Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis

Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis
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DOI:
10.1016/j.jcv.2020.104455
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发表时间:
2020-08-01
影响因子:
8.8
通讯作者:
Rodriguez-Villalobos, Hector
Rodriguez-Villalobos, Hector
中科院分区:
医学3区
文献类型:
--
作者:
Scohy, Anais;Anantharajah, Ahalieyah;Rodriguez-Villalobos, Hector

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背景:确保准确诊断对于限制SARS-CoV-2的传播和COVID-19的临床管理至关重要。尽管实时逆转录聚合酶链反应(RT-qPCR)是目前推荐的诊断SARS-CoV-2急性感染的实验室方法,但需要特殊设备和熟练工作人员等因素限制了这些耗时的分子技术的使用。最近,几个易于执行的快速抗原检测测试被开发出来,并在一些国家推荐作为一线diagnosis.Objectives:本研究的目的是评估的Coris COVID-19 Ag Respi-Strip测试,一种快速免疫层析检测SARS-CoV-2抗原,与RT-qPCR相比的性能。在106份阳性RT-qPCR样本中,32份通过快速抗原检测检出,总体灵敏度为30.2%。结论:较高的病毒载量与较好的抗原检出率相关。不幸的是,COVID-19 Ag Respi-Strip的整体灵敏度较差,不允许将其单独用作COVID-19诊断的一线检测。
Background: Ensuring accurate diagnosis is essential to limit the spread of SARS-CoV-2 and for the clinical management of COVID-19. Although real-time reverse transcription polymerase chain reaction (RT- qPCR) is the current recommended laboratory method to diagnose SARS-CoV-2 acute infection, several factors such as requirement of special equipment and skilled staff limit the use of these time-consuming molecular techniques. Recently, several easy to perform rapid antigen detection tests were developed and recommended in some countries as the first line of diagnostic.Objectives: The aim of this study was to evaluate the performances of the Coris COVID-19 Ag Respi-Strip test, a rapid immunochromatographic test for the detection of SARS-CoV-2 antigen, in comparison to RT-qPCR.Results: 148 nasopharyngeal swabs were tested. Amongst the 106 positive RT-qPCR samples, 32 were detected by the rapid antigen test, given an overall sensitivity of 30.2%. All the samples detected positive with the antigen rapid test were also positive with RT-qPCR.Conclusions: Higher viral loads are associated with better antigen detection rates. Unfortunately, the overall poor sensitivity of the COVID-19 Ag Respi-Strip does not allow using it alone as the frontline testing for COVID-19 diagnosis.