Testosterone, Unimed

• Brand: Unimed Inc
• Biomarker: Testosterone (Total)
• Original manufacturer: USA
• Test principle: Lateral flow immunoassay (immunochromatography, “sandwich”)
• Reaction time: 15 mins
• Sample type: Blood (finger-prick)
• Sample size (volume, etc.): 10 µL
• Measuring range: 1.0–15.0 ng/mL
• LOD: 1.0 ng/mL
• Accuracy (CV, R, R², R against CLIA):
• Accuracy (vs LC-MS/MS): Correlation coefficient 98% (serum comparison)
• Available certification: CE, UKCA
• Package: 25 Tests

Documents:
 Information Sheet
 Instructions for Use
 Validation Report
 How to perform test

The OnSight Testosterone Quantitative Test by Unimed provides a rapid quantitative screening tool for total testosterone measurement from a simple finger-prick blood sample (or serum). Using a lateral flow “sandwich” immunoassay and digital quantification with igloo reader pro, it delivers objective results in 15 minutes and supports clinical screening of testosterone abnormalities in both men and women. The system converts the test signal into a numeric concentration based on a pre-established calibration curve, enabling consistent interpretation at point-of-care and near-patient settings. Confirmatory testing with LC-MS/MS or other quantitative immunoassays is recommended when clinically required.