This kit is based on the solid-phase enzyme-linked immunosorbent assay (ELISA) with a double-antibody sandwich technique to detect residual host cell proteins (HCPs) from vero cells. A sheep polyclonal antibody specific to vero HCPs was employed in the assay to capture any remaining HCPs in the sample. The antibody coverage is assessed by the current mainstream method. Both the Calibration standards (or test sample) and the HRP (Horseradish Peroxidase) labeled anti-Vero HCP antibody were simultaneously added to the microtiter plate, which coated with the affinity purified capture antibody and followed by incubation and washing. Then TMB (3,3',5,5'-tetramethylbenzidine) substrate was added into reaction, HRP catalyzed the oxidation of TMB by H2O2 to produce a blue product (maximum absorption peak at 655 nm). Then the stop solution was added to terminate the enzymatic reaction, resulting in a yellow colored product (maximum absorption peak at 450nm). The absorbance values at 450 nm wavelength were positively correlated with the HCPs concentration in the Calibration standard and the sample. The concentration of HCPs in the sample can be calculated using the dose-response curve.
Components | Shipping Condition | Unit Size | Detection Method |
Vero HCP Calibration Standard | 2-8℃ | 96 Tests | Sandwich ELISA |
Anti-Vero HCP Microtiter Strips | |||
Reconstitution Solution | |||
Diluent | |||
Wash Buffer Concentrate (10×) | |||
Anti-Vero: HRP (100×) | |||
TMB Substrate | |||
Stop Solution | |||
Sealing Film |
Linearity & Range | 3-243 ng/mL, R2>0.990 |
Accuracy | Recovery Rate= 93.4%-108.1% |
LLOQ | 3 ng/mL |
LOD | 1 ng/mL |
Precision | 2.8%-5.0% (CV≤20%) |
Antibody Coverage (IMBS-2D) | 65.1%-85.1% |
Antibody Coverage (IMBS-LC/MS) | 76.9% |
Specificity | No cross-reactivity with E.coli, P.pastoris and Sf9 cell. |
Robustness | Incubation speed: 500 rpm - 600 rpm |
SHENTEK® Residual Host Cell DNA Sample Preparation Kit
SHENTEK® Residual Vero DNA Quantitation Kit (2G)
SHENTEK® Residual Vero-154 DNA Quantitation Kit