Badawy Eman R, Ezz El-Din Azza M, El Zohne Randa A
Department of Clinical Pathology, Faculty of Medicine, Assuit University, Egypt.
Egypt J Immunol. 2023 Jan;30(1):14-19.
The coronavirus disease 2019 (COVID-19) pandemic is our time's major global health crisis and the greatest health challenge. Reverse transcription-polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus (SARS-CoV-2) is the gold standard technique for diagnosis of symptomatic cases and asymptomatic carriers. By 2020, antigen rapid tests have been approved for use in Covid-19 testing by regulatory bodies all over the world owing to their benefits as they are rapid and cost effective. This work aimed to determine the diagnostic sensitivity and accuracy of the SARS-CoV-2 rapid antigen test in the detection of SARS-CoV-2 infection compared to RT-PCR data. The study included 111 symptomatic COVID-19 patients and 20 control subjects. Of the 111 study patients, 91 patients (81.98%) were positive by RT-PCR and 20 patients negative. The BIOZEK antigen COVID-19 Ag rapid test device was evaluated using sera from the 111 symptomatic COVID-19 patients. Of the 91 RT-PCR positive patients, 81 (90.1%) were positive by the antigen rapid diagnostic test (Ag-RDT). The control subjects were negative by both tests. The overall sensitivity, specificity, PPV, NPV, and accuracy of the Ag-RDT were 91.11%, 100%, 100%, 68.9%, and 91.8%, respectively and these increased as the level of viremia increased. In conclusion, the used Ag-RDT showed high sensitivity and accuracy for detecting of a SARS-CoV-2 infection, especially when the viral load was high. However, the test lacks sensitivity particularly in those with low viral load.
2019年冠状病毒病（COVID-19）大流行是我们这个时代主要的全球健康危机和最大的健康挑战。严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的逆转录聚合酶链反应（RT-PCR）检测是诊断有症状病例和无症状携带者的金标准技术。到2020年，由于抗原快速检测具有快速且经济高效的优点，已被世界各地的监管机构批准用于COVID-19检测。这项工作旨在确定与RT-PCR数据相比，SARS-CoV-2快速抗原检测在检测SARS-CoV-2感染中的诊断敏感性和准确性。该研究包括111名有症状的COVID-19患者和20名对照受试者。在111名研究患者中，91名患者（81.98%）RT-PCR检测呈阳性，20名患者呈阴性。使用111名有症状的COVID-19患者的血清对BIOZEK抗原COVID-19 Ag快速检测设备进行了评估。在91名RT-PCR阳性患者中，81名（90.1%）通过抗原快速诊断检测（Ag-RDT）呈阳性。对照受试者两项检测均为阴性。Ag-RDT的总体敏感性、特异性、阳性预测值、阴性预测值和准确性分别为91.11%、100%、100%、68.9%和91.8%，并且随着病毒血症水平的升高而增加。总之，所使用的Ag-RDT在检测SARS-CoV-2感染方面显示出高敏感性和准确性，尤其是在病毒载量高时。然而，该检测缺乏敏感性，特别是在病毒载量低的人群中。
