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Prospective Evaluation of Rapid Antigen Tests for Diagnosis of Respiratory Syncytial Virus and Human Metapneumovirus Infections

机译:快速抗原测试对呼吸道合胞病毒和人类间质肺病毒感染的诊断的前瞻性评估

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摘要

Respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) are two important viral pathogens that cause respiratory tract infections in the pediatric population. The rapid detection of these agents allows the prompt isolation and treatment of infected patients. In the present prospective study, we evaluated the performances of four rapid antigen detection assays, including a rapid chromatographic immunoassay (CIA) for RSV (Directigen EZ RSV; Becton Dickinson, Sparks, MD), a direct fluorescent-antibody assay (DFA) for RSV (Bartels; Trinity Biotech, Carlsbad, CA), and two DFAs for hMPV manufactured by Diagnostic Hybrids Inc. (DHI; Athens, OH) and Imagen (Oxoid Ltd., Basingstoke, Hampshire, United Kingdom). The clinical specimens tested comprised 515 nasopharyngeal aspirates submitted to the Clinical Microbiology Laboratory at Hartford Hospital from 1 November 2006 to 21 April 2007. Compared to the results of real-time reverse transcription-PCR (RT-PCR), the CIA had a sensitivity of 79.8% and a specificity of 89.5%. The RSV DFA with Bartels reagents showed a sensitivity of 94.1% and a specificity of 96.8%. For hMPV, the sensitivity and specificity were 62.5% and 99.8%, respectively, for the DHI DFA and 63.2% and 100%, respectively, for the Imagen DFA. The hands-on and test turnaround times for CIA were 10 and 30 to 60 min, respectively, and the hands-on and test turnaround times for the RSV and hMPV DFAs were 30 and 105 min, respectively. We conclude that while the RSV CIA is user-friendly, it lacks sensitivity and specificity, especially during off-peak months. In contrast, the RSV DFA is more sensitive and specific, but interpretation of its results is subjective and it demands technical time and expertise. Similarly, both hMPV DFAs are highly specific in comparison to the results of RT-PCR, but their sensitivities await further improvements.
机译:呼吸道合胞病毒(RSV)和人间质肺炎病毒(hMPV)是引起小儿人群呼吸道感染的两种重要病毒病原体。这些试剂的快速检测可以迅速隔离和治疗感染的患者。在本前瞻性研究中,我们评估了四种快速抗原检测测定法的性能,包括RSV的快速色谱免疫测定法(CIA)(Directigen EZ RSV; Becton Dickinson,Sparks,MD),直接荧光抗体测定法(DFA) RSV(Bartels;三位一体生物技术公司,加利福尼亚州卡尔斯巴德),以及两个由Diagnostic Hybrids Inc.(DHI;俄亥俄州雅典)和Imagen(Oxoid Ltd.,英国汉普郡贝辛斯托克)制造的用于hMPV的DFA。测试的临床标本包括2006年11月1日至2007年4月21日提交哈特福德医院临床微生物学实验室的515例鼻咽抽吸物。与实时逆转录PCR(RT-PCR)结果相比,CIA的敏感性为79.8%,特异性为89.5%。带有Bartels试剂的RSV DFA的灵敏度为94.1%,特异性为96.8%。对于hMPV,DHI DFA的敏感性和特异性分别为62.5%和99.8%,而Imagen DFA的敏感性和特异性分别为63.2%和100%。 CIA的动手和测试周转时间分别为10和30至60分钟,RSV和hMPV DFA的动手和测试周转时间分别为30和105分钟。我们得出的结论是,尽管RSV CIA易于使用,但缺乏敏感性和特异性,尤其是在非高峰月份。相比之下,RSV DFA更为敏感和具体,但是对其结果的解释是主观的,并且需要技术时间和专业知识。同样,与RT-PCR的结果相比,两种hMPV DFA都是高度特异性的,但是它们的敏感性有待进一步提高。

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