Allergen testing

This assay detects and quantifies almond protein using a highly specific ELISA (Enzyme-Linked Immunosorbent Assay). It confirms the presence or absence of almond contamination in raw materials, finished products, and manufacturing environments—critical for validating allergen-free claims and complying with FDA labeling regulations.

Samples are extracted and tested using a sandwich ELISA kit validated for almond protein. The assay uses antibody-antigen binding with colorimetric detection, and results are compared to a calibrated standard curve. Duplicate wells and positive/negative controls ensure result accuracy and reproducibility.

Results are reported in ppm (mg/kg) of almond protein. The test detects trace levels of contamination, typically as low as 2–5 ppm depending on the matrix, helping manufacturers avoid undeclared allergens and protect consumers with nut allergies.

This assay quantifies bovine serum albumin (BSA), a major whey protein found in bovine-derived ingredients such as colostrum, serum, and dairy protein concentrates. BSA is commonly measured to assess protein quality, processing impact, or validate functional labeling.

Samples are extracted in aqueous buffer and analyzed using either:

– Colorimetric protein assays (e.g., Bradford or BCA) with BSA-specific standards, or

– BSA-specific ELISA, using monoclonal antibodies to detect and quantify BSA against a certified standard curve.

Duplicate runs and quality controls ensure accurate quantification.

Results are reported in mg/g or % w/w of BSA. Values are assessed against specification targets for ingredient consistency, batch-to-batch variation, or formulation transparency.

This assay detects and quantifies Brazil nut protein using a sensitive ELISA (Enzyme-Linked Immunosorbent Assay). It confirms the presence or absence of Brazil nut contamination in raw ingredients, finished products, and production environments—essential for validating nut-free claims and meeting FDA allergen labeling requirements.

Samples are extracted and analyzed using a sandwich ELISA designed specifically for Brazil nut protein. The method uses antibody-based detection with colorimetric readout, and results are calculated against a certified standard curve. Duplicate testing and internal controls are used to ensure precision.

Results are reported in ppm (mg/kg) of Brazil nut protein. The assay is capable of detecting trace contamination at low ppm levels, providing critical assurance for allergen-sensitive consumers and label compliance.

This assay measures casein, the primary protein fraction in milk, to support nutritional labeling and quality control. Casein testing is important for confirming formulation accuracy, detecting adulteration, and ensuring consistent product composition.

Samples are analyzed using validated protein quantification techniques appropriate for dairy matrices. Results represent the concentration of total casein relative to other milk proteins. Quality controls and reference standards are used to ensure accuracy.

Testing verifies protein standardization, supports regulatory compliance, and confirms authenticity of dairy ingredients.

This assay detects and quantifies cashew protein using a highly sensitive ELISA (Enzyme-Linked Immunosorbent Assay). It is used to verify the absence or presence of cashew contamination in raw ingredients, finished products, and facility surfaces—critical for compliance with FDA labeling laws and allergen-control programs.

Samples are extracted and tested using a sandwich ELISA specific to cashew proteins. The method involves antibody-antigen binding with colorimetric detection, and results are measured against a validated standard curve. Duplicate wells and appropriate controls are included to ensure accurate quantification.

Results are reported in ppm (mg/kg) of cashew protein. The test can detect trace levels, typically down to 1–5 ppm depending on the matrix, allowing manufacturers to verify nut-free status and protect allergic individuals.

This assay detects celery DNA using PCR (Polymerase Chain Reaction), a highly specific method used to identify trace levels of celery contamination in food products, supplements, or ingredient supply chains—especially in regions where celery is a regulated allergen (e.g., EU).

DNA is extracted from the sample and amplified using celery-specific primers. The presence of celery is confirmed through real-time or endpoint PCR analysis, with duplicate reactions and appropriate positive and negative controls to ensure result validity.

Results are reported as Detected / Not Detected. The assay typically detects celery down to 10 ppm or lower, depending on the matrix and processing conditions.

This assay detects chestnut DNA using PCR (Polymerase Chain Reaction), a highly specific method for identifying trace amounts of tree nut material. PCR allergen testing is ideal for verifying raw material integrity, cross-contact control, and compliance with allergen labeling standards in processed foods and supplements.

DNA is extracted from the sample and amplified using chestnut-specific primers. The presence of chestnut DNA is confirmed through real-time or endpoint PCR analysis. Duplicate reactions and positive/negative controls are included to validate results and prevent false positives or negatives.

Results are reported as Detected / Not Detected, with sensitivity typically at or below 10 ppm depending on the product matrix. This method is especially useful when protein-based assays (ELISA) are not viable due to extreme processing or hydrolysis.

This assay detects and quantifies coconut protein using a validated ELISA (Enzyme-Linked Immunosorbent Assay). It is used to confirm the presence or absence of coconut contamination in raw materials, finished products, or manufacturing environments—critical for meeting FDA and international allergen labeling requirements.

Samples are extracted and analyzed using a coconut-specific sandwich ELISA. The method uses antibody-based colorimetric detection and quantifies results against a certified standard curve. Positive and negative controls are included to ensure accuracy and reproducibility.

Results are reported in ppm (mg/kg) of coconut protein. The method typically detects trace levels as low as 1–5 ppm depending on the product matrix, making it suitable for verifying allergen-free claims and preventing cross-contact risks.

This assay confirms the presence of corn (Zea mays) using DNA-based identification through PCR. It is used to verify botanical origin in raw ingredients, detect adulteration, and ensure accurate labeling for corn-derived or corn-free products.

DNA is extracted from the sample and amplified using corn-specific primers. PCR amplification confirms the presence of Zea mays DNA, with results determined through endpoint or real-time PCR. Positive and negative controls are used to ensure assay validity.

Results are reported as Detected / Not Detected. This method is suitable for confirming the botanical identity of corn in complex matrices, extracts, or raw material powders.

This assay detects egg proteins, such as ovalbumin and ovomucoid, in food samples to verify allergen-free claims and prevent cross-contact. It is essential for ensuring that even trace amounts of egg are identified in complex matrices, protecting sensitive consumers.

Samples are extracted using a protein solubilization buffer and applied to ELISA plates pre-coated with egg-specific antibodies. After incubation, a secondary enzyme-linked antibody is added, and a colorimetric reaction is developed. The intensity is measured spectrophotometrically and compared to a calibration curve constructed with known standards, with duplicate wells and controls confirming accuracy.

Results are reported in parts per million (ppm). Non-detectable or very low levels indicate that the product is effectively free from egg contamination, while any measurable level suggests potential cross-contact requiring further action.

This assay uses polymerase chain reaction (PCR) to detect trace amounts of fish DNA in food samples. It targets specific genetic markers unique to fish, ensuring that even processed products can be screened for the presence of fish allergens. This is vital for verifying allergen-free claims and for identifying fish species in products where authenticity is questioned.

DNA is extracted from the food sample using protocols that minimize inhibitors. The extracted DNA is amplified using fish-specific primers in a PCR reaction. Amplification is confirmed by gel electrophoresis or real-time PCR analysis (yielding a Ct value), with positive and negative controls ensuring the reliability of the result.

Results are qualitative, typically reported as 'Detected' or 'Not Detected'. A positive result confirms the presence of fish DNA, indicating potential allergen contamination, while a negative result supports a fish-free claim. Even trace detection is significant for allergen management.

This assay detects gluten proteins derived from wheat, barley, or rye in food products. It is critical for confirming that products labeled as gluten-free contain only trace levels of gluten. The method is designed to work with processed foods, ensuring that denatured gluten proteins are still detectable.

Samples are extracted with a specialized buffer that releases gluten proteins from the matrix. The extract is added to ELISA plates coated with antibodies against gluten epitopes. Following incubation and washing, a secondary enzyme-linked antibody is added and a color reaction is developed. Absorbance readings are compared to a standard curve, with duplicate analyses and controls ensuring consistency.

Gluten content is reported in ppm. Values below the established threshold (commonly 20 ppm) confirm gluten-free status, while any level above this may indicate contamination and require corrective measures. The results help verify allergen control and labeling accuracy.

This assay detects and quantifies hazelnut protein using a validated ELISA (Enzyme-Linked Immunosorbent Assay). It confirms the presence or absence of hazelnut contamination in raw materials, finished products, and manufacturing environments, ensuring compliance with allergen labeling regulations and protecting consumers with tree nut allergies.

Samples are extracted and tested using a hazelnut-specific sandwich ELISA. The method uses antibody-based detection with colorimetric readout and compares results against a calibrated standard curve. Duplicate wells and positive/negative controls ensure accuracy and reproducibility.

Results are reported in ppm (mg/kg) of hazelnut protein. The method can detect trace levels, typically down to 1–5 ppm depending on the matrix, making it suitable for verifying “nut-free” claims or identifying cross-contact.

This test quantifies Immunoglobulin G (IgG) — the most abundant immunoglobulin class in bovine colostrum, whey protein fractions, and immunoglobulin concentrate ingredients — in raw materials and dietary supplements using Enzyme-Linked Immunosorbent Assay (ELISA). IgG is the primary bioactive marker used to standardize bovine colostrum and immunoglobulin-enriched dairy ingredients, and its concentration is directly associated with the immune-supporting activity of these products. Accurate IgG quantification is essential for verifying the potency of colostrum and immunoglobulin concentrate raw materials, confirming label claims, and ensuring batch-to-batch consistency of these high-value immune nutrition ingredients. Results are reported in milligrams per gram or as a percentage of total protein.

A representative sample is accurately weighed and dissolved or diluted in an appropriate assay buffer. The quantification of IgG is performed using a validated sandwich ELISA format: a microplate is coated with a capture antibody specific to bovine IgG, followed by incubation with diluted sample and reference standards. After washing to remove unbound proteins, a species- and isotype-specific enzyme-conjugated detection antibody (e.g., anti-bovine IgG horseradish peroxidase conjugate) is added, followed by a chromogenic substrate (e.g., TMB). Quantification is performed against a multi-point calibration curve prepared from a certified bovine IgG reference standard. Samples are analyzed in duplicate or triplicate, and results are calculated from the mean absorbance values.

ELISA is the method of choice for IgG quantification in colostrum and immunoglobulin-enriched dairy matrices due to its high specificity for the target immunoglobulin isotype, sensitivity at the low concentrations relevant to finished supplement products, and ability to distinguish IgG from other immunoglobulin classes (IgA, IgM) and co-occurring dairy proteins. Unlike total protein assays, ELISA provides a direct, antibody-mediated measurement of IgG specifically, ensuring that potency results reflect the immunologically active fraction rather than total protein content. This supports label claim substantiation, raw material qualification, and cGMP compliance under 21 CFR 111.

This assay detects and quantifies lupin protein using a validated ELISA (Enzyme-Linked Immunosorbent Assay). It is used to confirm the presence or absence of lupin contamination in raw materials, finished products, and production environments—critical for meeting allergen labeling regulations in regions where lupin is a regulated allergen (e.g., EU, Australia).

Samples are extracted and tested using a sandwich ELISA specific to lupin protein. The method uses antibody-based colorimetric detection and quantifies results using a certified standard curve. Positive and negative controls are included to ensure accuracy.

Results are reported in ppm (mg/kg) of lupin protein. The method typically detects trace levels as low as 1–5 ppm depending on the matrix, making it suitable for allergen-free claim verification or contamination screening.

This assay detects and quantifies macadamia nut protein using a specific ELISA (Enzyme-Linked Immunosorbent Assay). It verifies the presence or absence of macadamia contamination in raw materials, finished products, or facility environments—helping manufacturers meet allergen labeling regulations and avoid cross-contact issues.

Samples are extracted and analyzed using a macadamia-specific sandwich ELISA. The method uses antibody-based detection with colorimetric readout and compares results to a validated standard curve. Duplicate wells and control samples ensure reliable results.

Results are reported in ppm (mg/kg) of macadamia protein. Detection limits typically range from 1–5 ppm, allowing for sensitive identification of trace contamination to support “nut-free” claims or allergen risk management.

This assay detects and quantifies mustard protein using a validated ELISA (Enzyme-Linked Immunosorbent Assay). It confirms the presence or absence of mustard contamination in raw materials, finished products, and manufacturing environments—essential for verifying “mustard-free” claims and meeting regulatory requirements in regions where mustard is a declared allergen (e.g., EU, Canada).

Samples are extracted and analyzed using a sandwich ELISA with antibodies specific to mustard protein. Colorimetric detection is used, and results are compared to a certified standard curve. Controls and duplicate wells ensure test precision and reliability.

Results are reported in ppm (mg/kg) of mustard protein. The method typically detects down to 1–5 ppm depending on the matrix, making it suitable for trace-level screening and allergen risk management.

This test evaluates an ingredient or finished product for the presence of detectable genetically modified organism (GMO) DNA using polymerase chain reaction (PCR)-based analysis. The assay is designed for materials derived from crops with commercially relevant genetically engineered varieties, such as corn, soy, canola, cotton, sugar beet, alfalfa, papaya, potato, or other applicable source crops. Testing may be performed as a qualitative screening assay, a crop-specific assay, an event-specific assay, or a quantitative real-time PCR (qPCR) assay, depending on the product’s declared species, intended claim, regulatory jurisdiction, and requested reporting threshold.

A representative sample is homogenized under contamination-controlled conditions, and DNA is extracted using a validated method appropriate for the matrix. DNA yield, purity, amplifiability, and the presence of PCR inhibitors are evaluated using suitable internal controls, including a species-specific endogenous gene target where applicable. Extracted DNA is analyzed by conventional PCR and/or real-time qPCR using validated primer and probe sets for relevant GMO screening elements and crop-specific targets. Appropriate assay controls are included in each batch, including extraction blanks, no-template controls, positive GMO DNA controls, non-GMO negative controls, and internal amplification controls. Where the initial screening assay indicates the presence of a GMO-associated sequence, confirmatory testing is performed using additional target-specific methods when sufficient sample DNA and applicable event coverage are available.

PCR is the most direct and widely accepted analytical approach for detecting genetically engineered plant material because it targets DNA sequences introduced, modified, or associated with specific GMO events. Compared with protein-based assays, PCR remains useful for many processed materials where genetically engineered proteins may be degraded or absent, provided that amplifiable DNA remains in the sample. Use of multiple screening targets, taxon-specific controls, and confirmatory event-specific methods improves confidence in the result and helps distinguish true positive findings from environmental or laboratory contamination. The test supports supplier qualification, raw-material verification, non-GMO claim substantiation, and quality-system documentation under dietary supplement cGMP requirements in 21 CFR 111.

This assay detects peanut proteins in food samples using a highly specific immunoassay. It is essential for verifying that products labeled as peanut‑free are free from cross-contact, thereby protecting consumers with peanut allergies.

Samples are extracted in a protein-solubilizing buffer and applied to ELISA plates pre-coated with antibodies against peanut proteins. After incubation and thorough washing, a secondary enzyme-linked antibody is added, and a colorimetric reaction is developed. The resulting absorbance is compared to a calibration curve created from known peanut protein standards, with duplicate wells and controls ensuring accuracy.

Results are reported in parts per million (ppm) of peanut protein. Values below the detection limit confirm the absence of peanut allergens, while any measurable level suggests potential cross-contact that may require process modifications.

This assay detects and quantifies pine nut protein using a specific ELISA (Enzyme-Linked Immunosorbent Assay). It confirms the presence or absence of pine nut contamination in food products, raw materials, or facility environments—critical for verifying “nut-free” claims and complying with allergen labeling requirements.

Samples are extracted using a validated buffer and tested with a pine nut-specific sandwich ELISA. Detection is based on antibody-antigen interaction with colorimetric readout, and results are quantified using a standard curve. Duplicate wells and positive/negative controls are included for quality assurance.

Results are reported in ppm (mg/kg) of pine nut protein. The method typically detects down to 1–5 ppm, providing sensitive detection for allergen risk assessment and label verification.

This assay detects and quantifies pistachio protein using a specific ELISA (Enzyme-Linked Immunosorbent Assay). It confirms the presence or absence of pistachio contamination in raw materials, finished goods, and manufacturing environments—essential for protecting consumers with tree nut allergies and validating allergen-free label claims.

Samples are extracted using a validated buffer and tested using a pistachio-specific sandwich ELISA. Colorimetric detection is used to measure antibody binding, and results are compared to a certified standard curve. Controls and duplicate wells are included to ensure precision.

Results are reported in ppm (mg/kg) of pistachio protein. Detection sensitivity typically ranges from 1–5 ppm depending on the matrix, making it suitable for both allergen screening and final product verification.

This assay detects sesame proteins in food products using an immunoassay format. Sesame is a potent allergen, so accurate detection is critical for verifying allergen claims and preventing cross-contact in production facilities.

Samples are extracted in a buffer optimized for protein recovery and applied to ELISA plates coated with sesame-specific antibodies. After incubation and multiple wash cycles, a secondary enzyme-linked antibody is added and a colorimetric reaction is developed. The absorbance is compared to a calibration curve constructed with sesame protein standards, with replicates and controls ensuring precision.

Results are expressed in ppm of sesame protein. Non-detectable values confirm that the product is free from sesame, while any measurable level indicates possible contamination, prompting review of allergen control measures.

This assay detects allergenic proteins from shellfish and crustaceans in food products. It is critical for ensuring that products labeled as free from these allergens do not contain cross-contact, protecting sensitive consumers from potentially severe allergic reactions.

Samples are extracted using an appropriate buffer and applied to ELISA plates pre-coated with antibodies specific to shellfish allergens. Following incubation and thorough washing, a secondary enzyme-linked antibody is added. The resulting colorimetric change is measured and compared against a calibration curve, with duplicate tests and controls confirming the assay’s reliability.

Results are reported in ppm of allergenic protein. A non-detect result supports a “free from” claim, while any measurable level requires corrective action in processing or labeling to ensure consumer safety.

This assay identifies soy proteins in food samples using a highly specific ELISA method. It is used to verify allergen claims and prevent unintended exposure for soy-allergic consumers, even in processed foods where proteins may be partially denatured.

The sample is extracted with a buffer that efficiently solubilizes soy proteins. The extract is incubated on an ELISA plate coated with soy-specific antibodies. After washing, a secondary antibody linked to an enzyme is added, followed by development of a color reaction. The absorbance is compared to a standard curve generated from soy protein standards, with quality controls ensuring reproducibility.

Results are provided in ppm. Non-detectable or very low levels confirm that soy is either absent or present only in trace amounts, while significant detection indicates potential cross-contact that needs to be addressed.

This assay detects milk proteins in food samples to confirm that products are either free of milk contamination or contain milk as intended. Milk allergens are highly potent and even trace amounts can trigger allergic reactions, making accurate detection critical.

Samples are extracted using a buffer optimized for milk protein recovery and applied to ELISA plates coated with milk-specific antibodies. After incubation and washing, a secondary enzyme-linked antibody is added and a color reaction is developed. The absorbance is measured against a calibration curve generated with milk protein standards, and duplicate analyses verify accuracy.

Results are expressed in ppm. Non-detectable values confirm that the product is free of milk allergens, while any measurable level indicates potential cross-contact, requiring review of manufacturing practices.

This assay detects and quantifies walnut and pecan proteins using a combined ELISA (Enzyme-Linked Immunosorbent Assay) validated for both tree nuts. It confirms the presence or absence of walnut or pecan contamination in raw materials, finished products, or manufacturing environments—critical for verifying allergen-free claims and meeting FDA labeling requirements.

Samples are extracted in a validated buffer and tested using a dual-reactive sandwich ELISA designed to detect both walnut and pecan proteins. Colorimetric detection is used, with results compared against certified standard curves. Controls and duplicate wells are used to ensure test accuracy.

Results are reported in ppm (mg/kg) for combined walnut and pecan protein. The assay typically detects trace levels down to 1–5 ppm, making it suitable for allergen screening in high-sensitivity applications.

This assay detects wheat (Triticum aestivum) DNA using PCR (Polymerase Chain Reaction). It is used to confirm the presence or absence of wheat in raw materials, extracts, and processed products—ideal for verifying ingredient identity and detecting trace wheat contamination in gluten-sensitive or allergen-controlled applications.

DNA is extracted from the sample and amplified using wheat-specific primers. PCR analysis confirms wheat DNA presence through endpoint or real-time detection. Positive and negative controls are included to ensure accuracy and avoid false results.

Results are reported as Detected / Not Detected. This method can identify wheat DNA at trace levels, even in processed or refined products, making it ideal for compliance with gluten-free and wheat-free claims.

This assay measures β-Lactoglobulin, the predominant whey protein in bovine milk, which plays a key role in determining nutritional value and allergen content. Testing supports product standardization, allergen control, and quality assurance for dairy and protein supplements.

Samples are analyzed using validated protein quantification and identification techniques suitable for dairy matrices. The assay distinguishes β-Lactoglobulin from other milk proteins and verifies its concentration or presence within the total protein fraction.

Testing confirms protein profile accuracy, ensures allergen transparency, and verifies compliance with product specifications.