Abstract：
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.
摘要：
我们评估了SureScreen制造的三种不同的多重侧流测定的性能，提供流感结果的微利和Goldsite，呼吸道合胞病毒（RSV）和SARS-CoV-2。在2023年4月4日至10月20日期间，纳入了1646名6个月及以上到香港一家医院门诊部就诊的急性呼吸系统疾病症状或体征≥2例的患者。与PCR相比，所有三个多重测试的点估计对甲型流感和SARS-CoV-2的敏感性>80％，微利和Goldsite公司生产的检测RSV的灵敏度>84%。除SureScreen测试对甲型流感的特异性为86.2%(95%CI:83.9%至88.3%)外，所有三项测试的特异性均>97%。导致假阴性的风险更高。三种多重测试在高病毒载量患者中表现更好。
