Performance evaluation of the Aptima CMV quant assay using plasma and non-plasma samples

Area of Science:

• Transplantation medicine
• Virology
• Molecular diagnostics

Background:

• Cytomegalovirus (CMV) infection significantly increases morbidity and mortality in transplant recipients.
• Molecular testing is the gold standard for monitoring CMV post-transplantation.

Purpose of the Study:

• To compare the analytical and clinical performance of the Aptima CMV Quant Assay on the Panther system against the ELITech MGB Alert® CMV 3.0 ASR on the ELITe InGenius® system.
• To evaluate the accuracy and sensitivity of CMV DNA quantification assays.

Main Methods:

• Analytical performance assessed using WHO-standardized CMV reference panels.
• Clinical performance evaluated with 249 plasma and non-plasma samples.
• Comparison of lower limit of detection (LOD), linearity, reproducibility, accuracy, and qualitative/quantitative concordance between two CMV assays.

Main Results:

• Aptima CMV assay exhibited a 95% LOD of 50 IU/mL, while MGB CMV assay had an LOD of 200 IU/mL.
• Both assays showed strong linearity (R²=0.9945) and accuracy (R²=0.986) with reference panels.
• The MGB CMV assay quantified CMV DNA approximately 0.5 Log IU/mL higher than the Aptima CMV assay, with minimal discordant results (6.8%) near the limit of quantification.

Conclusions:

• The Aptima CMV assay is a sensitive and accurate method for quantifying CMV DNA in both plasma and non-plasma specimens.
• The Aptima CMV assay performs well on the fully automated Panther system for post-transplant CMV monitoring.