Evaluation of Analytical Performance of Seven Rapid Antigen Detection Kits for Detection of SARS-CoV-2 Virus.
Evaluation of Analytical Performance of Seven Rapid Antigen Detection Kits for Detection of SARS-CoV-2 Virus.
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DOI：
10.2147/ijgm.s297762
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发表时间：
2021
影响因子：
2.3
通讯作者：
Beqaj S
中科院分区：
文献类型：
--
作者：
Eshghifar N;Busheri A;Shrestha R;Beqaj S
在无症状和有症状的患者中早期诊断2019年新型冠状病毒病（COVID-19）对于识别传染性个体并帮助防止病毒在社区中传播至关重要。已经开发了几种测定方法并在当今的临床实践中使用。这些检测试剂盒的分析和临床性能各不相同。为了准确诊断，医疗专业人员必须更加熟悉测试的实用性，以选择最合适的测试。本研究的目的是评价快速抗原检测用于检测SARS-CoV-2病毒抗原的分析性能相比，RT-PCR SARS-CoV-2分子检测。来自5名COVID-19患者的口咽拭子样本通过不同IVD公司开发的7种快速抗原检测进行了检测。采用RT-PCR检测SARS-CoV-2特异性RNA片段作为确证试验。这些标本中的循环阈值（Ct）值通常反映病毒载量，范围为15 - 35。对于分析评价，每个抗原试剂盒的浸提液加标不同浓度（4.6x104/mL至7.5x105/mL）的减毒ATCC病毒，并使用抗原检测试剂盒进行检测。在5份经RT-PCR确认为SARS-CoV-2阳性的标本中，只有1份标本经7种抗原检测试剂盒检测呈阳性。在Ct值为15的标本中观察到阳性结果。所有其他评价的快速检测试剂盒对所有5份阳性标本均呈阴性。使用ATCC减毒病毒的加标研究进一步证实了这一点，其中每个快速检测的浸提液加标浓度范围为4.6 × 104/mL至7.5 × 105/mL。这些加标标本均未显示阳性结果，表明这些抗原试剂盒的灵敏度非常低。这项比较研究表明，快速抗原检测的敏感性低于RT-PCR检测，并且对于检测无症状患者（通常携带低病毒载量）来说不是可靠的检测方法。在临床决策水平实施快速抗原检测之前，应全面评估其分析性能。
Early diagnosis of the novel coronavirus disease of 2019 (COVID-19) in asymptomatic and symptomatic patients is crucial to identify infectious individuals and to help prevent the spread of the virus in the community. Several assays have been developed and are in use in today’s clinical practice. These assays vary in their analytical and clinical performance. For an accurate diagnosis, medical professionals must become more familiar with the test’s utility to select the most appropriate test. This study aims to evaluate the analytical performance of rapid antigen tests used for the detection of SARS-CoV-2 viral antigen compared to RT-PCR SARS-CoV-2 molecular assay. Oropharyngeal swab specimens from five COVID-19 patients were tested by seven rapid antigen tests developed by different IVD companies. RT-PCR to detect specific RNA fragments of SARS-CoV-2 was used as a confirmatory test. The cycle threshold (Ct) value, which often reflects viral load, in these specimens ranged from 15 to 35. For the analytical evaluation, extraction fluid of each antigen kit was spiked with attenuated ATCC virus at different concentrations ranging from 4.6x104/mL to 7.5x105/mL and tested with antigen testing kits. Out of five confirmed positive SARS-CoV-2 specimens by RT-PCR, only one sample showed a positive result by one of the seven evaluated antigen testing kits. The positive result was observed in the specimen with a Ct value of 15. All other evaluated rapid tests were negative for all five positive specimens. This was further confirmed with the spiking study using ATCC attenuated virus, where extraction fluid of each rapid test was spiked with concentrations ranging from 4.6x104/mL to 7.5x105/mL. None of these spiked specimens showed positive results, indicating very low sensitivity of these antigen kits. This comparison study shows that rapid antigen tests are less sensitive than RT-PCR tests and are not reliable tests for testing asymptomatic patients, who often carry low viral load. Analytical performance of rapid antigen tests should be thoroughly evaluated before implementing it at clinical decision level.