SepsiDotTM Bedside Point-of-care Biosensor Kit

BRIEF TECHNOLOGY

We invented an electrochemical biosensor (based on first-of-its-kind enzymatic cascading reactions of three enzymes immobilized on acrylic microspheres coated onto a screen-printed electrode) and a small portable, handheld electronic reader. The biosensor will interface with its miniature electronic reader to give a reading for diagnosis of bacterial sepsis in any situation (at home, at nursing home, at clinics, at school, travelling to Haj, in flight, in hospital, at disaster zone, and warzone) with only with 1 drop of blood from fingertip of patient. The result of can be obtain with 10min and decision can be made either patient need antibiotic and hospitalization or not. 

INSPIRATION OF THE INVENTION

Sepsis deaths are preventable. However, there is lack of useful tools for early detection. Therefore, we invented this test kit to bridge this gap to safe more life.

PROBLEM STATEMENT & CURRENT ISSUES

Bacterial sepsis is the number 1 cause of death in Malaysia, with a prevalence of 35% annually and a mortality rate of 16% (1 in 5 sepsis patients). Bacterial sepsis is a curable disease with rapid (within 1 hour) antibiotic treatment; however, current diagnosis of bacterial sepsis can only be made in hospitals via time-consuming sophisticated lab investigations (24 to 48 hours duration) worldwide. Currently, bacterial sepsis is detected via bacterial cultures or the ELISA method which measures antibodies produced towards the pathogen. However, these methods require more than 24 hours to produce results. Furthermore, hospital-based investigations are only available for patients who are admitted to the hospital. Doctors need good diagnostic tools to identify patients having bacterial sepsis for prompt (within 1 hour) antibiotic initiation to reduce mortality(death) rates for bacterial sepsis.

INVENTIVENESS  & NOVELTY

This invention can detect the level of sPLA2-IIA in human serum to determine the presence of bacterial infection in human, making it a very useful tool for rapid assessment of sepsis in hospital emergency departments.

USEFULNESS & APPLICATION

• Able to rapidly diagnose bacterial sepsis within 10min for prompt antibiotic treatment (within 1 hour) and save lives.
• Its small and portable nature enable it to be used at any time, any place (such as at home, at nursing home, at clinics, at school, travelling to Haj, in flight, in hospital, in disaster zone, and warzone) and any population (children, adult and elderly)
• It can be easily operated by medical and non-medical train personal because it has a light indicator for action. The actions included “decision to bring the patient to hospital” for non-medical personal; and “decision to start antibiotic and deescalate the antibiotic” for medical trained personal.

IMPACT OF THE PRODUCT

• It assists in decision-making for prioritization of the usage of antibiotic and other limited medical resource during critical event such as during disaster and war.
• It also assists doctor to decide the need to start antibiotic or to deescalate it when patient has improved clinically. 
• It reduces the abuse/excessive use of antibiotic, further reduced the antibiotic resistance. It can be used as an antibiotic stewardship tool.
• Early detection of sepsis by non-medical person for early treatment and prevention sepsis

MARKET POTENTIAL

Our developed prototype will enable rapid bacterial sepsis diagnosis to be carried out, assisting physicians in risk stratification for effective patient management and improvement of clinical outcome. This will lead to shorter duration of hospitalizations, reduction of patient morbidity and mortality, contributing towards enhancing the quality of life for patients. At a conservative annual forecast of 900,000 sepsis patients, we anticipate that during the first year (2025) of marketing our product, a total of RM288,000 gross revenues would be generated (figure calculated based on 2% of the total Malaysian market share, i.e., 18000 tests (@RM16/test). 

TRL: 7