Abstract：
BACKGROUND: The SARS-CoV-2 pandemic has resulted in an unprecedented level of worldwide testing for epidemiologic and diagnostic purposes, and due to the extreme need for tests, the gold-standard Reverse Transcription Polymerase Chain Reaction (RT-PCR) testing capacity has been unable to meet the overall worldwide testing demand. Consequently, although the current literature has shown the sensitivity of rapid antigen tests (RATs) to be inferior to RT-PCR, RATs have been implemented on a large scale without solid data on performance.
OBJECTIVE: This study will compare analytical and clinical sensitivities and specificities of 50 lateral flow- or laboratory-based RATs and 3 strand invasion-based amplification (SIBA)-RT-PCR tests from 30 manufacturers to RT-PCR testing of samples obtained from the deep oropharynx. In addition, the study will compare sensitivities and specificities of the included RATs as well as RT-PCR on clinical samples obtained from the deep oropharynx, the anterior nasal cavity, saliva, the deep nasopharynx, and expired air to RT-PCR on deep oropharyngeal samples.
METHODS: In the prospective part of the study, 200 individuals found SARS-CoV-2 positive and 200 individuals found SARS-CoV-2 negative by routine RT-PCR testing will be retested with each RAT, applying RT-PCR as the reference method. In the retrospective part of the study, 304 deep oropharyngeal cavity swabs divided into 4 groups based on RT-PCR quantification cycle (Cq) levels will be tested with each RAT.
RESULTS: The results will be reported in several papers with different aims. The first paper will report retrospective (analytical sensitivity, overall and stratified into different Cq range groups) and prospective (clinical sensitivity) data for RATs, with RT-PCR as the reference method. The second paper will report results for RAT based on anatomical sampling location. The third paper will compare different anatomical sampling locations by RT-PCR testing. The fourth paper will focus on RATs that rely on central laboratory testing. Tests from 4 different manufacturers will be compared for analytical performance data on retrospective deep oropharyngeal swab samples. The fifth paper will report the results of 4 RATs applied both as professional use and as self-tests. The last paper will report the results from 2 breath tests in the study. A comparison of sensitivity and specificity between RATs will be conducted using the McNemar test for paired samples and the chi-squared test for unpaired samples. Comparison of the positive predictive value (PPV) and negative predictive value (NPV) between RATs will be performed by the bootstrap test, and 95% CIs for sensitivity, specificity, PPV, and NPV will be calculated as bootstrap CIs.
CONCLUSIONS: The study will compare the sensitivities of a large number of RATs for SARS-CoV-2 to with those of RT-PCR and will address whether lateral flow-based RATs differ significantly from laboratory-based RATs. The anatomical test locations for both RATs and RT-PCR will also be compared.
BACKGROUND: ClinicalTrials.gov NCT04913116; https://clinicaltrials.gov/ct2/show/NCT04913116.
UNASSIGNED: DERR1-10.2196/35706.
OBJECTIVE: This study will compare analytical and clinical sensitivities and specificities of 50 lateral flow- or laboratory-based RATs and 3 strand invasion-based amplification (SIBA)-RT-PCR tests from 30 manufacturers to RT-PCR testing of samples obtained from the deep oropharynx. In addition, the study will compare sensitivities and specificities of the included RATs as well as RT-PCR on clinical samples obtained from the deep oropharynx, the anterior nasal cavity, saliva, the deep nasopharynx, and expired air to RT-PCR on deep oropharyngeal samples.
METHODS: In the prospective part of the study, 200 individuals found SARS-CoV-2 positive and 200 individuals found SARS-CoV-2 negative by routine RT-PCR testing will be retested with each RAT, applying RT-PCR as the reference method. In the retrospective part of the study, 304 deep oropharyngeal cavity swabs divided into 4 groups based on RT-PCR quantification cycle (Cq) levels will be tested with each RAT.
RESULTS: The results will be reported in several papers with different aims. The first paper will report retrospective (analytical sensitivity, overall and stratified into different Cq range groups) and prospective (clinical sensitivity) data for RATs, with RT-PCR as the reference method. The second paper will report results for RAT based on anatomical sampling location. The third paper will compare different anatomical sampling locations by RT-PCR testing. The fourth paper will focus on RATs that rely on central laboratory testing. Tests from 4 different manufacturers will be compared for analytical performance data on retrospective deep oropharyngeal swab samples. The fifth paper will report the results of 4 RATs applied both as professional use and as self-tests. The last paper will report the results from 2 breath tests in the study. A comparison of sensitivity and specificity between RATs will be conducted using the McNemar test for paired samples and the chi-squared test for unpaired samples. Comparison of the positive predictive value (PPV) and negative predictive value (NPV) between RATs will be performed by the bootstrap test, and 95% CIs for sensitivity, specificity, PPV, and NPV will be calculated as bootstrap CIs.
CONCLUSIONS: The study will compare the sensitivities of a large number of RATs for SARS-CoV-2 to with those of RT-PCR and will address whether lateral flow-based RATs differ significantly from laboratory-based RATs. The anatomical test locations for both RATs and RT-PCR will also be compared.
BACKGROUND: ClinicalTrials.gov NCT04913116; https://clinicaltrials.gov/ct2/show/NCT04913116.
UNASSIGNED: DERR1-10.2196/35706.
摘要：
背景：SARS-CoV-2大流行导致了前所未有的全球流行病学和诊断性检测水平，由于极端需要测试，金标准逆转录聚合酶链反应（RT-PCR）检测能力已无法满足全球整体检测需求。因此,尽管目前的文献表明，快速抗原测试（RAT）的敏感性不如RT-PCR，RAT已经大规模实施,而没有关于性能的可靠数据。
目的：本研究将比较来自30家制造商的50种基于侧流或实验室的RAT和基于3链入侵的扩增（SIBA）-RT-PCR测试的分析和临床敏感性和特异性，以及从深口咽获得的样品的RT-PCR测试。此外,该研究将比较纳入的RAT的敏感性和特异性以及从深口咽获得的临床样本的RT-PCR，前鼻腔,唾液,深鼻咽部,和呼出的空气对深口咽样本进行RT-PCR。
方法：在前瞻性研究中，通过常规RT-PCR测试发现SARS-CoV-2阳性的200个人和发现SARS-CoV-2阴性的200个人将对每只大鼠进行重新测试，应用RT-PCR作为参考方法。在研究的回顾性部分，基于RT-PCR定量循环（Cq）水平将304个深口咽腔拭子分为4组，将对每个大鼠进行测试。
结果：结果将在几篇具有不同目的的论文中报告。第一篇论文将报告回顾性(分析敏感性，总体和分层为不同的Cq范围组）和RAT的前瞻性（临床敏感性）数据，以RT-PCR为参考方法。第二篇论文将报告基于解剖采样位置的RAT结果。第三篇论文将通过RT-PCR测试比较不同的解剖采样位置。第四篇论文将重点关注依赖于中央实验室测试的RAT。来自4个不同制造商的测试将比较回顾性深口咽拭子样品的分析性能数据。第五篇论文将报告作为专业用途和自我测试应用的4种RAT的结果。最后一篇论文将报告研究中2次呼气测试的结果。将使用配对样品的McNemar测试和非配对样品的卡方测试进行RAT之间的灵敏度和特异性的比较。RAT之间的阳性预测值（PPV）和阴性预测值（NPV）的比较将通过Bootstrap测试进行，灵敏度为95%CI，特异性，PPV,净现值将以bootstrapCIs计算。
结论：该研究将比较大量RAT对SARS-CoV-2和RT-PCR的敏感性，并将探讨基于侧向流的RAT是否与基于实验室的RAT显着不同。还将比较RAT和RT-PCR的解剖测试位置。
背景：ClinicalTrials.govNCT04913116;https://clinicaltrials.gov/ct2/show/NCT04913116。
UNASSIGNED：DERR1-10.2196/35706。
目的：本研究将比较来自30家制造商的50种基于侧流或实验室的RAT和基于3链入侵的扩增（SIBA）-RT-PCR测试的分析和临床敏感性和特异性，以及从深口咽获得的样品的RT-PCR测试。此外,该研究将比较纳入的RAT的敏感性和特异性以及从深口咽获得的临床样本的RT-PCR，前鼻腔,唾液,深鼻咽部,和呼出的空气对深口咽样本进行RT-PCR。
方法：在前瞻性研究中，通过常规RT-PCR测试发现SARS-CoV-2阳性的200个人和发现SARS-CoV-2阴性的200个人将对每只大鼠进行重新测试，应用RT-PCR作为参考方法。在研究的回顾性部分，基于RT-PCR定量循环（Cq）水平将304个深口咽腔拭子分为4组，将对每个大鼠进行测试。
结果：结果将在几篇具有不同目的的论文中报告。第一篇论文将报告回顾性(分析敏感性，总体和分层为不同的Cq范围组）和RAT的前瞻性（临床敏感性）数据，以RT-PCR为参考方法。第二篇论文将报告基于解剖采样位置的RAT结果。第三篇论文将通过RT-PCR测试比较不同的解剖采样位置。第四篇论文将重点关注依赖于中央实验室测试的RAT。来自4个不同制造商的测试将比较回顾性深口咽拭子样品的分析性能数据。第五篇论文将报告作为专业用途和自我测试应用的4种RAT的结果。最后一篇论文将报告研究中2次呼气测试的结果。将使用配对样品的McNemar测试和非配对样品的卡方测试进行RAT之间的灵敏度和特异性的比较。RAT之间的阳性预测值（PPV）和阴性预测值（NPV）的比较将通过Bootstrap测试进行，灵敏度为95%CI，特异性，PPV,净现值将以bootstrapCIs计算。
结论：该研究将比较大量RAT对SARS-CoV-2和RT-PCR的敏感性，并将探讨基于侧向流的RAT是否与基于实验室的RAT显着不同。还将比较RAT和RT-PCR的解剖测试位置。
背景：ClinicalTrials.govNCT04913116;https://clinicaltrials.gov/ct2/show/NCT04913116。
UNASSIGNED：DERR1-10.2196/35706。
