Development of a novel home sperm test.
BACKGROUND
The majority of men find the production of a semen sample an embarrassing and stressful experience. Consequently, the availability of an over-the-counter home sperm test, which would reliably and accurately allow the patient to obtain an assessment of fertility potential at their convenience, would be a major benefit. Our objective was to develop and evaluate a home sperm test that provides a visual estimate of the concentration of progressively motile sperm in a semen sample.


METHODS
Three particular challenges are described (i) developing a visualization system; (ii) optimization of the detection limit; and (iii) controlling variation due to changes in ambient temperature. The accuracy of the device was tested against two reference methods: computer-assisted sperm analysis (CASA) and a hyaluronate migration test (HMT).


RESULTS
In 129 semen samples, where both reference methods agreed (positive or negative), the accuracy of the device was 95%. The observed likelihood ratio of 8.8 indicated that a sample showing a red line in the device was over eight times more likely to have a positive (normal) result in CASA and HMT than a sample without a red line.


CONCLUSIONS
The final device provides a visual estimate of the concentration of progressively motile sperm in a semen sample using a test that is completed within approximately 1 h of production of the sample and can be used by the man in the comfort of his own home.
Björndahl
L
L
Assisted Conception Unit, Birmingham Women's Hospital and Reproductive Biology and Genetics Group, Division of Reproductive and Child Health, University of Birmingham, Birmingham, UK.
Kirkman-Brown
J
J
Hart
G
G
Rattle
S
S
Barratt
C L R
CL
D006801:Humans; D008297:Male; D012648:Self Care / Q000295:instrumentation*; D013076:Sperm Count / Q000295:instrumentation*; D013081:Sperm Motility; D013094:Spermatozoa / Q000166:cytology*