检测 SARS-CoV-2 变异多样性的快速抗原测试的性能以及与病毒培养阳性的相关性:对诊断发展和未来公共卫生战略的影响。

IF 5.1 1区 生物学 Q1 MICROBIOLOGY mBio Pub Date : 2024-10-31 DOI:10.1128/mbio.02737-24
Heather Goux, Jennetta Green, Andrew Wilson, Shanmuga Sozhamannan, Stephanie A Richard, Rhonda Colombo, David A Lindholm, Milissa U Jones, Brian K Agan, Derek Larson, David L Saunders, Rupal Mody, Jason Cox, Robert Deans, Joseph Walish, Anthony Fries, Mark P Simons, Simon D Pollett, Darci R Smith
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引用次数: 0

摘要

基于抗原的快速诊断检测(Ag-RDTs)能及时提供结果,使用简单,而且成本低于分子检测。最近的研究表明,抗原检测结果与病毒培养结果一致(病毒感染高峰期传染性的代表);然而,Ag-RDT 对较新的 SARS-CoV-2 变种的检测效果尚不清楚。在这项研究中,我们(i) 评估了 Ag-RDT 和诊断抗体检测一系列 SARS-CoV-2 变体的性能,(ii) 确定了 Ag-RDT 结果是否与培养阳性相关。我们注意到,在所有检测方法中,不同变异体的检测限仅有细微差别,而且不同变异体对 N 蛋白的抗体亲和力一致。与 PCR 阳性率(100%)相比,我们观察到 Ag-RDT 具有中等到较高的灵敏度(46.8%-83.9%),而且每次检测都对所有变体进行了评估。Ag-RDT 灵敏度和 PCR Ct 与活病毒检测呈反相关。总之,我们的研究结果表明,与 PCR 相比,市售的 Ag-RDT 具有不同的灵敏度,对不同变异株显示出相似的诊断有效性,并可预测传播风险。这些发现可用于支持更有针对性的 SARS-CoV-2 隔离策略,特别是如果其他研究能阐明 Ag-RDT 阳性与传播风险之间的直接联系。在检测任何 PCR 阳性感染的灵敏度与传染性病毒阳性的一致性之间的明显权衡也可为 SARS-CoV-2 和其他流行性呼吸道病原体的新 RDT 诊断开发策略提供参考:尽管有疫苗可用,但 COVID-19 仍是一个主要的健康问题,基于抗原的快速诊断检测(Ag-RDTs)通常用作护理点或家庭诊断检测。在本研究中,我们使用来自临床 COVID-19 病例的上呼吸道拭子样本,评估了两种市售 Ag-RDT 和一种研究型 Ag-RDT 检测多种 SARS-CoV-2 变体的性能。此外,我们还确定了 Ag-RDT 结果是否与培养阳性相关,培养阳性可能代表病毒的传播性。我们的研究结果对未来在 COVID-19 新变种高传播期的检测和应对策略具有重要意义。
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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.

Antigen-based rapid diagnostic tests (Ag-RDTs) provide timely results, are simple to use, and are less expensive than molecular assays. Recent studies suggest that antigen-based testing aligns with virus culture-based results (a proxy of contagiousness at the peak viral phase of illness); however, the performance of Ag-RDTs for newer SARS-CoV-2 variants is unclear. In this study, we (i) assessed the performance of Ag-RDTs and diagnostic antibodies to detect a range of SARS-CoV-2 variants and (ii) determined whether Ag-RDT results correlated with culture positivity. We noted only minor differences in the limit of detection by variant for all assays, and we demonstrated consistent antibody affinity to the N protein among the different variants. We observed moderate to high sensitivity (46.8%-83.9%) for Ag-RDTs when compared to PCR positivity (100%), and all variants were assessed on each assay. Ag-RDT sensitivity and PCR Ct showed an inverse correlation with the detection of viable virus. Collectively, our results demonstrate that commercially available Ag-RDTs offer variable sensitivity compared to PCR, show similar diagnostic validity across variants, and may predict the risk of transmissibility. These findings may be used to support more tailored SARS-CoV-2 isolation strategies, particularly if other studies clarify the direct association between Ag-RDT positivity and transmission risk. The apparent trade-off between sensitivity in the detection of any PCR-positive infection and concordance with infectious virus positivity may also inform new RDT diagnostic development strategies for SARS-CoV-2 and other epidemic respiratory pathogens.

Importance: Despite the availability of vaccines, COVID-19 continues to be a major health concern, and antigen-based rapid diagnostic tests (Ag-RDTs) are commonly used as point-of-care or at-home diagnostic tests. In this study, we evaluated the performance of two commercially available Ag-RDTs and a research Ag-RDT to detect multiple SARS-CoV-2 variants using upper respiratory tract swab samples from clinical COVID-19 cases. Furthermore, we determined whether Ag-RDT results correlated with culture positivity, a potential proxy of viral transmissibility. Our results have important implications to inform future testing and response strategies during periods of high COVID-19 transmission with new variants.

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来源期刊
mBio
mBio MICROBIOLOGY-
CiteScore
10.50
自引率
3.10%
发文量
762
审稿时长
1 months
期刊介绍: mBio® is ASM''s first broad-scope, online-only, open access journal. mBio offers streamlined review and publication of the best research in microbiology and allied fields.
期刊最新文献
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