urogenital samples, in addition to providing a short turn-around time and centralized testing lab quality at the POC for both self- and clinician-collected samples.

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来源期刊

Clinical chemistry 医学-医学实验技术

CiteScore

11.30

自引率

4.30%

发文量

212

审稿时长

1.7 months

期刊介绍： Clinical Chemistry is a peer-reviewed scientific journal that is the premier publication for the science and practice of clinical laboratory medicine. It was established in 1955 and is associated with the Association for Diagnostics & Laboratory Medicine (ADLM). The journal focuses on laboratory diagnosis and management of patients, and has expanded to include other clinical laboratory disciplines such as genomics, hematology, microbiology, and toxicology. It also publishes articles relevant to clinical specialties including cardiology, endocrinology, gastroenterology, genetics, immunology, infectious diseases, maternal-fetal medicine, neurology, nutrition, oncology, and pediatrics. In addition to original research, editorials, and reviews, Clinical Chemistry features recurring sections such as clinical case studies, perspectives, podcasts, and Q&A articles. It has the highest impact factor among journals of clinical chemistry, laboratory medicine, pathology, analytical chemistry, transfusion medicine, and clinical microbiology. The journal is indexed in databases such as MEDLINE and Web of Science.