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评估全自动多分析物即时检验 mariPOC® 检测甲型流感病毒和呼吸道合胞病毒的性能。

Evaluation of the automated multianalyte point-of-care mariPOC® test for the detection of influenza A virus and respiratory syncytial virus.

机构信息

Department of Bacteriology and Immunology, Haartman Institute, University of Helsinki, Helsinki, Finland.

出版信息

J Med Virol. 2013 Sep;85(9):1598-601. doi: 10.1002/jmv.23660.

DOI:10.1002/jmv.23660
PMID:23852685
Abstract

The aim of the study was to evaluate the performance of the new mariPOC(®) method against the direct fluorescent antibody assay (DFA) as the primary reference method for rapid virus detection from nasopharyngeal aspirates and swab samples. The study was an open prospective evaluation during the seasonal winter epidemics in the Mikkeli Central Hospital, Finland. Altogether, 283 samples were analyzed; 124 (43.8%) were from young children (<5 years old). Discrepant samples were resolved by PCR. With nasopharyngeal aspirate samples, the sensitivity and clinical specificity of the mariPOC(®) assay for influenza A virus and respiratory syncytial virus, were 85.7% (CI 69.7-95.2) and 90% (CI 52.0-80.5), and 100% and 99.5%, respectively. The mariPOC(®) performed less well with swab samples having sensitivities at 77.3% (CI 54.6-92.2) and 67.4% (CI 52-80.5), respectively. The specificities were as for nasopharyngeal aspirates. Importantly, similar performance was observed regardless of the cohort age group. In conclusion, the mariPOC(®) test system has a high potential and utility in duty units because it is fast, simple, and multianalyte. The importance of personnel training for proper sample collection should be emphasized.

摘要

本研究旨在评估新型 mariPOC(®) 方法的性能,将其作为快速病毒检测的主要参考方法,检测来自鼻咽抽吸物和拭子样本的直接荧光抗体检测(DFA)。该研究是在芬兰米凯利中央医院的季节性冬季流行期间进行的开放前瞻性评估。总共分析了 283 个样本;124 个(43.8%)来自年龄较小的儿童(<5 岁)。通过 PCR 解决不一致的样本。对于鼻咽抽吸物样本,mariPOC(®) 检测流感 A 病毒和呼吸道合胞病毒的灵敏度和临床特异性分别为 85.7%(CI 69.7-95.2)和 90%(CI 52.0-80.5),100%和 99.5%。拭子样本的 mariPOC(®) 性能较差,灵敏度分别为 77.3%(CI 54.6-92.2)和 67.4%(CI 52-80.5)。特异性与鼻咽抽吸物相同。重要的是,无论队列年龄组如何,都观察到了类似的性能。总之,由于 mariPOC(®) 检测系统快速、简单且多分析物,因此在值班单位具有很高的潜力和实用性。应强调人员培训对于正确采集样本的重要性。

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