Performance of the Simplexa™ Flu A/B & RSV Direct Kit on respiratory samples collected in saline solution.

Malin J Svensson, Ingrid Lind, Benita Zweygberg Wirgart, Maria Rotzén Östlund, Jan Albert
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引用次数: 11

Abstract

Background: Molecular assays for diagnosis of influenza A, influenza B, and respiratory syncytial virus (RSV) with short turnaround time are of considerable clinical importance. We have evaluated the diagnostic performance of the Simplexa(™) Flu A/B & RSV Direct Kit, which has a run time of 60 min, using different types of respiratory samples collected from patients with a suspected respiratory tract infection, including materials not previously evaluated on this kit.

Methods: In total, 210 clinical respiratory samples were analyzed using both the Simplexa direct assay and a laboratory-developed assay (LDA). The 210 clinical samples included 99 nasopharyngeal aspirates collected in 0.9% saline, 91 nasopharyngeal swabs in Σ-Virocult transport medium, 9 tracheal secretions, 8 bronchoalveolar lavages (BAL), and 3 other respiratory sample materials.

Results: The specificity of the Simplexa assay, using the LDA as gold standard and excluding secondary viral findings, was 100% for all three viruses, whereas the sensitivity was 94.0% for influenza A (47/50), 90.7% for influenza B (49/54), and 90.1% for RSV (46/51), respectively. Discordant results were only observed for samples with cycle threshold values (Ct) > 31 in the LDA. The Simplexa assay generated higher Ct values than the LDA for all three viruses and performed equally well on nasopharyngeal swabs and aspirates.

Conclusions: The short run time of the Simplexa direct assay, in combination with high specificity and good sensitivity regarding the sample materials used in this study, make it an interesting option for rapid detection of these three important viral respiratory pathogens in a variety of clinical sample materials.

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Simplexa™Flu A/B & RSV Direct试剂盒对生理盐水中呼吸道样本的检测性能
背景:短周转时间的甲型流感、乙型流感和呼吸道合胞病毒(RSV)的分子检测诊断具有重要的临床意义。我们评估了Simplexa(™)流感A/B & RSV直接试剂盒的诊断性能,该试剂盒运行时间为60分钟,使用从疑似呼吸道感染患者收集的不同类型的呼吸道样本,包括以前未在该试剂盒上评估的材料。方法:采用Simplexa直接测定法和实验室开发的测定法(LDA)对210例临床呼吸样本进行分析。210份临床样本包括0.9%生理盐水中收集的鼻咽吸痰99份,Σ-Virocult运输介质中鼻咽拭子91份,气管分泌物9份,支气管肺泡灌洗液(BAL) 8份,其他呼吸道样本材料3份。结果:Simplexa试验以LDA为金标准,排除继发性病毒发现,对所有三种病毒的特异性均为100%,而对甲型流感(47/50)、乙型流感(49/54)和RSV(46/51)的敏感性分别为94.0%、90.7%和90.1%。不一致的结果仅在LDA中周期阈值(Ct) > 31的样本中观察到。Simplexa试验在所有三种病毒中产生的Ct值都高于LDA,并且在鼻咽拭子和抽吸液中表现同样良好。结论:Simplexa直接检测的运行时间短,结合本研究所用样品材料的高特异性和良好的灵敏度,使其成为快速检测各种临床样品材料中这三种重要的病毒性呼吸道病原体的有趣选择。
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