Description

This kit employs a solid-phase enzyme-linked immunosorbent assay (ELISA) using a double-antibody sandwich technique to quantify residual host cell proteins (HCPs) originating from the CHO-K1 cell line.

A sheep polyclonal antibody specific to CHO-K1 HCPs is used in the assay to capture any residual HCPs in the samples. Calibration standards or test samples, together with the HRP-labeled anti-CHO-K1 HCP antibody, are simultaneously added to the microtiter plate pre-coated with an affinity-purified capture antibody, followed by incubation and washing. TMB (3,3′,5,5′-tetramethylbenzidine) substrate is added to the reaction and catalyzed by HRP to produce a blue-colored product (maximum absorption at 655 nm). The stop solution is then added to terminate the enzymatic reaction, resulting in a yellow-colored product (maximum absorption at 450 nm). The absorbance at 450 nm is positively correlated with the HCP concentration in both the calibration standards and the samples. The concentration of HCPs in the samples can be calculated using a dose–response curve.

Overview

Components	Shipping Condition	Unit Size	Detection Method
Anti-CHO-K1 HCP Microtiter Strips	2-8℃	96 Tests	Sandwich ELISA
CHO-K1 HCP Calibration Standard
Reconstitution Solution
Diluent
Wash Buffer Concentrate (10×)
Anti-CHO-K1 HCP:HRP (100×)
TMB Substrate
Stop Solution
Sealing Film

Specification

Linearity & Range	3-300 ng/mL, R²>0.990
Accuracy	Recovery Rate= 94.2%-122.6%
LLOQ	3 ng/mL
ULOQ	300 ng/mL
Precision	2.6%-6.1% (CV≤20%)
Antibody Coverage (IMBS-LC-MS)	94.6%
Specificity	No cross-reactivity with Sf9, HEK293T, E.coli BL21, P.pastoris HCP.
Robustness	Incubate at 25±5℃, CV≤ 20%
Robustness	Instrument suitability not limited to MD Spectra Max ABS and Thermo Multiskan FC

CHO K1 HCP ELISA Kit (one-step ELISA) SHENTEK®