Boukli Narjis, Flamand Claude, Chea Kim Lay, Heng Leangyi, Keo Seangmai, Sour Kimhoung, In Sophea, Chhim Panha, Chhor Bunthea, Kruy Lomor, Feenstra Jelena D M, Gandhi Manoj, Okafor Obiageli, Ulekliev Camilla, Auerswald Heidi, Horm Viseth Srey, Karlsson Erik A
Virology Unit, National Influenza Center, WHO H5 Regional reference Laboratory, World Health Organization COVID-19 Global Referral Laboratory, Institute Pasteur du Cambodge, Phnom Penh, Cambodia.
Epidemiology Unit, Institute Pasteur du Cambodge, Phnom Penh, Cambodia.
medRxiv. 2023 Jan 22:2023.01.19.23284806. doi: 10.1101/2023.01.19.23284806.
Molecular multiplex assays (MPAs) for simultaneous detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza and respiratory syncytial virus (RSV) in a single RT-PCR reaction reduce time and increase efficiency to identify multiple pathogens with overlapping clinical presentation but different treatments or public health implications.
Clinical performance of XpertXpress SARS-CoV-2/Flu/RSV (Cepheid, GX), TaqPath™ COVID-19, FluA/B, RSV Combo kit (Thermo Fisher Scientific, TP), and PowerChek™ SARS-CoV-2/Influenza A&B/RSV Multiplex RT-PCR kit II (KogeneBiotech, PC) was compared to individual Standards of Care (SoC). Thirteen isolates of SARS-CoV-2, human seasonal influenza, and avian influenza served to assess limit of detection (LoD). Then, positive and negative residual nasopharyngeal specimens, collected under public health surveillance and pandemic response served for evaluation. Subsequently, comparison of effectiveness was assessed.
The three MPAs confidently detect all lineages of SARS-CoV-2 and influenza viruses. MPA-LoDs vary from 1-2 Log10 differences from SoC depending on assay and strain. Clinical evaluation resulted in overall agreement between 97% and 100%, demonstrating a high accuracy to detect all targets. Existing differences in costs, testing burden and implementation constraints influence the choice in primary or community settings.
TP, PC and GX, reliably detect SARS-CoV-2, influenza and RSV simultaneously, with reduced time-to-results and simplified workflows. MPAs have the potential to enhancediagnostics, surveillance system, and epidemic response to drive policy on prevention and control of viral respiratory infections.
Viral respiratory infections represent a major burden globally, weighed down by the COVID-19 pandemic, and threatened by spillover of novel zoonotic influenza viruses. Since respiratory infections share clinical presentations, identification of the causing agent for patient care and public health measures requires laboratory testing for several pathogens, including potential zoonotic spillovers. Simultaneous detection of SARS-CoV-2, influenza, and RSV in a single RT-PCR accelerates time from sampling to diagnosis, preserve consumables, and streamline human resources to respond to other endemic or emerging pathogens. Multiplex assays have the potential to sustain and even expand surveillance systems, can utilize capacity/capability developed during the COVID-19 pandemic worldwide, thereby strengthening epidemic/pandemic preparedness, prevention, and response.
分子多重检测法（MPAs）可在单次逆转录聚合酶链反应（RT-PCR）中同时检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）、流感病毒和呼吸道合胞病毒（RSV），减少了检测时间，提高了识别具有重叠临床表现但治疗方法或公共卫生意义不同的多种病原体的效率。
将XpertXpress SARS-CoV-2/流感/RSV检测试剂（赛沛公司，GX）、TaqPath™ COVID-19、流感A/B、RSV组合试剂盒（赛默飞世尔科技公司，TP）和PowerChek™ SARS-CoV-2/甲型和乙型流感病毒/RSV多重逆转录聚合酶链反应试剂盒II（考格尼生物技术公司，PC）的临床性能与各自的标准护理方法（SoC）进行比较。使用13株SARS-CoV-2、人类季节性流感病毒和禽流感病毒分离株评估检测限（LoD）。然后，对在公共卫生监测和疫情应对期间收集的鼻咽标本的阳性和阴性剩余样本进行评估。随后，评估有效性的比较情况。
这三种分子多重检测法均可可靠地检测SARS-CoV-2和流感病毒的所有谱系。根据检测方法和毒株的不同，分子多重检测法的检测限与标准护理方法相比有1至2个对数10的差异。临床评估结果显示总体一致性在97%至100%之间，表明检测所有目标的准确性很高。成本、检测负担和实施限制方面的现有差异会影响在初级或社区环境中的选择。
TP、PC和GX检测试剂能够可靠地同时检测SARS-CoV-2、流感病毒和RSV，缩短了出结果时间，简化了工作流程。分子多重检测法有潜力加强诊断、监测系统和疫情应对，以推动有关病毒性呼吸道感染预防和控制的政策。
病毒性呼吸道感染是全球的一项主要负担，受到新冠疫情的重压，并受到新型人畜共患流感病毒溢出的威胁。由于呼吸道感染具有相同的临床表现，为了患者护理和公共卫生措施而识别致病病原体需要对包括潜在人畜共患溢出病毒在内的多种病原体进行实验室检测。在单次逆转录聚合酶链反应中同时检测SARS-CoV-2、流感病毒和RSV可加快从采样到诊断的时间，节省耗材，并优化人力资源以应对其他地方流行或新出现的病原体。多重检测法有潜力维持甚至扩大监测系统，可利用在全球新冠疫情期间发展起来的能力，从而加强疫情/大流行的防范、预防和应对。
