Food Safety and Environmental Testing

Allergen Testing by ELISA

CellMadeTM has chosen to implement SENSIspec ELISA methodologies developed by Goldstandard Diagnostics (Budapest, Hungary). Goldstandard Diagnostics provides exceptional validation of their ELISA kits, particularly regarding cross-reactivities, which clearly sets them apart from other food allergen ELISA kit suppliers.

Allergen testing is crucial for identifying and quantifying allergens in food products before they are released, ensuring consumer safety and regulatory compliance. This process aids food manufacturers in pinpointing areas in processing facilities that require decontamination and screening raw materials used during manufacturing. In the European Union, allergen testing is mandatory, with 14 allergens requiring labeling on food products upon identification.

Enzyme-Linked Immunosorbent Assay (ELISA) techniques are commonly utilized due to their sensitivity and specificity in detecting food allergens. In ELISA, allergen proteins are immobilized onto a solid surface and exposed to specific antibodies, forming an antigen-antibody complex. Detection is facilitated through enzyme-conjugated secondary antibodies, leading to a measurable color change proportional to the allergen's presence in the food product. Quantification is achievable by running a standard curve alongside the test samples.

ELISA methods offer advantages such as high sensitivity, with detection possible at low parts per million levels. However, limitations exist, including potential cross-reactivity between allergenic and non-allergenic protein forms. CellMadeTM Laboratories, adhering to ELISA Good Laboratory Practices, employs ELISA methods selected from trusted suppliers and participates in international laboratory proficiency tests to ensure accuracy.

CellMadeTM Laboratories offers comprehensive food allergen testing services tailored to each customer's needs, including product-specific validations if required. Detailed reports are provided summarizing test findings for in-process and batch release testing, along with insights for validation purposes.


Services

Ref Services Description Price
CLM-ALG-1 Almond

LOD: 0.2 ppm; Quantification range: 0.4-10 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-2 Brazil nut

LOD: 0.2 ppm; Quantification range: 1-40 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-3 Casein

LOD: 0.04 ppm; Quantification range: 0.2-6 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-4 Cashew

LOD: 0.2 ppm; Quantification range: 2-60 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-5 Coconut

LOD: 0.4 ppm ppm; Quantification range: 2-30 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-6 Crustaceans

LOD: Soy sauce 1.7 ppb Vegetable soup 3.6 ppb Bakery products 0.9 ppb Fish 8.5 ppb Meat 10.3 ppb; Quantification range: 20-400 ppb (LLOQ - ULOQ)

 On request
CLM-ALG-7 Egg white

LOD: 0.05 ppm; Quantification range: 0.4-10 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-8 Fish

LOD: 1,4 ppm; Quantification range: 4-100 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-9 Gluten – R5 Antibody

LOD: 3 ppm; Quantification range: 3-200 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-10 Hazelnut

LOD: 0.07 ppm; Quantification range: 1-40 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-11 Lupin

LOD: Sausage 0.2 ppm Bread 0.3 ppm Orange juice 0.7 ppm Ketchup 0.1 ppm Croquette 0.2 ppm; Quantification range: 2-30 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-12 Lysozyme

LOD: 2 ppb; Quantification range: 25-250 ppb (LLOQ - ULOQ)

 On request
CLM-ALG-13 Macadamia

LOD: 0.1 ppm; Quantification range: 1-40 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-14 Milk (Casein & BLG)

LOD: 0.05 ppm; Quantification range: 0.4-10 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-15 Molluscs

LOD: 1,7 ppb; Quantification range: 10-400 ppb (LLOQ - ULOQ)

 On request
CLM-ALG-16 Mustard

LOD: 1 ppm; Quantification range: 2-60 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-17 Ovalbumin

LOD: 4 ppb; Quantification range: 25-500 ppb (LLOQ - ULOQ)

 On request
CLM-ALG-18 Peanut

LOD: 0.1 ppm; Quantification range: 1-40 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-19 Pecan

LOD: 0.2 ppm; Quantification range: 2-60 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-20 Pistachio

LOD: 0.13 ppm; Quantification range: 1-40 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-21 Sesame

LOD: 2 ppm; Quantification range: 2-30 ppm (LLOQ - ULOQ)

 On request
CLM-ALG-22 Soybean

LOD: 16 ppb; Quantification range: 40-1000 ppb (LLOQ - ULOQ)

 On request
CLM-ALG-23 Walnut

LOD: 0.35 ppm; Quantification range: 2-60 ppm (LLOQ - ULOQ)

 On request