Swab池能够快速扩展用于严重急性呼吸系统综合征冠状病毒2型社区检测的高通量能力。

IF 4 3区 医学 Q2 VIROLOGY Journal of Clinical Virology Pub Date : 2023-10-01 DOI:10.1016/j.jcv.2023.105574
Jamie Fagg , Rupert Beale , Matthias E. Futschik , Elena Turek , David Chapman , Susan Halstead , Marc Jones , Joanna Cole-Hamilton , Rory Gunson , Malur Sudhanva , Paul E. Klapper , Harper Vansteenhouse , Sarah Tunkel , Anna Dominiczak , Timothy EA Peto , Tom Fowler
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引用次数: 0

摘要

背景:快速提升检测能力的挑战是新冠肺炎疫情应对的一个重要教训。高通量测试实验室需要对流程进行调整,因此样本池的实施具有挑战性。目的:本研究旨在评估在真实世界的社区检测条件下,使用相同的高通量管道,在源头汇集样本(拭子汇集)是否与个体的qRT-PCR检测一样有效,以识别严重急性呼吸系统综合征冠状病毒2型病例。方法:以个体测试为参考,对每个样本库的两组10个样本(样本库10:1030名参与者和103个样本库)和6个样本库6:1284名参与者,214个样本库进行一致性、敏感性、特异性和Ct值差异测试。结果:Swab池允许对现有的高通量严重急性呼吸系统综合征冠状病毒2型测试管道进行未经修改的应用,但精度损失很小。Pool10的一致性为98.1%(95%置信区间:93.3-99.8%),敏感性为95.7%(85.5-99.5%),特异性为100.0%(93.6-100.0%)。Pool6的一致性是97.2%(94.0-99.0%),敏感性是97.5%(93.7-99.3%),特异度是96.4%(87.7-99.6%)。池大小之间的结果测量差异不显著。大多数在池中未检测到的阳性个体样本的病毒浓度非常低。如果只有病毒浓度>400拷贝/ml的单个样本(即Ct值)结论:该研究通过拭子池和高通量实验室实施该方法的即时能力证明了高灵敏度和特异性,使其成为规划未来流行病快速扩大实验室能力的一种选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Swab pooling enables rapid expansion of high-throughput capacity for SARS-CoV-2 community testing

Background

The challenges of rapid upscaling of testing capacity were a major lesson from the COVID-19 pandemic response. The need for process adjustments in high-throughput testing laboratories made sample pooling a challenging option to implement.

Objective

This study aimed to evaluate whether pooling samples at source (swab pooling) was as effective as qRT-PCR testing of individuals in identifying cases of SARS-CoV-2 in real-world community testing conditions using the same high-throughput pipeline.

Methods

Two cohorts of 10 (Pool10: 1,030 participants and 103 pools) and 6 (Pool6: 1,284 participants and 214 pools) samples per pool were tested for concordance, sensitivity, specificity, and Ct value differences with individual testing as reference.

Results

Swab pooling allowed unmodified application of an existing high-throughput SARS-Cov-2 testing pipeline with only marginal loss of accuracy. For Pool10, concordance was 98.1% (95% Confidence interval: 93.3–99.8%), sensitivity was 95.7% (85.5–99.5%), and specificity was 100.0% (93.6–100.0%). For Pool6, concordance was 97.2% (94.0–99.0%), sensitivity was 97.5% (93.7–99.3%), and specificity was 96.4% (87.7–99.6%). Differences of outcomes measure between pool size were not significant. Most positive individual samples, which were not detected in pools, had very low viral concentration. If only individual samples with a viral concentration > 400 copies/ml (i.e. Ct value < 30) were considered positive, the overall sensitivity of pooling increased to 99.5%.

Conclusion

The study demonstrated high sensitivity and specificity by swab pooling and the immediate capability of high-throughput laboratories to implement this method making it an option in planning of rapid upscaling of laboratory capacity for future pandemics.

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来源期刊
Journal of Clinical Virology
Journal of Clinical Virology 医学-病毒学
CiteScore
22.70
自引率
1.10%
发文量
149
审稿时长
24 days
期刊介绍: The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice. The journal publishes on topics that include: • new diagnostic technologies • nucleic acid amplification and serologic testing • targeted and metagenomic next-generation sequencing • emerging pandemic viral threats • respiratory viruses • transplant viruses • chronic viral infections • cancer-associated viruses • gastrointestinal viruses • central nervous system viruses • one health (excludes animal health)
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