Medoro Alessandro, Davinelli Sergio, Voccola Serena, Cardinale Gaetano, Passarella Daniela, Marziliano Nicola, Intrieri Mariano
Department of Medicine and Health Sciences "V. Tiberio", University of Molise, 86100 Campobasso, Italy.
Centro Diagnostico Delta S.r.l., Consorzio Sannio Tech, Apollosa, 82030 Benevento, Italy.
Diagnostics (Basel). 2022 May 21;12(5):1279. doi: 10.3390/diagnostics12051279.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant outbreaks have highlighted the need of antigen-detecting rapid diagnostic tests (Ag-RDTs) that can be used at the point-of-care (POC). Although many Ag-RDTs have been approved for SARS-CoV-2 detection, studies demonstrating the clinical performance of Ag-RDTs against variants of concern, especially the new Omicron variant, are limited. The aim of this study was to evaluate the diagnostic sensitivity and specificity of the AMAZING COVID-19 Antigen Sealing Tube Test Strip (Colloidal Gold) in 584 early symptomatic and asymptomatic participants (age range 0-90 years). The performance of this Ag-RDT was assessed by comparing its results with reverse transcription RT-PCR (rRT-PCR). One hundred twenty positive samples were also analyzed with rRT-PCR to discriminate Omicron and Delta/Kappa variants (72.50% Omicron; 27.50% Delta/Kappa). Overall, the Ag-RDT showed high positive and negative percent values of 92.52% (95% CI, 86.61-95.95%) and 98.05% (95% CI, 96.41-98.95%), respectively, as well as an overall diagnostic accuracy of 96.92% (95% CI, 95.17-98.16%). Taken together, these data indicate that this inexpensive and simple-to-use Ag-RDT presents excellent analytical performance and can reliably detect Omicron and Delta/Kappa variants.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）变异株的爆发凸显了对可在现场即时检测（POC）使用的抗原检测快速诊断测试（Ag-RDT）的需求。尽管许多Ag-RDT已被批准用于SARS-CoV-2检测，但针对关注变异株，尤其是新型奥密克戎变异株的Ag-RDT临床性能研究有限。本研究的目的是评估AMAZING COVID-19抗原密封管测试条（胶体金法）在584名早期有症状和无症状参与者（年龄范围0至90岁）中的诊断敏感性和特异性。通过将该Ag-RDT的结果与逆转录RT-PCR（rRT-PCR）结果进行比较来评估其性能。还对120份阳性样本进行rRT-PCR分析以区分奥密克戎和德尔塔/卡帕变异株（72.50%为奥密克戎；27.50%为德尔塔/卡帕）。总体而言，该Ag-RDT的阳性和阴性百分比值分别为92.52%（95%CI，86.61 - 95.95%）和98.05%（95%CI，96.41 - 98.95%），总体诊断准确性为96.92%（95%CI，95.17 - 98.16%）。综上所述，这些数据表明这种廉价且易于使用的Ag-RDT具有出色的分析性能，并且能够可靠地检测奥密克戎和德尔塔/卡帕变异株。
