Head-to-head comparison of anterior nares and nasopharyngeal swabs for SARS-CoV-2 antigen detection in a community drive-through test centre in the UK.
Rachel L Byrne, Ghaith Aljayyoussi, Konstantina Kontogianni, Karina Clerkin, Mathew McIntyre, Jahanara Wardale, Christopher T Williams, Richard Body, Emily R Adams, Margaretha de Vos, Camille Escadafal, Ana I Cubas Atienzar
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引用次数: 0
Abstract
Objective: To conduct a head-to-head diagnostic accuracy evaluation of anterior nares (AN) and nasopharyngeal (NP) swabs for SARS-CoV-2 antigen detection using two brands of rapid diagnostic tests (Ag-RDT).
Methods: Two prospective diagnostic evaluations were carried out at different time points and participant cohorts to evaluate the performance of paired AN and NP swabs in two Ag-RDT brands: Sure-Status (PMC, India) and Biocredit (RapiGEN, South Korea). The sensitivity and specificity of AN and NP swabs for each of the index test cohorts were calculated against the reverse transcription quantitative PCR (RT-qPCR) TaqPath COVID-19 (ThermoFisher, UK) using NP swabs as reference standard.
Results: A total of 372 participants were recruited for the Sure-Status cohort and 232 for the Biocredit, of which 119 (32.1%) and 122 (53.7%) were SARS-CoV-2 positive by RT-qPCR, respectively. Sensitivity and specificity of AN swabs were equivalent to those obtained with NP swabs in both cohorts: 83.9% (95% CI 76.0-90.0) and 98.8% (95% CI 96.6-9.8) using NP swabs and 85.6% (95% CI 77.1-91.4) and 99.2% (95% CI 97.1-99.9) with AN swabs for Sure-Status and; 81.2% (95% CI 73.1-87.7) and 99.0% (95% CI 94.7-86.5) with NP swabs and 79.5% (95% CI 71.3-86.3) and 100% (95% CI 96.5-100) with AN swabs for Biocredit. The agreement of the AN and NP swabs was high for both brands with an inter-rater reliability (κ) of 0.918 and 0.833 for Sure-Status and Biocredit, respectively. The overall 50% limits of detection (LoD50) and 95% LoD (LoD95) were 0.9-2.4×104 and 3.0-3.2×108 RNA copies/mL for NP swabs and 0.3-1.1×105 and 0.7-7.9×107 RNA copies/mL for AN swabs, with no significant difference in LoD for any of the swab types or test brands.
Conclusions: The diagnostic accuracy of the two SARS-CoV-2 Ag-RDT brands evaluated in this study was equivalent using AN swabs than NP swabs. However, test line intensity was lower when using AN swabs, which could negatively influence the interpretation of the Ag-RDT results by lay users.
目的：对两种品牌的快速诊断检测试剂盒（Ag-RDT）对鼻腔（AN）和鼻咽（NP）拭子检测SARS-CoV-2抗原进行从头到尾的诊断准确性评估。方法：在不同的时间点和参与者队列中进行两项前瞻性诊断评估，以评估两种Ag-RDT品牌：Sure-Status （PMC，印度）和Biocredit （RapiGEN，韩国）配对AN和NP拭子的性能。以NP拭子作为参考标准，对照逆转录定量PCR (RT-qPCR) TaqPath COVID-19 （ThermoFisher， UK）计算AN和NP拭子对每个指标测试队列的敏感性和特异性。结果：Sure-Status队列共招募372名参与者，Biocredit队列共招募232名参与者，其中RT-qPCR检测SARS-CoV-2阳性的参与者分别为119名（32.1%）和122名（53.7%）。在两个队列中，AN拭子的敏感性和特异性与NP拭子相同：使用NP拭子的敏感性和特异性分别为83.9% （95% CI 76.0-90.0）和98.8% (95% CI 96.6-9.8)，使用AN拭子进行确定状态和；使用NP拭子的为81.2% （95% CI 73.1-87.7）和99.0% (95% CI 94.7-86.5)，使用AN拭子的为79.5% （95% CI 71.3-86.3）和100% （95% CI 96.5-100）。两个品牌的AN和NP拭子的一致性都很高，Sure-Status和Biocredit的评分间信度（κ）分别为0.918和0.833。NP拭子的50%检出限（LoD50）和95%检出限（LoD95）分别为0.9-2.4×104和3.0-3.2×108 RNA拷贝数/mL， AN拭子的0.3-1.1×105和0.7-7.9×107 RNA拷贝数/mL，不同拭子类型或检测品牌的LoD无显著差异。结论：本研究评估的两种SARS-CoV-2 Ag-RDT标记的诊断准确性使用AN拭子与NP拭子相当。然而，当使用AN拭子时，测试线强度较低，这可能会对非专业用户对Ag-RDT结果的解释产生负面影响。试验注册号：NCT04408170。
期刊介绍：
BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.
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