Comparison of several one-step home urinary luteinizing hormone detection test kits to OvuQuick (R)

Objective: To compare clinical accuracy and ease of use for several of the new rapid one-step home urinary LH detection kits compared with the preexis ting OvuQuick brand LH detection kit (designated as the standard). Design: Prospective cohort study. Setting: University-based infertility clinic. Patient(s): All women undergoing intrauterine inseminations at the clinic, regardless of infertility diagnosis, were offered enrollment during a 28-mo nth study period. Intervention(s): Each participant was supplied three one-step test kits (Ov uQuick One-Step, ClearPlan Easy, and SureStep) in addition to a multistep O vuQuick test kit and instructed to run the tests in parallel on the same ur ine sample and to record the results. Urine testing was performed every 12 hours, beginning 3 days before the anticipated onset of an LH surge, and co ntinued with the one-step kits every 12 hours for 48 hours after the surge was first detected by OvuQuick. Subjects also completed questionnaires eval uating the use of each test kit. Main Outcome Measure(s): Correlation of LH surge detection by one-step kits in comparison to surge detection by OvuQuick. Satisfaction and ease of use questionnaires. Result(s): Sixty-three volunteers returned useable data, from which 81 eval uable cycles were analyzed. The majority of patients found the newer oae-st ep kits to be easier to use and less time consuming than OvuQuick. The thre e one-step kits detected the LH surge within +/- one testing period (+/- 12 hours) of detection by OvuQuick 68%-84% of the time. OvuQuick One-Step, wi th modified instructions allowing for an equal color intensity in the test and reference areas, had the highest correlation with OvuQuick (84%). Howev er, with a study power (alpha = 0.05, beta = 0.10) sufficient to detect a 1 0% difference between Ovuquick and each one-step kit, all one-step kits wer e statistically equivalent to each other. There was no cycle in which a one -step kit detected a positive LH surge but OvuQuick did not. Conclusion(s): One-step urinary LH kits are easier for patients to use than a multistep home urinary LH kit and have reasonable correlation with the m ultistep kit when used clinically for tin-ling artificial inseminations. (C ) 2001 by American Society for Reproductive Medicine.