Automated microfluidic electrochemical biosensor for the detection of immune-mediated thrombotic disorders

Area of Science:

• Immunology
• Hematology
• Biotechnology

Background:

• Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) is a rare, life-threatening condition linked to COVID-19 vaccination.
• Current VITT diagnosis relies on multiple criteria and lacks a specific diagnostic assay.
• Existing diagnostic methods involve ELISA and functional assays for Heparin-Induced Thrombocytopenia (HIT).

Purpose of the Study:

• To develop a technically simple antigenic assay for the direct diagnosis of VITT-associated autoimmune antibodies.
• To identify cross-linked platelet factor 4 (PF4) as a specific antigenic target for VITT antibodies.
• To create a microfluidic electrochemical biosensor for automated VITT antibody detection.

Main Methods:

• Developed a microfluidic electrochemical biosensor incorporating cross-linked PF4 as the antigenic target.
• Utilized microliter volumes of patient sera for automated detection.
• Tested 51 patient samples, including VITT, healthy controls, and HIT patients.

Main Results:

• Demonstrated that cross-linked PF4 is a specific antigenic target for VITT antibodies.
• Achieved specific and sensitive detection of VITT antibodies using the biosensor.
• Obtained 100% sensitivity and specificity for VITT sera compared to controls and HIT patients.

Conclusions:

• The developed microfluidic electrochemical biosensor enables direct and accurate diagnosis of VITT.
• The assay shows high sensitivity and specificity, outperforming current diagnostic approaches.
• This innovation offers a promising tool for timely VITT diagnosis and improved patient outcomes.