METHODS: This single-center prospective study evaluated one qualitative (ESP) and two quantitative (LUMI and LUMI-P) rapid antigen tests using AN and NP swabs. Symptomatic patients aged 20 years or older, who were considered eligible for reverse-transcription quantitative polymerase chain reaction using NP samples within 9 days of onset were recruited. Sensitivity, specificity, and positive and negative concordance rates between AN and NP samples were assessed for the rapid antigen tests. We investigated the characteristics that affected the concordance between AN and NP sampling results.
RESULTS: A total of 128 cases were recruited, including 28 positive samples and 96 negative samples. The sensitivity and specificity of AN samples using ESP were 0.81 and 1.00, while those of NP samples were 0.94 and 1.00. The sensitivity of AN and NP samples was 0.91 and 0.97, respectively, and specificity was 1.00, for both LUMI and LUMI-P. The positive concordance rates of AN to NP sampling were 0.87, 0.94, and 0.85 for ESP, LUMI, and LUMI-P, respectively. No factor had a significant effect on the concordance between the sampling methods.
CONCLUSIONS: ESP, LUMI, and LUMI-P showed practical diagnostic accuracy for AN sampling compared to NP sampling. There was no significant factor affecting the concordance between AN and NP sampling for these rapid antigen tests.
方法:这项单中心前瞻性研究使用AN和NP拭子评估了一项定性(ESP)和两项定量(LUMI和LUMI-P)快速抗原测试。20岁或以上的症状患者,我们招募了在发病后9天内被认为符合使用NP样本进行逆转录定量聚合酶链反应的人.灵敏度,特异性,并评估了AN和NP样品之间的阳性和阴性一致率,以进行快速抗原测试。我们调查了影响AN和NP采样结果一致性的特征。
结果:共招募了128例,包括28个阳性样本和96个阴性样本。使用ESP的AN样品的敏感性和特异性分别为0.81和1.00,而NP样品的敏感性和特异性分别为0.94和1.00。AN和NP样品的灵敏度分别为0.91和0.97,对于LUMI和LUMI-P,特异性为1.00。ESP的AN与NP采样的阳性一致率分别为0.87、0.94和0.85。LUMI,和LUMI-P,分别。没有因素对采样方法之间的一致性有显着影响。
结论:ESP,LUMI,与NP采样相比,LUMI-P显示了AN采样的实际诊断准确性。对于这些快速抗原测试,没有影响AN和NP采样之间一致性的重要因素。