Point - Of - Care Precision - Comparative Study Of Microfluidic Chips Vs. Wearable Biosensors For Hbv Detection

Abstract

Background: Hepatitis B virus (HBV) remains a global health challenge, particularly in resource - limited settings where access to centralized laboratory diagnostics is limited. Point - of - care (POC) technologies such as microfluidic chips and wearable biosensors offer promising alternatives for rapid and decentralized HBV detection.

Methods: A prospective comparative study was conducted on 200 serum samples collected from patients in semi - urban clinics of Telangana, India. Two platforms were evaluated: (1) a microfluidic chip system integrating recombinase polymerase amplification with CRISPR - Cas12a for HBV DNA detection and (2) a sweat - based wearable electrochemical biosensor designed to detect HBsAg and HBV DNA. Performance metrics included sensitivity, specificity, limit of detection (LOD), time - to - result and operational feasibility. qPCR served as the reference standard.

Results: The microfluidic chip system achieved superior diagnostic accuracy with a sensitivity of 96.2% and specificity of 97.5%, an LOD of 10¹ IU/mL and a mean time - to - result of 20 minutes. In contrast the wearable biosensor demonstrated moderate accuracy with sensitivity of 84.5%, specificity of 88.0%, an LOD of 10³ IU/mL and a time - to - result of 30 minutes. Microfluidics maintained robust performance even at low viral loads whereas wearables showed a significant decline in sensitivity below 10³ IU/mL. Operational analysis revealed that while microfluidics required minimal instrumentation and small serum volumes, wearables offered greater portability, non - invasive sampling and integration with mobile applications at lower cost per test.

Conclusion: Microfluidic chip-based platforms demonstrated clinical - grade diagnostic performance suitable for POC HBV testing while wearable biosensors, though less accurate, provide advantages in accessibility and decentralized monitoring. Both technologies play complementary roles in HBV detection and monitoring offering pathways to improve early diagnosis and broaden access to care.