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Performance evaluation of the Aptima CMV quant assay using plasma and non-plasma samples by Amorce Lima; Vicki Healer; Laura Rowe; Suzane Silbert is a Medicine article available to read on EtoBox.

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Background Cytomegalovirus (CMV) infection has a major negative impact on transplantation and is associated with increased morbidity and mortality in this patient population. Quantitation of CMV infections using a molecular test is the preferred method for monitoring patients post-transplant. For this analysis, we compared the Aptima CMV Quant Assay (Aptima CMV) on the Panther system to the ELITech MGB Alert® CMV 3.0 ASR (MGB CMV) run on the ELITe InGenius®. Methods The analytical performance of the assay was assessed using commercially available CMV reference panels that meet the 1st WHO International Standard for Human Cytomegalovirus for nucleic acid amplification techniques. The clinical performance of the assay was determined using 249 plasma and non-plasma samples. Results The 95% LOD of the Aptima assay was determined to be 50 IU/mL and 200 IU/mL for the MGB CMV assay. A strong linear correlation with the reference panel (R2 = 0.9945), excellent reproducibility, and accuracy (R2 = 0.986) over the detection range of the assay was observed. Of the 249 clinical samples tested, only 17 (6.8%) yielded discordant results which were at or near the lower limit of quantification of t

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Author

Amorce Lima; Vicki Healer; Laura Rowe; Suzane Silbert

Publisher

Elsevier BV

Published

2023

Language

EN

Field

Medicine (Health Sciences)