Desalegn Zelalem, Sebre Shemse, Yohannes Meron, Seman Aminu, Shiferaw Welelta, Ademe Muluneh, Biazin Habtamu, Firdawoke Ededia, Asemamaw Yehenew, Teka Brhanu, Teshome Seifegebriel, Amogne Wondwossen, Addissie Adamu, Gebrehiwot Yirgu, Kantelhardt Eva, Abebe Tamrat
Department of Microbiology, Immunology and Parasitology, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Department of Medical Laboratory Sciences, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Infect Drug Resist. 2022 Aug 6;15:4299-4305. doi: 10.2147/IDR.S353844. eCollection 2022.
When faced with a public health problem such as the COVID-19 pandemic, devising a test with an accurate and rapid diagnostic capacity is critical to contain the disease. We compared the diagnostic performance of a rapid antigen test in comparison with a reference method, namely a real-time polymerase chain reaction (RT-PCR) assay.
We enrolled patients with confirmed COVID-19 from two selected hospital in Addis Ababa, Ethiopia, between January and November 2021. We assessed the performance of the Standard Q COVID-19 Ag Kit (SD Biosensor, Republic of Korea) in 200 nasopharyngeal and nasal swab samples.
Out of the 200 samples utilized for the diagnostic performance evaluation, equal proportion of the samples were confirmed positive and negative for SARS-CoV-2 based on RT-PCR. Of the 100 confirmed positive cases, 95 showed positive results with the rapid antigen test, yielding a sensitivity of 95% (95% confidence interval [CI] 88.7-98.4%). Of the 100 confirmed negative cases, there were three false-positive results, yielding a specificity of 97% (95% CI 91.5-99.4%). The sensitivity of the rapid antigen test was higher for samples with an RT-PCR cycle threshold (Ct) value ≤25 compared with samples with a higher Ct value.
The finding demonstrated that the detection capacity of the Standard Q COVID-19 Ag Test meets the requirements set by the Ministry of Health Ethiopia. The high sensitivity and specificity of the test device indicate the possibility of using it for diagnostic and clinical purposes in resource-constrained settings such as Ethiopia.
面对新冠疫情这样的公共卫生问题时，设计一种具有准确快速诊断能力的检测方法对于控制疾病至关重要。我们将一种快速抗原检测的诊断性能与一种参考方法，即实时聚合酶链反应（RT-PCR）检测进行了比较。
2021年1月至11月期间，我们在埃塞俄比亚亚的斯亚贝巴的两家选定医院招募了新冠确诊患者。我们评估了标准Q新冠抗原检测试剂盒（SD生物传感器公司，韩国）在200份鼻咽拭子和鼻拭子样本中的性能。
在用于诊断性能评估的200份样本中，基于RT-PCR检测，确诊为新冠病毒阳性和阴性的样本比例相等。在100例确诊阳性病例中，95例快速抗原检测结果为阳性，灵敏度为95%（95%置信区间[CI]88.7-98.4%）。在100例确诊阴性病例中，有3例假阳性结果，特异性为97%（95%CI 91.5-99.4%）。与RT-PCR循环阈值（Ct）值较高的样本相比，快速抗原检测对Ct值≤25的样本灵敏度更高。
研究结果表明，标准Q新冠抗原检测的检测能力符合埃塞俄比亚卫生部设定的要求。该检测设备的高灵敏度和特异性表明，在埃塞俄比亚这样资源有限的环境中，有可能将其用于诊断和临床目的。
