Alpha ID oral sample self collection study for DAAT diagnosis

A study was conducted to evaluate user interaction with the ORAcollect®-Dx (OCR-100) collection device. It evaluated users' ability to correctly collect a saliva sample following the provided instructions. It is designed to demonstrate that users understand the ORAcollect saliva collection instructions for use (IFU) provided in the AlphaID kit and successfully collect saliva samples that are acceptable for use in DAAT genotyping test (Manufacturer: Progenika Biopharma, S.A.). Patients' total were 133 from various regions of Spain. None of the participants have previous medical or laboratory experience nor previous experience with self-collection. The study was conducted in the outpatient setting. All self-collected participant saliva samples received were deemed acceptable for testing. 93 of 133 samples were received with the questionnaires (70%), of which 63 questionnaires were completely completed and 32% were partially completed. Most participants reported that they understood the instructions provided for sample collection. The overall comprehension score was 96.5% (11/315 incorrect answers were obtained on comprehension questions). Overall satisfaction was rated as 4.6 (Considering the scale: 1 (Not Satisfied) to 5 (Completely Satisfied)). The self-collection validation results were consistent as all samples had a high concentration of DNA. Therefore, this study demonstrated the acceptability of self-collection saliva samples using the ORAcollect®-Dx (OCR-100) collection device.