Growth promoter array

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Intended Use

The Evidence Investigator Growth Promoter Rapid Urine Screen Array is to be used for the simultaneous quantitative detection of multiple related growth promoter drug residue immunoassays (in parallel) from a single sample.

The Evidence Investigator Growth Promoter Rapid Urine Screen Array is intended for the screening of samples only and not for diagnostic procedures. Positive results should be confirmed by another method.

Clinical Significance

Growth-promoting hormones have been used by the livestock industry for over 30 years to improve an animal's ability to more efficiently utilize nutrients and produce leaner, more affordable meat.  Concerns over the use of hormones in food producing animals first arose during the late 1970s and early 1980s, when a number of incidents linked hormone residues in meat with various medical conditions.  As a result, the use of growth-promoting hormones in livestock production is either prohibited (1) (European Union) or strongly regulated (e.g. USA , Canada and Australia ). Compliance with these regulations is monitored by national monitoring programmes.

β-agonists are compounds having a stimulatory effect on β-adrenergic receptors and are used in human and veterinary medicine as bronchodilatory agents. The group includes drugs such as clenbuterol, carbuterol, salbutamol, methylclenbuterol, brombuterol, terbutaline, mabuterol, pirbuterol and mapenterol.  The metabolism of beta agonists is dependent on the chemical properties of each drug, with excretion reported in bile, urine, faeces and milk.  Accumulation of beta-agonists has been reported in tissues including liver, kidney and pigmented tissue e.g. retina.(2 )

In recent years β-agonists have been used to improve feed conversion efficiency and to increase lean meat to fat ratio in cattle.  Residues of beta-agonists with high oral bioavailability, long plasma half-life and slow rates of elimination, represent a potential health risk to consumers.  There have been documented cases of severe food poisoning resulting from the consumption of contaminated meat products.(3)

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has proposed MRLs for clenbuterol of 0.2ppb in muscle and fat, 0.6ppb in liver and kidney and 0.05ppb in milk. (4 )

Principle

The Evidence Investigator Biochip Array technology is used to perform simultaneous quantitative detection of multiple analytes from a single sample.

The core technology is the Randox Biochip, a solid-state device containing an array of discrete test regions containing immobilised antibodies specific to different growth promoter drug residues. A competitive chemiluminescent immunoassay is employed for the Growth Promoter Rapid Urine Screen Array. Increased levels of growth promoter drug residue in a specimen will lead to decreased binding of growth promoter drug residues conjugates labelled with horseradish peroxidase (HRP) and thus an decrease in chemiluminescence being emitted.

The light signal generated from each of the test regions on the biochip is detected using digital imaging technology and compared to that from a stored calibration curve. The concentration of analyte present in the sample is calculated from the calibration curve.

Several different immunoassay based multi-analyte arrays have been developed for use on Evidence Investigator. The Evidence Investigator Growth Promoter Rapid Urine Screen Array will quantitatively test for Boldenone, Zeranol, Ractopamine, Corticosteroid, Trenbolone, Stanozolol and β-Agonists simultaneously.

REFERENCES

1.Council Directive 2003/74/EC of 22 September 2003 amending Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists. Official Journal of the European Union; L262/17.

2.Smith, D.J. (1998) The pharmacokinetics, metabolism and tissue residues of beta-adrenergic agonists in livestock. J. Anim. Sci.; 76:173-194.

3. Mitchell, GA and Dunnavan, G. (1998) Illegal use of beta-adrenergic agonists in the United States . J.Anim.Sci.; 76: 208-211.

4.JECFA (1998) Evaluation of certain veterinary drug residues in food: Forty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives, WHOTechnical Report Series;876: 6-12.

Boldenone (BD)

Intended Use

The Evidence Investigator Boldenone test has been designed for the quantitative measurement of Boldenone in urine samples.

This test is for screening use only. Not for use in diagnostic procedures. Positive results should be confirmed using another method.

Clinical Significance

Boldenone is an anabolic steroid with a structural similarity to testosterone, which has been licensed in the USA for treatment of sick horses that are not intended for food use.  Following intra-muscular injection the parent drug is metabolized and 17β-boldenone, 17αboldenone, 5β-androst-1-ene-3, 17-dione and androsta-1,4-diene-3,17-dione have been detected in urine.  Until recently, boldenone was considered to be an exogenous steroid, meaning that detection of any metabolites constituted a violation.  However, recent studies have shown that both 17αboldenone and 17β-boldenone can be detected in the faeces of untreated cattle, although 17β-boldenone has not been detected in the urine of untreated cattle.(2) Consequently, the European Commission’s Standing Committee on the Food Chain and Animal Health (SANCO) has recommended that only 17β-boldenone conjugates in urine of young calves could be used as a proof of illegal treatment, provided that specific sampling procedures were applied to avoid faecal contamination. (3)

Principle

The Evidence Investigator Boldenone assay is a competitive chemiluminescent immunoassay for the detection of Boldenone in urine samples.

REFERENCES

1.Council Directive 2003/74/EC of 22 September 2003 amending Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists.  Official Journal of the European Union; L262/17.

2.De Brabander, H.F., Poelmans, S., Schilt, R., Stephany, R.W., Le Bizec, B., Draisci, R., Sterk, S.S., van Ginkel, L.A., Courtheyn, D., Van Hoof, N., Macri, A. and De Wasch, K. (2004) Presence and metabolism of the anabolic steroid boldenone in various animal species: a review. Food Additives and Contaminants; 21(6): 515-525.

3.Summary Record of the Standing Committee on the Food Chain and Animal Health, Held in Brussels ,  21-22 October 2003: SANCO-E.2(03)D/522491.

Corticosteroids (CS)

Intended Use

The Evidence Investigator Corticosteroids test has been designed for the quantitative measurement of Corticosteroids in urine samples.

This test is for screening use only. Not for use in diagnostic procedures. Positive results should be confirmed using another method.

Clinical Significance

Corticosteroids are a group of natural and synthetic analogues of the hormones secreted by the pituitary gland. These include glucocorticoids, such as dexamethasone, flumethasone and betamethasone.   Synthetic glucocorticoids are commonly used in veterinary medicine as anti-inflammatory agents, and illicit use as growth-promoters is suspected.  Dexamethasone is rapidly absorbed and excreted in urine and faeces, primarily as the parent molecule, conjugates and inactive 6-hydroxy metabolites (2).

Corticosteroids are licensed in several countries for a range of veterinary uses.  The European Union has set MRLs for dexamethasone (3) and betamethasone (4) of   0.3ppb in bovine milk, 2ppb in bovine and porcine liver and 0.75ppb in bovine and porcine muscle and kidney.

Principle

The Evidence Investigator Corticosteroids assay is a competitive chemiluminescent immunoassay for the detection of Corticosteroids in urine samples.

REFERENCES

1.Council Directive 2003/74/EC of 22 September 2003 amending Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists.  Official Journal of the European Union; L262/17.

2.JECFA (1995) Evaluation of certain veterinary drug residues in food: Forty-second report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Technical Report Series; 851: 27-30.

3.Commission Regulation (EC) No 508/1999 of 4 March 1999 amending Annexes I to IV to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.  Official Journal of the European Communities; L60/16.>

4.Commission Regulation (EC) No 2593/1999 of 8 December 1999 amending Annexes I, II and III of Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.  Official Journal of the European Communities; L315/29.

Ractopamine (RP)

Intended Use

The Evidence Investigator Ractopamine test has been designed for the quantitative measurement of Ractopamine in urine samples.

This test is for screening use only. Not for use in diagnostic procedures. Positive results should be confirmed using another method.

Clinical Significance

Ractopamine is a beta-agonist that is used for the improvement of weight gain, carcass leanness and feed efficiency in pigs.  Ractopamine is rapidly absorbed and excreted in urine, primarily as glucuronide conjugates, and the levels of ractopamine residues in animal tissue are low (2).  Ractopamine hydrochloride has been approved for use in pigs in the USA and several other countries, and is commonly marketed under the trade name Paylean ® (Elanco Animal Health).

The regulatory approach to ractopamine residues is varied.  The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has recommended MRLs for ractopamine in cattle and pig tissue of 10ppb in muscle and fat, 40ppb in liver and 90ppb in kidney.(2)  The USA has set higher tolerance levels for ractopamine of 30ppb in cattle muscle, 90ppb in cattle liver, 50ppb in pig muscle and 150ppb in pig liver.(3)  The European Union has provisionally prohibited the use of beta-agonists, such as ractopamine, in food producing animals; meaning that any detection of ractopamine would be a violation.(1)  The European Union is currently working towards specifying minimum required performance limits (MRPLs) for assays for prohibited substances.

Principle

The Evidence Investigator Ractopamine assay is a competitive chemiluminescent immunoassay for the detection of Ractopamine in urine samples.

REFERENCES

1.Council Directive 2003/74/EC of 22 September 2003 amending Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of β-agonists.  Official Journal of the European Union; L262/17.

2. JECFA (2004) Evaluation of certain veterinary drug residues in food: Sixty-second report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Technical Report Series; 925: 37-49.

3.Code of Federal Regulations, Title 21, Volume 6, 21CFR556.570.

Stanozolol (SZ)

Intended Use

The Evidence Investigator Stanozolol test has been designed for the quantitative measurement of Stanozolol in urine samples.

This test is for screening use only. Not for use in diagnostic procedures. Positive results should be confirmed using another method.

Clinical Significance

Stanozolol is a synthetic anabolic steroid with a structural similarity to testosterone, which has been licensed in the USA for treatment of cats and dogs; and in horses that are not intended for food use(2).  Stanozolol is also used in human medicine for the treatment of several complaints, e.g. hereditary angioedema.  Following intramuscular injection, the main metabolite of stanozolol identified in bovine urine is 16β-hydroxy-stanozolol.(3 )

The European Union has provisionally prohibited the use of androgenic substances, such as stanozolol, in food producing animals (1); meaning that any detection of stanozolol would be a violation.  The European Union is currently working towards specifying minimum required performance limits (MRPLs) for assays for prohibited substances.

Principle

The Evidence Investigator Stanozolol assay is a competitive chemiluminescent immunoassay for the detection of Stanozolol in urine samples.

REFERENCES

1.Council Directive 2003/74/EC of 22 September 2003 amending Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists.  Official Journal of the European Union; L262/17.

2.Code of Federal Regulations, Title 21, Volume 6, 21CFR522.2150.

3.Blokland, M.H., Sterk, S.S., Hartog, K.D., van Ginkel L.A. and Stephany, R.W. (2000), Preparation of lyophilised samples of bovine urine containing residues of 16-hydroxy-stanozolol. Euroresidue; IV: 232-236

Trenbolone (TB)

Intended Use

The Evidence Investigator Trenbolone test has been designed for the quantitative measurement of Trenbolone in urine samples.

This test is for screening use only. Not for use in diagnostic procedures. Positive results should be confirmed using another method.

Clinical Significance

Trenbolone is an anabolic steroid with a structural similarity to testosterone.  Trenbolone is normally administered as a trenbolone acetate ear implant, often in combination with other hormones.  Trenbolone acetate is rapidly hydrolyzed in the circulation to produce 17α and 17β-trenbolone.  In bovine species 17-α trenbolone is the major metabolite detected in urine, faeces, bile and liver, whereas 17β-trenbolone is the major metabolite detected in muscle. (2)

The regulatory approach to trenbolone residues is varied.  The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has recommended MRLs of 10ppb for 17-α trenbolone in liver and 2ppb for 17β-trenbolone in muscle (3), which have been adopted by Japan (3).  However, the USA does not consider a tolerance for trenbolone to be necessary (4).  The European Union has provisionally prohibited the use of androgenic substances, such as trenbolone, in food producing animals; meaning that any detection of trenbolone would be a violation.(1)  The European Union is currently working towards specifying minimum required performance limits (MRPLs) for assays for prohibited substances.

Principle

The Evidence Investigator Trenbolone assay is a competitive chemiluminescent immunoassay for the detection of Trenbolone in urine samples.

REFERENCES

1.Council Directive 2003/74/EC of 22 September 2003 amending Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists.  Official Journal of the European Union; L262/17.

2. JECFA (1989) Evaluation of certain veterinary drug residues in food: Thirty-fourth report of the Joint FAO/WHO Expert Committee on Food Additives, WHOTechnical Report Series; 788:40-42.

Specifications and Standards for Foods, Food Additives, etc. Under The Food Sanitation Law (www.jetro.go.jp).

4. Code of Federal Regulations, Title 21, Volume 6, 21CFR556.739.

Zeranol (ZN)

Intended Use

The Evidence Investigator Zeranol test has been designed for the quantitative measurement of Zeranol in urine samples.

This test is for screening use only. Not for use in diagnostic procedures. Positive results should be confirmed using another method.

Clinical Significance

Zeranol is a synthetic non-steroidal anabolic agent, with oestrogenic activity.  The main metabolites of zeranol in mammals are zeralanone and taleranol.  Zeranol and its metabolites are excreted as free compounds and as glucuronide or sulphate conjugates.  Zeranol is also produced naturally from the mycotoxin zearalenone, which is found in seven strains of Fusaria that have been identified in animal feedstuffs (2).  Therefore, any tissue residues of zeranol may be of natural origin.

The regulatory approach to zeranol residues is varied.  The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has recommended MRLs of 10ppb for zeranol in bovine liver and 2ppb for zeranol in bovine muscle (3), which have been adopted by Japan (4).  The USA does not consider a tolerance for zeranol to be necessary (5).  The European Union has provisionally prohibited the use of oestrogenic substances, such as zeranol, in food producing animals; meaning that any detection of zeranol would be a violation.(1)  The European Union is currently working towards specifying minimum required performance limits (MRPLs) for assays for prohibited substances. 

Principle

The Evidence Investigator Zeranol assay is a competitive chemiluminescent immunoassay for the detection of Zeranol in urine samples.

REFERENCES

1.Council Directive 2003/74/EC of 22 September 2003 amending Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of β-agonists.  Official Journal of the European Union; L262/17.

2.Richardson , K.E., Hagler, W.M. Jr. and Mirocha, C.J. (1985): Production of zearalenone and α-zearalenol, and  α-zearalanol by Fusarium spp. in rice culture. J. Agric. Food Chem.; >33: 862-866.

JECFA (1988) Evaluation of certain veterinary drug residues in food: thirty-second report of the Joint FAO/WHO Expert Committee on Food Additives, WHOTechnical Report Series;763: 26-28.

4. Specifications and Standards for Foods, Food Additives, etc. Under The Food Sanitation Law (www.jetro.go.jp).

5.Code of Federal Regulations, Title 21, Volume 6, 21CFR556.760.