MDCK Host Cell DNA Residue Detection Kit is used for the quantitative analysis of MDCK host cell DNA residuce in intermediate samples, semi-finished and finished products of vaious biological products.

This kit adopts Taqman fluorescent probe and the polymerase chain reaction (PCR) method, which has fg level minimum detection limit and can specifically and quickly detect the residual MDCK cell DNA. The kit needs to be used together with the the Residual DNA Sample Preparation Kit (Cat# 18461ES).

Feature

• Compliance with regulations: the products are fully validated according to the requirements of Chp, USP, ICH, etc., and their performance is in line with Chinese and foreign regulations and standards;
• Guarantee of quality: the raw materials of the kits are all self-developed, and the qPCR Mix and other enzyme products are produced in an ultra-clean enzyme factory;
• High sensitivity: the limit of quantification can reach 0.5 fg/μL level;
• High precision: high intra-batch repeatability and low inter-batch variation;
• Strong exclusivity: specific detection of residual DNA in MDCK cells without interference from other exogenous genomic DNA;
• Strong anti-interference: add internal control (IC), easy to exclude sample interference, reaction preparation abnormalities and other factors.

Application

Residual MDCK Host Cell DNA test in biological products.

Specification

Components

^*IC：Internal control.

Storage

This product should be stored at -25~-15℃ for 2 years.

Both 41319-A and 41319-B should be stored protected from light.

Figures

Limit of quantification

MDCK DNA was detected at 3 fg/uL, 1 fg/uL, 0.5 fg/uL, and 0.1 fg/uL with 10 replicates for each concentration. The results showed that at concentrations of 0.5 fg/uL and above, the CV was <20%, i.e., the limit of quantification of MDCK host cell DNA residues was 0.5 fg/uL.

 Table 1. Limit of quantification (LOQ) assay results for MDCK DNA

Documents:

Safety Data Sheet

Manuals