Multicenter performance evaluation of the Alinity m CMV assay for quantifying cytomegalovirus DNA in plasma samples
- 주제(키워드) nucleic acid amplification test , DNA , immunocompromised , transplantation , high-throughput diagnostic assay
- 주제(기타) Microbiology
- 설명문(일반) [Lee, Miae; Kim, Soo-Kyung; Chung, Hae-Sun] Ewha Womans Univ, Coll Med, Dept Pediat, Ewha, South Korea; [Albert, Eliseo; Gimenez, Estela; Navarro, David] Hosp Clin Univ Valencia, Valencia, Spain; [Wessels, Els; Vreeswijk, Tom; Claas, Eric C. J.] Leiden Univ, Med Ctr, Leiden, Netherlands; [Tai, Yan Chin] Abbott Labs Singapore Pte Ltd, Singapore, Singapore; [Reinhardt, Birgit] Abbott GmbH, Wiesbaden, Germany; [Sasaki, Mark M.] Abbott Mol Inc, Des Plaines, IL USA
- 등재 SCIE, SCOPUS
- OA유형 hybrid
- 발행기관 AMER SOC MICROBIOLOGY
- 발행년도 2023
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000211618
- 본문언어 영어
- Published As https://doi.org/10.1128/jcm.00415-23
- PubMed 37728341
초록/요약
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.
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