Mboumba Bouassa Ralph-Sydney, Lukumbisa Sarah, Bélec Laurent
Ecole Doctorale Régionale (EDR) d'Afrique Centrale en Infectiologie Tropicale, Franceville BP 876, Gabon.
Institut du Savoir Montfort, Montfort Hospital, Ottawa, ON K1K 0T2, Canada.
Diagnostics (Basel). 2025 Sep 5;15(17):2249. doi: 10.3390/diagnostics15172249.
The concurrent circulation of SARS-CoV-2 with influenza A and B viruses and respiratory syncytial virus (RSV) represents a new diagnostic challenge in the post-COVID-19 area, especially considering that these infections have overlapping clinical presentations but different approaches to treatment and management. Multiplexed molecular testing on point-of-care platforms that focus on the simultaneous detection of multiple respiratory viruses in a single tube constitutes a useful approach for diagnosis of respiratory infections in decentralized clinical settings. This study evaluated the analytical performances of the VitaSIRO ™ SARS-CoV-2/Flu/RSV Assay performed on the VitaSIRO ™ Instrument (Credo Diagnostics Biomedical Pte. Ltd., Singapore, Republic of Singapore). With a view to accreditation, the criteria of the 2022-revised EN ISO 15189:2022 norma were applied for the retrospective on-site verification of method using anonymized respiratory specimens collected during the last 2024-2025 autumn-winter season in France. Usability and satisfaction were comparable to current reference point-of-care platforms, such as the Cepheid GeneXpert Xpress System (Cepheid Diagnostics, Sunnyvale, CA, USA). Repeatability and reproducibility (2.34-4.49% and 2.78-5.71%, respectively) demonstrated a high level of precision. The platform exhibited a low invalid rate (2.9%), with most resolving on retesting. Analytical performance on 301 clinical samples showed high overall sensitivities: 94.8% for SARS-CoV-2 (Ct ≤ 33), 95.8% for influenza A and B viruses, 95.2% for RSV, and 95.4% for all viruses. Specificities were consistently high (99.2-100.0%). False negatives (2.6%) were predominantly associated with high Ct values. Agreement with the comparator reference NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Assay (Qiagen GmbH, Hilden, Germany) was almost perfect (Cohen's κ 0.939-0.974), and a total of 91.1%, 94.8%, and 100.0% of Ct values were within the 95% limits of agreement for the detection of SARS-CoV-2, influenza A and B viruses, and RSV, respectively, by Bland-Altman analyses. Passing-Bablok regression analyses demonstrated good Ct values correlation between VitaSIRO ™ and NeuMoDx™ assays, with a slight, non-significant, positive bias for the VitaSIRO ™ assay (mean absolute bias +0.509 to +0.898). These findings support VitaSIRO ™ Instrument as a user-friendly and reliable point-of-care platform for the rapid detection and differentiation of SARS-CoV-2, influenza A and B viruses, and RSV responding to the EN ISO 15189:2022 criteria for accreditation to be implemented in hospital or decentralized settings.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）与甲型和乙型流感病毒以及呼吸道合胞病毒（RSV）同时传播，这在新冠疫情后时代带来了新的诊断挑战，尤其是考虑到这些感染具有重叠的临床表现，但治疗和管理方法不同。即时检验平台上的多重分子检测专注于在单个试管中同时检测多种呼吸道病毒，这是在分散的临床环境中诊断呼吸道感染的一种有用方法。本研究评估了在VitaSIRO™仪器（新加坡共和国新加坡Credo Diagnostics Biomedical Pte. Ltd.）上进行的VitaSIRO™ SARS-CoV-2/流感/RSV检测的分析性能。为了获得认可，采用了2022年修订的EN ISO 15189:2022标准的标准，对2024 - 2025年法国上一个秋冬季节收集的匿名呼吸道标本进行方法的回顾性现场验证。可用性和满意度与当前的即时检验参考平台相当，如赛沛GeneXpert Xpress系统（美国加利福尼亚州森尼韦尔市赛沛诊断公司）。重复性和再现性（分别为2.34 - 4.49%和2.78 - 5.71%）显示出高精度水平。该平台的无效率较低（2.9%），大多数在重新检测后得到解决。对301份临床样本的分析性能显示总体敏感性较高：SARS-CoV-2为94.8%（Ct≤33），甲型和乙型流感病毒为95.8%，RSV为95.2%，所有病毒为95.4%。特异性一直很高（99.2 - 100.0%）。假阴性（2.6%）主要与高Ct值相关。与比较参考的NeuMoDx™流感A - B/RSV/SARS-CoV-2 Vantage检测（德国希尔德市Qiagen GmbH）的一致性几乎完美（科恩κ系数为0.939 - 0.974），通过布兰德 - 奥特曼分析，分别有91.1%、94.8%和100.0%的Ct值在检测SARS-CoV-2、甲型和乙型流感病毒以及RSV的95%一致性界限内。通过 - 巴布洛赫回归分析表明VitaSIRO™和NeuMoDx™检测之间的Ct值具有良好的相关性，VitaSIRO™检测存在轻微的、无统计学意义的正偏差（平均绝对偏差为 +0.509至 +0.898）。这些发现支持VitaSIRO™仪器作为一个用户友好且可靠的即时检验平台，用于快速检测和区分SARS-CoV-2、甲型和乙型流感病毒以及RSV，符合在医院或分散环境中实施的EN ISO 15189:2022认可标准。
