Köse Büsra, Schaumburg Frieder
Institute of Medical Microbiology, University Hospital Münster, Münster, Germany.
Microbiol Spectr. 2024 Aug 6;12(8):e0115324. doi: 10.1128/spectrum.01153-24. Epub 2024 Jul 11.
Seasonal increase of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza virus A/B (Flu A/B), and respiratory syncytial virus (RSV) require rapid diagnostic test methods for the management of respiratory tract infections. In this study, we compared the diagnostic accuracy of Savanna RVP4 (RVP4, QuidelOrtho) with Xpert Xpress Plus SARS-CoV-2/Flu/RSV (Xpert, Cepheid). Nasopharyngeal swabs from patients treated at a tertiary care hospital (Germany) were tested for SARS-CoV-2, Flu A/B, and RSV by RVP4 to assess diagnostic accuracy (reference standard: Xpert). The intra and inter assay precision of Ct-values was assessed by repeated test in triplicates (on day 1) and duplicates (days 2-3). All patients with a physician's order for a multiplex test for SARS-CoV-2, Flu, and RSV test were included. Duplicate swabs from the same patient, samples with a total volume ≤1 mL, or inappropriate shipment/storage were excluded. In total, 229 swabs were included between September 2023 and February 2024. The concordance between both tests was 96.5% (SARS-CoV-2), 98.7% (Flu A), and 99.6% (RSV). Flu B was not detected by both tests. The RVP4 test had a sensitivity of 85%-95% and a specificity of 100% for the detection of SARS-CoV-2, Flu A, and RSV. The intra and inter assay precision of Ct-values from RVP4 was 3% and 2% (SARS-CoV-2), 5% and 4% (Flu A), and 0% and 3% (RSV), respectively. The Savanna RVP4 has a favorable diagnostic accuracy for the detection of SARS-CoV-2, Flu A, and RSV.
We assessed the diagnostic accuracy of a new point-of-care test for the rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza virus A/B (Flu A/B), and respiratory syncytial virus (RSV). The new test has a concordance with the reference standard of 96.5% (SARS-CoV-2), 98.7% (Flu A), and 99.1% (RSV). The sensitivity of 85%-95% and specificity of 100% for the detection of SARS-CoV-2, Flu A, and RSV is comparable with similar nucleic acid amplification-based point of care tests but at lower costs.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）、甲型/乙型流感病毒（Flu A/B）和呼吸道合胞病毒（RSV）的季节性增加，需要快速诊断测试方法来管理呼吸道感染。在本研究中，我们比较了Savanna RVP4（RVP4，QuidelOrtho）与Xpert Xpress Plus SARS-CoV-2/Flu/RSV（Xpert，Cepheid）的诊断准确性。对一家三级护理医院（德国）治疗的患者的鼻咽拭子进行RVP4检测，以评估其对SARS-CoV-2、Flu A/B和RSV的诊断准确性（参考标准：Xpert）。通过一式三份重复检测（第1天）和一式两份重复检测（第2 - 3天）评估Ct值的批内和批间精密度。纳入所有有医生开具的SARS-CoV-2、流感和RSV多重检测医嘱的患者。排除同一患者的重复拭子、总体积≤1 mL的样本或运输/储存不当的样本。2023年9月至2024年2月期间共纳入229份拭子。两种检测方法之间的一致性在SARS-CoV-2方面为96.5%，在甲型流感方面为98.7%，在RSV方面为99.6%。两种检测方法均未检测到乙型流感。RVP4检测对SARS-CoV-2、甲型流感和RSV的检测灵敏度为85% - 9
