Molecular diagnosis of Cytomegalovirus infection: clinical performance of the Aptima transcription-mediated amplification assay toward conventional qPCR chemistry on whole blood samples

• DOI: 10.1128/jcm.00906-23
• Publication Date: 2024-02-13T14:01:02Z
• Authors: Paolo Bottino; Lisa Pastrone; Elisa Zanotto; Francesca Sidoti; Rossana Cavallo; Cristina Costa
• Keywords: Cytomegalovirus

ABSTRACT Human Cytomegalovirus (HCMV) infection is life-threatening for immunocompromised patients. Quantitative molecular assays on whole blood or plasma are the gold standard diagnosis of invasive HCMV and monitoring antiviral treatment in individuals at risk disease. For these reasons, an accurate standardization toward WHO 1st International Standard among different centers diagnostic kits represents effort better clinical management HCMV-positive Herein, we evaluate, first time, performance a new transcription-mediated amplification (TMA) assay versus quantitative polymerase chain reaction (qPCR) chemistry, used as routine method, samples. A total 755 specimens were collected tested simultaneously with TMA qPCR assays. The data showed qualitative agreement 99.27% positive quantified samples 89.39% those undetected between two methods. Evaluation viremia highlighted good correlation chemistries terms Units (ΔLog 10 IU/mL: −0.29 ± 0.40). significant patients monitored up to 3 months, thus allowing assessment transplant Therefore, chemistry testing, current routine. It also offers important advantages, such FDA approval In Vitro Diagnostic (IVD) both blood, automated workflow minimal hands-on random access loading, enabling rapid reliable HCMV-infected IMPORTANCE this paper, describe novel detection quantification human DNA from This pivotal analysis [transplanted, HIV-positive, Hematopoietic Stem Cell (HSC) recipients], tests high sensitivity specificity necessary evaluate viral load To our knowledge, in-depth evaluation Moreover, technical aspects make it suitable diagnostics.