Antimicrobial array ii

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INTENDED USE

The Evidence Investigator Anti Microbial Array II is to be used for the simultaneous quantitative detection of multiple related antimicrobial immunoassays (in parallel) from a single sample.
The Evidence Investigator Anti Microbial Array II is for the screening of samples only and not for use in diagnosis. Positive results should be confirmed by another method.

PRINCIPLE

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 substrate containing an array of discrete test regions of immobilised antibodies specific to different anti microbials.
A competitive chemiluminescent immunoassay is employed. Increased levels of antimicrobial in a sample will lead to decreased binding of antimicrobial labelled with horseradish peroxidase (HRP) and thus a decrease in the chemiluminescence signal emitted.

The light signal generated from each of the test regions on the biochip is detected using state-of-the-art digital imaging technology and compared to that from a stored calibration curve. The concentration of analyte present in the sample is then calculated from the calibration curve. Several different immunoassay based multi-analyte panels have been developed for use on the Evidence Investigator.

The Evidence Investigator Anti Microbial Array II will quantitatively test for quinolones, ceftiofur, thiamphenicol, streptomycin, tylosin and tetracyclines, simultaneously.

Quinolones (QNL) Assay

INTENDED USE

The Evidence Investigator QNL assay has been designed for the quantitative measurement of quinolones in honey, milk and feed samples. This assay is for screening use only. Not for use in diagnosis. Positive results should be confirmed by another method.

CLINICAL SIGNIFICANCE

Quinolones are antimicrobial agents that inhibit the activity of DNA gyrase and topoisomerase IV and are divided into two groups, based on antimicrobial spectrum and pharmacology [1]. They are active against a broad range of bacteria including enterobacteriaceae, streptococci, Chlamydia and Legionella. Quinolones are widely distributed to most body fluids and tissues. They are variably metabolized in the liver and excreted in the urine [2]. Quinolones 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 remain. In recent years quinolones have been used in apiculture for the treatment of bacterial brood infections and although not intended for use during the production of marketable honey their use could result in presence in honey.

Regulatory authorities have specified maximum residual levels (MRLs), or tolerances, for quinolones, which are considered to represent safe levels for human consumption [3-8]. In most cases the parent molecule is specified as the target molecule. However, no MRLs have been fixed for antibiotics in honey.

PRINCIPLE
The Evidence Investigator QNL assay is a competitive chemiluminescent assay for the detection of quinolones in honey, milk and feed samples.

REFERENCES

1. Department of Health and Human Services, Centres for Disease Control and Prevention, Quinolones and the Clinical Laboratory, http://www.cdc.gov.
2. The Merck Manual of Diagnosis and Therapy, http://www.merck.com.
3. The Japan Food Chemical Research Foundation, MHW Notification, No. 370, 1959, amendment No.499 2005.
4. Commission Regulation (EC) No 1182/2002 of 1 July 2002, Official Journal of the European Communities; L 172/13.
5. Code of Federal Regulations; Title 21, Volume 6, Part 556.169.
6. Code of Federal Regulations; Title 21, Volume 6, Part 556.228.
7. Commission Regulation (EC) No 2338/2000 of 20 October 2000, Official Journal of the European Communities; L 269/21.
8. Commission Regulation (EC) No 1356/2005 of 18 August 2005, Official Journal of the European Communities; L 214/3.
 

Ceftiofur (CEFT) Assay

INTENDED USE

The Evidence Investigator CEFT assay has been designed for the quantitative measurement of ceftiofur in honey, milk and feed samples.
This assay is for screening use only. Not for use in diagnosis. Positive results should be confirmed by another method.

CLINICAL SIGNIFICANCE

Cephalosporins are a sub-class of β-lactam antibiotics that are classified in generations, with later generations having expanded spectra against aerobic gram-negative bacilli [1]. Ceftiofur is a third generation cephalosporin antibiotic developed exclusively for veterinary use [2]. It has been approved worldwide for treatment of respiratory disease in swine, cattle, sheep, goats and horses, foot rot and metritis in cattle [3] and in various countries for early mortality infections in day-old chicks and turkey poults [3]. It is bactericidal in vitro, and inhibits cell wall synthesis [2]. Ceftiofur is rapidly converted to both free and protein bound metabolites when administered by intramuscular injection, and the free metabolites retain antimicrobial activity [4]. Ceftiofur has been reported to have more complex metabolism than other cephalosporins, due to the cleavage of its thioester bond to yield desfuroylceftiofur and furoic acid [2].
Ceftiofur is used extensively in veterinary medicine and its 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 remain.

In recent years ceftiofur has been used in apiculture for the treatment of bacterial brood infections and although not intended for use during the production of marketable honey their use could result in presence in honey. Regulatory authorities have specified maximum residual levels (MRLs), or tolerances, for ceftiofur, which are considered to represent safe levels for human consumption [5-7]. However, no MRLs have been fixed for antibiotics in honey.

PRINCIPLE
The Evidence Investigator CEFT assay is a competitive chemiluminescent assay for the detection of ceftiofur in honey, milk and feed samples.

REFERENCES
1. The Merck Manual of Diagnosis and Therapy, http://www.merck.com.
2. 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.
3. Hornish RE and Kotarski SF (2002) Cephalosporins in veterinary medicine - ceftiofur use in food animals. Curr. Top. Med. Chem.; 2(7): 717-31.
4. Moats WA and Buckley SA (1998) Determination of free metabolites of ceftiofur in animal tissues with an automated liquid chromatographic cleanup. J AOAC Int.; 81(4): 709-13.
5. Commission Regulation (EC) No 1231/2006 of 16 August 2006, Official Journal of the European Union; L 225/3.
6. Code of Federal Regulations; Title 21, Volume 6, Part 556.113.
7. The Japan Food Chemical Research Foundation, MHW Notification, No. 370, 1959, amendment No.499 2005.
 

Thiamphenicol (TAF) Assay

INTENDED USE

The Evidence Investigator TAF assay has been designed for the quantitative measurement of
thiamphenicol and florfenicol in honey, milk and feed samples.
This assay is for screening use only. Not for use in diagnosis. Positive results should be confirmed by another method.

CLINICAL SIGNIFICANCE

Thiamphenicol and florfenicol are broad spectrum antibiotics closely related in structure and activity to chloramphenicol. Thiamphenicol differs to Chloramphenicol by having a sulpho-group instead of a nitro-group [1,2]. Florfenicol has a sulpho-group instead of a nitro-group and a fluorine atom instead of the hydroxyl group in the terminal alcohol function [2]. Thiamphenicol and florfenicol have similar antibacterial spectra to chloramphenicol but have not been associated with aplastic anaemia. Both antibiotics have been used for the treatment of infectious diseases in cattle, pigs and poultry [1,2]. Florfenicol is rapidly absorbed and metabolized. Urinary metabolites include florfenicol amine, florfenicol alcohol, florfenicol oxamic acid and monochloroflorfenicol. Florfenicol amine is the longest lived major metabolite in the liver [3]. Thiamphenicol is rapidly absorbed and excreted, without undergoing major biotransformation, although glucuronidation occurs in porcine species [4].

Thiamphenicol and florfenicol 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 remain.
In recent years thiamphenicol and florfenicol have been used in apiculture for the treatment of bacterial brood infections and although not intended for use during the production of marketable honey their use could result in presence in honey. Regulatory authorities have specified maximum residual levels (MRLs), or tolerances, for phenicol drugs, which are considered to represent safe levels for human consumption[5-7]. However, no MRLs have been fixed for antibiotics in honey.

PRINCIPLE

The Evidence Investigator TAF assay is a competitive chemiluminescent assay for the detection of thiamphenicol and florfenicol in honey, milk and feed samples.

REFERENCES

1. European Medicines Agency (EMEA), Committee for Medicinal Products for Veterinary Use, Thiamphenicol Summary Report 3.
2. European Medicines Agency (EMEA), Committee for Medicinal Products for Veterinary Use, Florfenicol Summary Reports 1-6.
3. United States Pharmacopeia, Veterinary Antibiotic Monographs, Florfenicol.
4. 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.
5. Commission Regulation (EC) No 1181/2002 of 1 July 2002, Official Journal of the European Communities; L 172/13.
6. Code of Federal Regulations; Title 21, Volume 6, Part 556.283.
7. The Japan Food Chemical Research Foundation, MHW Notification, No. 370, 1959, amendment No.499 2005.
 

Streptomycin (STR) Assay

INTENDED USE

The Evidence Investigator STR assay has been designed for the quantitative measurement of streptomycin in honey, milk and feed samples.
This assay is for screening use only. Not for use in diagnosis. Positive results should be confirmed by another method.

CLINICAL SIGNIFICANCE

Streptomycin and dihydrostreptomycin are aminoglycosides, a group of bactericidal antibiotics that act by binding to the 30S ribosome and inhibiting protein synthesis [1]. They are used mainly to treat infections caused by aerobic gram-negative bacteria [1-3], although they also act synergistically against some gram-positive bacteria [2,3]. Aminoglycosides were originally isolated from various Streptomyces strains. Streptomycin was isolated from Streptomyces griseus in 1943 and neomycin was isolated from Streptomyces fradiae in 1949. Gentamicin was isolated from Micromonospora in 1963 and other aminoglycosides were subsequently developed, including amikacin, netilmicin and tobramycin [3]. Aminoglycosides are poorly adsorbed orally and are normally administered by intra-venous injection [1]. Aminoglycosides are generally not metabolized and are excreted as parent molecules [4,5]. The most persistent residues are detected in kidney [4,5].

In addition to their use to prevent bacterial infection, aminoglycosides have been used as growth promoters in food producing animals [6]. There has been some controversy surrounding the use of antibiotics as growth promoters for food animals due to the potential for development of aminoglycoside resistant pathogens, for instance, the use of the aminoglycoside apramycin as a growth promoter has been reported to be correlated to the isolation of resistant Salmonella, especially Salmonella enterica var. Typhimurium DT104, in cattle [6].

In recent years streptomycin and dihydrostreptomycin have been used in apiculture for the treatment of bacterial brood infections and although not intended for use during the production of marketable honey their use could result in presence in honey.

Regulatory authorities have specified maximum residual levels (MRLs), or tolerances, for streptomycin and dihydrostreptomycin, which are considered to represent safe levels for human consumption. The European Union and the USA have set separate limits for streptomycin and dihydrostreptomycin [7-9]. Japan has set MRLs for combined residues of streptomycin and dihydrostreptomycin [10]. However, no MRLs have been fixed for antibiotics in honey.

PRINCIPLE

The Evidence Investigator STR assay is a competitive chemiluminescent assay for the detection of streptomycin in honey, milk and feed samples.

REFERENCES
1. The Merck Manual of Diagnosis and Therapy, http://www.merck.com.
2. United States Pharmacopeia, Veterinary Antibiotic Monographs, Aminoglycosides.
3. Gonzalez LS and Spencer JP (1998) Aminoglycosides: A Practical Review. American Family Physician; 58(8): 1811-20.
4. 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.
5. European Medicines Agency (EMEA), Committee for Medicinal Products for Veterinary Use,
Dihydrostreptomycin/Streptomycin Summary Reports 1-3.
6. Hughes P and Heritage J (2004) Antibiotic growthpromoters in food animals. FAO Animal Production and Health Papers; 160: 129-52.
7. Commission Regulation (EC) No 1530/2002 of 27 August 2002. Official Journal of the European Communities; L 230/3.
8. Code of Federal Regulations; Title 21, Volume 6, Part 556.610.
9. Code of Federal Regulations; Title 21, Volume 6, Part 556.200.
10. The Japan Food Chemical Research Foundation, MHW Notification, No. 370, 1959, amendment No.499 2005.
 

Tylosin (TYL) Assay

INTENDED USE

The TYL assay has been designed for the quantitative measurement of tylosin in honey, milk and feed samples.

This assay is for screening use only. Not for use in diagnosis. Positive results should be confirmed by another method.

CLINICAL SIGNIFICANCE

The macrolides are a group of bactericidal antibiotics that act by binding to the 50S ribosomal subunit and inhibiting protein synthesis [1]. They are effective against grampositive cocci [aerobic and anaerobic] except for enterococci [1]. Tylosin and tilmicosin are macrolide antibiotics developed for veterinary use. Tylosin is administered orally or intra-muscularly, and is extensively metabolized, although no metabolites are detected at a greater concentration than the parent molecule [2]. The greatest accumulation of tylosin residues is detected in kidney [2,3]. Tilmicosin is mainly excreted in faeces and urine as parent compound, with the highest tissue levels detected in liver and kidney [2,4].

In addition to their use to prevent bacterial infection, macrolides have been used as growth promoters in food producing animals [5]. There has been some controversy surrounding the use of antibiotics as growth promoters for food animals due to the potential for development of antibiotic resistant pathogens [5].
In recent years tylosin and tilmicosin have been used in apiculture for the treatment of bacterial brood infections and although not intended for use during the production of marketable honey their use could result in presence in honey.

Regulatory authorities have specified maximum residual levels (MRLs), or tolerances, for tylosin and tilmicosin, which are considered to represent safe levels for human consumption. The parent compound is generally specified as the target molecule [6-9]. The European Union has specified tylosin A as the marker residue for tylosin [6]. However, no MRLs have been fixed for antibiotics in honey.

PRINCIPLE

The Evidence Investigator TYL assay is a competitive chemiluminescent assay for the detection of tylosin in honey, milk and feed samples.

REFERENCES

1. The Merck Manual of Diagnosis and Therapy, http://www.merck.com.
2. 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.
3. European Medicines Agency (EMEA), Committee for Medicinal Products for Veterinary Use, Tylosin Summary Reports 1-5.
4. European Medicines Agency (EMEA), Committee for Medicinal Products for Veterinary Use, Tilmicosin Summary Reports 1-7.
5. Hughes P and Heritage J (2004) Antibiotic growthpromoters in food animals. FAO Animal Production and Health Papers; 160: 129-52.
6. Commission Regulation (EC) No 1181/2002 of 1 July 2002. Official Journal of the European Communities; L172/13.
 

Tetracyclines (TCN) Assay

INTENDED USE

The Evidence Investigator TCN assay has been designed for the quantitative measurement of tetracyclines in honey, milk and feed samples.

This assay is for screening use only. Not for use in diagnosis. Positive results should be confirmed by another method.

CLINICAL SIGNIFICANCE

The tetracyclines are a group of closely related bacteriostatic antibiotics with similar antibacterial spectra. They inhibit bacterial protein synthesis by binding to the 30S subunit of the ribosome and are effective against many streptococci, gram-negative bacilli, rickettsiae, spirochetes, Mycoplasma, and Chlamydia [1]. Chlortetracycline and oxytetracycline were the first members of the tetracycline group to be discovered in the late 1940s [2]. Chlortetracycline was isolated from Streptomyces aureofaciens and oxytetracycline from Streptomyces rimosus [2]. Since then, a number of tetracyclines have been isolated or chemically synthesized, including tetracycline and doxycycline.

The tetracyclines are variably absorbed after oral administration and penetrate into most tissues and body fluids, with the highest levels in kidney and liver. All tetracyclines are excreted in urine and faeces, either as the parent molecule or as microbiologically inactive forms. The inactive 4-epimers are thought to be artefacts produced by chemical rather than biological processes and can form spontaneously during sample preparation [3].

Tetracyclines 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 remain.

In recent years tetracyclines have been used in apiculture for the treatment of bacterial brood infections and although not intended for use during the production of marketable honey their use could result in presence in honey.

Regulatory authorities have specified maximum residual levels (MRLs), or tolerances, for tetracyclines, which are considered to represent safe levels for human consumption. The European Union has set individual MRLs for tetracycline, oxytetracycline and chlortetracycline, with the target molecule being the sum of the parent compound and its 4-epimer [4]. The USA and Japan have set limits based on the sum of tetracycline, oxytetracycline and chlortetracycline residues [5,6]. However, no MRLs have been fixed for antibiotics in honey.

PRINCIPLE

The Evidence Investigator TCN assay is a competitive chemiluminescent assay for the detection of tetracyclines in honey, milk and feed samples.

REFERENCES

1. The Merck Manual of Diagnosis and Therapy, http://www.merck.com.
2. Chopra I, Roberts M (2001) Tetracycline antibiotics: mode of action, applications, molecular biology, and epidemiology of bacterial resistance. Microbiol Mol Biol Rev.; 65(2): 232-60.
3. European Medicines Agency (EMEA), Committee for Medicinal Products for Veterinary Use, Oxytetracycline, Tetracycline, Chlortetracycline, Summary Reports 1-3.
4. Commission Regulation (EC) No 508/1999 of 4 March 1999, Official Journal of the European Communities; L 60/16.
5. Code of Federal Regulations; Title 21, Volume 6, Part 556.500.
6. The Japan Food Chemical Research Foundation, MHW Notification, No. 370, 1959, amendment No.499 2005.