Total error profiling of a proinsulin time-resolved fluorescence immunoassay

P. E. De Pauw; R. B. Mackin; P. Goubert; C. Van Schravendijk; F. K. Gorus

doi:10.1016/j.jchromb.2008.11.024

Total error profiling of a proinsulin time-resolved fluorescence immunoassay

P. E. De Pauw, R. B. Mackin, P. Goubert, C. Van Schravendijk, F. K. Gorus

Research output: Contribution to journal › Article › peer-review

6 Scopus citations

Abstract

We applied total error profiling to evaluate the conversion of a known proinsulin (PI) enzyme-linked immunosorbent assay (ELISA) into a time-resolved fluorescence immunoassay (TRFIA). The formula and acceptance criteria proposed by the Ligand Binding Assay Bioanalytical Focus Group (LBABFG) of the American Association of Pharmaceutical Scientists (AAPS) were applied. We found that the expected dynamic range enlargement with TRFIA compared to ELISA ([0.5-240] versus resp. [0.7-98] pmol/L) is limited by an interference of C-peptide when present in the sample at high concentrations (>7000 pmol/L).

Original language	English (US)
Pages (from-to)	2403-2406
Number of pages	4
Journal	Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
Volume	877
Issue number	23
DOIs	https://doi.org/10.1016/j.jchromb.2008.11.024
State	Published - Sep 1 2009
Externally published	Yes

Keywords

C-peptide
Diabetes
Immunoassays
Proinsulin
Time-resolved fluorescence
Total error profiling
Validation

ASJC Scopus subject areas

Analytical Chemistry
Biochemistry
Clinical Biochemistry
Cell Biology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jchromb.2008.11.024

Cite this

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title = "Total error profiling of a proinsulin time-resolved fluorescence immunoassay",

abstract = "We applied total error profiling to evaluate the conversion of a known proinsulin (PI) enzyme-linked immunosorbent assay (ELISA) into a time-resolved fluorescence immunoassay (TRFIA). The formula and acceptance criteria proposed by the Ligand Binding Assay Bioanalytical Focus Group (LBABFG) of the American Association of Pharmaceutical Scientists (AAPS) were applied. We found that the expected dynamic range enlargement with TRFIA compared to ELISA ([0.5-240] versus resp. [0.7-98] pmol/L) is limited by an interference of C-peptide when present in the sample at high concentrations (>7000 pmol/L).",

keywords = "C-peptide, Diabetes, Immunoassays, Proinsulin, Time-resolved fluorescence, Total error profiling, Validation",

author = "{De Pauw}, {P. E.} and Mackin, {R. B.} and P. Goubert and {Van Schravendijk}, C. and Gorus, {F. K.}",

note = "Funding Information: The present work was supported by grants from the Juvenile Diabetes Research Foundation (JDRF, Grant 4-2005-1327), The Belgian Research Council (FWO Grants G.0517.04 and G. 0311.07), the Research Council from the Brussels Free University (OZR 1150 and 1449) and the Scientific Fund Willy Gepts (UZ Brussel). ",

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doi = "10.1016/j.jchromb.2008.11.024",

language = "English (US)",

volume = "877",

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T1 - Total error profiling of a proinsulin time-resolved fluorescence immunoassay

AU - De Pauw, P. E.

AU - Mackin, R. B.

AU - Goubert, P.

AU - Van Schravendijk, C.

AU - Gorus, F. K.

N1 - Funding Information: The present work was supported by grants from the Juvenile Diabetes Research Foundation (JDRF, Grant 4-2005-1327), The Belgian Research Council (FWO Grants G.0517.04 and G. 0311.07), the Research Council from the Brussels Free University (OZR 1150 and 1449) and the Scientific Fund Willy Gepts (UZ Brussel).

PY - 2009/9/1

Y1 - 2009/9/1

N2 - We applied total error profiling to evaluate the conversion of a known proinsulin (PI) enzyme-linked immunosorbent assay (ELISA) into a time-resolved fluorescence immunoassay (TRFIA). The formula and acceptance criteria proposed by the Ligand Binding Assay Bioanalytical Focus Group (LBABFG) of the American Association of Pharmaceutical Scientists (AAPS) were applied. We found that the expected dynamic range enlargement with TRFIA compared to ELISA ([0.5-240] versus resp. [0.7-98] pmol/L) is limited by an interference of C-peptide when present in the sample at high concentrations (>7000 pmol/L).

AB - We applied total error profiling to evaluate the conversion of a known proinsulin (PI) enzyme-linked immunosorbent assay (ELISA) into a time-resolved fluorescence immunoassay (TRFIA). The formula and acceptance criteria proposed by the Ligand Binding Assay Bioanalytical Focus Group (LBABFG) of the American Association of Pharmaceutical Scientists (AAPS) were applied. We found that the expected dynamic range enlargement with TRFIA compared to ELISA ([0.5-240] versus resp. [0.7-98] pmol/L) is limited by an interference of C-peptide when present in the sample at high concentrations (>7000 pmol/L).

KW - C-peptide

KW - Diabetes

KW - Immunoassays

KW - Proinsulin

KW - Time-resolved fluorescence

KW - Total error profiling

KW - Validation

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SN - 1570-0232

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JO - Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

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IS - 23

ER -

Total error profiling of a proinsulin time-resolved fluorescence immunoassay

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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