Leal Sixto M, Totten Arthur H, Xiao Li, Crabb Donna M, Ratliff Amy, Duffy Lynn B, Fowler Karen B, Mixon Emily, Winchell Jonas M, Diaz Maureen H, Benitez Alvaro J, Wolff Bernard J, Qin Xuan, Tang Y-W, Gonzalez Mark, Selvarangan Raj, Hong Tao, Brooks Edward, Dallas Steve, Atkinson T Prescott, Zheng Xiaotian, Dien Bard Jennifer, Waites Ken B
Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.
J Clin Microbiol. 2020 May 26;58(6). doi: 10.1128/JCM.00242-20.
We evaluated six commercial molecular tests targeting , namely, the BioFire FilmArray respiratory panel (RP), the Meridian Alethia Mycoplasma Direct, the GenMark ePlex respiratory pathogen panel (RPP), the Luminex NxTAG RPP, the ELITech ELITe InGenius MGB research use only (RUO) PCR, and the SpeeDx MP assays. Laboratory-developed PCR assays at the University of Alabama at Birmingham and the Centers for Disease Control and Prevention were used as reference standards. Among 428 specimens, 212 were designated confirmed positives for The highest clinical sensitivities were found with the InGenius PCR (99.5%) and the FilmArray RP (98.1%). The MP identified 93.3% of the confirmed-positive specimens, whereas 83.6, 64.6, and 55.7% were identified by the ePlex RPP, NxTAG RPP, and Mycoplasma Direct assays, respectively. There was no significant difference between the sensitivity of the reference methods and that of the FilmArray RP and InGenius assays, but the remaining four assays detected significantly fewer positive specimens ( < 0.05). Specificities of all assays were 99.5 to 100%. The MP assay detected macrolide resistance in 27/33 specimens, resulting in a sensitivity of 81.8%. This study provides the first large-scale comparison of commercial molecular assays for detection of in the United States and identified clear differences among their performance. Additional studies are necessary to explore the impact of various test performances on patient outcome.
我们评估了六种针对[具体病原体名称未给出]的商用分子检测方法，即BioFire FilmArray呼吸道检测板（RP）、Meridian Alethia支原体直接检测法、GenMark ePlex呼吸道病原体检测板（RPP）、Luminex NxTAG RPP、ELITech ELITe InGenius MGB仅供研究使用（RUO）的PCR以及SpeeDx MP检测法。阿拉巴马大学伯明翰分校和疾病控制与预防中心研发的实验室PCR检测法用作参考标准。在428份标本中，212份被指定为[具体病原体名称未给出]的确诊阳性标本。InGenius PCR（99.5%）和FilmArray RP（98.1%）的临床敏感性最高。MP检测法识别出93.3%的确诊阳性标本，而ePlex RPP、NxTAG RPP和支原体直接检测法分别识别出83.6%、64.6%和55.7%的确诊阳性标本。参考方法与FilmArray RP和InGenius检测法的敏感性之间无显著差异，但其余四种检测法检测到的阳性标本明显较少（P<0.05）。所有检测法的特异性为99.5%至100%。MP检测法在33份标本中检测出27份对大环内酯类耐药，敏感性为81.8%。本研究首次在美国对检测[具体病原体名称未给出]的商用分子检测法进行了大规模比较，并明确了它们性能之间的差异。有必要进行更多研究以探讨各种检测性能对患者预后的影响。
