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The clinical impact of a multiplex real-time PCR system for microbiological diagnosis of sepsis: a mortality study
Marcelo Grijalva1,2, Katherine De La Torre3, Nataly Sánchez4
1Departamento de Ciencias de la Vida, Universidad de las Fuerzas Armadas ESPE, Sangolquí, Ecuador.
Abstract:
To evaluate the impact of the use of a multiplex-real time PCR-based assay (SeptiFast M-Grade®) on in-hospital mortality in ICU sepsis patients. Demographic, clinical and microbiological data from ICU patients with suspected sepsis and available SeptiFast (SF) test results were gathered. The intervention group comprised patients in which SF indicated a clinical intervention; the non-intervention group included patients in whom SF result did not lead to any clinical intervention. The study looked at expected and observed in-hospital mortality rates in both intervention and non-intervention groups. Two-hundred and fifty-five patients (121 patients in the intervention group and 134 patients in the non-intervention group) were included in the study. When comparing both groups, we found no significant differences in severity scores, either in estimated or observed mortalities. Older age, high APACHE II scores, and infections caused by Gram-negative pathogens and carbapenem-resistant enterobacteria were all associated with a higher risk of death in both groups. Overall, blood cultures and SF agreed in 75.3% of cases. Positivity rates were 22.0% for blood culture, 29.4% for SF, and 38.0% combined. Though we did not find a correlation between SeptiFast-based intervention and changes in in-hospital mortality, SeptiFast improved positivity rates. The above improvement in microbiological diagnosis might be associated with fewer complications, lower hospitalization costs and presumably better long-term survival rates in sepsis patients.
Insights
The SeptiFast assay did not alter in-hospital mortality for ICU sepsis patients but improved microbiological diagnostic rates. This enhanced detection may lead to better outcomes and reduced costs.
Area of Science:
- Clinical Microbiology
- Infectious Diseases
- Intensive Care Medicine
Background:
- Sepsis remains a leading cause of mortality in intensive care units (ICUs).
- Rapid and accurate microbiological diagnosis is crucial for effective sepsis management.
- Multiplex PCR-based assays offer potential for faster pathogen identification compared to traditional blood cultures.
Purpose of the Study:
- To evaluate the impact of the SeptiFast M-Grade® multiplex PCR assay on in-hospital mortality in ICU sepsis patients.
- To compare the diagnostic yield and clinical intervention rates between SeptiFast and standard blood cultures.
- To identify factors associated with mortality in sepsis patients.
Main Methods:
- A retrospective study of 255 ICU patients with suspected sepsis and SeptiFast results.
- Patients were divided into intervention (SeptiFast guided) and non-intervention groups.
- Demographic, clinical, microbiological data, and mortality rates were analyzed.
Main Results:
- No significant difference in in-hospital mortality or severity scores between intervention and non-intervention groups.
- SeptiFast improved overall microbiological positivity rates (29.4%) compared to blood culture alone (22.0%).
- Older age, high APACHE II scores, Gram-negative pathogens, and carbapenem-resistant enterobacteria were associated with higher mortality.
Conclusions:
- SeptiFast-guided intervention did not directly impact in-hospital mortality in this cohort.
- The assay significantly enhanced microbiological diagnostic yield in sepsis patients.
- Improved diagnostic accuracy may contribute to reduced complications, costs, and potentially better long-term survival.
