Method: ELISA

Matrix: Human Plasma

Anticoagulant: K2EDTA

Special Sample Handling: Proteolytic inhibitors in blood collection tube; acidification of plasma (at clinical site)

Storage Temperature: -80 °C

LLOQ: 200 pg/mL

ULOQ: 5000 pg/mL

Sample Volume: 100 mcL

Precision & Accuracy:

  • LLOQ QC: 16.3% CV; 84.6% AR
  • Low QC: 4.7% CV; 95.4% AR
  • Mid QC: 4.5% CV; 97.5% AR
  • High QC: 3.5% CV; 91.4% AR
  • ULOQ QC: 8.9% CV; 102.8% AR
  • Plasma Controls: (Level-1 & -2) Inter assay CV ≤ 11.3%
  • Dilutional Linearity: 2 & 4-fold 7.7% Overall CV; 101.6% to 117.1% AR

Stability:

  • Short-Term (Bench-Top): 22 hours
  • Short-Term (Refrigeration): 69 hours
  • Long-Term (-80 °C): In progress
  • Freeze/Thaw Cycles: 3

Method Number: Q2403P1