Asif Shabana, Ahmed Aashi, Gul Ambreen, Abbasi Tariq
Department of Pathology, Margalla Hospital, Taxila.
Department of Biochemistry, HITEC Institute of Medical sciences (IMS, Taxila) NUMS, Rawalpindi.
J Ayub Med Coll Abbottabad. 2022 Oct-Dec;34(Suppl 1)(4):S928-S931. doi: 10.55519/JAMC-04-S4-10113.
Evidence on performance of Rapid Antigen Detection Tests to recognize SARS-CoV-2 symptomatic patients in our context is limited. This study was aimed to evaluate Panbio™ COVID-19 Ag Rapid Test Device (Abbott Diagnostics, Jena, Germany) in identifying SARS-CoV-2 infection in comparison with RT-PCR test.
This cross-sectional validation study was carried out at Margalla Hospital, Taxila from October, 2020 to March, 2021. Three hundred and eighty-two participants of both gender and all ages, symptomatic for 3-4 days were included in this study. For each participant, two nasopharyngeal swabs were collected by trained lab technicians according to SOPs, one for Rapid Antigen Test and other for RT-PCR.Covid-19 antibodies were checked 4-6 weeks after symptoms among 77 randomly selected participants to further evaluate the performance of Rapid Antigen Test. Data was analyzed using SPSS-26.
The mean age of the participants was 43.1 years (SD=15.9). More than half of participants were males (n=213%=55.8) and 169 (44.2%) were females. Sensitivity of Rapid Antigen Test was calculated to be 94.3%, whereas the specificity was 39.7%. Out of 34 RT-PCR negatives that were initially detected positive on Rapid Antigen Test, 33 demonstrated presence of COVID-19 antibodies.
Panbio™ COVID-19 Ag Rapid Test was found to have 93.4% overall sensitivity and relatively low overall specificity (37.9%). Rapid antigen testing using Panbio™ COVID-19 Ag Rapid Test Device can be effectively used to scale up mass testing to interrupt transmissibility of COVID-19 infection by generating quick result.
在我们的环境中，关于快速抗原检测试验识别有症状的新型冠状病毒肺炎患者的性能证据有限。本研究旨在评估Panbio™新冠病毒抗原快速检测试剂（德国耶拿雅培诊断公司）与逆转录聚合酶链反应（RT-PCR）检测相比，在识别新型冠状病毒感染方面的效果。
这项横断面验证研究于2020年10月至2021年3月在塔克西拉的马尔加拉医院进行。纳入了382名各年龄、性别的参与者，他们有3-4天的症状。对于每位参与者，经过培训的实验室技术人员按照标准操作规程采集两份鼻咽拭子，一份用于快速抗原检测，另一份用于RT-PCR检测。在77名随机选择的参与者出现症状4-6周后检测新冠病毒抗体，以进一步评估快速抗原检测的性能。使用SPSS-26软件进行数据分析。
参与者的平均年龄为43.1岁（标准差=15.9）。超过一半的参与者为男性（n=213，占55.8%），女性为169名（44.2%）。快速抗原检测的灵敏度计算为94.3%，而特异性为39.7%。在最初快速抗原检测呈阳性但RT-PCR检测为阴性的34例中，33例显示存在新冠病毒抗体。
发现Panbio™新冠病毒抗原快速检测的总体灵敏度为93.4%，总体特异性相对较低（37.9%）。使用Panbio™新冠病毒抗原快速检测试剂进行快速抗原检测可有效用于扩大大规模检测，通过快速得出结果来阻断新冠病毒感染的传播。
