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[严重急性呼吸综合征冠状病毒2抗原快速检测]

[SARS-CoV-2 antigen rapid tests].

作者信息

Reuter Tom, Lange Constanze, Zeyher Sharay, Wölk Benno, Kramer Jan

机构信息

LADR Zentrallabor Dr. Kramer & Kollegen, Lauenburger Str. 67, 21502, Geesthacht, Deutschland.

Universität zu Lübeck, Lübeck, Deutschland.

出版信息

Pravent Gesundh. 2022 Aug 9:1-7. doi: 10.1007/s11553-022-00970-0.


DOI:10.1007/s11553-022-00970-0
PMID:40479215
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9363140/
Abstract

BACKGROUND: For detection of SARS-CoV-2-infected persons ("severe acute respiratory syndrome coronavirus 2") quantitative Real-Time PCR (qRT-PCR) remains the gold standard. SARS-CoV‑2 antigen-detecting rapid diagnostic tests (Ag-RDTs) have the advantage of being fast and simple to use at any location. According to previous studies, Ag-RDTs seem to have poorer sensitivity and specificity. There are currently a few hundred Ag-RDTs available, but many of them have not been independently evaluated. OBJECTIVES: Evaluation of diagnostic performance of rapid antigen tests detecting SARS-CoV‑2 from 6 different manufacturers. MATERIALS AND METHODS: We performed Ag-RDTS with naso- and oropharnygeal swabs from laboratory routine which had had already resulted in a positive qRT-PCR test. To exclude possible dilution effects when samples were used for a second time, we also performed qRT-PCR analytics for already used samples. The initially measured Ct values could be confirmed. RESULTS: Ag-RDTs showed differences in discrimination between positive and negative results. In samples with lower virus concentrations (Ct value > 30), the results were not reliable and the discrimination between negative and positive results was not unambigious. CONCLUSIONS: Ag-RDTs with high sensitivity allow the identification of highly contagious patients anywhere. There are differences between manufacturers which are important when testing patients. An independent transparent evaluation of Ag-RDTs is necessary.

摘要

背景:对于严重急性呼吸综合征冠状病毒2(SARS-CoV-2)感染者的检测,定量实时荧光定量聚合酶链反应(qRT-PCR)仍然是金标准。SARS-CoV-2抗原检测快速诊断试验(Ag-RDTs)具有快速且可在任何地点使用的优点。根据以往研究,Ag-RDTs的敏感性和特异性似乎较差。目前有数百种Ag-RDTs可供使用,但其中许多尚未经过独立评估。 目的:评估6家不同制造商生产的检测SARS-CoV-2的快速抗原检测的诊断性能。 材料与方法:我们使用实验室常规采集的鼻咽拭子进行Ag-RDT检测,这些样本的qRT-PCR检测结果已呈阳性。为排除样本再次使用时可能产生的稀释效应,我们还对已使用的样本进行了qRT-PCR分析。最初测得的Ct值能够得到确认。 结果:Ag-RDTs在区分阳性和阴性结果方面存在差异。在病毒浓度较低(Ct值>30)的样本中,结果不可靠,阴性和阳性结果的区分不明确。 结论:高灵敏度的Ag-RDTs能够在任何地点识别出高传染性患者。不同制造商的产品存在差异,这在检测患者时很重要。对Ag-RDTs进行独立透明的评估是必要的。

相似文献

[1]
[SARS-CoV-2 antigen rapid tests].

Pravent Gesundh. 2022-8-9

[2]
Comparative evaluation of RT-PCR and antigen-based rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 detection: performance, variant specificity, and clinical implications.

Microbiol Spectr. 2024-6-4

[3]
Comparison of Rapid Antigen Tests' Performance Between Delta and Omicron Variants of SARS-CoV-2 : A Secondary Analysis From a Serial Home Self-testing Study.

Ann Intern Med. 2022-12

[4]
Avoiding False-Positive SARS-CoV-2 Rapid Antigen Test Results with Point-of-Care Molecular Testing on Residual Test Buffer.

Microbiol Spectr. 2022-8-31

[5]
Regional Evaluation of Two SARS-CoV-2 Antigen Rapid Diagnostic Tests in East Africa.

Microbiol Spectr. 2023-6-15

[6]
A Multicenter Clinical Diagnostic Accuracy Study of SureStatus, an Affordable, WHO Emergency Use-Listed, Rapid, Point-Of-Care Antigen-Detecting Diagnostic Test for SARS-CoV-2.

Microbiol Spectr. 2022-10-26

[7]
Impaired performance of SARS-CoV-2 antigen-detecting rapid diagnostic tests at elevated and low temperatures.

J Clin Virol. 2021-5

[8]
Performance of rapid antigen tests to detect SARS-CoV-2 variant diversity and correlation with viral culture positivity: implication for diagnostic development and future public health strategies.

mBio. 2024-12-11

[9]
Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: An updated systematic review and meta-analysis with meta-regression analyzing influencing factors.

PLoS Med. 2022-5

[10]
Diagnostic performance of CerTest and Panbio antigen rapid diagnostic tests to diagnose SARS-CoV-2 infection.

J Clin Virol. 2021-4

本文引用的文献

[1]
Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021.

Euro Surveill. 2021-11

[2]
Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis.

PLoS Med. 2021-8

[3]
Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test.

Med Microbiol Immunol. 2021-8

[4]
Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection.

Cochrane Database Syst Rev. 2021-3-24

[5]
Quantifying the impact of quarantine duration on COVID-19 transmission.

Elife. 2021-2-5

[6]
Viral Cultures for Coronavirus Disease 2019 Infectivity Assessment: A Systematic Review.

Clin Infect Dis. 2021-12-6

[7]
Duration of infectiousness and correlation with RT-PCR cycle threshold values in cases of COVID-19, England, January to May 2020.

Euro Surveill. 2020-8

[8]
Assessment of SARS-CoV-2 Screening Strategies to Permit the Safe Reopening of College Campuses in the United States.

JAMA Netw Open. 2020-7-1

[9]
Development and Evaluation of a duo SARS-CoV-2 RT-qPCR Assay Combining Two Assays Approved by the World Health Organization Targeting the Envelope and the RNA-Dependant RNA Polymerase (RdRp) Coding Regions.

Viruses. 2020-6-25

[10]
Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding.

Lancet. 2020-1-30

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