Anti-microbial array iii

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INTENDED USE

The Evidence Investigator Antimicrobial Array III is to be used for the simultaneous quantitative detection of multiple related Antimicrobial immunoassays (in parallel) from a single sample.

The Evidence Investigator Antimicrobial Array III is intended for the screening of samples only and not for diagnostic procedures. Positive results should be confirmed by another method.

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 Antimicrobial III markers. A competitive chemiluminescent immunoassay is employed for the Antimicrobial III array. Increased levels of Antimicrobial III markers in a specimen will lead to decreased binding of antibody labelled with horseradish peroxidase (HRP) and thus a 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 Antimicrobial Array III will quantitatively test for 3-amino-2-oxazolidinone (AOZ), 5-methylmorpholino-3-amino-2-oxazolidinone (AMOZ), 1-aminohydantoin hydrochloride (AHD), Semicarbazide (SEM) and Chloramphenicol (CAP) simultaneously.

 

3-amino-2-Oxazolidinone (AOZ) Assay

INTENDED USE

The Evidence Investigator 3-amino-2-Oxazolidinone (AOZ) test, a metabolite of furazolidone has been designed for the quantitative measurement of AOZ in honey and Prawn/Shrimp tissue samples.

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

CLINICAL SIGNIFICANCE

Furazolidone is a nitrofuran derivative used in the treatment of infections caused by bacteria and protozoa in cattle, pigs, poultry and fish [1]. Furazolidone was banned from use in the European Union in 1995 [2], although some uses are allowed in non-food producing animals [3]. Several countries including the USA, the Philippines, Australia, Thailand and Brazil are reported to have banned all uses of nitrofurans in food producing animals [3]. The ban on nitrofurans was introduced primarily because of concerns about their carcinogenicity and mutagenicity [1]. Nitrofurans have been detected in food items imported into the European Union [4], and there is evidence of continued illegal abuse of nitrofurans within the European Union [5].

Tissue residues of furazolidone are mainly protein bound and 3-amino-2-oxazolidinone (AOZ) is proposed as the marker residue [1]. In pig livers, AOZ could be released from 18% of the bound residues at 0 days withdrawal, and 6% after 45 days withdrawal [1]. The European Union has introduced Minimum Required Performance Levels (MRPLs) for banned substances, and has set a minimum detection limit for furazolidone assays of 1 ppb for poultry meat and aquaculture products [7].

PRINCIPLE

The Evidence Investigator AOZ assay is a competitive chemiluminescent immunoassay for the detection of AOZ in honey and Prawn/Shrimp tissue samples.

REFERENCES

1. European Medicines Agency (EMEA), Committee for Veterinary Medicinal Products, Furazolidone Summary Report.

2. Hurtaud-Pessel D., Verdon E., Blôt J. and Sanders P. (2004) Results of a Proficiency Study for the Determination of Nitrofuran Metabolites in Shrimps. Euroresidue V, Noordwijkerhout, The Netherlands, May 10-12, 2004, Poster 61.

3. Food Standards Agency, Chemical Safety and Toxicology Division, Legitimate Uses of Nitrofurans in Food, 8 May 2003.

4. Medicines Act Veterinary Information Service; Edition 52 (October 2004). Results of non-statutory surveillance: Nitrofurans.

5. Food Standards Agency, Food Alert, Ref: 24/2007.

6. Commission Regulation (EC) No. 508/1999 of 4 March 1999, Official Journal of the European Communities; L60/16.

7. Commission Decision 2003/181/EC of 13 March 2003, Official Journal of the European Communities; L71/17.

 

5-Methylmorpholino-3-amino-2-oxazolidinone (AMOZ) Assay

INTENDED USE

The Evidence Investigator 5-Methylmorpholino-3-amino-2-oxazolidinone (AMOZ) test, a metabolite of Furaltadone has been designed for the quantitative measurement of AMOZ in honey and Prawn/Shrimp tissue samples.

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

CLINICAL SIGNIFICANCE

Furaltadone is a nitrofuran derivative used in the treatment of infections caused by bacteria and protozoa in cattle, pigs, poultry and fish [1]. Furaltadone was banned from use in the European Union in 1993 [2], although some uses are allowed in non-food producing animals [1]. Several count ries including the USA, the Philippines, Australia, Thailand and Brazil are reported to have banned all uses of nitrofurans in food producing animals [1]. The ban on nitrofurans was introduced primarily because of concerns about their carcinogenicity and mutagenicity [3]. Nitrofurans have been detected in food items imported into the European Union [4], and there is evidence of continued illegal abuse of nitrofurans within the European Union [5].

Tissue residues of furaltadone are mainly protein bound and 3-amino-5-morpholinomethyl-2-oxazolidinone (AMOZ) is proposed as the marker residue [6]. Furaltadone is listed in Annex IV of European Council Regulation 2377/90, and no maximum residue limits (MRLs) have been assigned in the European Union [7]. The European Union has introduced Minimum Required Performance Levels (MRPLs) for banned substances, and has set a minimum detection limit for furaltadone assays of 1 ppb for poultry meat and aquaculture products [8].

PRINCIPLE

The Evidence Investigator AMOZ assay is a competitive chemiluminescent immunoassay for the detection of AMOZ in honey and Prawn/Shrimp tissue samples.

REFERENCES

1. Food Standards Agency, Chemical Safety and Toxicology Division, Legitimate Uses of Nitrofurans in Food, 8 May 2003.

2. Hurtaud-Pessel D., Verdon E., Blôt J. and Sanders P. (2004) Results of a Proficiency Study for the Determination of Nitrofuran Metabolites in Shrimps. Euroresidue V, Noordwijkerhout, The Netherlands, May 10-12, 2004, Poster 61.

3. European Medicines Agency (EMEA), Committee for Veterinary Medicinal Products, Furazolidone Summary Report.

4. Medicines Act Veterinary Information Service; Edition 52 (October 2004). Results of non-statutory surveillance: Nitrofurans.

5. Food Standards Agency, Food Alert, Ref: 24/2007.

6. Kennedy G (2004) Analytical methods for nitrofurans: Lessons to be learned and new developments. Joint FAO/WHO Technical Workshop on Residues of Veterinary Drugs without ADI/MRL (2004: Bangkok, Thailand).

7. Commission Regulation (EC) No. 508/1999 of 4 March 1999, Official Journal of the European Communities; L60/16.

8. Commission Decision 2003/181/EC of 13 March 2003, Official Journal of the European Communities; L71/17.

 

1-aminohydantoin hydrochloride (AHD) Assay

INTENDED USE

The Evidence Investigator 1-aminohydantoin hydrochloride (AHD) test, a metabolite of nitrofurantoin has been designed for the quantitative measurement of AHD in honey and Prawn/Shrimp tissue samples.

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

CLINICAL SIGNIFICANCE

Nitrofurantoin is a nitrofuran derivative used in the treatment of infections caused by bacteria and protozoa in cattle, pigs, poultry and fish [1] Nitrofurantoin was banned from use in the European Union in 1993 [2], although some uses are allowed in non-food producing animals [1]. Several countries including the USA, the Philippines, Australia, Thailand and Brazil are reported to have banned all uses of nitrofurans in food producing animals [1]. The ban on nitrofurans was introduced primarily because of concerns about their carcinogenicity and mutagenicity [3]. Nitrofurans have been detected in food items imported into the European Union [4], and there is evidence of continued illegal abuse of nitrofurans within the European Union [5].

Tissue residues of nitrofurantoin are mainly protein bound and 1-aminohydantoin (AHD) is proposed as the marker residue [6]. Nitrofurantoin is listed in Annex IV of European Council Regulation 2377/90, and no maximum residue limits (MRLs) have been assigned in the European Union [7]. The European Union has introduced Minimum Required Performance Levels (MRPLs) for banned substances, and has set a minimum detection limit for nitrofurantoin assays of 1 ppb for poultry meat and aquaculture products [8].

PRINCIPLE

The Evidence Investigator AHD assay is a competitive chemiluminescent immunoassay for the detection of AHD in honey and Prawn/Shrimp tissue samples.

REFERENCES

1. Food Standards Agency, Chemical Safety and Toxicology Division, Legitimate Uses of Nitrofurans in Food, 8 May 2003.

2. Hurtaud-Pessel D., Verdon E., Blôt J. and Sanders P. (2004) Results of a Proficiency Study for the Determination of Nitrofuran Metabolites in Shrimps. Euroresidue V, Noordwijkerhout, The Netherlands, May 10-12, 2004, Poster 61.

3. European Medicines Agency (EMEA), Committee for Veterinary Medicinal Products, Furazolidone Summary Report.

4. Medicines Act Veterinary Information Service; Edition 52 (October 2004). Results of non-statutory surveillance: Nitrofurans.

5. Food Standards Agency, Food Alert, Ref: 24/2007.

6. Kennedy G (2004) Analytical methods for nitrofurans: Lessons to be learned and new developments. Joint FAO/WHO Technical Workshop on Residues of Veterinary Drugs without ADI/MRL (2004: Bangkok, Thailand).

7. Commission Regulation (EC) No. 508/1999 of 4 March 1999, Official Journal of the European Communities; L60/16.

8. Commission Decision 2003/181/EC of 13 March 2003, Official Journal of the European Communities; L71/17.

 

Semicarbazide (SEM) Assay

INTENDED USE

The Evidence Investigator Semicarbazide (SEM) test, a metabolite of nitrofurazone has been designed for the quantitative measurement of SEM in honey and Prawn/Shrimp tissue samples.

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

CLINICAL SIGNIFICANCE

Nitrofurazone is a nitrofuran derivative used in the treatment of infections caused by bacteria and protozoa in cattle, pigs, poultry and fish [1] Nitrofurazone was banned from use in the European Union in 1993 [2], although some uses are allowed in non-food producing animals [1]. Several countries including the USA, the Philippines, Australia, Thailand and Brazil are reported to have banned all uses of nitrofurans in food producing animals [1]. The ban on nitrofurans was introduced primarily because of concerns about their carcinogenicity and mutagenicity [3]. Nitrofurans have been detected in food items imported into the European Union [4], and there is evidence of continued illegal abuse of nitrofurans within the European Union [5].

Tissue residues of nitrofurazone are mainly protein bound and semicarbazide (SEM) is proposed as the marker residue [6]. Nitrofurazone is listed in Annex IV of European Council Regulation 2377/90, and no maximum residue limits (MRLs) have been assigned in the European Union [7] . The European Union has introduced Minimum Required Performance Levels (MRPLs) for banned substances, and has set a minimum detection limit for nitrofurazone assays of 1 ppb for poultry meat and aquaculture products [8].

PRINCIPLE

The Evidence Investigator SEM assay is a competitive chemiluminescent immunoassay for the detection of SEM in honey and Prawn/Shrimp tissue samples.

REFERENCES

1. Food Standards Agency, Chemical Safety and Toxicology Division, Legitimate Uses of Nitrofurans in Food, 8 May 2003.

2. Hurtaud-Pessel D., Verdon E., Blôt J. and Sanders P. (2004) Results of a Proficiency Study for the Determination of Nitrofuran Metabolites in Shrimps. Euroresidue V, Noordwijkerhout, The Netherlands, May 10-12, 2004, Poster 61.

3. European Medicines Agency (EMEA), Committee for Veterinary Medicinal Products, Furazolidone Summary Report.

4. Medicines Act Veterinary Information Service; Edition 52 (October 2004). Results of non-statutory surveillance: Nitrofurans.

5. Food Standards Agency, Food Alert, Ref: 24/2007.

6. Kennedy G (2004) Analytical methods for nitrofurans: Lessons to be learned and new developments. Joint FAO/WHO Technical Workshop on Residues of Veterinary Drugs without ADI/MRL (2004: Bangkok, Thailand).

7. Commission Regulation (EC) No. 508/1999 of 4 March 1999, Official Journal of the European Communities; L60/16.

8. Commission Decision 2003/181/EC of 13 March 2003, Official Journal of the European Communities; L71/17.

 

Chloramphenicol (CAP) Assay

INTENDED USE

The Evidence Investigator Chloramphenicol (CAP) test has been designed for the quantitative measurement of CAP in honey and Prawn/Shrimp tissue samples.

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

CLINICAL SIGNIFICANCE

Chloramphenicol is a broad spectrum antibiotic isolated from the soil bacterium Streptomyces venezuela[1]. It is bacteriostatic in action and inhibits bacterial protein synthesis by binding to the ribosomal 50S subunit [2]. Chloramphenicol has been used to treat a wide range of human and animal conditions.

Chloramphenicol is well absorbed orally and is distributed widely in body fluids. It is metabolized in the liver to the inactive glucuronide. Both chloramphenicol and the glucuronide metabolite are excreted in urine. Metabolism studies in food animals demonstrated numerous differences in metabolic profiles between bovine, porcine and poultry species, although the parent drug was the major metabolite identified in muscle for all species. In cattle and poultry, chloramphenicol, chloramphenicol glucuronide and hydroxyamphenicol are major metabolites in liver and kidney, whereas chloramphenicol glucuronide is the most abundant metabolite in porcine plasma, fat and kidney. Three mutagenic metabolites of chloramphenicol (nitrosochloramphenicol, dehydrochloramphenicol and dehydrochloramphenicol base) were not detected in animal metabolic studies [1].

Serious side effects have been observed following chloramphenicol treatment, including a form of aplastic anaemia [2]. As a result, chloramphenicol use in food producing animals has been prohibited in several countries meaning that any detection of chloramphenicol residues in food produce would be a violation.

The European Union has introduced Minimum Required Performance Levels (MRPLs) for banned substances, and has set a minimum detection limit for chloramphenicol assays of 0.3 ppb in meat, eggs, milk, urine, aquaculture products and honey [3].

PRINCIPLE

The Evidence Investigator CAP assay is a competitive chemiluminescent immunoassay for the detection of Chloramphenicol in honey and Prawn/Shrimp tissue samples.

REFERENCES

1. Joint FAO/WHO Expert Committee on Food Additives (JECFA), Online Edition: "Residues of some veterinary drugs in foods and animals" FNP41, http://www.fao.org.

2. The Merck Manual of Diagnosis and Therapy, http://www.merck.com.

3. Commission Decision 2003/181/EC of 13 March 2003. Official Journal of the European Union; L 71/17.