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: 100 pg/mL

ULOQ: 1600 pg/mL

Sample Volume: 100 mcL

Precision & Accuracy:

  • LLOQ QC: 10.1% CV; 78.1% AR
  • Low QC: 5.7% CV; 86.3% AR
  • Mid QC: 5.8% CV; 93.2% AR
  • High QC: 2.9% CV; 91.0% AR
  • ULOQ QC: 4.7% CV; 92.7% AR
  • Plasma Controls: (Level-1 & -2) Inter assay CV ≤ 16.7%
  • Dilutional Linearity: 2 & 4-fold 13.3% Overall CV; 76.4% to 89.5 % AR

Stability:

  • Short-Term (Bench-Top): 5.5 hours
  • Short-Term (Refrigeration): 112 hours
  • Long-Term (-80 °C): In progress
  • Freeze/Thaw Cycles: 3

Method Number: Q2402P1