Product Classification

ResiQuant® E. coli HCP ELISA Kit-Plasmid

ResiQuant® E. coli HCP ELISA Kit-Plasmid

Catalog No.Product NameSpecification
CRH00-3041

ResiQuant® E.coli HCP ELISA

Kit-Plasmid

48T
CRH00-3042

ResiQuant® E.coli HCP ELISA

Kit-Plasmid

96T



Product Overview

The ResiQuant® E. coli HCP ELISA Kit-Plasmid is a simple-to-use and semi-quantitative ELISA kit. This kit is specifically intended for the detection of host cell protein contaminants in products derived from  Escherichia coli     (E. coli) expression. The limit of detection (LOD) for this kit is 0.5 ng/mL, and the limit of quantitation (LLOQ) is 1.0 ng/mL. It is suitable for use throughout the manufacturing process as well as for product release.


Sensitive measurement: the limit of detection (LOD) is 0.5 ng/ml and the limit of quantification (LLOQ) is 1.0 ng/ml; spiking recovery rate qualified, within the range of 70%-130%

High Antibody Coverage: Characterized by Antibody Affinity Extraction (AAE) and Mass Spectrometry, with 84% coverage, highly risk impurities also included

Specifications & Data

LOD0.5 ng/mlStorage2°C to 8°C
LLOQ1.0 ng/mLShipping ConditionDry Ice
Recovery Rate70%~130%Host CellE. coli
Intra-batch≤15%Shelf Life12 months
Inter-batch≤20%Quantity48/96 reactions
AccuracyRSD≤20%IncludesAssay Kit only



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Fig 1. Data analysis is suggested using a nonlinear fit of the sigmoidal curve generated by a range of standard concentrations.

image.png


Fig 2. Antibody coverage rate was evaluated by AAE and LC-MS. E. coli HCPs and AAE purified E. coli HCPs were applied to LC-MS as pre-AAE and Post-AAE respectively. The sum of the identified post-AAE and pre-AAE HCPs was recognized as the total number of the whole HCPs. The recovery rate was calculated using the number of the whole HCPs divided by the number of post-AAE HCPs


Documents

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