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 Methods

Current diagnosis methods have low predictability, delays in diagnosis, lack of sensitivity, and an 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 that can be seamlessly implemented into hospitals and clinics. The objectives include:

1. Reducing time-to-treatment.
2. Reducing variability in data interpretation.
3. Reducing 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 achieve the following outcomes:

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

Clinical Validation

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.