CHO HCP ELISA Kit

 Product Description  

This kit employs a fed-batch culture process using CHO to immunize goats for the production of HCP-specific antibodies. The kit is based on a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to detect residual CHO-HCPs in biologics process samples. The wells of the ELISA plates are pre-coated with Anti-CHO-HCPs goat polyclonal antibodies. CHO-HCPs calibrators and test samples are added to the solid-phase antibody-coated wells, followed by the addition of the detection antibodies-HRP conjugate. Through a one-step incubation, any residual CHO-HCPs present in the test samples are captured by the solid-phase antibodies and simultaneously detected by the detection antibodies, forming a "coated antibody-(CHO-HCPs antigen)-detection antibodies-HRP conjugate" complex. Unbound substances are removed by washing, and TMB substrate is added for color development. The reaction is then stopped, and the absorbance is measured at dual wavelengths of 450 nm and 630 nm. The absorbance of the samples is positively correlated with the residual amount of CHO-HCPs in the process samples. The concentration of CHO HCPs in the samples can be calculated using a dose-response curve.

 Features  

• Simple operation:One-step procedure, pre-diluted standards

• Excellent stability:Shelf life-18 months

• Reliable raw materials:Extensive project application experience

 Performance  

• High Coverage Rate

Exhibits broad recognition of HCPs across varying molecular weights and isoelectric points, achieving coverage rates >80% (82% by 2D-Western Blot; 95% by AAE-LC-MS). The antibody pair detects over 2000 distinct CHO HCPs and covers all 25 CHO high-risk HCP.

• Excellent Kit Stability

Accelerated stability testing of the complete Vazyme DD8102 kit at 37°C. After 10 days of accelerated, the sample reactivity decreased by less than 20%. Furthermore, all critical parameters – LOD, LOQ, accuracy, precision, and specificity – consistently met the product specifications.

• Minimal Matrix Effects

Spike-and-recovery experiments were conducted with process samples of known concentration across various matrices. Vazyme's product demonstrated significantly lower matrix interference and higher accuracy compared to competitor kits, evidenced by smaller variations in detected concentrations and consistently acceptable recovery rates.

• Superior Precision and Accuracy

Precision (intra- and inter-assay) and accuracy were evaluated using Quality Controls (QCs) at 5 concentrations prepared from process samples of known concentration. All coefficients of variation (CV) were below 15%, and all biases were within ±20%, confirming the assay meets requirements for precision and accuracy.

 Components  

 Storage  

Store at 2 ~ 8°C and ship on ice pack.