ProCISION™Research Use OnlySandwich

ProCISION E. coli HCP

E. coli BL21(DE3) — insulin, filgrastim, G-CSF, IFN-α, somatropin. Strain-matched calibrators available.

For Research Use Only. Not for use in diagnostic procedures.

Specifications

Format
Quantitative sandwich ELISA
Calibration
8-point standard curve, 4PL fit, R² ≥ 0.990
LOD
≤ 1 ng/mL (HCP) · ≤ 0.5 ng/mL (residuals)
LOQ
≤ 5 ng/mL (HCP) · ≤ 2 ng/mL (residuals)
Spike recovery
80–120% in drug substance
Precision
CV < 10% intra · < 15% inter · < 20% inter-lot
Result reported
ng impurity per mg drug substance (ppm)
Assay time
3.5–4 hours

Kit contents

  • Pre-coated microplate
  • Lyophilised standard with certified concentration on CoA
  • Biotinylated detection antibody
  • Streptavidin-HRP
  • High and low controls
  • Assay diluent
  • Conjugate diluent
  • 20× wash buffer
  • TMB substrate
  • Stop solution
  • Three plate sealers
  • Instructions for use

Ordering

Catalog no.
PNB2002
Pack format
96 wells, 8 × 12 break-apart strips
Storage
2–8 °C. Do not freeze.

Prices are quoted on request. Select a pack size and quantity, then request a quote. Our sales team will respond with pricing, availability and lead time.

Downloads

  • Instructions for use (IFU)
  • Safety data sheet (SDS)
  • Certificate of analysis (CoA)
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