RIDASCREEN® Total Gluten
Art. No. R7041

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RIDASCREEN® Total Gluten

Art. No. R7041

Intended use

RIDASCREEN® Total Gluten is a sandwich enzyme immunoassay for the quantitative determination of intact (non-hydrolyzed) gluten from gluten-containing cereals (wheat, rye and barley) in oat and oat products (oat content > 50 %). The test is AOAC Official Method of Analysis – First Action (2018.15).

For the analysis of oat-free food samples and samples with low oat content
(< 50 %) in the RIDASCREEN® Total Gluten ELISA an application note has been prepared (not part of the AOAC approval). For this purpose, the use of an additional reagent is necessary (RIDASCREEN® Total Gluten Additive TG, Art. No. RA0041). Further information on the use of the reagent can be found in the application note “Analysis of food samples with no or low oat content in RIDASCREEN® Total Gluten”. It is recommended to analyze samples with unknown oat content also according to this application note.

General Information

The use of wheat flour and gluten in foodstuffs is extremely common because of their heat stability and useful effects on e.g. texture, moisture retention and flavor. Coeliac disease is a permanent intolerance to gluten that results in damage to the small intestine and is reversible when gluten is avoided by diet. According to the Codex Alimentarius (CODEX STAN 118/1979) two categories for labeling of food according to the gluten content now exist:
1.) “glutenfree” = Food products, containing < 20 mg/kg Gluten
2.) “very low gluten = Food products containing 20 – 100 mg/kg Gluten
The threshold of 20 mg/kg has been adopted by many national legislations in many countries.

Traditionally, cereal proteins are subdivided according to their solubility (Osborne fractionation). Unfortunately, the subdivision according to solubility is not an accurate criterion, since co-solubilization and co-precipitation occur frequently. Furthermore, additional factors such as temperature can have a high influence on the result. Especially the subdivision into prolamins and glutelins (which form together the gluten proteins) according to their solubility is very difficult.
Due to the combination of four different monoclonal antibodies, the RIDASCREEN® Total Gluten enables the detection of almost all gluten proteins.

Accessories

Dear customers,

we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2024, you can find our documents on the eIFU portal eifu.r-biopharm.com/food.

Specifications
Art. NoR7041
Test formatMicrotiter plate with 96 wells (12 strips with 8 removable wells each)
Sample preparationHomogenization, extraction and centrifugation
Incubation time50 min
Room temperature
LOD (Detection Limit)4 mg/kg (ppm) gluten
depending on matrix
LOQ (Limit of quantification

5 mg/kg (ppm) gluten

Validated matrices

Oat products: wheat in oats, rye in oats, barley in oats, oat-based cookies, oat-based porridge, oat flour, oat flakes, oat groats, oat cereals
oat-free food samples: rice flour, corn flour, soy flour, cookies, sausage, starch, pseudo cereals, legumes, vegetarian meat alternatives

Detected analyte

• gliadins from wheat
• corresponding prolamins from rye and barley
• high-molecular-weight (HMW) glutenin subunits (GS) from wheat and HMW-secalins from rye as well as low-molecular-weight (LMW)-GS from wheat

EvaluationMicrotiter plate spectrophotometer (450 nm)
ApprovalsAOAC-OMA 2018-15, First Action Status