Immunoassay Reagent AFIAS™ Follicle Stimulating Hormone (FSH) CLIA Non-Waived For AFIAS-1, AFIAS-3, AFIAS-6, AFIAS-10 Immunoassay Analyzers 24 Tests

Features

• Rapid quantitative FSH measurement at the point of care in 12 minutes from whole blood, serum, or plasma - no laboratory send-out required
• Use across physician offices, fertility clinics, and urgent care settings without specialized training
• Broad clinical utility across the full FSH testing spectrum: supports diagnosis of premature ovarian failure, poor ovarian reserve, Turner syndrome, gonadal dysgenesis, and testicular failure, as well as menopausal transition monitoring
• Reference ranges validated across follicular, mid-cycle, luteal, and postmenopausal phases in females and males
• High analytical performance with working range of 1–100 mIU/mL, LoQ of 1 mIU/mL, and CV ≤ 6.3% across repeatability, within-laboratory, lot-to-lot, between-site, and between-reader studies
• Accuracy confirmed at 96.0–102.0% recovery across 3 lots; strong comparability to reference method (R=0.9924, y=0.9929x+0.1806)

More Information

• SDS