WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.
Infectious Disease Control and Vaccinations Unit, Department of Health Security, Finnish Institute for Health and Welfare, Mannerheimintie 166, 00300 Helsinki, Finland; Department of Public Health, Faculty of Medicine, University of Helsinki, Yliopistonkatu 4, 00100 Helsinki, Finland.
Diagn Microbiol Infect Dis. 2024 Sep;110(1):116421. doi: 10.1016/j.diagmicrobio.2024.116421. Epub 2024 Jul 4.
We assessed the performance of three different multiplex lateral flow assays manufactured by SureScreen, Microprofit and Goldsite which provide results for influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. Between 4 April and 20 October 2023, 1646 patients 6 months and older presenting to an outpatient department of a hospital in Hong Kong with ≥2 symptoms or signs of an acute respiratory illness were enrolled. The point estimates for all three multiplex tests had sensitivity >80% for influenza A and SARS-CoV-2 compared to PCR, and the tests manufactured by Microprofit and Goldsite had sensitivity >84% to detect RSV. Specificity was >97% for all three tests except for the SureScreen test which had specificity 86.2% (95% CI: 83.9% to 88.3%) for influenza A. Sensitivity was lower than reported by the manufacturers, resulting in a higher risk of false negatives. The three multiplex tests performed better in patients with high viral loads.
我们评估了 SureScreen、Microprofit 和 Goldsite 三家公司生产的三种不同的多重侧向流动检测试剂盒的性能,这些试剂盒可同时检测流感、呼吸道合胞病毒(RSV)和 SARS-CoV-2。2023 年 4 月 4 日至 10 月 20 日,我们招募了 1646 名 6 个月及以上、因≥2 种急性呼吸道疾病症状或体征而到香港一家医院门诊部就诊的患者。与 PCR 相比,这三种多重检测方法的点估计值对于流感 A 和 SARS-CoV-2 的敏感性均>80%,而 Microprofit 和 Goldsite 生产的检测方法对于 RSV 的敏感性>84%。除了对于流感 A 的特异性为 86.2%(95%CI:83.9% 至 88.3%)的 SureScreen 检测之外,所有三种检测的特异性均>97%。敏感性低于制造商报告的水平,导致假阴性的风险更高。在病毒载量较高的患者中,这三种多重检测方法的表现更好。