QuantiFluor® Dx dsDNA System
IVD for Quantitation of Double-Stranded DNA in Solution
- Sensitive and specific quantitation of dsDNA
- Suitable for use with in vitro diagnostic assays, including the OncoMate® MSI Dx Analysis System
- IVD Medical Device
- Manufactured under cGMP for consistent, lot-to-lot performance
Catalog Number:
Size
Catalog Number: E5900
Simple, Accurate DNA Quantitation for Diagnostic Assays
The QuantiFluor® Dx dsDNA System contains a fluorescent DNA-binding dye that enables sensitive quantification of small amounts of double-stranded DNA (dsDNA) in a purified sample. The system can be used with both single-tube and plate fluorometers that are capable of excitation in the range of 475–505nm and measuring emission in the range of 520–550nm.
Reliable Quantitation for the OncoMate® MSI Dx Analysis System Workflow
The QuantiFluor® Dx dsDNA System is an ideal option for the OncoMate® MSI Dx Analysis System, a fluorescent, multiplex PCR-based test to detect microsatellite instability (MSI) in colorectal cancer tumor samples.
Isolate DNA
from FFPE samples using the Maxwell® CSC DNA FFPE Kit and the Maxwell® CSC Instrument
Quantitate DNA
using fluorescent DNA quantitation reagents (e.g., QuantiFluor® Dx dsDNA System) and instruments
Amplify DNA
using the OncoMate® MSI Dx Analysis System
Calibrate the Dye Spectrum
using the OncoMate® 5C Matrix Standards
Separate and Detect Fragments
using the Applied Biosystems® 3500 Dx Genetic Analyzer
Data Analysis and Reporting
using the OncoMate® MSI Dx Interpretive Software
Robust Performance to Support Your Diagnostic Workflows
The QuantiFluor® Dx dsDNA System demonstrated robust performance in a clinical setting, generating DNA quantification values to enable valid results with an amplification-based test, the OncoMate® MSI Dx Analysis System, and further comparison to an orthogonal method. Suitable DNA concentration values for 308 FFPE tumor and normal tissue samples from various sources and exceptional storage duration (>10 years) were generated and contributed to the low sample reprocessing observed for the OncoMate® MSI Dx Analysis System method comparison clinical study.
The QuantiFluor® Dx dsDNA System provided predictive quantification for 308 DNA eluates from formalin-fixed, paraffin-embedded (FFPE) tumor and normal tissue samples.
Medical Information
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Intended Use Statement
The QuantiFluor® Dx dsDNA System is a fluorescent dye-based test intended to quantify double-stranded DNA (dsDNA) in a sample containing purified nucleic acid. Fluorescent output is compared to results from a standard curve to calculate a dsDNA concentration. The dsDNA concentration results from the QuantiFluor® Dx dsDNA System are suitable for use in in vitro diagnostic assays.
The QuantiFluor® Dx dsDNA System is intended for use, in combination with a suitable fluorometer, to perform double-stranded DNA (dsDNA) quantification. The quantification data obtained using the QuantiFluor® Dx dsDNA System is suitable for use in preparation of dsDNA samples intended to be tested for in vitro diagnostic purposes.
The QuantiFluor® Dx dsDNA System is not intended for use as part of a specific in vitro diagnostic test. The QuantiFluor® Dx dsDNA System is intended for professional use only. Diagnostic results obtained using the quantification data identified with this system must be interpreted in conjunction with other clinical or laboratory data.
Protocols
Complete Protocol
Specifications
Catalog Number:
What's in the box?
| Item | Part # | Size | Available Separately |
|---|---|---|---|
QuantiFluor® dsDNA Dye |
E258A | 1 × 1ml | |
|
Lambda DNA Standard |
E259A | 1 × 100μg | |
|
20X TE Buffer (pH 7.5) |
E260A | 1 × 25ml | View Product |
SDS
Search for SDSCertificate of Analysis
Use Restrictions
For In Vitro Diagnostic Use. This product is only available in certain countries.Storage Conditions
U.S. Pat. Nos. 8,598,198 and 9,206,474 and other patents and patents pending.
Resources
Other Resources
Related Products
Frequently Used With
Maxwell® CSC Instrument
Benchtop instrument for automated nucleic acid purification from a range of clinical sample types. For In Vitro Diagnostic Use.
AS6000
Maxwell® CSC DNA FFPE Kit
Isolates DNA from FFPE samples for in vitro diagnostic assays using the Maxwell® CSC Instrument.
AS1350
OncoMate® MSI Dx Analysis System
IVD Medical Device for MSI testing. PCR-based fragment-sizing test used to determine microsatellite instability (MSI) status.
MD2140
OncoMate® 5C Matrix Standard
Used to calibrate capillary electrophoresis instruments prior to running the OncoMate® MSI Dx Analysis System.
MD4850
