实时荧光 RT-PCR 与抗原检测试剂用于 SARS-CoV-2 检测的比较评估：性能、变异株特异性和临床意义。

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

机构信息

Department of Medical Laboratory Technology, Faculty of Applied Sciences, Accra Technical University, Accra, Ghana.

Biomedical and Public Health Research Unit, Council for Scientific and Industrial Research - Water Research Institute, Accra, Ghana.

出版信息

Microbiol Spectr. 2024 Jun 4;12(6):e0007324. doi: 10.1128/spectrum.00073-24. Epub 2024 Apr 29.

DOI:10.1128/spectrum.00073-24

PMID:38683014

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11237673/

Abstract

The COVID-19 pandemic has highlighted the critical need for accurate and efficient diagnostic tools for detecting severe acute respiratory coronavirus 2 (SARS-CoV-2) infections. This study presents a comparison of two diagnostic tests: RT-PCR and antigen detection rapid diagnostic tests (Ag-RDTs). This study focused on their performance, variant specificity, and their clinical implications. A simultaneous testing of 268 samples was carried out for SARS-CoV-2 using RT-PCR and Ag-RDTs [flourescence immunoassay (FIA) and lateral flow immunoassay (LFIA)]. Viral load was quantified, and variant identification was performed using a PCR-based assay. The prevalence was found to be 30.2% using reverse transcription PCR (RT-PCR), 26.5% using FIA, and 25% using LFIA. When comparing the FIA and LFIA, the overall diagnostic performance was found to be 80.25% vs 76.54%, 96.79% vs 97.33%, 91.55% vs 90.51%, and 91.88% vs 92.56% for sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), respectively. Both Ag-RDTs showed a strong agreement with RT-PCR (κ = 0.78-0.80). The overall accuracies of the FIA and LFIA were 92.41% and 92.13%, respectively. The FIA showed higher sensitivity (73.68%) and PPV (92.08%) than the LFIA (65.79% and 90.56%, respectively) in asymptomatic patients. At low Ct values (<25), both Ag-RDTs had 100% sensitivity, but the sensitivity reduced to 31.82% for FIA and 27.27% for LFIA at Ct values > 30. The diagnostic sensitivity of FIA compared to LFIA for detecting the Alpha variant was 78.85% vs. 69.23% and 72.22% vs. 83.33% for the Delta variant. Both Ag-RDTs had 100% sensitivity for detecting Omicron. Both Ag-RDTs performed well in patients with high viral loads and Omicron variant infections compared to those infected with Alpha and Delta variants. This study confirms the comparable performance of RT-PCR and Ag-RDTs, specifically FIA and LFIA, for SARS-CoV-2 detection. The FIA showed higher sensitivity and PPV in asymptomatic cases, while both Ag-RDTs exhibited strong agreement with RT-PCR results. Notably, Ag-RDTs, particularly FIA, proved effective in detecting the Omicron variant and cases with high viral loads, highlighting their potential clinical utility in managing the COVID-19 pandemic.IMPORTANCEThis study is of utmost importance in providing effective responses to manage the COVID-19 pandemic. It rigorously compares the diagnostic accuracy, variant specificity, and practical considerations of reverse transcription PCR (RT-PCR) and antigen detection rapid diagnostic tests (Ag-RDTs) for severe acute respiratory coronavirus 2 (SARS-CoV-2), answering critical questions. The results of this study will help healthcare professionals choose the appropriate testing methods, allocate resources effectively, and enhance public health strategies. Given the evolution of the virus, understanding the performance of these diagnostic tools is crucial to adapting to emerging variants. Additionally, the study provides insights into logistical challenges and accessibility issues, which will contribute to refining testing workflows, particularly in resource-limited settings. Ultimately, the study's impact extends to global healthcare, providing valuable information for policymakers, clinicians, and public health officials as they work together for mitigating the impact of the pandemic.

摘要

新型冠状病毒肺炎大流行凸显了准确、高效的诊断工具对于检测严重急性呼吸冠状病毒 2（SARS-CoV-2）感染的关键需求。本研究比较了两种诊断检测方法：逆转录聚合酶链反应（RT-PCR）和抗原检测快速诊断试验（Ag-RDTs）。本研究重点关注它们的性能、变体特异性及其临床意义。对 268 个样本同时进行了 SARS-CoV-2 的检测，使用 RT-PCR 和 Ag-RDTs（荧光免疫测定（FIA）和侧向流动免疫测定（LFIA））。使用基于 PCR 的检测方法对病毒载量进行定量，并进行变体鉴定。使用逆转录 PCR（RT-PCR）发现流行率为 30.2%，使用 FIA 为 26.5%，使用 LFIA 为 25%。当比较 FIA 和 LFIA 时，整体诊断性能分别为 80.25%对 76.54%、96.79%对 97.33%、91.55%对 90.51%和 91.88%对 92.56%，灵敏度、特异性、阳性预测值（PPV）和阴性预测值（NPV）。两种 Ag-RDT 均与 RT-PCR 具有很强的一致性（κ=0.78-0.80）。FIA 和 LFIA 的总准确度分别为 92.41%和 92.13%。FIA 在无症状患者中显示出更高的灵敏度（73.68%）和 PPV（92.08%），而 LFIA 分别为 65.79%和 90.56%。在低 Ct 值（<25）时，两种 Ag-RDT 的灵敏度均为 100%，但在 Ct 值>30 时，FIA 的灵敏度降至 31.82%，LFIA 的灵敏度降至 27.27%。FIA 与 LFIA 相比，检测 Alpha 变体的灵敏度分别为 78.85%对 69.23%和 72.22%对 83.33%，检测 Delta 变体的灵敏度分别为 78.85%对 69.23%和 72.22%对 83.33%。两种 Ag-RDT 对检测 Omicron 的灵敏度均为 100%。与感染 Alpha 和 Delta 变体的患者相比，两种 Ag-RDT 在高病毒载量和 Omicron 变体感染的患者中均表现出良好的性能。本研究证实了 RT-PCR 和 Ag-RDTs，特别是 FIA 和 LFIA，在 SARS-CoV-2 检测方面具有相当的性能。FIA 在无症状病例中显示出更高的灵敏度和 PPV，而两种 Ag-RDT 均与 RT-PCR 结果具有很强的一致性。值得注意的是，Ag-RDT 特别是 FIA，在检测 Omicron 变体和高病毒载量病例方面非常有效，突出了它们在管理 COVID-19 大流行方面的潜在临床应用价值。

重要性

本研究在提供应对 COVID-19 大流行的有效措施方面具有至关重要的意义。它严格比较了逆转录聚合酶链反应（RT-PCR）和抗原检测快速诊断试验（Ag-RDTs）在严重急性呼吸冠状病毒 2（SARS-CoV-2）检测方面的诊断准确性、变体特异性和实际考虑因素，回答了关键问题。本研究的结果将有助于医疗保健专业人员选择适当的检测方法，有效地分配资源，并增强公共卫生策略。鉴于病毒的不断演变，了解这些诊断工具的性能对于适应新出现的变体至关重要。此外，该研究还提供了有关后勤挑战和可及性问题的见解，这将有助于改进检测工作流程，特别是在资源有限的环境中。最终，该研究的影响扩展到全球医疗保健领域，为政策制定者、临床医生和公共卫生官员提供了有价值的信息，使他们能够共同努力减轻大流行的影响。