SureFood® ALLERGEN Gluten

Product detail

Real-time PCR kit for the detection of gluten-containing cereal DNA in food and feed

SureFood® ALLERGEN Gluten

Art. No.: S3606

Intended Use

The SureFood® ALLERGEN Gluten is a real-time PCR assay for the direct, qualitative and/or quantitative detection of specific DNA sequences from gluten-containing cereals, including wheat (Triticum spp.), rye (Secale cereale), barley (Hordeum vulgare) and oat (Avena sativa), in food and feed according to Directive (EC) No. 1169/2011.

Each reaction contains an internal amplification control (IAC).

For quantitative determination, the laboratory reference material SureFood® QUANTARD Allergen 40 (Art. No. S3301), containing 40 mg wheat/kg food sample, and a detection system including a standard series are required.

General Information

The real-time PCR assay can be performed with commonly used real-time PCR instruments equipped for simultaneous detection of two fluorescence emission channels, FAM and VIC/HEX.

The instruments internally technically verified include:

Agilent Mx3005P
Agilent AriaDx
Bio-Rad CFX96
Applied Biosystems 7500
Bio Molecular Systems MIC
Qiagen Rotor-Gene Q
Roche cobas® z 480 Analyzer
Roche LightCycler® 480 II

Accessories

SureFood® PREP Advanced
SureFood® QUANTARD Allergen 40
SureFast® Mag PREP Food

Specifications

Parameter	Specification
Art. No.	S3606
Test format	100 reactions
Sample preparation	For DNA preparation, the use of SureFood® PREP Advanced (Art. No. S1053), protocol 1, or SureFast® Mag PREP Food (Art. No. F1060) is recommended.
LOD (Detection limit)	≤ 0.4 mg/kg using SureFood® PREP Advanced, protocol 1.
LOQ (Limit of quantification)	1 mg/kg using SureFood® PREP Advanced, protocol 1.

Files

Instructions for Use (IFU): German/English.
Material Safety Data Sheet (MSDS/SDS): German and English documents.

For batches placed on the market after January 1, 2024, electronic documentation, including the IFU, SDS, Application Notes and Certificate of Analysis (CoA), is available through the manufacturer's eIFU portal.