Comparison of the performance of direct fluorescent antibody staining, a point-of-care rapid antigen test and virus isolation with that of RT-PCR for the detection of novel 2009 influenza A (H1N1) virus in respiratory specimens

Comparison of the performance of direct fluorescent antibody staining, a point-of-care rapid antigen test and virus isolation with that of RT-PCR for the detection of novel 2009 influenza A (H1N1) virus in respiratory specimens
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DOI:
10.1099/jmm.0.017244-0
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发表时间:
2010-06-01
影响因子:
3
通讯作者:
Henke-Gendo, Cornelia
Henke-Gendo, Cornelia
中科院分区:
医学3区
文献类型:
--
作者:
Ganzenmueller, Tina;Kluba, Jeanette;Henke-Gendo, Cornelia

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尽管2009年新型大流行甲型H1N1流感病毒(A/H1N1/2009)的感染在流感传播的第一个夏季(“淡季”)似乎相对较轻,但发病率和住院率很高,还有几例死亡病例。因此,A/H1N1/2009的快速检测对于有效治疗和感染控制措施至关重要。与季节性流感相比,护理点(POC)快速抗原检测和直接荧光抗体(DFA)染色确保了快速检测,到目前为止,A/H1N1/2009的诊断一直基于RT-PCR。对2009年5月至9月第一波疫情期间收集的526份呼吸道标本进行DFA染色和RT-PCR病毒分离检测A/H1N1/2009。在A/H1N1/2009 pcr阴性样本中,有91%(48/526)检测到A/H1N1/2009病毒,其中137份样本采用RealAccurate Respiratory RT-PCR检测,42.3%(58/137)检测到其他呼吸道病毒(主要是肠病毒/鼻病毒和腺病毒),所有方法检测到A/H1N1/2009病毒的特异性都很好,但灵敏度不同(POC试验18.2%,DFA染色38.7%,病毒分离)。45 7%)。因此,POC试验不适合诊断,只有在病毒浓度较高的标本中(对应的中位数C,值=19 0,范围=16 5-21 4),DFA染色也能检测到病毒浓度较低的标本(中位数C(1)值=24 0,范围=16 5-29 8),病毒分离耗时太长,中位数时间为75天。DFA染色优于POC检测,可能适用于预计病毒复制水平相当高的患者。然而,在DFA阴性标本中,应通过RT-PCR排除a /H1N1/2009
Although infections with the novel pandemic 2009 influenza A (H1N1) virus (A/H1N1/2009) appeared to be relatively mild during the first summer of circulation ('off season'), there has been significant morbidity and hospitalization and several fatal cases. Thus, rapid detection of A/H1N1/2009 is crucial for efficient treatment and infection control measures In contrast to seasonal influenza, where point-of-care (POC) rapid antigen tests and direct fluorescent antibody (DFA) staining ensure rapid detection, diagnosis of A/H1N1/2009 has so far been based on RT-PCR This study retrospectively compared the performance of the Quidel QuickVue POC test, DFA staining and virus isolation with that of RT-PCR for A/H1N1/2009 detection in 526 respiratory specimens collected during the first wave of the outbreak from May to September 2009. A/H1N1/2009 was detected in 9 1% (48/526) of samples One hundred and thirty-seven of the A/H1N1/2009 PCR-negative samples were additionally tested using a RealAccurate Respiratory RT-PCR panel, revealing other respiratory viruses (mainly entero/rhino- and adenoviruses) in 42 3% (58/137) All methods analysed detected A/H1N1/2009 with excellent specificity but different sensitivities (POC test 18 2%, DFA staining 38 7%, virus isolation. 45 7%). Therefore, the POC test was not suitable for diagnosis, detecting A/H1N1/2009 only if present in high concentrations (corresponding median C, value=19 0, range=16 5-21 4) DFA staining was also able to detect A/H1N1/2009 in specimens with a lower virus concentration (median C(1) value=24 0, range=16 5-29 8) Virus isolation, which was positive after a median time of 7 5 days, was too time-consuming In summary, DFA staining is superior to POC testing and may be appropriate for patients expected to have a rather high level of virus replication Nevertheless, in DFA-negative specimens, A/H1N1/2009 should be excluded by RT-PCR