Table 1. Summary of available home semen tests.
Test | Method | Parameters tested | Categories tested | Accuracy (%) | Parameters missing | Cost | No. of tests per kit | Time until result (min) | FDA approval? |
---|---|---|---|---|---|---|---|---|---|
SpermCheck Fertility | Immunochromato-graphic assay | Concentration | 20 million | 98 | Motility, semen volume, Morphology, pH | $39.99 | 2 | 30 | Yes; 2010 |
SpermCheck Vasectomy | Immunochromato-graphic assay | >250,000 | Sensitivity 93 | Motility, semen volume, morphology, pH | $59.99 | 2 | 30 | ||
Specificity 97 | |||||||||
Trak | Centrifuge | Concentration & volume | <15 million/mL | 93.3 | Motility, morphology, pH | $89.99 | 2 | 36 | Yes; 2016 |
15–55million/mL | 82.4 | $149.99 | 4 | ||||||
>55 million/mL | 95.5 | $199.99 | 6 | ||||||
SwimCount | Colorimetric reaction (3-(4,5-di-methyl-thiazol-2-yl)-2,5-diphenyltetrazolium bromide,yellow tetrazole dye) | Progressively motile sperm concentration | <5 million | Accuracy 95 | Morphology, pH Total count | $57 | 1 | 60 | Yes; 2019 |
5–20 million | Sensitivity 88 | ||||||||
>20 million | Specificity 74 | ||||||||
FertilitySCORE | Colorimetric reaction (Resazuin dye) | Motile sperm concentration | <20 million/mL | 93 | Morphology Total count | GBP £19.95 ($25) | 2 | 90 | No; available in UK |
>20 million/mL | |||||||||
Men's Loupe | Ball Len's microscope with smartphone | Concentration & motility | No categories, manual counting required | Sensitivity 87.5 | pH, morphology | $15 | 4 | 5 | No; product only available in Japan |
User has to manually count motile & non-motile sperm | Specificity 90.9 | ||||||||
SEEM | Smartphone based device with optical tracking | Concentration & motility | No categories | Concentration: r=0.382 | Semen volume, morphology, pH | $45 | 2 | 15–30 | No |
Motility: r=0.594 | |||||||||
Yo sperm clip | Smartphone based device with optical tracking and internal algorithm | Motile sperm concentration | <6 million/mL | iPhone 7: 98.3 | Volume, concentration, morphology, pH | Mobile: $69.95 | 2 | 10–15 | Yes; 2017 |
>6 million/mL | Galaxy S2: 97.2 | Mac Window: $69.95 | |||||||
ExSeed | Smartphone based device with optical tracking | Semen volume | - | - | Morphology | £74.99 ($82) | 2 | 15–20 | No; only available in Denmark & UK |
Concentration | pH | £149.99 ($199.99) | 5 | ||||||
Motility | |||||||||
Total motile sperm count | |||||||||
Point of care automated-smartphone based system by Kanakasabapathy et al [40] | Microfluidics & optical attachment for smartphone | Concentration | <100 million | Concentration: accuracy 97.1 | Morphology | ~$5 | - | ~1 | No; pre-clinical testing |
Motility | >100 million | HBA: accuracy 87, sensitivity 100, specificity 69, sperm viability (4.9%)a; 1.2b, DNA fragmentation (5.7%)a; 0.7b | pH | ||||||
Volume | |||||||||
Hyaluronic binding assay (HBA) & Sperm viability | |||||||||
DNA fragmentation |
FDA: US Food and Drug Administration, -: data not provided.
aPercentages reported as standard-deviations. bAbsolute mean bias evaluated by Bland-Altman analysis.