The Rapid Antigen Detection Test for SARS-CoV-2 Underestimates the Identification of COVID-19 Positive Cases and Compromises the Diagnosis of the SARS-CoV-2 (K417N/T, E484K, and N501Y) Variants.

The Rapid Antigen Detection Test for SARS-CoV-2 Underestimates the Identification of COVID-19 Positive Cases and Compromises the Diagnosis of the SARS-CoV-2 (K417N/T, E484K, and N501Y) Variants.
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SARS-COV-2的快速抗原检测试验低估了COVID-19阳性病例的鉴定,并损害了SARS-COV-2(K417N/T,E484K和N501Y)变体的诊断。

DOI:
10.3389/fpubh.2021.780801
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发表时间:
2021
影响因子:
5.2
通讯作者:
Sandino AM
Sandino AM
中科院分区:
医学3区
文献类型:
--
作者:
Barrera-Avalos C;Luraschi R;Vallejos-Vidal E;Mella-Torres A;Hernández F;Figueroa M;Rioseco C;Valdés D;Imarai M;Acuña-Castillo C;Reyes-López FE;Sandino AM

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通过逆转录定量聚合酶链反应(RT-qPCR)及时检测冠状病毒2型引起的严重急性呼吸综合征(SARS-CoV-2)是当前大流行期间识别阳性病例的黄金策略。然而,更快和更便宜的方法也被应用于COVID-19的大规模诊断。因此,快速抗原测试(RAT)被广泛使用。然而,考虑到当前流行病背景下新病毒变体的传播,有必要评估其检测效率。在这项研究中,我们评估了在智利圣地亚哥广泛用于检测和SARS-CoV-2诊断的RAT(SD BIOLINE,韩国)的灵敏度和特异性。大鼠显示了90%(扩增范围为20 ≤ Cq <25)和10%(扩增范围为25 ≤ Cq <30)的阳性SARS-CoV-2病例先前通过RT-qPCR鉴定。重要的是,对于Cq值>30内的样品,获得0%检测。在SARS-CoV-2变异体检测中,RAT在RT-qPCR扩增范围20 ≤ Cq <25的样本中具有42.8%的检测灵敏度,所述样本含有与β或γ SARS-CoV-2变异体相关的单核苷酸多态性(SNP)K417 N/T、N501 Y和E484 K。这项研究提醒人们在大规模诊断水平上使用RAT时必须特别注意,特别是在目前出现几种新的SARS-CoV-2变体的情况下,这些变体可能产生假阴性和可能的病毒爆发的危害。
Timely detection of severe acute respiratory syndrome due to coronavirus 2 (SARS-CoV-2) by reverse transcription quantitative polymerase chain reaction (RT-qPCR) has been the gold- strategy for identifying positive cases during the current pandemic. However, faster and less expensive methodologies are also applied for the massive diagnosis of COVID-19. In this way, the rapid antigen test (RAT) is widely used. However, it is necessary to evaluate its detection efficiency considering the current pandemic context with the circulation of new viral variants. In this study, we evaluated the sensitivity and specificity of RAT (SD BIOSENSOR, South Korea), widely used for testing and SARS-CoV-2 diagnosis in Santiago of Chile. The RAT showed a 90% (amplification range of 20 ≤ Cq <25) and 10% (amplification range of 25 ≤ Cq <30) of positive SARS-CoV-2 cases identified previously by RT-qPCR. Importantly, a 0% detection was obtained for samples within a Cq value>30. In SARS-CoV-2 variant detection, RAT had a 42.8% detection sensitivity in samples with RT-qPCR amplification range 20 ≤ Cq <25 containing the single nucleotide polymorphisms (SNP) K417N/T, N501Y and E484K, associated with beta or gamma SARS-CoV-2 variants. This study alerts for the special attention that must be paid for the use of RAT at a massive diagnosis level, especially in the current scenario of appearance of several new SARS-CoV-2 variants which could generate false negatives and the compromise of possible viral outbreaks.
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