Food Diagnostics - Allergens

• Cleaning verification for Allergen Control Programs FLASH supports process
• Verification requirements that ensure cleaning method
• Independently validated to effectively remove allergens, are consistently applied

Biocontrol Flash is a rapid snap test for on line verification of protein contamination after cleaning. This protein visual test reacts with protein molecules left on the cleaned surface. As all the big eight allergens specified by FDA are all proteins, this test is used for allergen control by many food manufacturers. The test forms an essential part of the overall HACCP program. It has two levels of sensitivity- 20 ppb when used at room temperature and 3 ppb when incubated at 70°C making it easy for QA managers to manage the risk of cross contamination. Specific levels of the big eight allergens are as specified in the table shown. After activation the swab head change color to green for pass and grey for caution and two shades of purple for fail. Any color change after 14 min should be disregarded.

Video URL : Gliadin / Gluten

This is a rapid test for gluten using the antibody antigen complex in a lateral flow format. This is a qualitative test for gluten which is 50% prolamin and 50% gluten. This follows the rules of Codex Alimentarius which stipulates the use of R5 antibody for detection.    r-Biopharm is the only company that is allowed to ese the R5 antibody for test strips. RIDA QUICK Gliadin is a ready to swab test for gluten detection on production surfaces and is CIP waters. No high dose hook effect is observed at high concentration. The hook effect or the prozone effect is an immunologic phenomenon whereby the effectiveness of antibodies to form immune complexes is sometimes impaired when concentrations of an antibody or an antigen are very high. The formation of immune complexes stops increasing with greater concentrations and then decreases with extremely high concentrations, producing a hook shape on a graph. The detection limit is 1.6 to 3 ppb gluten/100 cm2 on surfaces, 4.4 ppm/kg gluten for raw materials depending on food matrix, processed food 6.3 ppm/kg gluten depending on food matrix, 10 ppt/ml gluten for cleansing water without cleansing reagent and 50-100 ppt for cleansing water with cleansing reagent.

Video URL : Bioavid Lateral Flow Test Procedure

Bioavid Lateral Flow Kits are available for testing the big 8 allergens plus more. This is a qualitative test where little skills are needed. Evaluation of results are done by observing the test and control lines on the dip stick. The procedure is first to swab the surface of an area usually of 100 cm2 with a clean cotton swab and then relelease the sample from the swab into a 1 ml of prepared buffer. Solid samples must be ground and homogeneuos, dissolved in water with added saline (8 gm/l) and throughly mixed. The extracted samples are filtered and added into the assay. The test strip in then dipped into the vial and wait for 5 mins. Read results from the test line. Limit of detection vary according to the sample.

• Accepted as AOAC-OMA (2012.01)
• AACCI 38.50.01
• certified at AOAC-RI (120601)
• Codex Alimentarius Method (Type I)

This method determines and quantifies gluten in corn and wheat based products using an ELIZA method. The kit is designed to determine gluten levels at less than 80 mg/kg and is intended for evaluation samples with respect to the regulatory level of 20 mg/kg. Forn foods to be labelled as gluten free it must have levels less than 20 mg/kg.

This is a sandwich ELIZA test validated for raw products like wheat, rye, barley, buckwheat, rice, corn, oats, teff, and spices and also for processed food like nodles, ready to serve meals, baked products, sausages, beverages, and ice cream. RIDASCREEN Gliadin uses the antibody R5-mAb as specified in the codex and has a detection limit of 1.5mg/kg of gliadin. The limit of quantification is 2.5mg/kg. Extraction of all RIDASCREEN competitive test is by r-Biopharm unique coctail extraction buffer. It has an incubation time of 90 min and is AOAC OMA and AACCI approved.

For a faster test result use RIDASCREEN Fast Gliadin with an incubation time of 30 min. The limit of detection is however higher at 2 mg/kg and limit of quantification is at 5mg/kg. For lower level of detection use RIDASCREEN sensitive with a limit of detection at 0.2 mg/kg of gliadin and limit of quantification of 1.25 mg/kg glaidin.

The incubation time is 60 min. All the above RIDASCREEN test need intact prolamins and larger peptide fragments of sample with at least two epitopes. For smaller fragments use RIDASCREEN competitive. This test has a limit of detection of 1.4 mg/kg of glaidin and a limit of quantification of 5 mg/kg Incubation time is 40 min and the method is AOAC OMA and AACCI approved.

• Accepted as AOAC-OMA (2012.01)
• AACCI 38.50.01
• certified at AOAC-RI (120601)
• Codex Alimentarius Method (Type I)

r-Biopharm SureFood Allergen 4plex Allergen Test Kit is a real-time PCR for the direct, qualitative detection and differentiation of specific wheat (Triticum), barley (Hordeum vulgare) and rye (Secale cereale) DNA sequences. The real-time PCR assay can be performed with commonly used real-time PCR instruments, equipped for detection of four fluorescence emissions at the channels FAM, VIC/HEX, ROX and Cy5 at the same time. The technical validation of instruments was performed on Roche Light Cycler 480 II, Qiagen Rotor-Gene Q, Applied Biosystems 7500, Bio-Rad CFX96, r-Biopharm RIDACYCLER, Agilent AriaDx and Agilent Mx3005P. SureFood PCR tests are also available for other allergens like molluscs, fish, crustacean, sesame, walnut, pistachio, pecan, peanut, macadamia, hazel nut, cashew, brazil nuts, almond, Soya and gluten.