Self Test Kit: Rapid Diagnosis of Urogenital Infections in Military Women

Lower genital tract infections occur commonly among 17-25 year old women and pose a significant problem for military women especially on deployment. This project is to develop a rapid self-test kit for common, treatable cervicalvaginal and urinary tract infections. We have completed the developmental phase of the test kit and tested the performance in 486 women with genital complaints. We have also evaluated womens ability to self test and evaluate their own results in 289 subjects. Additional modifications have been made to correct suboptimal sensitivity, specificity and predictive value. This test exceeded the performance of clinicalwet mount evaluation and syndromic management schemes. A number of additional modifications were made and tested during this year based on sensitivityspecificity and quality assurance testing. Among the 289 women in the self-test phase, all women were successfully able to obtain specimens and perform testing. The patient interpretation of dipstick results was equally successful with 94 agreement between patient and clinician interpretation of results for lactoferrin dipstick and 80 for the pHamine test. The self-test kit results suggested appropriate treatment in 80 of the cases. Thus, we remain optimistic that this project will result in a self-test kit for use on deployment andor in other resource poor environments.