Multi-site performance evaluation of the Alinity m Molecular assay for quantifying Epstein-Barr virus DNA in plasma samples.

Autor:	Wessels E; Leiden University Medical Center , Leiden, the Netherlands., Albert E; Hospital Clinico Universitario de Valencia , Valencia, Spain., Vreeswijk T; Leiden University Medical Center , Leiden, the Netherlands., Claas ECJ; Leiden University Medical Center , Leiden, the Netherlands., Giménez E; Hospital Clinico Universitario de Valencia , Valencia, Spain., Reinhardt B; Abbott GmbH , Wiesbaden, Germany., Sasaki MM; Abbott Molecular Inc. , Des Plaines, Illinois, USA., Navarro D; Hospital Clinico Universitario de Valencia , Valencia, Spain.
Jazyk:	angličtina
Zdroj:	Journal of clinical microbiology [J Clin Microbiol] 2023 Oct 24; Vol. 61 (10), pp. e0047223. Date of Electronic Publication: 2023 Sep 20.
DOI:	10.1128/jcm.00472-23
Abstrakt:	Detection and monitoring of acute infection or reactivation of Epstein-Barr virus (EBV) are critical for treatment decision-making and to reduce the risk of EBV-related malignancies and other associated diseases in immunocompromised individuals. The analytical and clinical performance of the Alinity m EBV assay was evaluated at two independent study sites; analytical performance was assessed by evaluating precision with a commercially available 5-member EBV verification panel, while the clinical performance of the Alinity m EBV assay was compared to the RealTi me EBV assay and a laboratory-developed test (LDT) as the routine test of record (TOR). Analytical analysis demonstrated standard deviation (SD) between 0.08 and 0.13 Log IU/mL. A total of 300 remnant plasma specimens were retested with the Alinity m EBV assay, and results were compared to those of the TOR at the respective study sites ( n = 148 with the RealTi m e EBV assay and n = 152 with the LDT EBV assay). Agreement between Alinity m EBV and RealTi m e EBV or LDT EBV assays had kappa values of 0.88 and 0.84, respectively, with correlation coefficients r of 0.956 and 0.912, while the corresponding observed mean bias was -0.02 and -0.19 Log IU/mL. The Alinity m EBV assay had a short median onboard turnaround time of 2:40 h. Thus, the Alinity m system can shorten the time to results and, therefore, to therapy. Competing Interests: E.A. received a travel grant from Abbott. B.R. is an employee of Abbott GmbH, Wiesbaden, Germany. M.M.S. is an employee of Abbott Molecular Inc., Des Plaines, IL, USA. D.N. received grant funding and conference fees from Abbott. E.C.J.C., E.G., E.W., and T.V. have no conflicts of interest to disclose. This study was funded by Abbott Laboratories.
Databáze:	MEDLINE
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