QuantiFluor® Dx dsDNA System

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.

Diagram showing how the quantifluor DX DNA binding dye is used to quantify DNA in diagnostic assays.

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.

Illustration of a Maxwell CSC Instrument for DNA Isolation

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

Illustration of a PCR amplification tube and pipette tip

Amplify DNA

using the OncoMate® MSI Dx Analysis System

Illustration of an electropharogram for CE calibration

Calibrate the Dye Spectrum

using the OncoMate® 5C Matrix Standards

Illustration of a capillary electrophoresis instrument

Separate and Detect Fragments

using the Applied Biosystems® 3500 Dx Genetic Analyzer

Illustration of an electropherogram the OncoMate MSI Dx Analysis System

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.

17949ma — 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

QuantiFluor® Dx dsDNA System Technical ManualPDF (1944 KB) – English

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

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Certificate of Analysis

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Use Restrictions

For In Vitro Diagnostic Use. This product is only available in certain countries.

QuantiFluor® Dx dsDNA System

IVD for Quantitation of Double-Stranded DNA in Solution

Simple, Accurate DNA Quantitation for Diagnostic Assays