Lack of specificity of cyclosporine immunoassays: Results of a College of American Pathologists study

Steven J. Soldin; Bernard W. Steele; David L. Witte; Edward Wang; Ronald J. Elin

Lack of specificity of cyclosporine immunoassays: Results of a College of American Pathologists study

Steven J. Soldin, Bernard W. Steele, David L. Witte, Edward Wang, Ronald J. Elin

Pathology

Research output: Contribution to journal › Article

49 Scopus citations

Abstract

Objective. - To evaluate the cross-reactivity of the 6 most abundant cyclosporine A (CsA) metabolites in commonly used assays for CsA. Design. - Whole blood samples containing either only 62 ng/mL CsA (A) or 62 ng/mL CsA and between 49 and 86 ng/mL of 1 of the 6 most abundant CsA metabolites (B) were lyophilized. One sample of A and 1 of B were mailed to each of the laboratories participating in the College of American Pathologists Proficiency Testing Program quarterly during a 3-year period (1999-2001). Method means and coefficients of variation were calculated for each mailing. Results. - The study showed significant cross-reactivity of metabolites in all the immunoassay systems studied. Overall degree of interference decreased from Abbott TDx polyclonal > Abbott TDx monoclonal > DiaSorin > Syva EMIT. High-performance liquid chromatography methods gave results close to those found using mass spectrometric techniques. Conclusions. - Significant metabolite interference was found to occur with the immunoassay systems studied.

Original language	English (US)
Pages (from-to)	19-22
Number of pages	4
Journal	Archives of Pathology and Laboratory Medicine
Volume	127
Issue number	1
State	Published - Jan 1 2003

ASJC Scopus subject areas

Pathology and Forensic Medicine
Medical Laboratory Technology

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Soldin, S. J., Steele, B. W., Witte, D. L., Wang, E., & Elin, R. J. (2003). Lack of specificity of cyclosporine immunoassays: Results of a College of American Pathologists study. Archives of Pathology and Laboratory Medicine, 127(1), 19-22.

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abstract = "Objective. - To evaluate the cross-reactivity of the 6 most abundant cyclosporine A (CsA) metabolites in commonly used assays for CsA. Design. - Whole blood samples containing either only 62 ng/mL CsA (A) or 62 ng/mL CsA and between 49 and 86 ng/mL of 1 of the 6 most abundant CsA metabolites (B) were lyophilized. One sample of A and 1 of B were mailed to each of the laboratories participating in the College of American Pathologists Proficiency Testing Program quarterly during a 3-year period (1999-2001). Method means and coefficients of variation were calculated for each mailing. Results. - The study showed significant cross-reactivity of metabolites in all the immunoassay systems studied. Overall degree of interference decreased from Abbott TDx polyclonal > Abbott TDx monoclonal > DiaSorin > Syva EMIT. High-performance liquid chromatography methods gave results close to those found using mass spectrometric techniques. Conclusions. - Significant metabolite interference was found to occur with the immunoassay systems studied.",

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N2 - Objective. - To evaluate the cross-reactivity of the 6 most abundant cyclosporine A (CsA) metabolites in commonly used assays for CsA. Design. - Whole blood samples containing either only 62 ng/mL CsA (A) or 62 ng/mL CsA and between 49 and 86 ng/mL of 1 of the 6 most abundant CsA metabolites (B) were lyophilized. One sample of A and 1 of B were mailed to each of the laboratories participating in the College of American Pathologists Proficiency Testing Program quarterly during a 3-year period (1999-2001). Method means and coefficients of variation were calculated for each mailing. Results. - The study showed significant cross-reactivity of metabolites in all the immunoassay systems studied. Overall degree of interference decreased from Abbott TDx polyclonal > Abbott TDx monoclonal > DiaSorin > Syva EMIT. High-performance liquid chromatography methods gave results close to those found using mass spectrometric techniques. Conclusions. - Significant metabolite interference was found to occur with the immunoassay systems studied.

AB - Objective. - To evaluate the cross-reactivity of the 6 most abundant cyclosporine A (CsA) metabolites in commonly used assays for CsA. Design. - Whole blood samples containing either only 62 ng/mL CsA (A) or 62 ng/mL CsA and between 49 and 86 ng/mL of 1 of the 6 most abundant CsA metabolites (B) were lyophilized. One sample of A and 1 of B were mailed to each of the laboratories participating in the College of American Pathologists Proficiency Testing Program quarterly during a 3-year period (1999-2001). Method means and coefficients of variation were calculated for each mailing. Results. - The study showed significant cross-reactivity of metabolites in all the immunoassay systems studied. Overall degree of interference decreased from Abbott TDx polyclonal > Abbott TDx monoclonal > DiaSorin > Syva EMIT. High-performance liquid chromatography methods gave results close to those found using mass spectrometric techniques. Conclusions. - Significant metabolite interference was found to occur with the immunoassay systems studied.

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