Miłosz Mateusz, Słota Michał, Jakubowski Jakub, Kwiatkowski Piotr, Kasperczyk Sławomir, Kozłowska Małgorzata, Pawłowska Barbara, Matuszek Patryk, Kuta Ewa
EUROIMMUN Poland Sp. z o.o., Wrocław, Poland.
ARKOP Sp. z o.o., Bukowno, Poland.
Cent Eur J Immunol. 2022;47(1):58-62. doi: 10.5114/ceji.2022.113992. Epub 2022 Feb 28.
In December 2019, the World Health Organization (WHO) reported that China had accumulated pneumonia of unclear etiology in Wuhan. According to WHO recommendations, in strictly defined situations, antigen tests can be implemented into the diagnostic algorithm to reduce the number of molecular tests performed and support the rapid identification and treatment of COVID-19 patients. According to WHO recommendations, the antigen test for diagnostic use should have a sensitivity of ≥ 80% and a specificity of ≥ 97% compared to molecular tests (NAAT). Based on the comparative analysis, the sensitivity and specificity of the SARS-CoV-2 Antigen ELISA test were determined concerning the RT-PCR reference method. The sensitivity of the SARS-CoV-2 Antigen ELISA was 100% (51/51) and the specificity was 98.84%. The obtained data demonstrate that the analyzed antigen test meets both the WHO and the Ministry of Health criteria.
2019年12月，世界卫生组织（WHO）报告称，中国武汉出现了多例病因不明的肺炎病例。根据WHO的建议，在严格定义的情况下，可以将抗原检测纳入诊断流程，以减少分子检测的数量，并支持对COVID-19患者的快速识别和治疗。根据WHO的建议，用于诊断的抗原检测与分子检测（核酸扩增检测）相比，灵敏度应≥80%，特异性应≥97%。基于对比分析，针对逆转录聚合酶链反应（RT-PCR）参考方法确定了新型冠状病毒抗原酶联免疫吸附测定（ELISA）检测的灵敏度和特异性。新型冠状病毒抗原ELISA检测的灵敏度为100%（51/51），特异性为98.84%。所得数据表明，所分析的抗原检测符合WHO和卫生部的标准。
