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Standardization of two immunoassays for human glandular kallikrein 2.

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Standardization of two immunoassays for human glandular kallikrein 2. / Haese, Alexander; Vaisanen, Ville; Finlay, Judith A; Pettersson, Kim; Rittenhouse, Harry G; Partin, Alan W; Bruzek, Debra J; Sokoll, Lori J; Lilja, Hans; Chan, Daniel W.

In: CLIN CHEM, Vol. 49, No. 4, 4, 2003, p. 601-610.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Haese, A, Vaisanen, V, Finlay, JA, Pettersson, K, Rittenhouse, HG, Partin, AW, Bruzek, DJ, Sokoll, LJ, Lilja, H & Chan, DW 2003, 'Standardization of two immunoassays for human glandular kallikrein 2.', CLIN CHEM, vol. 49, no. 4, 4, pp. 601-610. <http://www.ncbi.nlm.nih.gov/pubmed/12651813?dopt=Citation>

APA

Haese, A., Vaisanen, V., Finlay, J. A., Pettersson, K., Rittenhouse, H. G., Partin, A. W., Bruzek, D. J., Sokoll, L. J., Lilja, H., & Chan, D. W. (2003). Standardization of two immunoassays for human glandular kallikrein 2. CLIN CHEM, 49(4), 601-610. [4]. http://www.ncbi.nlm.nih.gov/pubmed/12651813?dopt=Citation

Vancouver

Haese A, Vaisanen V, Finlay JA, Pettersson K, Rittenhouse HG, Partin AW et al. Standardization of two immunoassays for human glandular kallikrein 2. CLIN CHEM. 2003;49(4):601-610. 4.

Bibtex

@article{0284c531f92647e7a09b31830c9a7a0e,
title = "Standardization of two immunoassays for human glandular kallikrein 2.",
abstract = "BACKGROUND: Measurement of human kallikrein 2 (hK2) has improved early detection and staging of prostate cancer. However, reported concentrations of hK2 among currently used assays have not been standardized in any way. We compared two hK2 assays and five different recombinant hK2 variants (rhK2) and suggest a common calibrator as an important step and putative reference substance in hK2 assay standardization. METHODS: We measured 146 sera by two hK2 assays, using assay-specific calibrators to assess the difference between the two assays. Serial dilutions of five rhK2 preparations were measured repeatedly, with one preparation assigned as calibrator and the others as unknowns to define which variant provided the closest match between the two assays. This rhK2 variant was used to recalibrate both assays. We measured hK2 concentrations in the same 146 patients to evaluate the change in the difference. RESULTS: Use of assay-specific calibrators for comparison of the two assays yielded a Deming regression equation of: y = 0.789 (95% confidence interval, 0.674-0.922)x + 0.014 (0.004-0.025) micro g/L; R(2) = 0.667. Analysis of five rhK2 variants revealed that the enterokinase (ek)-rhK2 form provided the best match between both assays. Using the ek-rhK2 as a common calibrator, we observed a change in the slope of the regression curve to: y = 1.106 (0.872-1.340)x + 0.006 (-0.002 to 0.016) micro g/L; R(2) = 0.648, suggesting an increase in the mean estimate of agreement between the two assays. CONCLUSION: Calibration with a common calibrator substantially increased agreement between the assays. The ek-rhK2 variant provided the best performance of all tested rhK2 variants and should undergo mass spectrometry and amino acid analysis for exact mass determination and value assignment to evaluate its potential as a reference material for immunoassays for hK2.",
author = "Alexander Haese and Ville Vaisanen and Finlay, {Judith A} and Kim Pettersson and Rittenhouse, {Harry G} and Partin, {Alan W} and Bruzek, {Debra J} and Sokoll, {Lori J} and Hans Lilja and Chan, {Daniel W}",
year = "2003",
language = "Deutsch",
volume = "49",
pages = "601--610",
journal = "CLIN CHEM",
issn = "0009-9147",
publisher = "American Association for Clinical Chemistry Inc.",
number = "4",

}

RIS

TY - JOUR

T1 - Standardization of two immunoassays for human glandular kallikrein 2.

AU - Haese, Alexander

AU - Vaisanen, Ville

AU - Finlay, Judith A

AU - Pettersson, Kim

AU - Rittenhouse, Harry G

AU - Partin, Alan W

AU - Bruzek, Debra J

AU - Sokoll, Lori J

AU - Lilja, Hans

AU - Chan, Daniel W

PY - 2003

Y1 - 2003

N2 - BACKGROUND: Measurement of human kallikrein 2 (hK2) has improved early detection and staging of prostate cancer. However, reported concentrations of hK2 among currently used assays have not been standardized in any way. We compared two hK2 assays and five different recombinant hK2 variants (rhK2) and suggest a common calibrator as an important step and putative reference substance in hK2 assay standardization. METHODS: We measured 146 sera by two hK2 assays, using assay-specific calibrators to assess the difference between the two assays. Serial dilutions of five rhK2 preparations were measured repeatedly, with one preparation assigned as calibrator and the others as unknowns to define which variant provided the closest match between the two assays. This rhK2 variant was used to recalibrate both assays. We measured hK2 concentrations in the same 146 patients to evaluate the change in the difference. RESULTS: Use of assay-specific calibrators for comparison of the two assays yielded a Deming regression equation of: y = 0.789 (95% confidence interval, 0.674-0.922)x + 0.014 (0.004-0.025) micro g/L; R(2) = 0.667. Analysis of five rhK2 variants revealed that the enterokinase (ek)-rhK2 form provided the best match between both assays. Using the ek-rhK2 as a common calibrator, we observed a change in the slope of the regression curve to: y = 1.106 (0.872-1.340)x + 0.006 (-0.002 to 0.016) micro g/L; R(2) = 0.648, suggesting an increase in the mean estimate of agreement between the two assays. CONCLUSION: Calibration with a common calibrator substantially increased agreement between the assays. The ek-rhK2 variant provided the best performance of all tested rhK2 variants and should undergo mass spectrometry and amino acid analysis for exact mass determination and value assignment to evaluate its potential as a reference material for immunoassays for hK2.

AB - BACKGROUND: Measurement of human kallikrein 2 (hK2) has improved early detection and staging of prostate cancer. However, reported concentrations of hK2 among currently used assays have not been standardized in any way. We compared two hK2 assays and five different recombinant hK2 variants (rhK2) and suggest a common calibrator as an important step and putative reference substance in hK2 assay standardization. METHODS: We measured 146 sera by two hK2 assays, using assay-specific calibrators to assess the difference between the two assays. Serial dilutions of five rhK2 preparations were measured repeatedly, with one preparation assigned as calibrator and the others as unknowns to define which variant provided the closest match between the two assays. This rhK2 variant was used to recalibrate both assays. We measured hK2 concentrations in the same 146 patients to evaluate the change in the difference. RESULTS: Use of assay-specific calibrators for comparison of the two assays yielded a Deming regression equation of: y = 0.789 (95% confidence interval, 0.674-0.922)x + 0.014 (0.004-0.025) micro g/L; R(2) = 0.667. Analysis of five rhK2 variants revealed that the enterokinase (ek)-rhK2 form provided the best match between both assays. Using the ek-rhK2 as a common calibrator, we observed a change in the slope of the regression curve to: y = 1.106 (0.872-1.340)x + 0.006 (-0.002 to 0.016) micro g/L; R(2) = 0.648, suggesting an increase in the mean estimate of agreement between the two assays. CONCLUSION: Calibration with a common calibrator substantially increased agreement between the assays. The ek-rhK2 variant provided the best performance of all tested rhK2 variants and should undergo mass spectrometry and amino acid analysis for exact mass determination and value assignment to evaluate its potential as a reference material for immunoassays for hK2.

M3 - SCORING: Zeitschriftenaufsatz

VL - 49

SP - 601

EP - 610

JO - CLIN CHEM

JF - CLIN CHEM

SN - 0009-9147

IS - 4

M1 - 4

ER -