High-sensitivity SpectroChip-integrated LFIA platform for rapid point-of-care quantification of cardiovascular...

Area of Science:

• Biomedical Engineering
• Analytical Chemistry
• Clinical Diagnostics

Background:

• Cardiovascular disease diagnosis requires timely and precise biomarker measurement.
• Existing methods can be time-consuming, delaying critical treatment decisions.
• Point-of-care (POC) diagnostics offer a potential solution for rapid assessment.

Purpose of the Study:

• To evaluate THE ONE InstantCare device, a novel POC platform utilizing SpectroChip and gold nanoparticle-conjugated lateral flow immunoassays (LFIA).
• To quantify five key cardiovascular biomarkers: Troponin I (cTnI), Creatine Kinase Myocardial Band (CK-MB), N-terminal pro-B-type Natriuretic Peptide (NT-proBNP), D-dimer, and C-reactive Protein (CRP).
• To assess the device's accuracy and reliability for clinical use in emergency settings.

Main Methods:

• Development of a POC platform integrating SpectroChip technology with AuNPs-LFIA.
• Quantification of cardiovascular biomarkers using standard curves generated in fetal bovine serum (FBS).
• Spectral data analysis involving baseline correction, noise reduction, and relative absorbance calculation (ΔA).
• Clinical validation using patient serum samples compared against a standard clinical analyzer (Abbott Alinity ci-series).

Main Results:

• The platform demonstrated high sensitivity with low limits of detection (LOD) for all five biomarkers.
• Calibration curves showed excellent linearity (R² > 0.98) for all biomarkers.
• Clinical validation revealed strong agreement with the Abbott Alinity ci-series analyzer (R² > 0.91, r > 0.95).
• Bland-Altman analysis confirmed consistency within 95% confidence intervals.

Conclusions:

• THE ONE InstantCare device provides fast, reliable, and quantitative measurement of multiple cardiovascular biomarkers.
• The novel POC system shows significant potential for improving emergency cardiovascular diagnostics.
• This technology could lead to more affordable and accessible heart disease management.