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实时 RT-PCR 检测 SARS-CoV-2 RNA 的汇总策略:比较 5 份和 10 份样本的汇总。

Pooling Strategy for Detection of SARS-CoV-2 RNA by Real-Time RT-PCR: Comparison of Pooling 5 and 10 Samples.

出版信息

Clin Lab. 2023 Aug 1;69(8). doi: 10.7754/Clin.Lab.2023.220830.

DOI:10.7754/Clin.Lab.2023.220830
PMID:37560855
Abstract

BACKGROUND

We evaluated whether it was appropriate to screen SARS-CoV-2 in sample pools of 5 and 10. This study was aimed to evaluate whether the pooling strategy would be an appropriate strategy for SARS-CoV-2 screening.

METHODS

In the study, 5 and 10 sample pools were formed using 720 nasopharyngeal swab samples, of which 72 were positive, and 648 were negative. The samples were analyzed in three groups according to their Ct values as high, medium, and low viral load. SARS-CoV-2 RNA in nasopharyngeal swab samples was detected by the real-time PCR method on the Bio-Rad platform.

RESULTS

The sensitivity of 5-sample pooling was 77.8%, and the sensitivity of 10-sample pooling was 75%. The false-negative rate was 22.2% in 5 sample poolings and 25% in 10 sample poolings. Out of the samples with medium and high viral loads, none of the positive samples were lost in either pool. In pools containing both 5 samples and 10 samples, the individual mean Ct values of the samples detected as false-negative were significantly higher (low viral load) than those of the other samples (p < 0.001).

CONCLUSIONS

In this study, 5 and 10 pooling seems useful in detecting patients with medium and high viral loads. Pooling strategies that allow mass screening of SARS-CoV-2 can contribute to early detection of patients at high risk of SARS-CoV-2 transmission in low prevalence areas, as well as timely public health interventions.

摘要

背景

我们评估了在 5 份和 10 份样本中进行 SARS-CoV-2 筛查是否合适。本研究旨在评估 pooling 策略是否适用于 SARS-CoV-2 的筛查。

方法

在这项研究中,使用 720 份鼻咽拭子样本构建了 5 份和 10 份样本池,其中 72 份为阳性,648 份为阴性。根据 Ct 值,将样本分为高、中、低病毒载量三组进行分析。采用实时 PCR 法,在 Bio-Rad 平台上检测鼻咽拭子样本中的 SARS-CoV-2 RNA。

结果

5 份样本 pooling 的敏感性为 77.8%,10 份样本 pooling 的敏感性为 75%。5 份样本 pooling 的假阴性率为 22.2%,10 份样本 pooling 的假阴性率为 25%。在中高病毒载量的样本中,两个 pooling 中均未丢失阳性样本。在包含 5 份和 10 份样本的 pooling 中,被检测为假阴性的样本的个体平均 Ct 值明显高于其他样本(低病毒载量)(p<0.001)。

结论

在本研究中,5 份和 10 份样本 pooling 似乎可用于检测中高病毒载量的患者。pooling 策略可用于 SARS-CoV-2 的大规模筛查,有助于在低流行地区早期发现 SARS-CoV-2 传播风险高的患者,并及时进行公共卫生干预。

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