Clinical utility of in-hospital qPCR for cytomegalovirus detection: a single-center analysis

Cytomegalovirus (CMV) reactivation is a major concern in immunocompromised patients. This study aimed to evaluate the clinical utility of in-hospital quantitative real-time polymerase chain reaction (qPCR) testing for CMV detection compared with the conventional antigenemia (AG) assay.

We analyzed 1327 tests performed on 274 patients between January 2022 and December 2023 at a single institution. CMV DNA levels were measured using the Cobas 6800 system, and the results were compared with those of the AG assay. Concordance rates between the two methods were assessed, and the correlation between CMV DNA levels and AG-positive cell counts was analyzed. Clinical case studies were also reviewed to evaluate longitudinal performance.

The number of qPCR tests increased steadily, with 71 % of the results available within one day and an average turnaround time of approximately 1.2 days. qPCR and AG concordance were evaluated in 326 tests, showing overall agreement rates of 68.7%-85.3%, depending on the positivity criteria. The positive agreement between qPCR and AG was 100 % when the detection threshold was set at a positive qPCR threshold ≥34.5 IU/mL or below the lower limit of quantification. A positive correlation was observed between the CMV DNA levels and AG-positive cell counts (Spearman r = 0.679).

In-hospital qPCR for CMV detection yielded rapid, reliable, and standardized results. These findings support its role as an essential diagnostic tool in hematological and transplant settings, where timely CMV monitoring is critical for patient management.