Evaluation of the Alinity m CMV assay for detecting and quantifying cytomegalovirus DNA in non-plasma samples

• Published in: Journal of virological methods 2025-02, Vol.332, p.115069, Article 115069
• Main Authors: Scohy, Anaïs, Argudín, Maria A., Kabera, Florence, Olive, Nathalie, Kabamba Mukadi, Benoît
• Format: Article
• Language: English
• Subjects: Body Fluids - virology; Cytomegalovirus; Cytomegalovirus - genetics; Cytomegalovirus - isolation & purification; Cytomegalovirus Infections - diagnosis; Cytomegalovirus Infections - virology; DNA, Viral - blood; DNA, Viral - genetics; High-throughput molecular assay; Humans; Molecular Diagnostic Techniques - methods; Molecular Diagnostic Techniques - standards; Nucleic acid amplification test; Sensitivity and Specificity; Viral Load - methods
• ISSN: 0166-0934; 1879-0984; 1879-0984
• DOI: 10.1016/j.jviromet.2024.115069

CMV infection remains a well-recognized threat in immunocompromised patients and is a major cause of congenital infection. If plasma and whole blood are routinely used as clinical samples for detection of CMV infection and disease, CMV laboratory testing in non-blood samples is becoming more and more relevant to support the diagnosis, prognosis and management of CMV infection. Accurate CMV viral load assessment in various body fluids is therefore essential. We evaluated the performance of the Alinity m CMV assay for detecting and quantifying CMV in plasma, amniotic fluid, bronchoalveolar lavage, cerebrospinal fluid, saliva and urine. Using a commercially available CMV reference panel and CMV culture supernatant, we assessed the linearity and accuracy of the Alinity m CMV assay across the different sample types. Excellent linear correlations (r values > 0.98) and a good accuracy (bias < ± 0.50 Log10 IU/mL and SD < 0.23) were observed. In conclusion, the Alinity m CMV assay is suitable to detect and quantify CMV DNA in plasma but also in all non-plasma samples tested. Random and continuous access capabilities of the Alinity m enable rapid and efficient laboratory detection and quantification of CMV DNA. •CMV detection in non-plasma samples helps diagnosis and management of infections.•Alinity m CMV assay enables rapid and efficient quantification of CMV viral load.•Alinity m CMV assay is suitable to quantify CMV DNA in non-plasma samples.•No PCR inhibition was observed with different non-plasma samples.