Molecular versus serological diagnostics for CMV disease prediction in high-risk patients

Background: Human cytomegalovirus (CMV) infection can cause severe, life-threatening complications in immunocompromised transplant patients, immunodeficient individuals, and fetuses. Early prediction of CMV disease risk is essential for proper patient management and the prevention of long-term complications. This study highlights the superior importance of molecular over serological CMV testing for disease prediction in a selected group of 72 at-risk patients: 48 kidney transplant recipients, five neonates with abnormalities, nine pregnant women, and 10 HIV-positive patients. Methods: CMV DNA was detected using qualitative and/or quantitative PCR methods, and serological analysis was performed with chemiluminescent (CLIA) and immunofluorescent (ELFA) techniques to detect anti-CMV IgM and IgG. Results: 27.7% (20 of 72) of all suspected patients were CMV DNA positive: 14 of 48 suspected kidney transplant recipients, two of five neonates, and two of 10 HIV-positive patients. Among the 20 CMV DNA-positive patients, only 20% (4 of 20) tested positive for anti-CMV IgM: two neonates and two HIV-positive patients. Borderline and low-positive IgM results obtained by CLIA in five of 14 kidney transplant recipients were confirmed negative upon retesting with ELFA. Conclusion: None of the CMV DNA-positive kidney transplant recipients followed up were anti-CMV IgM positive, whereas 66.6% (4 of 6) of the CMV DNA-positive neonates and HIV-positive individuals were anti-CMV IgM positive. Proper clinical interpretation of CMV results, considering viral biology, host immunity, and patient risk group characteristics, is crucial for preventing organ rejection and congenital malformations, identifying the most effective treatments, and improving overall health in at-risk groups.