Diagnostic performance of the Sepsis qPCR MX-30® panel compared with conventional blood culture in pediatric febrile neutropenia: a single-center retrospective study.
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BACKGROUND: Febrile neutropenia (FN) is a frequent and potentially life-threatening complication in patients with hematologic malignancies. Prompt and accurate identification of bloodstream pathogens is essential to optimize antimicrobial therapy and improve outcomes. Although conventional blood culture (BC) remains the diagnostic gold standard, its limitations have led to increased interest in rapid molecular diagnostics such as real-time polymerase chain reaction (RT-qPCR). OBJECTIVE: This study aimed to evaluate the diagnostic performance of the Sepsis qPCR MX-30® panel in comparison to conventional blood culture in detecting causative pathogens during febrile neutropenia episodes in immunocompromised pediatric patients. METHODS: A retrospective analysis was conducted on 251 febrile neutropenia episodes in 80 children with hematologic disorders between February 2023 and November 2024. Blood samples for both BC and the Sepsis qPCR MX-30® panel were collected concurrently. The performance metrics of the qPCR panel were assessed by calculating sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), with BC as the reference. RESULTS: Of the 251 episodes, the qPCR panel detected pathogens in 54 episodes (21.5%), while BC confirmed infection in 45 episodes (17.9%). Overall accuracy was 68.5% (172/251 episodes with agreement on presence or absence of infection). Among the 10 episodes positive by both methods, pathogen-level concordance (same organism detected) was observed in 7 episodes (70%). The calculated sensitivity, specificity, PPV, and NPV of the qPCR panel were 22.2%, 78.6%, 18.5%, and 82.2%, respectively. Discordant results were frequent: 44 qPCR-positive cases were BC-negative, and 35 BC-positive cases were not detected by qPCR.Notably, the panel enabled early detection of several antimicrobial resistance genes and fungal pathogens not identified by culture. CONCLUSION: The Sepsis qPCR MX-30® panel offers a faster turnaround time than conventional blood cultures and may serve as a complementary diagnostic tool for early pathogen detection in febrile neutropenic children. However, due to its limited sensitivity and PPV, it cannot replace BC in clinical practice. Further studies are warranted to optimize assay design and clinical interpretation, especially in the context of PCR-positive but culture-negative findings. CLINICAL TRIAL: Not applicable.