title: Proficiency monitoring of monoclonal antibody cocktail-based enzyme-linked immunosorbent assay for detection of allergen-specific immunoglobulin E in dogs.
abstract: The purpose of our study was to document the continued comparative proficiency of different laboratories that perform a monoclonal antibody-based enzyme-linked immunosorbent assay (macELISA) for detection of allergen-specific immunoglobulin (Ig)E in dogs. Replicate samples of 18 different sera pools were independently evaluated in a single blinded fashion by each of 16 different operators functioning in 10 different laboratories. The average intra-assay variance among reactive assay calibrators in all laboratories was 6.0% (range: 2.7-16.1%), while the average intralaboratory interassay variance was 7.5% (range: 3.9-10.9%). The overall interassay interlaboratory variance was consistent among laboratories and averaged 11.4% (range: 8.5-12.5%). All laboratories yielded similar profiles and magnitudes of responses for replicate unknown samples; dose response profiles observed in each of the laboratories were indistinguishable. Considering the positive or negative results, interassay interlaboratory concordance of results exceeded 90%. Correlation of optical density values between and among all laboratories was strong (r > 0.9, P < 0.001). Collectively, the results demonstrated that the macELISA for measuring allergen-specific canine IgE is reproducible, and documents that consistency of results can be achieved not only in an individual laboratory by differing operators but also among laboratories using the same monoclonal-based ELISA.
authors.affiliation: Greer Laboratories Inc., Lenoir, NC (Lee, Blankenship, McKinney)IDEXX GmbH, Ludwigsburg, Germany (Kern)IDEXX Laboratories Inc., Westbrook, ME (Buch)IDEXX Laboratories Inc. Markham, Ontario, Canada (Greenwood)Univet Diagnostic Services, Sant Cugat, Barcelona, Spain (Brazis)Biovac, Beaucouzé Cedex, France (Drouet)Agrolabo SpA, Scarmagno, Torino, Italy (Tambone)Artu Biologicals, Almere, The Netherlands (Faas)Axiom Veterinary Laboratories, Newton Abbot, Devon, UK (Weaver) klee@greerlabs.com.
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Lee
authors.affiliation: Greer Laboratories Inc., Lenoir, NC (Lee, Blankenship, McKinney)IDEXX GmbH, Ludwigsburg, Germany (Kern)IDEXX Laboratories Inc., Westbrook, ME (Buch)IDEXX Laboratories Inc. Markham, Ontario, Canada (Greenwood)Univet Diagnostic Services, Sant Cugat, Barcelona, Spain (Brazis)Biovac, Beaucouzé Cedex, France (Drouet)Agrolabo SpA, Scarmagno, Torino, Italy (Tambone)Artu Biologicals, Almere, The Netherlands (Faas)Axiom Veterinary Laboratories, Newton Abbot, Devon, UK (Weaver).
authors.forename: Karen
authors.initials: K
authors.lastname: Blankenship
authors.affiliation: Greer Laboratories Inc., Lenoir, NC (Lee, Blankenship, McKinney)IDEXX GmbH, Ludwigsburg, Germany (Kern)IDEXX Laboratories Inc., Westbrook, ME (Buch)IDEXX Laboratories Inc. Markham, Ontario, Canada (Greenwood)Univet Diagnostic Services, Sant Cugat, Barcelona, Spain (Brazis)Biovac, Beaucouzé Cedex, France (Drouet)Agrolabo SpA, Scarmagno, Torino, Italy (Tambone)Artu Biologicals, Almere, The Netherlands (Faas)Axiom Veterinary Laboratories, Newton Abbot, Devon, UK (Weaver).
authors.forename: Brennan
authors.initials: B
authors.lastname: McKinney
authors.affiliation: Greer Laboratories Inc., Lenoir, NC (Lee, Blankenship, McKinney)IDEXX GmbH, Ludwigsburg, Germany (Kern)IDEXX Laboratories Inc., Westbrook, ME (Buch)IDEXX Laboratories Inc. Markham, Ontario, Canada (Greenwood)Univet Diagnostic Services, Sant Cugat, Barcelona, Spain (Brazis)Biovac, Beaucouzé Cedex, France (Drouet)Agrolabo SpA, Scarmagno, Torino, Italy (Tambone)Artu Biologicals, Almere, The Netherlands (Faas)Axiom Veterinary Laboratories, Newton Abbot, Devon, UK (Weaver).
authors.forename: Gerhard
authors.initials: G
authors.lastname: Kern
authors.affiliation: Greer Laboratories Inc., Lenoir, NC (Lee, Blankenship, McKinney)IDEXX GmbH, Ludwigsburg, Germany (Kern)IDEXX Laboratories Inc., Westbrook, ME (Buch)IDEXX Laboratories Inc. Markham, Ontario, Canada (Greenwood)Univet Diagnostic Services, Sant Cugat, Barcelona, Spain (Brazis)Biovac, Beaucouzé Cedex, France (Drouet)Agrolabo SpA, Scarmagno, Torino, Italy (Tambone)Artu Biologicals, Almere, The Netherlands (Faas)Axiom Veterinary Laboratories, Newton Abbot, Devon, UK (Weaver).
authors.forename: Jesse
authors.initials: J
authors.lastname: Buch
authors.affiliation: Greer Laboratories Inc., Lenoir, NC (Lee, Blankenship, McKinney)IDEXX GmbH, Ludwigsburg, Germany (Kern)IDEXX Laboratories Inc., Westbrook, ME (Buch)IDEXX Laboratories Inc. Markham, Ontario, Canada (Greenwood)Univet Diagnostic Services, Sant Cugat, Barcelona, Spain (Brazis)Biovac, Beaucouzé Cedex, France (Drouet)Agrolabo SpA, Scarmagno, Torino, Italy (Tambone)Artu Biologicals, Almere, The Netherlands (Faas)Axiom Veterinary Laboratories, Newton Abbot, Devon, UK (Weaver).
authors.forename: Janice
authors.initials: J
authors.lastname: Greenwood
authors.affiliation: Greer Laboratories Inc., Lenoir, NC (Lee, Blankenship, McKinney)IDEXX GmbH, Ludwigsburg, Germany (Kern)IDEXX Laboratories Inc., Westbrook, ME (Buch)IDEXX Laboratories Inc. Markham, Ontario, Canada (Greenwood)Univet Diagnostic Services, Sant Cugat, Barcelona, Spain (Brazis)Biovac, Beaucouzé Cedex, France (Drouet)Agrolabo SpA, Scarmagno, Torino, Italy (Tambone)Artu Biologicals, Almere, The Netherlands (Faas)Axiom Veterinary Laboratories, Newton Abbot, Devon, UK (Weaver).
authors.forename: Pilar
authors.initials: P
authors.lastname: Brazis
authors.affiliation: Greer Laboratories Inc., Lenoir, NC (Lee, Blankenship, McKinney)IDEXX GmbH, Ludwigsburg, Germany (Kern)IDEXX Laboratories Inc., Westbrook, ME (Buch)IDEXX Laboratories Inc. Markham, Ontario, Canada (Greenwood)Univet Diagnostic Services, Sant Cugat, Barcelona, Spain (Brazis)Biovac, Beaucouzé Cedex, France (Drouet)Agrolabo SpA, Scarmagno, Torino, Italy (Tambone)Artu Biologicals, Almere, The Netherlands (Faas)Axiom Veterinary Laboratories, Newton Abbot, Devon, UK (Weaver).
authors.forename: Laurent
authors.initials: L
authors.lastname: Drouet
authors.affiliation: Greer Laboratories Inc., Lenoir, NC (Lee, Blankenship, McKinney)IDEXX GmbH, Ludwigsburg, Germany (Kern)IDEXX Laboratories Inc., Westbrook, ME (Buch)IDEXX Laboratories Inc. Markham, Ontario, Canada (Greenwood)Univet Diagnostic Services, Sant Cugat, Barcelona, Spain (Brazis)Biovac, Beaucouzé Cedex, France (Drouet)Agrolabo SpA, Scarmagno, Torino, Italy (Tambone)Artu Biologicals, Almere, The Netherlands (Faas)Axiom Veterinary Laboratories, Newton Abbot, Devon, UK (Weaver).
authors.forename: Cecilia
authors.initials: C
authors.lastname: Tambone
authors.affiliation: Greer Laboratories Inc., Lenoir, NC (Lee, Blankenship, McKinney)IDEXX GmbH, Ludwigsburg, Germany (Kern)IDEXX Laboratories Inc., Westbrook, ME (Buch)IDEXX Laboratories Inc. Markham, Ontario, Canada (Greenwood)Univet Diagnostic Services, Sant Cugat, Barcelona, Spain (Brazis)Biovac, Beaucouzé Cedex, France (Drouet)Agrolabo SpA, Scarmagno, Torino, Italy (Tambone)Artu Biologicals, Almere, The Netherlands (Faas)Axiom Veterinary Laboratories, Newton Abbot, Devon, UK (Weaver).
authors.forename: Rebecca
authors.initials: R
authors.lastname: Faas
authors.affiliation: Greer Laboratories Inc., Lenoir, NC (Lee, Blankenship, McKinney)IDEXX GmbH, Ludwigsburg, Germany (Kern)IDEXX Laboratories Inc., Westbrook, ME (Buch)IDEXX Laboratories Inc. Markham, Ontario, Canada (Greenwood)Univet Diagnostic Services, Sant Cugat, Barcelona, Spain (Brazis)Biovac, Beaucouzé Cedex, France (Drouet)Agrolabo SpA, Scarmagno, Torino, Italy (Tambone)Artu Biologicals, Almere, The Netherlands (Faas)Axiom Veterinary Laboratories, Newton Abbot, Devon, UK (Weaver).
authors.forename: Gareth
authors.initials: G
authors.lastname: Weaver
mesh_terms: D000485:Allergens / Q000276:immunology*; D000818:Animals; D000911:Antibodies, Monoclonal / Q000276:immunology; D002170:Canada; D019411:Clinical Laboratory Techniques / Q000592:standards / Q000662:veterinary; D003876:Dermatitis, Atopic / Q000175:diagnosis / Q000662:veterinary*; D004283:Dog Diseases / Q000175:diagnosis* / Q000276:immunology / Q000517:prevention & control; D004285:Dogs; D004797:Enzyme-Linked Immunosorbent Assay / Q000662:veterinary*; D005060:Europe; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology*; D015203:Reproducibility of Results; D014481:United States; D014730:Veterinary Medicine / Q000592:standards
chemical_list: D000485:Allergens; D000911:Antibodies, Monoclonal; D007073:Immunoglobulin E
keywords: Allergy; enzyme-linked immunosorbent assay; immunoglobulin E; immunotherapy; proficiency.