Evaluating the feasibility and performance of CRISPR point-of-care testing for the diagnosis of gonorrhoea and chlamydia in adults presenting for sexually transmissible infection testing

This observational study evaluates the accuracy and feasibility of using a novel Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-based point-of-care diagnostic platform for detecting Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) in consecutive symptomatic adults attending sexual health clinics across a 12 month period. The point-of-care testing platform detects each pathogen through targeting two independent genomic regions through isothermal amplification and CRISPR-Cas reaction using Cas12a and Cas13a, each with distinct fluorescent reporters, and the fluorescence intensities are measured with the T8-ISO instrument. Training in performing the CRISPR point-of-care test will be provided by the University of Melbourne research team who have developed the assay, Trained staff may subsequently train other staff members to perform the test after competency in the testing procedure has been confirmed, The point-of-care instrument will be located in a non-clinical area within sexual health clinics and testing will be performed by a trained staff member (e.g. nurses, research assistants etc.) on the same day as participant sample collection. The samples assessed will be urine, and if collected, genital swabs. Participant interaction is complete at the time of sample collection, participants will not receive the results of the point-of-care test. Test results are available from the point-of-care test after approximately 40 minutes with the point-of-care device visually displaying a positive, negative or invalid result. Results are also stored on the device and will be exported via spreadsheet to review the device logs for accuracy of recorded result.