Evaluation of RealStar PCR leads to improved CMV diagnosis in immunocompromised patients, highlighting superior accuracy over reference test.
Abstract Cytomegalovirus (CMV) infections pose a significant risk to individuals with compromised immune systems, particularly those undergoing stem cell transplantation. This study aimed to evaluate a novel real-time PCR based DNA detection approach in whole blood samples with the aim of helping high-risk groups improve CMV diagnosis and therapy. The objective of the study was to validate the efficacy of the RealStar® CMV PCR quantification assay kit 1.0 to diagnose CMV infection. The assay identified CMV in 21 of the 35 blood samples and other infections in 14 samples. The reference Qiagen Artus CMV PCR test exhibited inferior accuracy compared to the RealStar® CMV PCR Kit 1.0. The assay demonstrated a repeatability of 2.14% and reproducibility of 1.29%. Blood components and non-CMV infections did not influence the analytical specificity, which remained at 100%. The test exhibited a detection limit of 265 IU/mL (95% CI: 255–372), which correlated with the reference method (r = 0.93). The RealStar® CMV PCR Kit 1.0 demonstrated strong linearity (R² = 0.95) and achieved 100% predictive value for detecting CMV DNA in blood samples from immunocompromised individuals.
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Shaheen et al. (2025) studied this question.
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