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严重急性呼吸综合征冠状病毒2型快速抗原检测相对于逆转录聚合酶链反应C值的诊断性能

Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in relation to RT-PCR C Value.

作者信息

Mandal Dipendra Kumar, Bhattarai Bibek Raj, Pokhrel Sushant, Chhusyabaga Mandira, Bhandari Parmananda, Bhatt Mahendra Prasad, Marhattha Sujan Babu

机构信息

Department of Laboratory Medicine, Manmohan Memorial Institute of Health Sciences, Kathmandu, Nepal.

Sukraraj Tropical and Infectious Disease Hospital, Teku, Kathmandu, Nepal.

出版信息

Adv Virol. 2022 May 10;2022:9245248. doi: 10.1155/2022/9245248. eCollection 2022.

Abstract

BACKGROUND

Early detection of the SARS-CoV-2 is crucial for both the improvement of turnaround time and limiting the spread of the virus in the community. Thus, this study aims to establish rapid antigen tests as an effective diagnostic tool to improve the testing strategies of COVID-19 diagnosis.

METHODS

A laboratory based cross-sectional study was performed on the patients that visited Sukraraj Tropical and Infectious Disease Hospital (STIDH) in Kathmandu, Nepal, from November 2020 to January 2021. A total of 213 nasopharyngeal swabs were collected from both symptomatic and asymptomatic patients for rapid antigen test, followed by RT-PCR assay as reference test for confirmation of COVID-19. A standard questionnaire was administered to collect other information from patients. Data were collected and analyzed using SPSS version 20.

RESULTS

Out of 213 individuals, 75 tested positive in Ag-RDT test, while 118 tested positive for SARS-CoV-2 RNA genome via Real time PCR assay. The overall diagnostic performance of Ag-RDT showed 63.6% sensitivity and 97.9% specificity. The diagnostic accuracy of Ag- RDT was 78.9% with value 0.590, showing moderate agreement with RT-PCR. Significant difference ( value <0.001) was observed between Ag- RDT and Ag- RDT results when compared to C values obtained from RT- PCR.

CONCLUSION

The promising performance of Ag-RDT renders it useful as screening tool alongside RT-PCR to reduce transmission via improving contact tracing, implementation of local mitigation strategies, and refining existing testing protocol for diagnosis of COVID-19.

摘要

背景

早期检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)对于缩短周转时间和限制病毒在社区中的传播都至关重要。因此,本研究旨在将快速抗原检测确立为一种有效的诊断工具,以改进2019冠状病毒病(COVID-19)的检测策略。

方法

于2020年11月至2021年1月,对到访尼泊尔加德满都苏克拉拉杰热带病与传染病医院(STIDH)的患者进行了一项基于实验室的横断面研究。从有症状和无症状患者中总共采集了213份鼻咽拭子进行快速抗原检测,随后以逆转录聚合酶链反应(RT-PCR)检测作为确诊COVID-19的参考检测。使用标准问卷收集患者的其他信息。数据采用SPSS 20版进行收集和分析。

结果

在213名个体中,75人快速抗原检测(Ag-RDT)呈阳性,而118人通过实时PCR检测SARS-CoV-2 RNA基因组呈阳性。Ag-RDT的总体诊断性能显示敏感性为63.6%,特异性为97.9%。Ag-RDT的诊断准确率为78.9%,kappa值为0.590,与RT-PCR显示中度一致性。与RT-PCR获得的C值相比,Ag-RDT和Ag-RDT结果之间观察到显著差异(p值<0.001)。

结论

Ag-RDT的良好性能使其可作为RT-PCR之外的筛查工具,通过改善接触者追踪、实施局部缓解策略以及完善现有的COVID-19诊断检测方案来减少传播。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6645/9113911/26fd531f9420/AV2022-9245248.001.jpg

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