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评估用于基于实时荧光定量聚合酶链反应的2019冠状病毒病诊断的样本混合效率。

Evaluating the efficiency of specimen (sample) pooling for real-time PCR based diagnosis of COVID-19.

作者信息

Shukla Surabhi, Upadhyay Vandana, Maurya Vinod Kumar

机构信息

Department of Microbiology, Maharshi Vashistha Autonomous State Medical College, Basti, Uttar Pradesh, 272124, India.

Department of Microbiology, Maharshi Vashistha Autonomous State Medical College, Basti, Uttar Pradesh, 272124, India.

出版信息

Indian J Med Microbiol. 2021 Jul;39(3):339-342. doi: 10.1016/j.ijmmb.2021.03.011. Epub 2021 Mar 26.

Abstract

PURPOSE

This study is aims at evaluating the efficacy and sensitivity of specimen pooling for testing of SARS-CoV-2 virus to determine the accuracy, resource savings, and identification of borderline positive cases without impacting the accuracy of the testing.

METHOD

This study was conducted between August and October 2020, we performed COVID-19 testing by RT-PCR on the samples from varying prevalence of rural population (non-hot spot) referred to COVID laboratory, in the first step, the samples were collated into pools of 5 or 10. These pools were tested by RT-PCR. Negative pools were reported as negative whereas positive pools of 5 and 10 were then de-convoluted and each sample was tested individually.

RESULTS

In the present study, we tested 1580 samples in 158 pools of 10 and 17,515 samples in 3503 pools of 5. Among 10 samples pool, 11 (13%) pools flagged positive in the first step. In the second step, among 11 pools (110 samples) de-convoluted strategy was followed in which 10 individual samples came positive. Among 5 samples pool, 164 (13%) pools flagged positive in the first step. In the second step, among 164 pools (820 samples) de-convoluted strategy was followed in which 171 individual samples came positive. The pooled sample testing strategy saves substantial resources and time during surge testing and enhanced pandemic surveillance. This approach requires around 76%-93% fewer tests in low to moderate prevalence settings and group sizes up to 5-10 in a population, compared to individual testing.

CONCLUSION

Pooled sample RT- PCR analysis strategies can save substantial resources and time for COVID-19 mass testing in comparison with individual testing without compromising the quality of outcome of the test. In particular, the pooled sample approach can facilitate mass screening in the early asymptomatic stages of COVID-19 infections.

摘要

目的

本研究旨在评估样本混合检测对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)病毒检测的有效性和敏感性,以确定其准确性、资源节省情况以及在不影响检测准确性的前提下识别临界阳性病例。

方法

本研究于2020年8月至10月进行,我们对转诊至新冠病毒实验室的不同农村人口患病率(非热点地区)的样本进行了逆转录聚合酶链反应(RT-PCR)新冠病毒检测。第一步,将样本整理成5人或10人的混合样本。这些混合样本通过RT-PCR进行检测。阴性混合样本报告为阴性,而5人组和10人组的阳性混合样本随后进行解卷积,每个样本单独检测。

结果

在本研究中,我们对158个10人混合样本中的1580个样本以及3503个5人混合样本中的17515个样本进行了检测。在10人样本组中,11个(13%)混合样本在第一步检测中呈阳性。在第二步中,对11个混合样本(110个样本)采用了解卷积策略,其中10个个体样本呈阳性。在5人样本组中,164个(13%)混合样本在第一步检测中呈阳性。在第二步中,对164个混合样本(820个样本)采用了解卷积策略,其中171个个体样本呈阳性。混合样本检测策略在激增检测和加强疫情监测期间节省了大量资源和时间。与个体检测相比,这种方法在低至中等患病率环境以及人群分组规模达5至10人的情况下,所需检测次数减少约76%至93%。

结论

与个体检测相比,混合样本RT-PCR分析策略可为新冠病毒大规模检测节省大量资源和时间,且不影响检测结果质量。特别是,混合样本方法有助于在新冠病毒感染的早期无症状阶段进行大规模筛查。

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