Comparison of several one-step home urinary luteinizing hormone detection test kits to OvuQuick.
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 preexisting OvuQuick brand LH detection kit (designated as the standard).


METHODS
Prospective cohort study.


METHODS
University-based infertility clinic.


METHODS
All women undergoing intrauterine inseminations at the clinic, regardless of infertility diagnosis, were offered enrollment during a 28-month study period.


METHODS
Each participant was supplied three one-step test kits (OvuQuick One-Step, ClearPlan Easy, and SureStep) in addition to a multistep OvuQuick test kit and instructed to run the tests in parallel on the same urine 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 continued with the one-step kits every 12 hours for 48 hours after the surge was first detected by OvuQuick. Subjects also completed questionnaires evaluating the use of each test kit.


METHODS
Correlation of LH surge detection by one-step kits in comparison to surge detection by OvuQuick. Satisfaction and ease of use questionnaires.


RESULTS
Sixty-three volunteers returned useable data, from which 81 evaluable cycles were analyzed. The majority of patients found the newer one-step kits to be easier to use and less time consuming than OvuQuick. The three 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, with modified instructions allowing for an equal color intensity in the test and reference areas, had the highest correlation with OvuQuick (84%). However, with a study power (alpha = 0.05, beta = 0.10) sufficient to detect a 10% difference between Ovuquick and each one-step kit, all one-step kits were statistically equivalent to each other. There was no cycle in which a one-step kit detected a positive LH surge but OvuQuick did not.


CONCLUSIONS
One-step urinary LH kits are easier for patients to use than a multistep home urinary LH kit and have reasonable correlation with the multistep kit when used clinically for timing artificial inseminations.
Nielsen
M S
MS
University of Utah School of Medicine, Salt Lake City, USA.
Barton
S D
SD
Hatasaka
H H
HH
Stanford
J B
JB
D000328:Adult; D015331:Cohort Studies; D003258:Consumer Behavior; D005260:Female; D006801:Humans; D008183:Luteal Phase; D007986:Luteinizing Hormone / Q000097:blood / Q000652:urine; D010061:Ovulation Detection / Q000379:methods*; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D011795:Surveys and Questionnaires
D011933:Reagent Kits, Diagnostic; D007986:Luteinizing Hormone