Chen L, Tian Y, Chen S, Liesenfeld O
Roche Molecular Systems , Marlborough 01752, MA, USA.
Medical and Scientific Affairs, Roche Molecular Systems , Pleasanton 94588, CA, USA.
Eur J Microbiol Immunol (Bp). 2015 Dec 4;5(4):236-45. doi: 10.1556/1886.2015.00046. eCollection 2015 Dec.
Rapid and accurate diagnosis of influenza is important for patient management and infection control. We determined the performance of the cobas(®) Influenza A/B assay, a rapid automated nucleic acid assay performed on the cobas(®) Liat System for qualitative detection of influenza A and influenza B from nasopharyngeal (NP) swab specimens. Retrospective frozen and prospectively collected NP swabs from patients with signs and symptoms of influenza collected in universal transport medium (UTM) were tested at multiple sites including CLIA-waived sites using the cobas® Influenza A/B assay. Results were compared to the Prodesse Pro-Flu+ assay and to viral culture. Compared to the Prodesse ProFlu+ Assay, sensitivities of the cobas(®) Influenza A/B assay for influenza A and B were 97.7 and 98.6%, respectively; specificity was 99.2 and 99.4%. Compared to viral culture, the cobas(®) Influenza A/B assay showed sensitivities of 97.5 and 96.9% for influenza virus A and B, respectively; specificities were 97.9% for both viruses. Polymerase chain reaction (PCR)/sequencing showed that the majority of viral culture negative but cobas(®) Influenza A/B positive results were true positive results, indicating that the cobas(®) Influenza A/B assay has higher sensitivity compared to viral culture. In conclusion, the excellent accuracy, rapid time to result, and remarkable ease of use make the cobas(®) Influenza A/B nucleic acid assay for use on the cobas(®) Liat System a highly suitable point-of-care solution for the management of patients with suspected influenza A and B infection.
快速准确地诊断流感对于患者管理和感染控制至关重要。我们测定了cobas®甲型/乙型流感检测法的性能，这是一种在cobas® Liat系统上进行的快速自动化核酸检测法，用于从鼻咽（NP）拭子标本中定性检测甲型流感和乙型流感。在包括CLIA豁免实验室在内的多个地点，使用cobas®甲型/乙型流感检测法对在通用运输培养基（UTM）中收集的、有流感症状和体征患者的回顾性冷冻及前瞻性收集的NP拭子进行检测。将结果与Prodesse Pro-Flu+检测法及病毒培养结果进行比较。与Prodesse ProFlu+检测法相比，cobas®甲型/乙型流感检测法对甲型和乙型流感的敏感性分别为97.7%和98.6%；特异性分别为99.2%和99.4%。与病毒培养相比，cobas®甲型/乙型流感检测法对甲型和乙型流感病毒的敏感性分别为97.5%和96.9%；两种病毒的特异性均为97.9%。聚合酶链反应（PCR）/测序表明，大多数病毒培养阴性但cobas®甲型/乙型流感检测法阳性的结果为真阳性结果，这表明cobas®甲型/乙型流感检测法与病毒培养相比具有更高的敏感性。总之，出色的准确性、快速出结果以及显著的易用性使得用于cobas® Liat系统的cobas®甲型/乙型流感核酸检测法成为管理疑似甲型和乙型流感感染患者的高度合适的即时检测解决方案。
