Clinical evaluation, validation and stability testing of a developed paper-based blood grouping diagnostic test device

Blood transfusion necessitates an obligatory test to examine donor-recipient compatibility. Regardless of the typical traditional methods, new blood typing approaches are considered for uncomplicated, correct, and precise testing. In this study, we evaluated the rapid and affordable point-of-care blood typing device and explored new approaches to increase its stability/shelf life. A total of 729 blood samples were validated using this paper-based device. Medical students/staff (total 260) of MNR Medical College & Hospital, Telangana, India, and 57 volunteers from India MedTech Expo 2023 and G20 3rd Health Working Group Meeting organized by Govt. of India, were considered for on-spot testing. The participants were asked to sign the consent form and enter their blood groups, which were later used for confirmation and validation. Out of 260 medical students/staff, this blood typing paper device successfully validated blood groups of 204 samples and tested 45 unknown blood groups. It also provided corrected blood groups to 11, thus having a sensitivity of 100 %. The device tested on MedTech Expo and G20 Health Meeting volunteers showed 100 % specificity. Around 400 blood samples collected from the hospital were tested with the paper device and compared simultaneously with the conventional glass slide method. 12 blood samples were tested via tube method and compared to paper devices. The sensitivity in all cases was superior to that of the traditional method with 100 % specificity. The developed device with a new biofunctionalization strategy exhibited excellent stability for 3 and 6 months at room temperature and 2-8 °C, respectively. This simple and easy diagnostic test device epitomizes a major stride towards enabling comprehensive screening of blood typing both in children and adults. It signifies its feasibility in resource-limited clinical settings towards making a positive diagnosis.