Alinity m CMV Assay Delivers Precise, Rapid Viral Load Monitoring With Sub-3-Hour Turnaround
The first field evaluation of the Alinity m CMV assay across three hospital laboratories demonstrated excellent correlation with both the RealTime CMV assay and a laboratory-developed test (r >= 0.942), with total precision SD of 0.08-0.28 log IU/mL. Mean bias was minimal (up to 0.34 log IU/mL), and median onboard turnaround was under 3 hours. The automated platform can shorten time to result and optimise antiviral therapy decisions for immunocompromised transplant patients.
The original study
Multicenter performance evaluation of the Alinity m CMV assay for quantifying cytomegalovirus DNA in plasma samples.
- Authors
- Lee M, Albert E, Wessels E, Kim S-K, Chung H-S, Giménez E, et al.
- Journal
- Journal of clinical microbiology
- Type
- Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't
- PMID
- 37728341
Original abstract
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 RealTime 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 (n = 304 with RealTime CMV and n = 153 with LDT CMV). The Alinity m CMV assay had excellent correlation (correlation coefficient r ≥0.942) in comparison to the RealTime 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.