Medical Devices
CardiAI is developing an advanced point-of-care diagnostic platform that integrates a colloidal gold-based NT-proBNP lateral flow assay with a quantitative reader and mobile app. This system utilizes gold nanoparticle–antibody conjugates to achieve high sensitivity and specificity in detecting NT-proBNP, a key biomarker for heart failure and cardiac dysfunction. The test provides results within 10–15 minutes, enabling immediate clinical decision-making. Its simple and user-friendly format makes it suitable for use in emergency departments, clinics, and even at home. The quantitative reader is designed to convert the test strip’s colorimetric signal into a precise NT-proBNP concentration, supporting accurate and quantitative interpretation. Results are tracked and managed via an integrated mobile app, which enables longitudinal monitoring and supports remote healthcare management.
Colloidal Gold-Based NT-proBNP Lateral Flow Assay
- Utilizes gold nanoparticle–antibody conjugates for high sensitivity and specificity in detecting NT-proBNP, a key marker for heart failure and cardiac dysfunction].
- Provides results within 10–15 minutes, enabling immediate clinical decision-making.
- Simple, user-friendly format suitable for emergency departments, clinics, and home use.
Quantitative Reader and Mobile App
- The reader converts the test strip’s colorimetric signal into a precise NT-proBNP concentration, supporting quantitative interpretation.
- Results are tracked and managed via an integrated mobile app, enabling longitudinal monitoring and remote healthcare support.
Clinical Impact
- Cost-effective and portable, the system eliminates reliance on expensive laboratory-based or chemiluminescence assays[3][2].
- High sensitivity and specificity for NT-proBNP, supporting early detection and management of heart failure and related cardiac conditions.
- Regulatory pathway: The system is being validated for analytical performance and is targeting MDSAP certification and additional regulatory approvals.
Future Directions: Multiplexed Cardiac Marker Detection
CardiAI is actively expanding its platform to enable multiplexed detection of additional cardiac biomarkers, specifically cardiac troponin I (cTnI) and D-Dimer:
- Multiplexing Technology: Development is underway to integrate multiple test lines or advanced labeling techniques (such as magnetic beads or SERS nanotags) on a single LFA strip, allowing simultaneous quantification of NT-proBNP, cTnI, and D-Dimer[4][5].
- Clinical Rationale: Combining these markers provides a more comprehensive cardiac risk profile. Studies show that joint measurement of NT-proBNP, cTnI, and D-Dimer improves diagnostic accuracy and prognostic value for acute coronary syndromes, heart failure, and pulmonary embolism.
- Performance Goals: The multiplexed assay aims for sub-ng/mL sensitivity and a broad dynamic range to meet clinical thresholds for each marker.
- Validation and Regulatory Plans: Ongoing multicenter studies are evaluating the multiplex assay’s performance against reference lab methods, with plans for CE marking and FDA clearance.
Clinical Applications
- Cost-effective and portable, the system eliminates reliance on expensive laboratory-based or chemiluminescence assays[3][2].
- High sensitivity and specificity for NT-proBNP, supporting early detection and management of heart failure and related cardiac conditions.
- Regulatory pathway: The system is being validated for analytical performance and is targeting MDSAP certification and additional regulatory approvals.
Clinical Applications
Feature/Direction | Current System (NT-proBNP) | Future Multiplexed System (NT-proBNP, cTnI, D-Dimer) |
Biomarkers Detected | NT-proBNP | NT-proBNP, cTnI, D-Dimer |
Detection Method | Colloidal gold LFA | Multiplexed LFA with advanced labeling |
Quantitative Reader | Yes | Yes |
Mobile App Integration | Yes | Yes |
Clinical Utility | Heart failure diagnosis/monitoring | Expanded: ACS, PE, risk stratification |
Validation/Regulatory Status | In progress | In progress |

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