FPSA ELISA Kit

INTENDED USE

The fPSA ELISA Kit is an in vitro diagnostic assay designed to:

• Quantitatively measure free PSA (unbound) in human serum/plasma

• Calculate %fPSA ratio (fPSA/tPSA) for improved prostate cancer risk stratification

• Aid in differentiating malignant vs. benign prostatic conditions

KEY FEATURES

✔ High Sensitivity - Detects as low as 0.05 ng/mL (LoD)
✔ WHO-Traceable Standards - Aligns with IRMM CRM 613 reference materials
✔ CLIA-Compatible - Validated for clinical laboratory workflows
✔ Time-Efficient - Complete results in <2.5 hours
✔ 96-Well Format - Supports high-throughput screening (manual/automated)

PERFORMANCE SPECIFICATIONS

CLINICAL UTILITY

• Prostate Cancer Screening: Improved specificity vs. tPSA alone

• %fPSA Calculation:

  • 25% suggests benign prostatic hyperplasia (BPH)

  • <10% indicates higher cancer probability

• Post-Treatment Monitoring

KIT COMPONENTS

• Pre-coated anti-fPSA 96-well microplate

• fPSA calibrators (0, 0.5, 2, 5, 10, 20, 50 ng/mL)

• Enzyme conjugate & TMB substrate

• Wash buffer (20X concentrate)

• Detailed protocol with %fPSA calculation formula

SAMPLE REQUIREMENTS

• Type: Serum (gold standard) or EDTA plasma

• Volume: 100 μL recommended for duplicate testing

• Stability:

  • 7 days at 2-8°C

  • 6 months at -20°C (avoid >3 freeze-thaw cycles)

ORDERING INFO

• Catalog No.: fPSA-ELISA-96

• Pack Size: 96 tests (expandable to 5x96 bulk packs)

• Regulatory Status: CE-IVD (or specify RUO)

• Storage: 2-8°C (24-month shelf life)