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A multi-country field validation of the FluChip-8G Insight Assay
Journal of Virological Methods ( IF 3.1 ) Pub Date : 2020-11-30 , DOI: 10.1016/j.jviromet.2020.114029
John Mark Velasco 1 , Sanjaya Shrestha 2 , Maria Theresa Valderama 3 , Jasmin Shrestha 2 , Binob Shrestha 2 , Paula Corazon Diones 3 , Susie Leonardia 3 , Yongyuth Poolpanichupatam 3 , Kittinun Hussem 3 , Domingo Chua 4 , Fatima Claire Navarro 4 , Maribel Develos 4 , Louis Macareo 3 , Damon Ellison 3 , Stefan Fernandez 3 , Chonticha Klungthong 3
Affiliation  

Introduction

It is critical to rapidly detect novel and non-seasonal influenza strains. Currently available assays have limited sensitivity in detecting novel influenza subtypes. We performed a multi-country field validation of the FluChip-8G Insight, an assay able to detect and characterize influenza A/B viruses and non-seasonal influenza viruses.

Materials and methods

We evaluated the performance of the FluChip-8G Insight on nasal and throat swab clinical samples from Thailand, Philippines and Nepal. Influenza PCR positive and negative samples tested using the US CDC Human Influenza Dx Panel reference standard were selected for testing using the FluChip-8G Influenza Insight.

Results

A total of 909 specimens were included in the analysis. The overall sensitivity and specificity of the FluChip-8G Insight to detect combined influenza A+B was 86 % and 100%, respectively. PPV and NPV were estimated at 100 % (95 % CI 99–100) and 73 % (95 % CI 68–78), respectively. Sensitivity across all influenza subtypes was 100% for specimens with <20 and 20–25 Ct values, respectively, but as Ct values increased, sensitivity across all influenza subtypes decreased significantly (p < 0.001) for specimens with Ct values ≥32.

Conclusion

The FluChip-8G Insight showed good precision and reproducibility among all 3 sites with robust identification of both influenza A and B targets with Ct values <32 and in the absence of co-infection. Positioning this platform in countries considered as hotspots for the emergence of novel/zoonotic influenza strains can increase the lead time in detecting and containing novel influenza strains with pandemic potential.



中文翻译:

FluChip-8G Insight Assay 的多国现场验证

介绍

快速检测新型和非季节性流感毒株至关重要。目前可用的检测方法在检测新型流感亚型方面的灵敏度有限。我们对 FluChip-8G Insight 进行了多国现场验证,这是一种能够检测和表征甲型/乙型流感病毒和非季节性流感病毒的检测方法。

材料和方法

我们评估了 FluChip-8G Insight 在来自泰国、菲律宾和尼泊尔的鼻腔和咽喉拭子临床样本上的性能。选择使用美国 CDC 人类流感 Dx Panel 参考标准检测的流感 PCR 阳性和阴性样品,使用 FluChip-8G Influenza Insight 进行检测。

结果

共有 909 个样本被纳入分析。FluChip-8G Insight 检测 A+B 流感组合的总体灵敏度和特异性分别为 86% 和 100%。PPV 和 NPV 分别估计为 100% (95% CI 99-100) 和 73% (95% CI 68-78)。对于 Ct 值 <20 和 20-25 的样本,所有流感亚型的敏感性分别为 100%,但随着 Ct 值的增加,对于 Ct 值≥32 的样本,所有流感亚型的敏感性显着降低(p < 0.001)。

结论

FluChip-8G Insight 在所有 3 个位点中均显示出良好的精确度和重现性,在没有合并感染的情况下,可以可靠地识别 Ct 值 <32 的甲型和乙型流感靶标。将该平台定位在被认为是新型/人畜共患流感毒株出现热点的国家,可以增加检测和控制具有大流行潜力的新型流感毒株的准备时间。

更新日期:2020-12-11
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