VIVA-ELISA: Advanced Laboratory Test for Rapid Detection of NLRP3 Inflammasome Activation in Critical Septic Patients

Introduction

Sepsis causes almost 20% of global annual deaths. It involves a dysregulated systemic inflammatory response driven by proinflammatory cytokines. If untreated, it progresses to organ dysfunction, low blood pressure, and septic shock.

Current Diagnosis Challenges

Current diagnosis methods have:

• Low predictability
• Delays in diagnosis
• Lack of sensitivity
• Inability to predict the course of the patient's deterioration

There is thus a need for a rapid, accurate, affordable, and early identification of the mortality risk.

Project Background

VIVA-ELISA is a follow-up to the ERC project SPEDI-TEST conducted at the Biomedical Research Institute of Murcia (IMIB), of which Viva in Vitro is a spin-off. Studies show that 100% of deaths of septic patients are correlated to early impairment of the NLRP3 inflammasome activation in monocytes within the initial 24 hours.

Diagnostic Method Development

A novel in vitro diagnostic method was developed for the fast detection of early impairment of the NLRP3 inflammasome activation. This method can stratify patients at a higher risk of developing life-threatening complications, resulting in an early and more accurate prognosis.

VIVA-ELISA Objectives

VIVA-ELISA will advance this concept by developing:

• An easy-to-use, highly sensitive immunoassay
• Seamless implementation into hospitals and clinics
• Reduction in time-to-treatment
• Decreased variability in data interpretation
• Lower hospitalization costs, currently averaging $32,000 per patient

Our solution, designed as a classic quantitative sandwich ELISA, requires only a small blood sample to measure ex vivo NLRP3 activation.

Expected Outcomes

We aim to:

1. Reduce sepsis mortality rates by 25 to 40%
2. Reduce morbidity and recovery time
3. Decrease chronic sequelae for patients
4. Enable the possibility of personalized treatments and immunotherapy
5. Contribute to the sustainability of healthcare systems

Validation and Compliance

VIVA-ELISA will also validate this technology in initial clinical studies and will carry out the necessary work to comply with current EU/US regulations before its introduction into the market.