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用于检测呼吸道病毒的自动化多分析物即时检测设备mariPOC®的分析性能。

Analytical performance of the automated multianalyte point-of-care mariPOC® for the detection of respiratory viruses.

作者信息

Sanbonmatsu-Gámez Sara, Pérez-Ruiz Mercedes, Lara-Oya Ana, Pedrosa-Corral Irene, Riazzo-Damas Cristina, Navarro-Marí José María

机构信息

Servicio de Microbiología, Hospital Universitario Virgen de las Nieves, Avenida de las Fuerzas Armadas 2, 18012 Granada, Spain; Instituto de Investigación Biosanitaria de Granada, Calle Dr Azpitarte 4, 18012 Granada, Spain.

Servicio de Microbiología, Hospital Universitario Virgen de las Nieves, Avenida de las Fuerzas Armadas 2, 18012 Granada, Spain; Instituto de Investigación Biosanitaria de Granada, Calle Dr Azpitarte 4, 18012 Granada, Spain.

出版信息

Diagn Microbiol Infect Dis. 2015 Nov;83(3):252-6. doi: 10.1016/j.diagmicrobio.2015.07.010. Epub 2015 Jul 18.

Abstract

The analytical performance of mariPOC® respi test (ArcDia® Laboratories, Turku, Finland) was evaluated using nucleic acid amplification techniques (NAATs) as the gold standard. The mariPOC assay allows automated detection of antigens from 8 respiratory viruses: influenza A and B viruses, respiratory syncytial virus, adenovirus, human metapneumovirus, and parainfluenza viruses 1-3. Positive results from samples with high viral load are available in 20min. Nasopharyngeal aspirates (n=192) from patients with acute respiratory infection and from previously positive samples were analyzed by mariPOC and NAATs (Simplexa(TM) FluA/FluB & RSV kit [n=118] and Luminex® Respiratory virus panel xTAG® RVP FAST [n=74]). Sensitivity, specificity, positive predictive value, and negative predictive value of mariPOC were 85.4%, 99.2%, 95.9%, and 97%, respectively, and 84.6% of positive results were reported in 20min. The good analytical performance and extended portfolio of mariPOC show this rapid assay as a good alternative for the etiological diagnosis of acute respiratory infection in laboratories that are not equipped with molecular assays.

摘要

以核酸扩增技术(NAATs)作为金标准,对mariPOC®呼吸检测试剂盒(芬兰图尔库的ArcDia®实验室)的分析性能进行了评估。mariPOC检测可自动检测8种呼吸道病毒的抗原:甲型和乙型流感病毒、呼吸道合胞病毒、腺病毒、人偏肺病毒以及1-3型副流感病毒。病毒载量高的样本在20分钟内即可得出阳性结果。采用mariPOC和NAATs(Simplexa™ FluA/FluB & RSV试剂盒[n = 118]以及Luminex®呼吸道病毒检测板xTAG® RVP FAST[n = 74])对急性呼吸道感染患者的鼻咽抽吸物(n = 192)以及先前呈阳性的样本进行了分析。mariPOC的灵敏度、特异性、阳性预测值和阴性预测值分别为85.4%、99.2%、95.9%和97%,84.6%的阳性结果在20分钟内即可报告。mariPOC良好的分析性能和扩展的检测项目表明,对于未配备分子检测设备的实验室而言,这种快速检测方法是急性呼吸道感染病因诊断的良好替代方法。

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