A-375 Fast-Track Sepsis Detection: Genes2Me *Sepsis-Q* Direct Blood Test for 32 Pathogens in 120 Minutes

Background Sepsis detection has traditionally relied on time-consuming blood cultures, often delaying diagnosis and treatment despite being the gold standard.1-4 The Genes2Me Sepsis-Q Real-Time RT-PCR Kit offers a rapid and accurate solution by detecting 32 pathogens, including Gram-positive and Gram-negative bacteria, viruses, and fungi, directly from whole blood samples. Using multiplex real-time PCR technology across five fluorescence channels, the kit delivers results within 90 minutes, with a total turnaround time of approximately 2 hours. Optimized for two advanced platforms, Sepsis-Q meets diverse diagnostic needs, significantly reducing delays compared to traditional methods. Methods The Sepsis-Q Kit is optimized for two platforms:OnePCR POCT: A compact, sample-in-result-out platform designed for rapid, single-sample testing. This system uses a four-tube assay and five fluorescence detection channels to detect 20 high-priority pathogens, covering approximately 94% prevalence of sepsis-causing agents. Fully automated, OnePCR streamlines the entire workflow, from nucleic acid extraction to result generation, making it ideal for point-of-care settings requiring rapid decisions.Rapi-Q POCT with Rapi-X16: For high-throughput diagnostics, this system integrates the Rapi-X16 automated extraction unit, enabling simultaneous extraction of 1 to 16 samples. The Rapi-Q platform supports an eight-tube assay, ensuring the detection of all 32 sepsis pathogens and achieving comprehensive 100% prevalence coverage. This solution caters to laboratories and facilities requiring batch processing without compromising accuracy or efficiency. Both platforms utilize Genes2Me’s proprietary Direct Blood Kit, featuring specialized reagents like CellCrack Buffer and GeneErase Enzyme pathogen enrichment beads for efficient nucleic acid extraction directly from whole blood. By automating nucleic acid extraction, amplification, and detection, these systems provide precise, reproducible results with minimal manual intervention. Integrated with the OnePCR and Rapi-Q platforms, the Sepsis-Q kit revolutionizes sepsis diagnostics, delivering rapid, end-to-end solutions for timely and targeted therapeutic decisions. Its high sensitivity, robust performance, and user-friendly workflows significantly enhance patient outcomes and reduce sepsis-related mortality, setting a new standard for reliable sepsis detection in both point-of-care and high-throughput settings. Results The Sepsis-Q Kit demonstrated analytical sensitivity at 100 copies/reaction and achieved 100% specificity, with no cross-reactivity observed with pathogens such as Chlamydia pneumoniae and Mycoplasma pneumoniae. Interference testing with human DNA, hemoglobin, NaCl, and BSA confirmed no impact on assay performance. Precision testing showed CV < 2%, and the kit exhibited an overall accuracy of 98%. Conclusion The Sepsis-Q Real-Time RT-PCR Kit offers a reliable, rapid solution for sepsis detection, with high sensitivity and specificity. Its integration with OnePCR and Rapi-Q platforms provides end-to-end automation for both point-of-care and high-throughput settings, significantly improving diagnostic speed and enabling timely, targeted treatment, ultimately reducing sepsis-related mortality.