One-step ELISA Kit to quantify and characterize host cell proteins (HCPs) in products manufactured by expression in E.coli originated from BL21, such as interleukin (IL), recombinant human interferon (rhIFN), recombinant human tumor necrosis factor (rhTNF), growth-promoting factor (EGF/FGF/PDGF), et.al.
Components | Shipping Condition | Unit Size | Detection Method |
E.coli HCP-E Calibration Standard | 2-8℃ | 96 Tests | Sandwich ELISA |
Anti-E.coli HCP-E Microtiter Strips | |||
Reconstitution Solution | |||
Diluent | |||
Wash Buffer Concentrate (10×) | |||
Anti-E.coli HCP-E:HRP (100×) | |||
TMB Substrate | |||
Stop Solution | |||
Sealing Film |
Linearity & Range | 1.5-243 ng/mL, R2>0.990 |
Accuracy | Recovery Rate= 83.8%-110.2% |
LLOQ | 1.5 ng/mL |
ULOQ | 243 ng/mL |
LOD | 1.19ng/mL |
Precision | 4.5%-8.6% (CV≤15%) |
Antibody Coverage (IMBS-2D) | 70.6%-100% |
Antibody Coverage (IMBS-LC/MS) | 88.8% |
Specificity | No cross-reactivity with CHO, Vero, HEK293T, Hansenula polymorpha HCPs |
Robustness | Incubate at 25±5℃, CV≤ 15% Instrument suitability not limited to Thermo Multiskan FC, Bio-Tek Synergy2 |
SHENTEK® Residual Host Cell DNA Sample Preparation Kit
SHENTEK® Residual E. coli DNA Quantitation Kit
SHENTEK® E.coli (K-12 & Alkaline Lysis) HCP ELISA Kit