Acoustophoretic sample preparation integrated chemiluminescence immunoassay microsystem for automated detection of hormones in whole blood

초록

Background: Highly sensitive and automated hormone analysis is essential for reproductive health diagnostics. Although chemiluminescence immunoassays (CLIAs) offer excellent analytical sensitivity, translating them into compact point-of-care (POC) platforms remains challenging due to complex matrix interferences and technical reliance on expensive magnetic bead-based automation hardware. Results: Here, we present a fully automated, magnetic-free CLIA micro-system (MDwave-C1) that integrates dual acoustophoretic modules for automated whole-blood plasma separation and immune-bound microbead concentration using standard carboxylated polystyrene microbeads. By applying lateral acoustic radiation forces, the platform eliminates the need for external magnetic actuators, reducing operational component costs. The system incorporates an all-in-one reagent cartridge with a 30% volumetric safety margin, dual-axis motion control, and a vertically actuated photomultiplier tube for direct photon collection. Analytical characterization confirmed an acoustic plasma separation efficiency of 93% and particle trapping recovery of 94–98%. The system achieved a broad 5-order-of-magnitude linear dynamic range (10 to 1,200,000 RLU) and excellent reproducibility (CV < 1%). Clinical validation evaluating five infertility-related hormones—LH, FSH, β-hCG, total testosterone, and estradiol—demonstrated high diagnostic precision (mean CV < 5%) and exceptional selectivity against endogenous matrix interferences (bias < ±10%). Method comparison with a commercial analyzer (Roche Cobas e411) showed robust clinical correlation (R2 > 0.97). Significance: By bridging the operational gap between centralized laboratory instrumentation and point-of-care accessibility, this acoustofluidic, magnetic-free diagnostic platform provides a robust, cost-effective, and fully automated solution for clinical diagnostics.

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