Description

SHENTEK™ Plasmid DNA Quantitation Kit is used to quantitate plasmid DNA residues in gene therapy products, such as the plasmid DNA of lentiviral vector preparation in CAR-T cell therapy. This kit uses duplex real-time PCR technology to detect trace amounts of residual plasmid DNA by means of consensual plasmid sequences, such as replicon of ColE1/pMB1/pBR322/pUC. The target gene (FAM) performs rapid, specific, and reliable quantitative determination of the 102 copies/μL level of residual Plasmid DNA. IPC—Internal Positive Control (VIC) is included in the Plasmid Primer&Probe MIX to evaluate the performance of each PCR reaction. Customers can send DNA sequence of empty plasmid backbones to our technicians for confirmation in advance. For extraction information, please refer to the SHENTEK™ Residual Host Cell DNA Sample Preparation Kit User Guide (Product No. 1104191).

Introduction

Components	Shipping Condition	Unit Size	Product Line	Detection Method
Plasmid linear DNA Control	-20℃	100 Reactions	SHENTEK™	Probe-based qPCR
qPCR Master MIX
DNA Dilution Buffer (DDB)
Plasmid Primer&Probe MIX (Incl IPC)	-20℃, protect from light

Specification

Range	4.97-4.97x106 copies/μL, R2=0.99968, AE=94.3%
Accuracy	Recovery = 88.4%-115.2% , CV<30%
LOQ	4.97 copies/μL
LOD	1.66 copies/μL
Precision	3.3%-17.8% (<30%)
Robustness	Freeze-thaw stability over 5 cycles
Robustness	Instrument suitability not limited to Thermo, Biorad, Roche, HZSKBio qPCR equipments

Documents

User Guide

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SHENTEK™ Residual Host Cell DNA Sample Preparation Kit

Residual Plasmid DNA Quantitation Kit (3G) SHENTEK™