Antimicrobial array i

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Intended Use

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

The Evidence Investigator Anti Microbial Array I 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 sulphonamides. A competitive chemiluminescent immunoassay is employed for the anti microbial array. Increased levels of sulphonamides in a specimen will lead to decreased binding of sulphonamides 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.

The Evidence Investigator Anti Microbial Array I will quantitatively test for Sulphadimethoxine (SDM), Sulphadiazine (SZ), Sulphadoxine (SD), Sulphamethizole (SMZ), Sulphachlorpyridazine (SCP), Sulphamethoxypyridazine (SMP), Sulphamerazine  (SM), Sulphisoxazole (SS), Sulphathiazole (ST), Sulphamethazine  (SMT), Sulphaquinoxaline (SQ) and Sulphapyridine (SP) simultaneously.

Sulphadimethoxine (SDM) Assay

Intended Use

The Evidence Investigator Sulphadimethoxine (SDM) test has been designed for the quantitative measurement of SDM in urine, tissue, honey and feed samples.

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

Clinical Significance

Sulphadimethoxine is a member of the sulphonamide group of synthetic antibiotics. The sulphonamides are competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle and have a bacteriostatic effect on a broad range of gram-positive and gram–negative organisms. The sulphonamides are distributed widely throughout all organs and tissues; and are metabolized primarily by the liver, producing inactive acetylated and glucuronide forms, which are excreted in urine. (1)

Sulphonamides are used extensively in veterinary medicine and their use in food producing animals could result in potentially harmful concentrations in tissue, organs and milk.  The potential risk is reduced by withdrawal of the drug for a fixed period before slaughter, although residual levels may still remain. Regulatory authorities have specified maximum residual levels (MRL) for sulphonamide drugs, which are considered to represent safe levels for human consumption. 

The European Commission has specified a MRL of 100ppb for all substances belonging to the sulphonamide group. (2 )This limit applies to muscle, fat, liver and kidney from all food producing species; and milk from bovine, caprine and ovine sources.  The MRL also specifies that the combined total residues of all substances within the sulphonamide group should not exceed 100 ppb.  The target molecule for all sulphonamides is the parent molecule, i.e. sulphadimethoxine.  The European MRL is in agreement with the MRLs for sulphadimethoxine set by Canada (3) and the USA (4), although a lower limit of 10 ppb has been set for milk samples in Canada and the USA .

Principle

The Evidence Investigator SDM assay is a competitive chemiluminescent immunoassay for the detection of Sulphadimethoxine in urine, tissue, honey and feed samples.

REFERENCES

1.    The Merck Manual of Diagnosis and Therapy, Chapter 153: Antibacterial Drugs.

2.    Commission Regulation (EC) No. 508/1999 of 4(th) March 1999, Official Journal of the European Communities L 60/16.

3.    Maximum Residue Limits Set by Canada , Veterinary Drugs Directorate, Health Canada (www.hc-sc.gc.ca)

4.  Code of Federal Regulations, Title 21, Volume 6, 21CFR556.630.

Sulphadiazine (SZ) Assay

Intended Use

The Evidence Investigator Sulphadiazine (SZ) test has been designed for the quantitative measurement of SZ in urine, tissue, honey and feed samples.

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

Clinical Significance

Sulphadiazine is a member of the sulphonamide group of synthetic antibiotics.  The sulphonamides are competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle and have a bacteriostatic effect on a broad range of gram-positive and gram–negative organisms. The sulphonamides are distributed widely throughout all organs and tissues; and are metabolized primarily by the liver, producing inactive acetylated and glucuronide forms, which are excreted in urine. (1 )

Sulphonamides are used extensively in veterinary medicine and their use in food producing animals could result in potentially harmful concentrations in tissue, organs and milk.  The potential risk is reduced by withdrawal of the drug for a fixed period before slaughter, although residual levels may still remain.  Regulatory authorities have specified maximum residual levels (MRL) for sulphonamide drugs, which are considered to represent safe levels for human consumption. 

The European Commission has specified a MRL of 100ppb for all substances belonging to the sulphonamide group. (2 )This limit applies to muscle, fat, liver and kidney from all food producing species; and milk from bovine, caprine and ovine sources.  The MRL also specifies that the combined total residues of all substances within the sulphonamide group should not exceed 100 ppb.  The target molecule for all sulphonamides is the parent molecule, i.e. sulphadiazine.  The European MRL is in agreement with the Canadian MRL for sulphadiazine.(3)

Principle

The Evidence Investigator SZ assay is a competitive chemiluminescent immunoassay for the detection of Sulphadiazine in urine, tissue, honey and feed samples.

REFERENCES

1.    The Merck Manual of Diagnosis and Therapy, Chapter 153: Antibacterial Drugs.

2.    Commission Regulation (EC) No. 508/1999 of 4(th)  March 1999, Official Journal of the European Communities L 60/16.

3.  Maximum Residue Limits Set By Canada, Veterinary  Drugs Directorate, Health Canada (www.hc-sc.gc.ca)

Sulphadoxine (SD) Assay

Intended Use

The Evidence Investigator Sulphadoxine (SD) test has been designed for the quantitative measurement of SD in urine, tissue, honey and feed samples.

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

Clinical Significance

Sulphadoxine is a member of the sulphonamide group of synthetic antibiotics.  The sulphonamides are competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle and have a bacteriostatic effect on a broad range of gram-positive and gram–negative organisms. The sulphonamides are distributed widely throughout all organs and tissues; and are metabolized primarily by the liver, producing inactive acetylated and glucuronide forms, which are excreted in urine. (1)

Sulphonamides are used extensively in veterinary medicine and their use in food producing animals could result in potentially harmful concentrations in tissue, organs and milk.  The potential risk is reduced by withdrawal of the drug for a fixed period before slaughter, although residual levels may still remain.  Regulatory authorities have specified maximum residual levels (MRL) for sulphonamide drugs, which are considered to represent safe levels for human consumption. 

The European Commission has specified a MRL of 100ppb for all substances belonging to the sulphonamide group. (2 )This limit applies to muscle, fat, liver and kidney from all food producing species; and milk from bovine, caprine and ovine sources.  The MRL also specifies that the combined total residues of all substances within the sulphonamide group should not exceed 100ppb.  The target molecule for all sulphonamides is the parent molecule, i.e. sulphadoxine.  The European MRL is in agreement with the Canadian MRL for sulphadoxine, although a lower limit of 10ppb has been set for milk samples in Canada.(3)

Principle

The Evidence Investigator SD assay is a competitive chemiluminescent immunoassay for the detection of Sulphadoxine in urine, tissue, honey and feed samples.

REFERENCES

1. The Merck Manual of Diagnosis and Therapy, Chapter 153: Antibacterial Drugs.

2. Commission Regulation (EC) No. 508/1999 of 4(th) March 1999, Official Journal of the European Communities L 60/16.

3. Maximum Residue Limits Set By Canada, Veterinary Drugs Directorate, Health Canada (www.hc-sc.gc.ca)

Sulphamethizole (SMZ) Assay

Intended Use

The Evidence investigator Sulphamethizole (SMZ) test has been designed for the quantitative measurement of SMZ in urine, tissue, honey and feed samples.

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

Clinical Significance

Sulphamethizole is a member of the sulphonamide group of synthetic antibiotics.  The sulphonamides are competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle and have a bacteriostatic effect on a broad range of gram-positive and gram–negative organisms. The sulphonamides are distributed widely throughout all organs and tissues; and are metabolized primarily by the liver, producing inactive acetylated and glucuronide forms, which are excreted in urine. (1 )

Sulphonamides are used extensively in veterinary medicine and their use in food producing animals could result in potentially harmful concentrations in tissue, organs and milk.  The potential risk is reduced by withdrawal of the drug for a fixed period before slaughter, although residual levels may still remain.  Regulatory authorities have specified maximum residual levels (MRL) for sulphonamide drugs, which are considered to represent safe levels for human consumption. 

The European Commission has specified a MRL of 100ppb for all substances belonging to the sulphonamide group. (2 )This limit applies to muscle, fat, liver and kidney from all food producing species; and milk from bovine, caprine and ovine sources.  The MRL also specifies that the combined total residues of all substances within the sulphonamide group should not exceed 100ppb.  The target molecule for all sulphonamides is the parent molecule, i.e. sulphamethizole.

Principle

The Evidence Investigator SMZ assay is a competitive chemiluminescent immunoassay for the detection of Sulphamethizole in urine, tissue, honey and feed samples.

REFERENCES

1.    The Merck Manual of Diagnosis and Therapy, Chapter 153: Antibacterial Drugs.

2.    Commission Regulation (EC) No. 508/1999 of 4(th) March 1999, Official Journal of the European Communities L 60/16.

Sulphamethoxypyridazine (SMP) Assay

Intended Use

The Evidence Investigator Sulphamethoxypyridazine (SMP) test has been designed for the quantitative measurement of SMP in urine, tissue, honey and feed samples.

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

Clinical Significance

Sulphamethoxypyridazine is a member of the sulphonamide group of synthetic antibiotics. The sulphonamides are competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle and have a bacteriostatic effect on a broad range of gram-positive and gram–negative organisms. The sulphonamides are distributed widely throughout all organs and tissues; and are metabolized primarily by the liver, producing inactive acetylated and glucuronide forms, which are excreted in urine. (1)

Sulphonamides are used extensively in veterinary medicine and their use in food producing animals could result in potentially harmful concentrations in tissue, organs and milk.  The potential risk is reduced by withdrawal of the drug for a fixed period before slaughter, although residual levels may still remain.  Regulatory authorities have specified maximum residual levels (MRL) for sulphonamide drugs, which are considered to represent safe levels for human consumption. 

The European Commission has specified a MRL of 100ppb for all substances belonging to the sulphonamide group. (2 )This limit applies to muscle, fat, liver and kidney from all food producing species; and milk from bovine, caprine and ovine sources.  The MRL also specifies that the combined total residues of all substances within the sulphonamide group should not exceed 100ppb.  The target molecule for all sulphonamides is the parent molecule, i.e. sulphamethoxypyridazine. 

Principle

The Evidence Investigator SMP assay is a competitive chemiluminescent immunoassay for the detection of Sulphamethoxypyridazine in urine, tissue, honey and feed samples.

REFERENCES

1.    The Merck Manual of Diagnosis and Therapy, Chapter 153: Antibacterial Drugs.

2.    Commission Regulation (EC) No. 508/1999 of 4(th) March 1999, Official Journal of the European Communities L 60/16.

Sulphachlorpyridazine (SCP) Assay

Intended Use

The Evidence Investigator Sulphachlorpyridazine (SCP) test has been designed for the quantitative measurement of SCP in urine, tissue, honey and feed samples.

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

Clinical Significance

Sulphachlorpyridazine is a member of the sulphonamide group of synthetic antibiotics.  The sulphonamides are competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle and have a bacteriostatic effect on a broad range of gram-positive and gram–negative organisms. The sulphonamides are distributed widely throughout all organs and tissues; and are metabolized primarily by the liver, producing inactive acetylated and glucuronide forms, which are excreted in urine. (1)

Sulphonamides are used extensively in veterinary medicine and their use in food producing animals could result in potentially harmful concentrations in tissue, organs and milk.  The potential risk is reduced by withdrawal of the drug for a fixed period before slaughter, although residual levels may still remain.  Regulatory authorities have specified maximum residual levels (MRL) for sulphonamide drugs, which are considered to represent safe levels for human consumption. 

The European Commission has specified a MRL of 100ppb for all substances belonging to the sulphonamide group. (2 )This limit applies to muscle, fat, liver and kidney from all food producing species; and milk from bovine, caprine and ovine sources.  The MRL also specifies that the combined total residues of all substances within the sulphonamide group should not exceed 100ppb.  The target molecule for all sulphonamides is the parent molecule, i.e. Sulphachlorpyridazine. The European MRL is in agreement with the MRLs for Sulphachlorpyridazine set by Canada (3) and the USA . (4)

Principle

The Evidence Investigator SCP assay is a competitive chemiluminescent immunoassay for the detection of Sulphachlorpyridazine in urine, tissue, honey and feed samples.

REFERENCES

1.The Merck Manual of Diagnosis and Therapy, Chapter 153: Antibacterial Drugs.

2. Commission Regulation (EC) No. 508/1999 of 4(th) March 1999, Official Journal of the European Communities L 60/16.

3.  Maximum Residue Limits Set by Canada , Veterinary Drugs Directorate, Health Canada (www.hc-sc.gc.ca)

4.  Code of Federal Regulations, Title 21, Volume 6, 21CFR556.630.

Sulphamerazine (SM) Assay

Intended Use

The Evidence Investigator Sulphamerazine (SM) test has been designed for the quantitative measurement of SM in urine, tissue, honey and feed samples.

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

Clinical Significance

Sulphamerazine is a member of the sulphonamide group of synthetic antibiotics. The sulphonamides are competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle and have a bacteriostatic effect on a broad range of gram-positive and gram–negative organisms. The sulphonamides are distributed widely throughout all organs and tissues; and are metabolized primarily by the liver, producing inactive acetylated and glucuronide forms, which are excreted in urine. (1)

Sulphonamides are used extensively in veterinary medicine and their use in food producing animals could result in potentially harmful concentrations in tissue, organs and milk.  The potential risk is reduced by withdrawal of the drug for a fixed period before slaughter, although residual levels may still remain.  Regulatory authorities have specified maximum residual levels (MRL) for sulphonamide drugs, which are considered to represent safe levels for human consumption. 

The European Commission has specified a MRL of 100ppb for all substances belonging to the sulphonamide group. (2)This limit applies to muscle, fat, liver and kidney from all food producing species; and milk from bovine, caprine and ovine sources.  The MRL also specifies that the combined total residues of all substances within the sulphonamide group should not exceed 100ppb.  The target molecule for all sulphonamides is the parent molecule, i.e. sulphamerazine.  The European MRL is in agreement with the MRLs for sulphamerazine set by Canada (3).

Principle

The Evidence Investigator SM assay is a competitive chemiluminescent immunoassay for the detection of Sulphamerazine in urine, tissue, honey and feed samples.

REFERENCES

1. The Merck Manual of Diagnosis and Therapy, Chapter 153: Antibacterial Drugs.

2. Commission Regulation (EC) No. 508/1999 of 4(th) March 1999, Official Journal of the European Communities L 60/16.

3.  Maximum Residue Limits Set by Canada , Veterinary Drugs Directorate, Health Canada (www.hc-sc.gc.ca)

Sulphisoxazole (SS) Assay

Intended Use

The Evidence Investigator Sulphisoxazole (SS) test has been designed for the quantitative measurement of SS in urine, tissue, honey and feed samples.

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

Clinical Significance

Sulphisoxazole is a member of the sulphonamide group of synthetic antibiotics.  The sulphonamides are competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle and have a bacteriostatic effect on a broad range of gram-positive and gram–negative organisms. The sulphonamides are distributed widely throughout all organs and tissues; and are metabolized primarily by the liver, producing inactive acetylated and glucuronide forms, which are excreted in urine. (1)

Sulphonamides are used extensively in veterinary medicine and their use in food producing animals could result in potentially harmful concentrations in tissue, organs and milk.  The potential risk is reduced by withdrawal of the drug for a fixed period before slaughter, although residual levels may still remain.  Regulatory authorities have specified maximum residual levels (MRL) for sulphonamide drugs, which are considered to represent safe levels for human consumption. 

The European Commission has specified a MRL of 100ppb for all substances belonging to the sulphonamide group. (2 )This limit applies to muscle, fat, liver and kidney from all food producing species; and milk from bovine, caprine and ovine sources.  The MRL also specifies that the combined total residues of all substances within the sulphonamide group should not exceed 100ppb.  The target molecule for all sulphonamides is the parent molecule, i.e. sulphisoxasole.

Principle

The Evidence Investigator SS assay is a competitive chemiluminescent immunoassay for the detection of Sulphisoxazole in urine, tissue, honey and feed samples.

REFERENCES

1.  The Merck Manual of Diagnosis and Therapy, Chapter 153: Antibacterial Drugs.

2. Commission Regulation (EC) No. 508/1999 of 4(th) March 1999, Official Journal of the European Communities L 60/16.

Sulphathiazole (ST) Assay

Intended Use

The Evidence Investigator Sulphathiazole (ST) test has been designed for the quantitative measurement of ST in urine, tissue, honey and feed samples.

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

Clinical Significance

Sulphathiazole is a member of the sulphonamide group of synthetic antibiotics.  The sulphonamides are competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle and have a bacteriostatic effect on a broad range of gram-positive and gram–negative organisms. The sulphonamides are distributed widely throughout all organs and tissues; and are metabolized primarily by the liver, producing inactive acetylated and glucuronide forms, which are excreted in urine. (1)

Sulphonamides are used extensively in veterinary medicine and their use in food producing animals could result in potentially harmful concentrations in tissue, organs and milk.  The potential risk is reduced by withdrawal of the drug for a fixed period before slaughter, although residual levels may still remain.  Regulatory authorities have specified maximum residual levels (MRL) for sulphonamide drugs, which are considered to represent safe levels for human consumption. 

The European Commission has specified a MRL of 100ppb for all substances belonging to the sulphonamide group. (2 )This limit applies to muscle, fat, liver and kidney from all food producing species; and milk from bovine, caprine and ovine sources.  The MRL also specifies that the combined total residues of all substances within the sulphonamide group should not exceed 100ppb.  The target molecule for all sulphonamides is the parent molecule, i.e. sulphathiazole.  The European MRL is in agreement with the MRLs for sulphathiazole set by Canada (3) and the USA (4), although a lower limit of 10ppb has been set for milk samples in Canada .

Principle

The Evidence Investigator ST assay is a competitive chemiluminescent immunoassay for the detection of Sulphathiazole in urine, tissue, honey and feed samples.

REFERENCES

1.    The Merck Manual of Diagnosis and Therapy, Chapter 153: Antibacterial Drugs.

2.    Commission Regulation (EC) No. 508/1999 of 4(th) March 1999, Official Journal of the European Communities L 60/16.

3.    Maximum Residue Limits Set by Canada , Veterinary Drugs Directorate, Health Canada (www.hc-sc.gc.ca)

4.    Code of Federal Regulations, Title 21, Volume 6, 21CFR556.630.

Sulphamethazine (SMT) Assay

Intended Use

The Evidence Investigator Sulphamethazine (SMT) test has been designed for the quantitative measurement of SMT in urine, tissue, honey and feed samples.

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

Clinical Significance

Sulphamethazine is a member of the sulphonamide group of synthetic antibiotics. The sulphonamides are competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle and have a bacteriostatic effect on a broad range of gram-positive and gram–negative organisms. The sulphonamides are distributed widely throughout all organs and tissues; and are metabolized primarily by the liver, producing inactive acetylated and glucuronide forms, which are excreted in urine. (1 )

Sulphonamides are used extensively in veterinary medicine and their use in food producing animals could result in potentially harmful concentrations in tissue, organs and milk.  The potential risk is reduced by withdrawal of the drug for a fixed period before slaughter, although residual levels may still remain.  Regulatory authorities have specified maximum residual levels (MRL) for sulphonamide drugs, which are considered to represent safe levels for human consumption. 

The European Commission has specified a MRL of 100ppb for all substances belonging to the sulphonamide group. (2 )This limit applies to muscle, fat, liver and kidney from all food producing species; and milk from bovine, caprine and ovine sources.  The MRL also specifies that the combined total residues of all substances within the sulphonamide group should not exceed 100ppb.  The target molecule for all sulphonamides is the parent molecule, i.e. sulphamethazine.  The European MRL is in agreement with the MRLs for sulphamethazine set by Canada (3), USA (4 )and Japan ( 5),although lower limits of 10ppb and 25ppb have been set for milk samples in Canada and Japan respectively.

Principle

The Evidence Investigator SMT assay is a competitive chemiluminescent immunoassay for the detection of Sulphamethazine in urine, tissue, honey and feed samples.

REFERENCES

1.   The Merck Manual of Diagnosis and Therapy, Chapter 153: Antibacterial Drugs.

2.   Commission Regulation (EC) No. 508/1999 of 4(th) March 1999, Official Journal of the European Communities L 60/16.

3.   Maximum Residue Limits Set by Canada , Veterinary Drugs Directorate, Health Canada (www.hc-sc.gc.ca)

4.  Code of Federal Regulations, Title 21, Volume 6,21CFR556.630.

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

Sulphaquinoxaline (SQ) Assay

Intended Use

The Evidence Investigator Sulphaquinoxaline (SQ) test has been designed for the quantitative measurement of SQ in urine, tissue, honey and feed samples.

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

Clinical Significance

Sulphaquinoxaline is a member of the sulphonamide group of synthetic antibiotics. The sulphonamides are competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle and have a bacteriostatic effect on a broad range of gram-positive and gram–negative organisms. The sulphonamides are distributed widely throughout all organs and tissues; and are metabolized primarily by the liver, producing inactive acetylated and glucuronide forms, which are excreted in urine. (1 )

Sulphonamides are used extensively in veterinary medicine and their use in food producing animals could result in potentially harmful concentrations in tissue, organs and milk.  The potential risk is reduced by withdrawal of the drug for a fixed period before slaughter, although residual levels may still remain.  Regulatory authorities have specified maximum residual levels (MRL) for sulphonamide drugs, which are considered to represent safe levels for human consumption. 

The European Commission has specified a MRL of 100ppb for all substances belonging to the sulphonamide group. (2 )This limit applies to muscle, fat, liver and kidney from all food producing species; and milk from bovine, caprine and ovine sources.  The MRL also specifies that the combined total residues of all substances within the sulphonamide group should not exceed 100ppb.  The target molecule for all sulphonamides is the parent molecule, i.e. sulphaquinoxaline.  The European MRL is in agreement with the MRLs for sulphaquinoxaline set by Canada (3) and the USA (4), although a lower limit of 10ppb has been set for milk samples in Canada .

Principle

The Evidence Investigator SQ assay is a competitive chemiluminescent immunoassay for the detection of Sulphaquinoxaline in urine, tissue, honey and feed samples.

REFERENCES

1.    The Merck Manual of Diagnosis and Therapy, Chapter 153: Antibacterial Drugs.

2.    Commission Regulation (EC) No. 508/1999 of 4(th) March 1999, Official Journal of the European Communities L 60/16.

3.    Maximum Residue Limits Set by Canada , Veterinary Drugs Directorate, Health Canada (www.hc-sc.gc.ca)

4.  Code of Federal Regulations, Title 21, Volume 6,21CFR556.630.

Sulphapyridine (SP) Assay

Intended Use

The Evidence Investigator Sulphapyridine (SP) test has been designed for the quantitative measurement of SP in urine, tissue, honey and feed samples.

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

Clinical Significance

Sulphapyridine is a member of the sulphonamide group of synthetic antibiotics.  The sulphonamides are competitive inhibitors of p-aminobenzoic acid in the folic acid metabolism cycle and have a bacteriostatic effect on a broad range of gram-positive and gram–negative organisms. The sulphonamides are distributed widely throughout all organs and tissues; and are metabolized primarily by the liver, producing inactive acetylated and glucuronide forms, which are excreted in urine. (1 )

Sulphonamides are used extensively in veterinary medicine and their use in food producing animals could result in potentially harmful concentrations in tissue, organs and milk.  The potential risk is reduced by withdrawal of the drug for a fixed period before slaughter, although residual levels may still remain.  Regulatory authorities have specified maximum residual levels (MRL) for sulphonamide drugs, which are considered to represent safe levels for human consumption. 

The European Commission has specified a MRL of 100ppb for all substances belonging to the sulphonamide group. (2)This limit applies to muscle, fat, liver and kidney from all food producing species; and milk from bovine, caprine and ovine sources.  The MRL also specifies that the combined total residues of all substances within the sulphonamide group should not exceed 100ppb.  The target molecule for all sulphonamides is the parent molecule, i.e. sulphapyridine.  The European MRL is in agreement with the Canadian MRL for sulphapyridine, although a lower limit of 10ppb has been set for milk samples in Canada.(3)

Principle

The Evidence Investigator SP assay is a competitive chemiluminescent immunoassay for the detection of Sulphapyridine in urine, tissue, honey and feed samples.

REFERENCES

1.  The Merck Manual of Diagnosis and Therapy, Chapter 153: Antibacterial Drugs.

2.  Commission Regulation (EC) No. 508/1999 of 4(th) March 1999, Official Journal of the European Communities L 60/16.

3. Maximum Residue Limits Set by Canada , Veterinary Drugs Directorate, Health Canada (www.hc-sc.gc.ca)