Generon solutions-for-allergens-detection product-catalogue-rev1_150415_nb

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Generon solutions

for allergens detectionProduct Catalogue

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In the modern industrial high throughput and

automated food processing, allergens are

becoming an increasingly important issue for

food safety.

Although the dose/response thresholds have

not yet been defined (as they may vary

among individuals), some individuals are so

sensitive to these allergens that even a

miniscule amount can cause serious problems

or even death.

In Europe, a norm concerning the control of

food allergens was issued in 2003 (Dir.

2003/89/CE) and later amended in 2006 (Dir.

2006/142/CE). The norm includes a list

(Annex IIIa) of ingredients that must be

compulsory pointed out in the label as they

can elicit allergic syndromes.

Food companies but also restaurants must

therefore aim for a real and effective control

of the allergen contamination through

convenient and reliable methods detecting

and n case quantifying allergens in order to

check effectiveness of cleansing procedures

and ingredients segregation. This will in turn

guarantee consumers about the trueness of

the labeling thus providing a real protection

of allergic individuals.

Allergens contamination may be revealed

through the specific detection either of the

allergen itself or of a marker indicating the

potential presence of the allergen, markers

include: specific proteins and/or DNA

fragments of the allergenic ingredient.

Although LC-MS is becoming popular in this

field, ELISA and PCR are the most diffused and

convenient methods for the detection and

quantification of food allergens as they

require inexpensive instruments and simple

laboratories setup. Both these methods have

analytical limits therefore, when possible,

their combined use is the most appropriate

approach according to scientific literature.

Thanks to the internal R&D activities and to

the collaboration with highly qualified

technical partners Generon offers clients a

comprehensive portfolio of products for the

detection of allergens including both

immunochemical and molecular kits. Generon

catalogue includes also various process

controls to increase reliability of the tests.

Catalogue Index

• Allergens Molecular Detection

• Ion-Force DNA extraction Page 3

• DNA extract Quantification Page 4

• SPECIALfinder™ Products Page 5

• Allergens Immunochemical Detection

• ELISA tests Page 11

• Lateral flow tests Page 15

• Laboratory Setup

• Equipment and Accessories Page 16

Summary

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The sampling procedure determines the

“representativeness” of a result, whereas

quality and quantity of the analytes may vary

depending on the sample preparation.

Sampling and sample preparation are thus

crucial steps in the process of allergen

detection.

The limit of detection of the analytical

method as a whole is determined, not by the

most sensitive part of the procedure, but by

the least. In most cases this is the sample size.

A sample has to be representative of the

batch/lot of the product from which it was

taken, and the sample plan and sample size

have to meet statistical requirements with

respect to homogeneity and threshold limit

up to which the result should be reliable.

IonForce DNA Extractor is a kit planned to

maximize the yield and purity of the DNA

extracted from simple or complex matrixes

(rich in PCR inhibitors). It is an essential

system to obtain repeatable and reproducible

data in allergen molecular detection from

samples containing minimal traces of

contaminants.

• KEY Advantages

• 1-4-ALL APPROACH allows

extraction from swabs, vegetal or

animal matrices using the same kit

with specific protocols

• SCALABLE PROTOCOL allows

extractions from large and

representative sampling units

• FRAGMENTED DNA RECOVERY

allows extractions from processed

matrices

• PROGRESSIVE CLEAN-UP allows

removal of PCR inhibitors from

complex matrices

Ion-Force DNA Extraction

Core components

EXD001 Ion Force DNA extractor - 100 extractions

EXD010-P DNA Extraction Vacuum BOX

EXD010-A Adapters for Vacuum BOX (12 Pack)

ACC2908 Vacuum Pump for ION-Force

Ancillary Equipment for sample preparation phase

ACC2080 Benchtop Waring blender

ACC2525 200 ml PP sample containers

Ancillary Equipment for extraction phase

ACC2400 TS Heating-ThermoMixers, for 1 Thermoblock

ACC2402 TS Exchangeable thermoblock for 6x50 ml tubes

ACC2029 Water heating bath

ACC2507 15 ml PP tubes

ACC2508 50 ml PP tubes

ACC2907 Disposable syringe reservoirs ION-Force

ACC2906 Syringe disc filters for ION-Force

ACC2564 2.0 ml microtubes

ACC2905 Microtube rack

ACC2063 Microcentrifuge 0,5-2 ml tubes 14500 rpm

ACC2008 Benchtop Centrifuge fixed rotor for 50 ml tubes

ACC2007 15 ml tube adaptors for ACC2008

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The overall testing success in molecular

methods depends on DNA isolation. For many

reasons different matrices and also different

samples yield different amount of DNA

extract per gram. DNA Quantity defines

representation, and the contribution to

sampling error.

It’s therefore convenient to measure the

quantity of the DNA obtained after the

extraction and to normalize the quantity of

DNA loaded in a molecular reaction because

normalization:

• Provides uniformity in testing

• To comply with the sampling scheme

• To comply with validated process/assays

• Enhances robustness of testing, higher

success rate, hence, in the long run

reduces cost, and on the average may

improve turn around time

• Although qPCR enables in-assay

normalization, normalization allows for

semi-quantitative analysis.

DNA extract Quantification

Equipment and reagents for DNA Quantification

ACC040 Promega Quantus Fluorimeter

ACC040DS Quantus dsDNA reagent - 2000 Reactions

ACC040T Quantus 0,5 ml tubes - 5000 pcs

ACC2064 Palmtop spin-down centrifuge for tubes and PCR strips 7200 rpm

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Real-Time PCR is the gold-standard for the

detection of DNA of contaminating

ingredients (like allergens) as it offers many

analytical advantages, for example: the

possibility to include a process control and/or

a reaction control; the possibility to detect

multiple allergens on the same DNA extract;

the possibility to detect the allergen even if

previously exposed to the cooking

temperatures of most food because DNA

typically remains intact.

In addition PCR-based allergens analyses

might include testing for presence of

amplifiable DNA from the particular species of

interest or from any amplifiable DNA from

plants or Eukaryotes as a further process

control.

SPECIALfinder is the portfolio of products for

the DNA based detection of allergens

developed by Generon that includes:

SPECIALfinder Assays - tests developed and

validated according to UNI-EN 15634-1: 2009

guidelines to detect the target allergen DNA

with high specificity and sensitivity. Absence

of cross-reactivity was tested towards a large

number of food ingredients to avoid false

positives. All the tests are made using prime-

quality molecular biology grade reagents.

Combining SPECIALfinder Assays to ION-

FORCE DNA Extractor, it’s possible to perform

allergens detection on any kind of matrix:

ingredients, semi-finished and finished

products environmental swabs.

SPECIALfinder DigiCount - total DNA

extracted from allergens using Generon ION-

Force DNA with SPECIALfinder Assays target

sequences content, quantified using Droplet

Digital PCR technology.

SPECIALfinder spyX - powdered allergen

dispersions contaminating corn flour at 200

ppm that can be used as analytical process

and extraction control with both molecular

and immunochemical methods.

Eventually, SPECIALfinder constitutes a turn-

key solution for demanding clients willing to

perform allergens control with a high level of

accuracy and confidence in the results.

SPECIALfinder™ Products

SPECIALfinder™ Products

• SPECIALfinder™ Assays Page 5

• SPECIALfinder™ DigiCount Page 7

• SPECIALfinder™ SpyX Page 8

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Thanks to the internal R&D activities and to

the collaboration with highly qualified

technical partners Generon developed a

comprehensive portfolio of assays for

allergenic substances detection via PCR.

SPECIALfinder assays are extremely useful to

detect allergens in highly processed foods

because DNA is less prone to degradation

than proteins. Moreover, for celery, PCR is the

only tool to detect the allergen.

PCR is extremely specific and so the risk of

false positives is almost null. All the kits were

extensively tested against multiple food

ingredients to verify the absence of cross-

reactivity when working according to

instructions.

The DNA extracted from the matrices to be

controlled can be used to detect multiple

parameters, moreover the majority of the

tests share the same thermal profile, thus

SPECIALfinder allows for a very smooth and

convenient test procedure.

SPECIALfinder™ Screening Assays should be

paired with an appropriate polymerase mix

that contains an internal amplification control

(IAC) for identification of false-negative results

due to PCR inhibition, although when

performing amplifiability controls this is

redundant.

SPECIALfinder™ Assays

Mastermixes

Part # Description Amount

ENG002 GENERase PLUS Mastermix 100 Reactions

ENG002-50 GENERase PLUS Mastermix 50 Reactions

Complementary polymerases to assays sold separately. GENERase PLUS includes the internal amplification control to be detected in

the HEX fluorophore channel.

Assays


PAV01A SPECIALfinder Soy (soia) 100 Reactions

PAV01A-50 SPECIALfinder Soy (soia) 50 Reactions

PAV02A SPECIALfinder Peanut (arachide) 100 Reactions

PAV02A-50 SPECIALfinder Peanut (arachide) 50 Reactions

PAV03A SPECIALfinder Hazelnut (nocciola) 100 Reactions

PAV03A-50 SPECIALfinder Hazelnut (nocciola) 50 Reactions

PAV05A SPECIALfinder Pecan Nut (noce Pecan) 100 Reactions

PAV05A-50 SPECIALfinder Pecan Nut (noce Pecan) 50 Reactions

PAV06A SPECIALfinder Walnut (noce) 100 Reactions

PAV06A-50 SPECIALfinder Walnut (noce) 50 Reactions

PAV07A SPECIALfinder Pistachio Nut (pistacchio) 100 Reactions

PAV07A-50 SPECIALfinder Pistachio Nut (pistacchio) 50 Reactions

PAV08A SPECIALfinder Cashew (anacardo) 100 Reactions

PAV08A-50 SPECIALfinder Cashew (anacardo) 50 Reactions

PAV09A SPECIALfinder Almond (mandorla) 100 Reactions

PAV09A-50 SPECIALfinder Almond (mandorla) 50 Reactions

PAV10A SPECIALfinder Rye (segale) 100 Reactions

PAV10A-50 SPECIALfinder Rye (segale) 50 Reactions

con/nue→

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SPECIALfinder™ Assays

Assays


PAV11A SPECIALfinder Oats (avena) 100 Reactions

PAV11A-50 SPECIALfinder Oats (avena) 50 Reactions

PAV13A SPECIALfinder Sesame (sesamo) 100 Reactions

PAV13A-50 SPECIALfinder Sesame (sesamo) 50 Reactions

PAV15A SPECIALfinder Celery (sedano) 100 Reactions

PAV15A-50 SPECIALfinder Celery (sedano) 50 Reactions

PAV16A SPECIALfinder Brazil nut (noce brasiliana) 100 Reactions

PAV16A-50 SPECIALfinder Brazil nut (noce brasiliana) 50 Reactions

PAV20A SPECIALfinder Fish (pesce) 100 Reactions

PAV20A-50 SPECIALfinder Fish (pesce) 50 Reactions

PAV21A SPECIALfinder Macadamia Nut (macadamia) 100 Reactions

PAV21A-50 SPECIALfinder Macadamia Nut (macadamia) 50 Reactions

COMBOScreen Boxes


PAV00C SPECIALfinder – Combo Kit - 4xTargets (25 Rx/Target) 100 Reactions

Convenient boxes containing multiple assays on customer choice (to be selected among the target listed above). For evaluationpurposes only.

Generic Amplifiability Target


PGE06A MODIfinder 28S Assay 100 Reactions

PGE06A-50 MODIfinder 28S Assay 50 Reactions

PGE08A MODIfinder Chloroplast Endo Assay 100 Reactions

PGE08A-50 MODIfinder Chloroplast Assay 50 Reactions

All the assays allows for qualitative DNA detection with a detection limit of 5 genomic copies depending on matrix and DNApreparation. Reaction volume 20 µl (sample 5 µl). Each assay box contains a positive and negative control.

SPECIALfinder assays for Lupine (lupino) - Barley (orzo) - Mustard (senape) - Gluten (glutine) - Crustaceans (crostacei) - Shellfish(molluschi) are in development.

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SPECIALfinder™ DigiCount

Standard Solutions Catalog


PAV01R SPECIALfinder DigiCount Soy (soia) 1 Vial

PAV02R SPECIALfinder DigiCount Peanut (arachide) 1 Vial

PAV03R SPECIALfinder DigiCount Hazelnut (nocciola) 1 Vial

PAV05R SPECIALfinder DigiCount Pecan Nut (noce Pecan) 1 Vial

PAV06R SPECIALfinder DigiCount Walnut (noce) 1 Vial

PAV07R SPECIALfinder DigiCount Pistachio Nut (pistacchio) 1 Vial

PAV08R SPECIALfinder DigiCount Cashew (anacardo) 1 Vial

PAV09R SPECIALfinder DigiCount Almond (mandorla) 1 Vial

PAV10R SPECIALfinder DigiCount Rye (segale) 1 Vial

PAV11R SPECIALfinder DigiCount Oats (avena) 1 Vial

PAV13R SPECIALfinder DigiCount Sesame (sesamo) 1 Vial

PAV15R SPECIALfinder DigiCount Celery (sedano) 1 Vial

PAV16R SPECIALfinder DigiCount Brazil nut (noce brasiliana) 1 Vial

PAV20R* SPECIALfinder DigiCount Fish (pesce) 1 Vial

PAV21R SPECIALfinder DigiCount Macadamia Nut (macadamia) 1 Vial

Target DNA extracted from certified material using ION-Force DNA Extraction kit, quantified using ddPCR and the respective

SPECIALfinder assay. Each vial contains 100 µL of standardized buffered solution of eukaryotic DNA at 100 copies/µL.

(*) By default the DNA is extracted from cod, other species available on request.

The basis of digital PCR (dPCR) is to quantify

the absolute number of targets present in a

sample, using limiting dilutions, PCR and

Poisson statistics. To do so, the PCR mix is

distributed across a large number of

partitions containing zero, one or more copies

of the target nucleic acid. After end-point PCR

amplification, each partition is scrutinized and

defined as positive (‘‘1’’, presence of PCR

product) or negative (‘‘0’’, absence of PCR

product) hence the term ‘‘digital’’. The

absolute number of target nucleic acid

molecules contained in the original sample

before partitioning can be calculated directly

from the ratio of positive to total partitions,

using binomial Poisson statistics.

Digital PCR is an alternative technique for

quantifying gene copy number which may

provide more accurate measurements than

other approaches currently available as it is

not dependant on amplification efficiency. Of

particular importance, ddPCR measurements

are made independent of any calibrator and,

therefore, this technique has the potential to

be considered as a primary method for use in

certification of nucleic acid reference

materials.

The measurement principle has a high

metrological quality and can overcome

several of Real-Time GMO analysis difficulties

by transforming exponential data from

conventional PCR to digital signals that simply

indicate whether or not amplification has

occurred after a defined number of cycles.

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SPECIALfinder™ SpyX

Spiked matrix catalog


PAV01X SPECIALfinder spyX Soy (soia) 1 Tube

PAV02X SPECIALfinder spyX Peanut (arachide) 1 Tube

PAV03X SPECIALfinder spyX Hazelnut (nocciola) 1 Tube

PAV04X SPECIALfinder spyX Wheat (frumento) 1 Tube

PAV06X SPECIALfinder spyX Nut (noce) 1 Tube

PAV07X SPECIALfinder spyX Pistachio (pistacchio) 1 Tube

PAV08X SPECIALfinder spyX Cashew (anacardo) 1 Tube

PAV09X SPECIALfinder spyX Almond (mandorla) 1 Tube

PAV10X SPECIALfinder spyX Rye (segale) 1 Tube

PAV11X SPECIALfinder spyX Oats (avena) 1 Tube

PAV13X SPECIALfinder spyX Sesame (sesamo) 1 Tube

PAV15X SPECIALfinder spyX Celery (sedano) 1 Tube

PAV16X SPECIALfinder spyX Brazil nut (noce brasiliana) 1 Tube

PAV18X SPECIALfinder spyX Lupin (lupino) 1 Tube

PAV20X SPECIALfinder spyX Fish (pesce) 1 Tube

PAV21X SPECIALfinder spyX Macadamia Nut (macadamia) 1 Tube

PAV05X SPECIALfinder spyX Pecan Nut (noce Pecan) 1 Tube

PAV12X SPECIALfinder spyX Barley (orzo) 1 Tube

PAV14X SPECIALfinder spyX Mustard (senape) 1 Tube

PAV19X SPECIALfinder spyX Crustaceans (crostacei) 1 Tube

Each 50 ml tube contains 200 ppm (mg/kg) of freeze-dried allergen dispersed in 5 g of corn flour. Customizations are available on

demand

Process control is defined as an activity

involved in ensuring a process is predictable,

stable, and consistently operating at the

target level of performance with only normal

variation.

The importance of process control is often

undervalued in both molecular biology (as

attention was mainly oriented toward the

primers&probe design) and immunochemistry

(focus on antibody only).

In both these technical approaches the

number of steps composing the process

cannot be reduced just to the detection and

the matrix has a deep impact in the outcome

of the analysis.

To address this topic Generon developed SpyX

– freeze dried and powdered allergens

dispersed in corn flour to be processed as

unknown samples or further dispersed to

validate analytical processes on specific

matrices.

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Allergens Immunochemical Detection

Food allergies affect an estimated 2 to 4% ofthe population around the world, often withrisks of severe effects, thus making foodallergies a serious concern for public healtharound the world. While declaration ofingredients derived from allergenic sourceswhen used as direct ingredients or processingaids has helped to protect allergic consumerscross-contact can occasionally occur despitethe food manufacturer’s best efforts to avoidit. The food industry strives to mitigate thisrisk through use of allergen control plans andvalidated cleaning and sanitation procedures.

Although information on minimum elicitingdoses of allergic individuals has emerged forvarious food allergens in recent years, there isstill little consensus in the scientificcommunity about it. Therefore currentlymany countries have not implementedregulatory thresholds. Japan currentlyrequires labeling when the concentration ofprotein from the allergenic source is > 10ppm.

With the lack of regulatory thresholds, foodindustry is tasked with complying withessentially a zero threshold level of allergenicresidue. This is operationally impossible giventhe complexity of manufacturing facilities and

the numerous routes of allergencontamination and cross-contact that canoccur throughout the supply chain.

Analytical validation to ensure removal ofallergenic residue from equipment surfaces orto ensure that the finished product does notcontain the allergenic residue of concern isutilized by the food industry to minimize therisk of hidden allergens in the products.

There are numerous quantitative andqualitative methods that are available formonitoring residues from allergenic sources.It is quite important for food manufacturers tounderstand the advantages and limitations ofthe available analytical tools when selectingan appropriate method to ensure that theanalytical results provide meaningful datathat can be used for risk managementpurposes.

Immunochemical methods are a broadclassification of analytical methods used forthe detection of allergenic food residues.These methods rely on binding of specificantibodies to the allergenic food protein to bedetected or to a protein typical of theallergenic substance.

Products

• ELISA kits Page 10

• Gluten detection Page 11

• Other allergens Page 12

• Histamine detection Page 13

• Lateral Flow kits Page 14

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Enzyme-linked immunosorbent assays

(ELISAs) are the methods most widely used by

the food industry for detecting specific

allergenic protein.

ELISAs provide several advantages including:

• They detect protein(s) from the allergenic

source of interest, which make these

assays ideal for validation of the removal of

specific allergenic proteins

• The readout is obtained by the

development of a visible color thus

allowing either a quantitative analysis

through a inexpensive spectrophotometer

or a semi-quantitative measurement

through a visual evaluation.

• They are sufficiently sensitive to ensure the

safety of the allergic consumer (detection

limits generally range in the low milligram

per kilogram [ppm] range)

• The reagents used in the assay are suited

for use within the food processing facility

• They provide a rapid assessment that can

be run in the food processing facility or in a

food industry laboratory.

Quantitative ELISAs can be developed in the

sandwich or competitive formats. The

sandwich ELISA is the most common format

used for detection of food allergens; the

intensity of the color is proportional to the

concentration of allergen present in the

sample.

Quantification can be accomplished by

comparing the absorbance of each sample to

the absorbance of a standard curve.

In competitive ELISA any allergenic protein

present in the sample will competitively

inhibit binding of the antibodies so color

intensity is inversely proportional to the

concentration of the allergen present in the

sample. One advantage of competitive ELISA

is that it allows detection of fermented or

hydrolyzed proteins where the allergenic

proteins may be partially digested.

Generon offers a comprehensive panel of

ELISA kits to detect allergens in swab and food

products thanks to the collaboration with

international partners like Elution

Technologies, Ingenasa and LDN which where

selected after an extensive evaluation of their

kit performances in our R&D laboratory.

Generon provides also a complete pre- and

post-sales support to bring the best from

these analytical tools through on-site

trainings.

Our catalogue also include all the ancillary

equipment to perform the experiments and

process controls (see SPECIALfinder spyX @

page 8) to verify their correct execution.

Allergens ELISA Detection

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Gluten ELISA Detection

The term “gluten” refers to a specific complex

of proteins found in the endosperm of some

cereal grains (e.g. wheat, rye, and barley). It is

the group of proteins that give elasticity to

dough, allowing it to rise or give a chewy

texture to baked goods.

Celiac disease is a chronic inflammatory

disorder of the small intestine in genetically

susceptible individuals. It is triggered by

ingesting gluten.

As many as 1% of the general population in

the world will develop celiac disease, while

the prevalence is up to 10% for those with an

affected immediate family member. Although

celiac disease has no known cure, individuals

who have this disease are advised to avoid all

sources of gluten in their diet. Over time,

strictly avoiding consumption of all gluten

sources can improve the symptoms and

reduce the associated health risks of celiac

disease.

Gluten sensitivity is an inflammatory

condition caused by dietary gluten in the

intestines. This is distinct from celiac disease

in that it is not an autoimmune disorder and

there is no simple antibody test for this

condition. It is difficult to estimate the

prevalence of this condition due to a high rate

of self-diagnosis, it’s estimated that gluten

sensitivity affects 6% of the population. The

only reliable treatment is the elimination of

gluten from the diet.

Both EFSA and FDA issued a final rule that

defines what characteristics a food has to

have to bear a label that proclaims it “gluten-

free.” The rule also holds foods labeled

“without gluten,” “free of gluten,” and “no

gluten” to the same standard. The limit of

tolerated contamination was set at 20 ppm.

Generon supplies Ingenasa R5 based ELISA

kits compliant to the indications of the CODEX

Alimentarius.

Ingenasa Kits for the ELISA detection of gluten

Part # Description

LFD030-Q Ingezim Gluten kit - Quick: R5 antibody based detection Sandwich ELISA kit to quantify prolamines from

wheat, rye and barley in food declared as gluten-free. Detection limit: 1.5 mg/kg (ppm) gliadin or 3.0 mg/kg

(ppm) gluten. The kit includes an extraction buffer β-mercaptoethanol Free and 5 standard points for

calibration curve. 96 determinations in 12x8 well precoated strips.

LFD031 Ingezim semiQ Gluten Kit: R5 antibody based detection Sandwich ELISA kit to visually detect presence of

gluten over a precautional threshold of 10 ppm. 32 Determinations.

LFD053 Ingezim Hydrolyzed Gluten kit: R5 competitive ELISA to quantify potential toxic peptide sequences from

prolamines from wheat, rye and barley in fermented and hydrolyzed food (e.g. beer, starch, starch syrup, malt

extracts); sample preparation with a dedicated patented buffer. Detection limit: 0.25 mg/kg (ppm) hydrolyzed

gluten. 48 Determinations in 6x8 wells precoated strips.

MCE024 Gluten Extraction Cocktail Solution with β-mercaptoethanol 1000 ml

MCE024-1 Gluten Extraction Cocktail Solution with β-mercaptoethanol 100 ml

MCE024-5 Gluten Extraction Cocktail Solution with β-mercaptoethanol 500 ml

Elution Technologies ELISA kits

Part # Description Amount Assay Range

E-75ALM (E-75ALM-48) Almond Protein ELISA Kit 96 (or 48) Determinations 1.0 – 27 ppm

E-75CAS (E-75CAS-48) Bovine Casein ELISA Kit 96 (or 48) Determinations 0.5 – 12 ppm

E-75MLK (E-75MLK-48) Bovine Total Milk ELISA Kit 96 (or 48) Determinations 1.0 – 81 ppm

E-75BZL (E-75BZL-48) Brazil Nut Protein ELISA Kit 96 (or 48) Determinations 1.0 – 27 ppm

E-75CSH (E-75CSH-48) Cashew Protein ELISA Kit 96 (or 48) Determinations 0.9 – 24.3 ppm

E-75CNT (E-75CNT-48) Coconut Protein ELISA Kit 96 (or 48) Determinations 2.0 – 54 ppm

E-75RST (E-75RST-48) Crustacean Protein ELISA Kit 96 (or 48) Determinations 2.0 – 54 ppm

E-75EOM (E-75EOM-48) Egg White Protein ELISA Kit 96 (or 48) Determinations 0.5 – 13.5 ppm

E-75FSH (E-75FSH-48) Fish Protein ELISA Kit 96 (or 48) Determinations 1.0 – 27 ppm

E-75HZL (E-75HZL-48) Hazelnut Protein ELISA Kit 96 (or 48) Determinations 1.0 – 81 ppm

E-75MCD (E-75MCD-48) Macadamia Nut Protein ELISA Kit 96 (or 48) Determinations 0.3 – 27 ppm

E-75MSK (E-75MSK-48) Mollusk Protein ELISA Kit 96 (or 48) Determinations 1.0 – 27 ppm

E-75MST (E-75MST-48) Mustard Protein ELISA Kit 96 (or 48) Determinations 1.5 – 40.5 ppm

E-75PNT (E-75PNT-48) Peanut Protein ELISA Kit 96 (or 48) Determinations 2.0 – 54 ppm

E-75PCN (E-75PCN-48) Pecan Protein ELISA Kit 96 (or 48) Determinations 0.7 - 54 ppm

E-75PNE (E-75PNE-48) Pine Nut Protein ELISA Kit 96 (or 48) Determinations 1.5 – 40.5 ppm

E-75SME (E-75SME-48) Sesame Protein ELISA Kit 96 (or 48) Determinations 2.0 – 54 ppm

E-75SOY (E-75SOY-48) Soy Protein ELISA Kit 96 (or 48) Determinations 2.0 – 54 ppm

E-75WNT (E-75WNT-48) Walnut Protein ELISA Kit 96 (or 48) Determinations 2.0 – 54 ppm

Ingenasa ELISA kits

Part # Description Amount Assay Range

LFD032 Ingezim β-lattoglobulin Kit 48 Determinations 0.1 – 0.8 ppm

LFD054 Ingezim Casein Kit 48 Determinations 0.2 – 2.0 ppm

LFD055 Ingezim Ovoalbumin Kit 48 Determinations 0.2 – 2.0 ppm

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For the detection of all but gluten allergens

Generon relies on the products of Elution

Technologies a US company born through the

collaboration between a major service lab

(BIA Diagnostics) specialized in allergens

detection and a manufacturer of antibodies

(ICL) in response to industry demand for new

and improved detection methods for food

allergens. The unique capabilities of BIA and

ICL allow Elution Technologies to be at the

forefront of this business and provide

unmatched technical support on products.

Both for Elution Technologies and Generon

the needs of our customers are the focus of

all our activities that’s why we partnered, to

build lasting and mutually profitable

relationships with our clients. Generon offers

training on these products in its own demo

laboratory or on-site.

Other Allergens Detection

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Histamine Detection

Histamine is a product of decomposition of

histidine caused by the growth of certain

bacteria in seafood. Fish containing high levels

of histamine has been associated with many

examples of poisoning commonly referred to

as “scombroid poisoning,” a major health

problem for consumers.

Glutamate is one of the most abundant

naturally occurring non-essential amino acids.

It is widely used by food manufacturers as a

food additive to enhance the flavor. Under

normal conditions, humans have the ability to

metabolize glutamate that has a very low

acute toxicity. But sensitive individuals may

experience transient adverse reactions such

as headache, dizziness, flushing, and

generalized weakness – a symptom complex

which is termed Chinese Restaurant

Syndrome.

Generon distribute in Italy LDN´s assays based

on ELISA for the quantitative and/or semi-

quantitative determination of Histamine and

glutamate.

LDN Kits for the ELISA detection of histamine and glutamate

Part # Description

LFD047 HistaSure™ ELISA High Sensitivity Kit: immunoassay (ELISA) for the quantitative determination

of Histamine in fish meal, fresh fish, canned fish, sausage, cheese, milk and wine in less than 90

minutes. In a comparative study where different commercial Histamine test kits had been compared the

HistaSure™ ELISA High-Sensitive showed the best correlation to the HPLC-method and the authors concluded

that this kit “is found to be a reliable method for testing histamine in TFPs (traditional food

products)either for regulatory or HACCP applications in monitoring such hazard”.

Detection limit: 0.15 µg/l (ppb). 96 determinations in 12x8 well precoated strips.

LFD048 HistaSure™ ELISA Fast Track Kit: immunoassay (ELISA) for the quantitative or semi-quantitative determination

of Histamine in fish and fish-derived products providing results in less than 30 minutes. Validated and certified

by the AOAC Research Institute for many different fish species and matrices such as fresh/frozen yellowfin

tuna, canned tuna-chunk light in water, fresh/frozen mahimahi, canned sardines in oil and fish meal.

Detection range 0.44 – 300 ppm. 48 determinations in 6x8 well precoated strips.

LFD049 HisQuick™ Photometric Kit: rapid colorimetric assay for the quantitative or semi-quantitative determination

of Histamine in fish meal in less than 15 minutes. Easy sample preparation suitable for “in-field” analysis.

Detection range 125 - 2 000 ppm. 48 determinations 12x8 break apart wells microtiter plate

LFD052 Glutamate Food ELISA Kit: immunoassay (ELISA) for the quantitative determination of Glutamate in food

in less than 3 hours.

Detection range 0.3 - 60 µg/ml. 96 determinations 12x8 break apart wells microtiter plate

15

Lateral Flow Kits

Lateral flow assays (LFAs) are a qualitative

immunochromatographic form of an ELISA.

These assays are also referred to as lateral

flow dipsticks (LFDs) and works just like a

home pregnancy test.

An extracted food sample, swab, or final rinse

water sample is first applied to the sample

filter area. If present, the allergenic proteins

of interest will bind to the coupled antibody

and continue to wick through the LFA by

capillary action. The coupled antibody-

allergen (if present in the sample) will migrate

to the test zone, and the coupled allergen will

bind to the antibodies present in this zone,

forming a visible line that indicates the

positive presence of the specific allergen of

interest.

The intensity of the line can be correlated to

the concentration of the allergen present in

the sample. Semi-quantitative results can be

obtained if a strip reader is utilized.

In 10 minutes these rapid tests for portable

onsite monitoring of specific food allergens

accurately detects both processed and

unprocessed proteins. Although they can be

used for finished products they provide major

advantages in the analysis of CIP, swabbing,

and raw ingredients when time to result is

fundamental.

All Elution Technologies LFDs comes complete

of all the necessary disposable for analysis

including 25 swabs.

Product Catalogue

Part # Description Amount Cut-Off

ALMD-1007 Almond Protein Rapid Test 25 LFD 2 ppm

MILK-1004 Bovine Total Milk Rapid Test 25 LFD 2 ppm

CASH-1013 Cashew Protein Rapid Test 25 LFD 2 ppm

COCO-1011 Coconut Protein Rapid Test 25 LFD 2 ppm

BEGG-1003 Egg Protein Rapid Test 25 LFD 1 ppm

FISH-1014 Fish Protein Rapid Test 25 LFD 2 ppm

GLTN-1005 Gluten Rapid Test 25 LFD 5 ppm

PNT-1017 Peanut Protein Rapid Test 25 LFD 2 ppm

PCN-1016 Pecan Protein Rapid Test 25 LFD 2 ppm

PIST-1006 Pistachio Protein Rapid Test 25 LFD 2 ppm

BSOY-1002 Soy Protein Rapid Test 25 LFD 2 ppm

WLNT-1015 Walnut Protein Rapid Test 25 LFD 2 ppm

LFD050 LDN HistaSure™ Fish Rapid Test for Histamine 24 LFD 50 ppm

16

Equipment and Accessories

A certain number of ancillary equipment and

lab commodities (mainly plasticware) are

required to perform the analysis although in

many cases a part of the plasticware is

included in the kits.

Generon portfolio includes also these items in

order to provide the customer a turn-key

solution for allergen testing, whatever the

detection method selected is.

Ancillary equipment for allergens detection using molecular biology


ACC2016 Variable Volume Micropipette 2-20 µl 1 Unit



ACC2011 Multichannel micropipette 8x 0.5-10 µl 1 Unit

ACC2516 Micropipette tips 2-20 µl with filter 96 tips box



ACC2017 Micropipette rack 1 Unit

ACC2038 Balance 100g - 0.001g precision 1 Unit


ACC2080 Benchtop Waring blender 1 Unit

ACC2525 200 ml PP sample containers 250

ACC2064 Palmtop spin-down centrifuge for tubes and PCR strips 7200 rpm 1 Unit

ACC2063 Microcentrifuge 0,5-2 ml tubes 14500 rpm 1 Unit

ACC2564 2.0 ml microtubes 1000

ACC2905 Microtube rack 1 Unit

ACC2507 15 ml PP tubes 500 Units

ACC2508 50 ml PP tubes 500 Units

ACC2909 15 ml tube rack 1 Unit

ACC2509 50 ml tube rack 1 Unit

ACC2003 Variable speed vortex 1 Unit

ACC2095 Benchtop PCR hood 1 Unit

ACC2008 Benchtop Centrifuge fixed rotor for 50 ml tubes 1 Unit

ACC2007 15 ml tube adaptors set for ACC2008 1 Unit

ACC2908 Vacuum Pump for ION-Force 1 Unit

ACC2300 DB Heating-ThermoMixers, for 1 Thermoblock 1 Unit

ACC2301 DB Heating-Thermomixer for 2 Thermoblocks 1 Unit

ACC2302 DB Exchangeable thermoblock for 6x50 ml tubes 1 Unit

ACC2303 DB Exchangeable thermoblock for 2 ml tubes 1 Unit

ACC2400 TS Heating-ThermoMixers, for 1 Thermoblock 1 Unit

ACC2402 TS Exchangeable thermoblock for 6x50 ml tubes 1 Unit

ACC2403 TS Exchangeable thermoblock for 2 ml tubes 1 Unit

ACC2000 Notebook PC 1 Unit

BR3594990 Industrial Diagnostics CFX96™ DeepWell Real-Time PCR Detection System 1 Unit

BR3593995 Industrial Diagnostics MiniOpticon™ Real-Time PCR Detection System 1 Unit

17

Equipment and Accessories

Ancillary equipment for allergen detection using ELISA


ACC1028 ELISA microplate reader 1 Unit

ACC1000 Notebook PC 1 Unit

ACC1030 Orbital microplate shaker 1 Unit

ACC1027 Automatic microplate washer 1 Unit

ACC1004 1000 ml Bottle for washing buffer preparation 1 Unit

ACC1505 1000 ml graduated cylinder 1 Unit




ACC1018 Multichannel micropipette 8x 30-300 µl 1 Unit

ACC1021 Reservoir for multichannel pipette 100 Units

ACC1514 Micropipette tips 100-1000 µl 96 Tips Box

ACC1515 Micropipette tips 20-200 µl with filter 96 Tips Box


ACC1019 Multistep pipette 1 Unit

ACC1020 Multistep pipette syringe non-sterile 1 Bag



ACC1525 200 ml PP sample containers 250 Units

ACC1912 Orbital shaker for containers 1 Unit

ACC1504 200 mm diameter pre-plied paper filters 100

ACC1064 Palmtop spin-down centrifuge 7200 rpm 1 Unit

ACC1564 2.0 ml microtubes 1000 Units

ACC1905 Microtube rack 1 Unit

ACC1003 Variable speed vortex 1 Unit

Ancillary equipment for allergen detection using lateral flows






ACC3525 200 ml PP sample containers 250 Units

ACC3912 Orbital shaker for containers 1 Unit

18

Contacts and Addresses

International Contacts

Mr. Nicola Bortoletto [email protected] Mobile +39 346 5995589

Mrs. Caterina Novi [email protected] Mobile +39 345 6581422

Mr. Mustafa Aguezzoul [email protected] Mobile +33 65 2822140

Mr. Enrico Arletti [email protected] Mobile +39 348 4227992

Stradello Aggazzotti,104 – Modena - � +39 059 8637161� +39 059 8637162

� [email protected] � www.generon.it

Responsabili commerciali di zona in Italia

Piemonte, Liguria e VDA Stefano Callea - [email protected] +39 349 5503780

Lombardia Daniela Superchi - [email protected] +39 347 5644144

Triveneto Alessandro Ruffato - [email protected] +39 349 0651399

Simone Ruffato - [email protected] +39 349 5291261

Emilia Romagna, Marche, Toscana Francesco Rossi - [email protected] +39 344 2685914

Puglia e Basilicata Vito Lorusso - [email protected] +39 328 6274587

Altre regioni Caterina Novi - [email protected] +39 345 6581422

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