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

Journal of Clinical Microbiology, vol. 61, pp. e0041523

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.

Authors 12

1. Miae Lee

   Ewha Womans University

   Affiliation as printed

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

2. Eliseo Albert

   Hospital Clínico Universitario de Valencia

   Affiliation as printed

   Hospital Clinico Universitario de Valencia , Valencia, Spain

3. Els Wessels Aachen

   Leiden University Medical Center

   Affiliation as printed

   Leiden University Medical Center , Leiden, the Netherlands

4. Soo‐Kyung Kim

   Ewha Womans University

   Affiliation as printed

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

5. Hae‐Sun Chung

   Ewha Womans University

   Affiliation as printed

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

6. Estela Giménez

   Hospital Clínico Universitario de Valencia

   Affiliation as printed

   Hospital Clinico Universitario de Valencia , Valencia, Spain

7. Tom Vreeswijk Aachen

   Leiden University Medical Center

   Affiliation as printed

   Leiden University Medical Center , Leiden, the Netherlands

8. Eric C. J. Claas Aachen

   Leiden University Medical Center

   Affiliation as printed

   Leiden University Medical Center , Leiden, the Netherlands

9. Yan‐Chin Tai

   Abbott (Singapore)

   Affiliation as printed

   Abbott Laboratories (Singapore) Pte. Ltd. , Singapore

10. Birgit Reinhardt

    Abbott (Germany)

    Affiliation as printed

    Abbott GmbH , Wiesbaden, Germany

11. Mark M. Sasaki

    Abbott (United States)

    Affiliation as printed

    Abbott Molecular Inc. , Des Plaines, Illinois, USA

12. David Navarro

    Hospital Clínico Universitario de Valencia

    Affiliation as printed

    Hospital Clinico Universitario de Valencia , Valencia, Spain