Elf Sonja, Auvinen Pauliina, Jahn Lisa, Liikonen Karoliina, Sjöblom Solveig, Saavalainen Päivi, Mäki Minna, Eboigbodin Kevin E
Research and Development, Orion Diagnostica Oy, P. O. BOX 83, FI-02101 Espoo, Finland.
Research and Development, Orion Diagnostica Oy, P. O. BOX 83, FI-02101 Espoo, Finland; Research Programs Unit, Immunobiology, and Haartman Institute, Department of Medical Genetics, University of Helsinki, FI-00014 Helsinki, Finland.
Diagn Microbiol Infect Dis. 2018 Sep;92(1):37-42. doi: 10.1016/j.diagmicrobio.2018.04.006. Epub 2018 Apr 18.
Isothermal nucleic acid amplification methods can potentially shorten the amount of time required to diagnose influenza. We developed and evaluated a novel isothermal nucleic acid amplification method, RT-SIBA to rapidly detect and differentiate between influenza A and B viruses in a single reaction tube. The performance of the RT-SIBA Influenza assay was compared with two established RT-PCR methods. The sensitivities of the RT-SIBA, RealStar RT-PCR, and CDC RT-PCR assays for the detection of influenza A and B viruses in the clinical specimens were 98.8%, 100%, and 89.3%, respectively. All three assays demonstrated a specificity of 100%. The average time to positive result was significantly shorter with the RT-SIBA Influenza assay (<20 min) than with the two RT-PCR assays (>90 min). The method can be run using battery-operated, portable devices with a small footprint and therefore has potential applications in both laboratory and near-patient settings.
等温核酸扩增方法有可能缩短诊断流感所需的时间。我们开发并评估了一种新型等温核酸扩增方法——RT-SIBA，可在单个反应管中快速检测并区分甲型和乙型流感病毒。将RT-SIBA流感检测方法的性能与两种既定的RT-PCR方法进行了比较。RT-SIBA、RealStar RT-PCR和CDC RT-PCR检测方法在临床标本中检测甲型和乙型流感病毒的灵敏度分别为98.8%、100%和89.3%。这三种检测方法的特异性均为100%。RT-SIBA流感检测方法获得阳性结果的平均时间（<20分钟）明显短于两种RT-PCR检测方法（>90分钟）。该方法可使用电池供电的便携式设备进行操作，占用空间小，因此在实验室和床旁检测环境中均具有潜在应用价值。
