快速抗原检测作为一种鉴定 SARS-CoV-2 感染的工具及其作为自测设备的潜力。
Rapid antigen test as a tool for the identification of SARS-CoV-2 infection and its potential as a self-testing device.
机构信息
Fundação Oswaldo Cruz, Instituto René Rachou, Diagnóstico e Terapia de Doenças Infecciosas e Câncer, Belo Horizonte, MG, Brasil.
Universidade Federal de Minas Gerais, Instituto de Ciências Biológicas, Programa de Pós-Graduação em Patologia, Belo Horizonte, MG, Brasil.
出版信息
Rev Soc Bras Med Trop. 2023 May 22;56:e01672022. doi: 10.1590/0037-8682-0167-2022. eCollection 2023.
BACKGROUND
SARS-CoV-2 virus originated in Wuhan (China) in December (2019) and quickly spread worldwide. Antigen tests are rapid diagnostic tests (RDT) that produce results in 15-30 min and are an important tool for the scale-up of COVID-19 testing. COVID-19 diagnostic tests are authorized for self-testing at home in some countries, including Brazil. Widespread COVID-19 diagnostic testing is required to guide public health policies and control the speed of transmission and economic recovery.
METHODS
Patients with suspected COVID-19 were recruited at the Hospital da Baleia (Belo Horizonte, Brazil). The SARS-CoV-2 antigen-detecting rapid diagnostic tests were evaluated from June 2020 to June 2021 using saliva, nasal, and nasopharyngeal swab samples from 609 patients. Patient samples were simultaneously tested using a molecular assay (RT-qPCR). Sensitivity, specificity, accuracy, and positive and negative predictive values were determined using the statistical program, MedCalc, and GraphPad Prism 8.0.
RESULTS
The antigen-detecting rapid diagnostic tests displayed 98% specificity, 60% sensitivity, 96% positive predictive value, and moderate concordance with RT-qPCR. Substantial agreement was found between the two methods for patients tested < 7 days of symptom onset.
CONCLUSIONS
Our findings support the use of Ag-RDT as a valuable and safe diagnostic method. Ag-RDT was also demonstrated to be an important triage tool for suspected COVID-19 patients in emergencies. Overall, Ag-RDT is an effective strategy for reducing the spread of SARS-CoV-2 and contributing to COVID-19 control.
背景
SARS-CoV-2 病毒于 2019 年 12 月在中国武汉起源，并迅速在全球范围内传播。抗原检测是一种快速诊断检测方法，可在 15-30 分钟内得出结果，是扩大 COVID-19 检测规模的重要工具。一些国家，包括巴西，授权在家中进行 COVID-19 诊断测试的自我检测。需要进行广泛的 COVID-19 诊断检测，以指导公共卫生政策并控制传播速度和经济复苏。
方法
在巴西贝洛奥里藏特的 Hospital da Baleia 招募了疑似 COVID-19 的患者。从 2020 年 6 月至 2021 年 6 月，使用来自 609 名患者的唾液、鼻腔和鼻咽拭子样本评估了 SARS-CoV-2 抗原检测快速诊断检测。患者样本同时使用分子检测（RT-qPCR）进行检测。使用 MedCalc 统计程序和 GraphPad Prism 8.0 确定了敏感性、特异性、准确性、阳性和阴性预测值。
结果
抗原检测快速诊断检测显示 98%的特异性、60%的敏感性、96%的阳性预测值，与 RT-qPCR 具有中等一致性。对于症状发作<7 天的患者，两种方法之间发现了大量一致性。
结论
我们的研究结果支持将 Ag-RDT 用作有价值且安全的诊断方法。Ag-RDT 还被证明是急诊科疑似 COVID-19 患者的重要分诊工具。总的来说，Ag-RDT 是减少 SARS-CoV-2 传播和控制 COVID-19 的有效策略。
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