The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by trained personnel.
Age > 16 years
Subject (or legally authorized representative) is willing to provide written informed consent before any study procedures
Female gender
Subject is able and willing to provide vaginal swab specimen for study procedures (3-4 swabs)
Subject 15 years of age or younger
Male gender
Female currently menstruating
Subject is unable or unwilling to provide informed consent
Parallel
iStatis Gonorrhea Antigen Test
DeviceVaginal swabs are tested on the iStatis Gonorrhea Antigen Test
Performance Evaluation
The performance between iStatis Gonorrhea Test and the reference test result for vaginal swabs (operator-collected and self-collected) will be calculated for all sites combined. Diagnostic sensitivity and specificity values and 95% CIs will be calculated for all subjects combined. The percentage of invalids (tests that fail to produce a control dot with accurate use) will be identified and reported.
iStatis Gonorrhea Test usability evaluation
Overall test usability and self collection usability will be determined via a questionnaire completed by trained personnel who used the device during testing and study participants that performed sample self-collection respectively. The usability questionnaire will use a scale of one (1) to 5 (1 - very difficult/very unlikely to 5 - very easy/very likely), with a rating of 3 being satisfactory.
iStatis Gonorrhea Test contrived result interpretation evaluation
Trained operators will evaluate a panel of contrived (mock) iStatis devices. These devices are designed to represent a comprehensive range of test outcomes, including strong positives, weak positives, negatives and invalid results. Operators will interpret the results of the mock devices and record their interpretations which will be compared to the correct interpretation of the device.
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bioLytical Laboratories
Lead sponsor
Epicentre
Collaborator
