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评估用于大规模 COVID-19 筛查的 SARS-CoV-2 检测样本混合。

Evaluation of pooling of samples for testing SARS-CoV- 2 for mass screening of COVID-19.

机构信息

Biogenix G42 lab, Abu Dhabi, UAE.

G42 Health care, Abu Dhabi, UAE.

出版信息

BMC Infect Dis. 2021 Apr 17;21(1):360. doi: 10.1186/s12879-021-06061-3.

Abstract

BACKGROUND

The current pandemic of the SARS-CoV-2 virus, widely known as COVID-19, has affected millions of people around the world. The World Health Organization (WHO) has recommended vigorous testing to differentiate SARS-CoV-2 from other respiratory infections to aid in guiding appropriate care and management. Situations like this have demanded robust testing strategies and pooled testing of samples for SARS-CoV-2 virus has provided the solution to mass screening of people for COVID-19. A pooled testing strategy can be very effective in testing when resources are limited, yet it comes with its own limitations. These benefits and limitations need critical consideration when it comes to testing highly infectious diseases like COVID-19.

METHODS

This study evaluated the pooled testing of nasopharyngeal swabs for SARS-COV-2 by comparing the sensitivity of individual sample testing with 4-and 8-pool sample testing. Median cycle threshold (Ct) values were compared, and the precision of pooled testing was assessed through an inter- and intra-assay of pooled samples. Coefficient of variance was calculated for inter- and intra-assay variability.

RESULTS

The sensitivity becomes considerably lower when the samples are pooled. There is a high percentage of false negative reports with larger sample pool size and when the patient viral load is low or weak positive samples. High variability was seen in the intra- and inter-assay, especially among weak positive samples and when more number of samples are pooled together.

CONCLUSION

As COVID - 19 infection numbers and need for testing remain high, we must meticulously evaluate the testing strategy for each country depending on its testing capacity, infrastructure, economic strength, and need to determine the optimal balance on the cost-effective strategy of resource saving and risk/ cost of missing positive patients.

摘要

背景

当前,由 SARS-CoV-2 病毒引发的、广为人知的 COVID-19 疫情已在全球范围内影响了数百万人。世界卫生组织(WHO)建议大力开展检测,以区分 SARS-CoV-2 和其他呼吸道感染,从而有助于指导提供适当的护理和管理。在这种情况下,需要强有力的检测策略,对 SARS-CoV-2 病毒进行合并检测为大规模筛查人群是否感染 COVID-19 提供了一种解决方案。合并检测策略在资源有限的情况下可以非常有效地进行检测,但它也有其自身的局限性。在涉及像 COVID-19 这样的高度传染性疾病的检测时,这些益处和局限性需要得到批判性的考虑。

方法

本研究通过比较单独样本检测与 4 合并样本和 8 合并样本检测的敏感性,评估了对鼻咽拭子进行合并 SARS-CoV-2 检测的方法。比较了中位循环阈值(Ct)值,并通过对合并样本的室内和室间检测评估了合并检测的精密度。计算了室内和室间变异的变异系数。

结果

当样本合并时,敏感性会显著降低。当样本池较大且患者病毒载量较低或弱阳性样本时,会出现较高比例的假阴性报告。室内和室间检测都存在较大的变异性,尤其是弱阳性样本和合并样本数量较多时。

结论

随着 COVID-19 感染人数和检测需求的持续增加,我们必须根据每个国家的检测能力、基础设施、经济实力和确定节省资源的成本效益策略的最优平衡以及漏检阳性患者的风险/成本的需要,仔细评估其检测策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/760e/8052830/d6e43340e752/12879_2021_6061_Fig1_HTML.jpg

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