Diagnostic performance of GENEDIA W and ActiveXpress+ COVID-19 antigens tests among symptomatic individuals in Peru and The United Kingdom.
Diagnostic performance of GENEDIA W and ActiveXpress+ COVID-19 antigens tests among symptomatic individuals in Peru and The United Kingdom.
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DOI：
10.1371/journal.pone.0281925
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发表时间：
2023
期刊：
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
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作者：
为了生成关于COVID-19抗原快速诊断试验（Ag-RDT）准确性的独立性能数据，需要在多个研究中心进行前瞻性诊断评价研究，以评估其在不同临床环境中的性能。本报告描述了GENEDIA W COVID-19 Ag器械（绿色Cross Medical Science Corp.，韩国忠北）和ActiveXpress+ COVID-19完整检测试剂盒（英国爱丁堡遗传学有限公司），在秘鲁和英国的两个检测中心。从秘鲁利马初级护理点的456名有症状患者和英格兰利物浦COVID-19驾车通过测试点的610名有症状参与者中收集的鼻咽拭子通过Ag-RDT进行分析，并与RT-PCR进行比较。使用来自B.1.1.7谱系的临床SARS-CoV-2分离株的直接培养上清液的系列稀释液评估两种Ag-RDT的分析评价。GENEDIA品牌的总体敏感性和特异性分别为60.4% [95%CI 52.4-67.9%]和99.2% [95%CI 97.6-99.7%]; Active Xpress+的敏感性和特异性分别为66.2% [95%CI 54.0-76.5%]和99.6% [95%CI 97.9-99.9%]。两种Ag-RDT的分析检测限确定为5.0 x 102 pfu/ml，约等于1.0 x 104 gcn/ml。在两次评价期间，英国队列的中位Ct值均低于秘鲁队列。当按Ct分开时，两种Ag-RDT在Ct<20时具有最佳灵敏度（在秘鲁; 95% [95% CI 76.4-99.1%]和100.0% [95% CI 74.1-100.0%];在英国; GENDIA和ActiveXpress+分别为59.2% [95% CI 44.2-73.0%]和100.0% [95% CI 15.8-100.0%]）。虽然Genedia的总体临床灵敏度在两个队列中均不符合WHO快速免疫测定的最低性能要求，但ActiveXpress+在英国的小型队列中达到了这一要求。这项研究说明了在两个全球环境中的Ag-RDTs的比较性能，并考虑了不同的评价方法。
In order to generate independent performance data regarding accuracy of COVID-19 antigen-based rapid diagnostic tests (Ag-RDTs), prospective diagnostic evaluation studies across multiple sites are required to evaluate their performance in different clinical settings. This report describes the clinical evaluation the GENEDIA W COVID-19 Ag Device (Green Cross Medical Science Corp., Chungbuk, Korea) and the ActiveXpress+ COVID-19 Complete Testing Kit (Edinburgh Genetics Ltd, UK), in two testing sites Peru and the United Kingdom. Nasopharyngeal swabs collected from 456 symptomatic patients at primary points of care in Lima, Peru and 610 symptomatic participants at a COVID-19 Drive-Through testing site in Liverpool, England were analyzed by Ag-RDT and compared to RT-PCR. Analytical evaluation of both Ag-RDTs was assessed using serial dilutions of direct culture supernatant of a clinical SARS-CoV-2 isolate from the B.1.1.7 lineage. For GENEDIA brand, the values of overall sensitivity and specificity were 60.4% [95% CI 52.4–67.9%], and 99.2% [95% CI 97.6–99.7%] respectively; and for Active Xpress+ the overall values of sensitivity and specificity were 66.2% [95% CI 54.0–76.5%], and 99.6% [95% CI 97.9–99.9%] respectively. The analytical limit of detection was determined at 5.0 x 102 pfu/ml what equals to approximately 1.0 x 104 gcn/ml for both Ag-RDTs. The UK cohort had lower median Ct values compared to that of Peru during both evaluations. When split by Ct, both Ag-RDTs had optimum sensitivities at Ct<20 (in Peru; 95% [95% CI 76.4–99.1%] and 100.0% [95% CI 74.1–100.0%] and in the UK; 59.2% [95% CI 44.2–73.0%] and 100.0% [95% CI 15.8–100.0%], for the GENDIA and the ActiveXpress+, respectively). Whilst the overall clinical sensitivity of the Genedia did not meet WHO minimum performance requirements for rapid immunoassays in either cohort, the ActiveXpress+ did so for the small UK cohort. This study illustrates comparative performance of Ag-RDTs across two global settings and considers the different approaches in evaluation methods.
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