Multicenter performance evaluation of the Alinity m CMV assay for quantifying cytomegalovirus DNA in plasma samples

Author:

Lee Miae1ORCID,Albert Eliseo2,Wessels Els3,Kim Soo-Kyung1,Chung Hae-Sun1,Giménez Estela2,Vreeswijk Tom3,Claas Eric C. J.3,Tai Yan Chin4ORCID,Reinhardt Birgit5ORCID,Sasaki Mark M.6,Navarro David2

Affiliation:

1. Ewha Womans University College of Medicine , Seoul, Republic of Korea

2. Hospital Clinico Universitario de Valencia , Valencia, Spain

3. Leiden University Medical Center , Leiden, the Netherlands

4. Abbott Laboratories (Singapore) Pte. Ltd. , Singapore

5. Abbott GmbH , Wiesbaden, Germany

6. Abbott Molecular Inc. , Des Plaines, Illinois, USA

Abstract

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 RealTi m e 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 RealTi m e CMV and n = 153 with LDT CMV). The Alinity m CMV assay had excellent correlation (correlation coefficient r ≥0.942) in comparison to the RealTi m e 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.

Funder

Abbott Laboratories

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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