Klotz KL et al. (2008) Clinical and consumer trial performance of a sensitive immunodiagnostic home test that qualitatively detects low concentrations of sperm following vasectomy. J Urol 180: 2569–2576

Poor compliance with postvasectomy semen analysis (to determine whether residual sperm have been cleared from the reproductive tract) is attributed to patient embarrassment with regard to providing semen samples, and the inconvenience of returning to the clinic. A home testing kit could, therefore, improve patient compliance. Klotz and colleagues report on clinical and consumer testing of a lateral flow immunochromatographic diagnostic device, SpermCheck® Vasectomy (ContraVac, Inc., Charlottesville, VA), which can detect sperm at concentrations of 250,000 sperm per ml of semen or greater.

A total of 144 semen samples were collected from 100 patients who underwent vasectomy; all samples were tested with SpermCheck® Vasectomy, and the sperm concentration for each sample was also determined using a hemacytometer. Sperm concentrations >250,000/ml were detected by hemacytometer in 40 samples, 37 of which produced a positive result with the SpermCheck® device (93% sensitivity). The concentrations of the three samples with false-negative results were all <385,000/ml (some investigators suggest that concentrations <1,000,000/ml indicate postvasectomy sterility). Negative test results were recorded for 101 of the 104 samples with sperm concentrations less than 250,000/ml (97% specificity).

Consumer studies revealed that the diagnostic test has 98% agreement with hemacytometer results, and could achieve the same results whether carried out by home users or laboratory personnel.

The authors conclude that SpermCheck® Vasectomy, which is approved by the US FDA, is a simple yet sensitive home test that will potentially improve compliance with postvasectomy semen analysis.