Hindiyeh M, Goulding C, Morgan H, Kenyon B, Langer J, Fox L, Dean G, Woolstenhulme D, Turnbow A, Billetdeaux E, Shakib S, Gordon C, Powers A, Vardeny G, Johnson M, Skodack-Jones L, Carroll K
Department of Pathology, University of Utah Health Sciences Center, Salt Lake City, USA.
J Clin Virol. 2000 Aug;17(2):119-26. doi: 10.1016/s1386-6532(00)00081-0.
Demand for the rapid diagnosis of influenza infections has increased with the advent of the availability of neuraminidase antiviral therapy for influenza A and B. Several rapid assays that detect both influenza A and B are now available.
In this study we compared the performance of the BioStar FLU OIA assay to Bartels Viral Respiratory Screening and Identification Kit (Bartels Inc., Issaquah, WA), and cell culture.
A total of 145 patient specimens for influenza virus detection submitted in either viral transport medium or in sterile containers were evaluated by the three methods. Specimen types included nasal washings, nasal swabs, sputum, throat swabs, and bronchial alveolar lavage (BAL) fluids.
Fifty six positive specimens were identified based on culture and/or DFA. Of these, 30 specimens were positive by the OIA assay for an overall sensitivity of 54%. The OIA assay detected 48% (n = 21) of the 44 culture positive specimens and 81% (n = 29) of the 36 DFA positive specimens. Eighty six of the 89 culture/DFA negative samples were negative by the OIA assay (97% specificity). Analysis of the OIA assay sensitivity from samples submitted in M4 transport medium or in sterile containers revealed that M4 transport medium does not reduce the sensitivity of the OIA assay. Fifteen of the 27 positive samples submitted in M4 transport medium were positive by the OIA assay (56% sensitivity) compared to 15 of 29 positive samples transported in sterile containers (52% sensitivity). Twelve specimens were either culture and/or DFA positive for viruses other than influenza, but negative by the OIA assay, suggesting that there was no cross reactivity of the OIA assay with the other virus types recovered in this study.
The overall excellent specificity of the BioStar FLU OIA allows for treatment of positive patients for influenza, however, a negative result should be confirmed by DFA and culture.
随着甲型和乙型流感神经氨酸酶抗病毒疗法的出现，对流感感染快速诊断的需求有所增加。现在有几种可同时检测甲型和乙型流感的快速检测方法。
在本研究中，我们将BioStar FLU OIA检测法与巴特尔病毒呼吸道筛查与鉴定试剂盒（巴特尔公司，华盛顿州伊斯萨夸）以及细胞培养法的性能进行了比较。
采用这三种方法对总共145份提交至病毒运输培养基或无菌容器中的用于流感病毒检测的患者标本进行了评估。标本类型包括鼻腔灌洗液、鼻拭子、痰液、咽拭子和支气管肺泡灌洗（BAL）液。
基于培养和/或直接荧光抗体法（DFA）鉴定出56份阳性标本。其中，OIA检测法检测出30份阳性标本，总体灵敏度为54%。OIA检测法检测出44份培养阳性标本中的48%（n = 21）以及36份DFA阳性标本中的81%（n = 29）。89份培养/DFA阴性样本中有86份经OIA检测法检测为阴性（特异性为97%）。对提交至M4运输培养基或无菌容器中的样本进行的OIA检测法灵敏度分析显示，M4运输培养基不会降低OIA检测法的灵敏度。提交至M4运输培养基中的27份阳性样本中有15份经OIA检测法检测为阳性（灵敏度为56%），而运输至无菌容器中的29份阳性样本中有15份（灵敏度为52%）。12份标本培养和/或DFA检测对流感以外的病毒呈阳性，但经OIA检测法检测为阴性，这表明OIA检测法与本研究中检出的其他病毒类型无交叉反应。
BioStar FLU OIA总体出色的特异性使得流感阳性患者可接受治疗，然而，阴性结果应由DFA和培养法加以确认。
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