Ewha Womans University College of Medicine , Seoul, Republic of Korea.
Hospital Clinico Universitario de Valencia , Valencia, Spain.
J Clin Microbiol. 2023 Oct 24;61(10):e0041523. doi: 10.1128/jcm.00415-23. Epub 2023 Sep 20.
Monitoring of cytomegalovirus (CMV) viral load is critical for informing treatment decisions in order to prevent the severe health consequences of CMV infection or reactivation of latent CMV in immunocompromised individuals. This first field evaluation examined the analytical and clinical performance of the Alinity m CMV assay. Analytical performance was assessed with a commercially available six-member panel, while the clinical performance evaluation compared the Alinity m CMV assay to the RealTie CMV assay and a laboratory-developed test (LDT) as the test of record at three large hospital-based clinical laboratories. Precision of the Alinity m CMV assay was demonstrated with total standard deviation (SD) between 0.08 and 0.28 Log IU/mL. A total of 457 plasma specimens were tested on the Alinity m CMV assay and compared to the test of record at each site ( = 304 with RealTie CMV and = 153 with LDT CMV). The Alinity m CMV assay had excellent correlation (correlation coefficient ≥0.942) in comparison to the RealTie CMV or LDT CMV assays. The mean observed bias ranged from -0.03 to 0.34 Log IU/mL. Median onboard turnaround time of Alinity m CMV was less than 3 h. When the CMV assay is run on the Alinity m system, it has the capacity to shorten time to result and, therefore, to therapy.
巨细胞病毒 (CMV) 病毒载量监测对于指导治疗决策至关重要，以便预防 CMV 感染或潜伏 CMV 在免疫功能低下个体中重新激活的严重健康后果。这项首次现场评估检查了 Alinity m CMV 检测的分析和临床性能。分析性能使用市售的六成员面板进行评估，而临床性能评估将 Alinity m CMV 检测与 RealTie CMV 检测和实验室开发的检测 (LDT) 进行比较，LDT 作为三个大型基于医院的临床实验室的参考检测。Alinity m CMV 检测的精密度通过总标准偏差 (SD) 在 0.08 到 0.28 Log IU/mL 之间得到证明。总共在 Alinity m CMV 检测上测试了 457 份血浆标本，并与每个站点的参考检测进行了比较（= 304 份与 RealTie CMV 比较，= 153 份与 LDT CMV 比较）。与 RealTie CMV 或 LDT CMV 检测相比，Alinity m CMV 检测具有极好的相关性（相关系数≥0.942）。观察到的平均偏差范围从-0.03 到 0.34 Log IU/mL。Alinity m CMV 的 onboard 周转时间中位数小于 3 小时。当在 Alinity m 系统上运行 CMV 检测时，它有能力缩短结果时间，从而缩短治疗时间。
