Clinical Scorecard: Evaluation of the Agata Sepsis® Platform for Molecular Diagnosis of Sepsis in Hospitalized Patients
At a Glance
Category
Detail
Condition
Sepsis, a systemic inflammatory response syndrome caused by bacterial, fungal, or viral bloodstream infections leading to metabolic and immune disruption.
Key Mechanisms
Decreased tissue perfusion from vascular dilation, vascular endothelium damage by proinflammatory cytokines, and multiple organ failure from cell death culminating in septic shock.
Target Population
Hospitalized patients suspected of sepsis, including neonates and adults in emergency and inpatient settings.
Care Setting
Hospital settings including emergency departments and intensive care units, with emphasis on early diagnosis within the first 6 hours.
Key Highlights
Sepsis causes over 11 million deaths annually worldwide, with higher incidence and mortality in low- and middle-income countries.
Early diagnosis using integrated biomarkers and rapid molecular tools reduces progression to septic shock and multiorgan failure significantly.
The Agata Sepsis® Platform enables rapid (approx. 4 hours) genus- and species-level pathogen identification from blood cultures using whole-genome sequencing and deep learning.
Guideline-Based Recommendations
Diagnosis
Apply Sepsis-3 criteria and standardized clinical scales for early recognition.
Use biomarkers such as procalcitonin (>2 ng/mL) and lactate (>2 mmol/L) combined with directed cultures to improve diagnostic accuracy.
Incorporate rapid molecular diagnostic tools like the Agata Sepsis® Platform to reduce time to pathogen identification.
Management
Initiate treatment within the 'golden hour' (<6 hours postdiagnosis) to reduce septic shock and organ failure risks.
Adjust empirical antimicrobial therapy based on rapid pathogen identification and resistance profiling.
Monitoring & Follow-up
Monitor clinical progression closely to detect multiorgan dysfunction early.
Use serial biomarker measurements and clinical scoring systems to assess treatment response.
Risks
Delayed diagnosis increases risk of multiorgan dysfunction by 7.3% per hour.
Multidrug-resistant pathogens reduce empirical treatment success by up to 68%, necessitating rapid resistance detection.
Patient & Prescribing Data
Hospitalized patients with suspected sepsis, including neonates and adults in Mexico and similar epidemiological settings.
Early molecular diagnosis facilitates targeted antimicrobial therapy, potentially improving survival and reducing mortality from 21% to under 10% in neonates.
Clinical Best Practices
Implement early detection protocols integrating clinical criteria, biomarkers, and rapid molecular diagnostics.
Use rapid whole-genome sequencing platforms like Agata Sepsis® to shorten pathogen identification time from days to hours.
Educate clinical staff on interpretation of molecular diagnostic results to optimize antimicrobial stewardship.
Prioritize early treatment initiation within 6 hours of diagnosis to improve outcomes.
Monitor local epidemiology for multidrug-resistant organisms to guide empirical therapy.
by María Guadalupe Moreno-Treviño, Francisco González-Salazar, Rafael Baltazar Reyes León-Cachón, Gerardo Rivera-Silva, Mayra Ivonne Hernández-Coria, Javier Acedo-Zúñiga, Ivan Alejandro de la Peña-Mireles, José Luis Elizondo-Murillo, Claudio Garibay-Orijel
