Multicenter evaluation of the Bayer Immuno 1(TM) CA 15-3(TM) assay

Carol D. Cheli; Deborah L. Morris; Linda Kish; Joan Goldblatt; Irene Neaman; W. Jeffrey Allard; Kwok K. Yeung; Alan H.B. Wu; Robert Moore; Daniel W. Chan; Herbert A. Fritsche; Morton K. Schwartz; Donald L. Very

doi:10.1093/clinchem/44.4.765

Multicenter evaluation of the Bayer Immuno 1(TM) CA 15-3(TM) assay

Carol D. Cheli, Deborah L. Morris, Linda Kish, Joan Goldblatt, Irene Neaman, W. Jeffrey Allard, Kwok K. Yeung, Alan H.B. Wu, Robert Moore, Daniel W. Chan, Herbert A. Fritsche, Morton K. Schwartz, Donald L. Very

School of Medicine

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

6 Scopus citations

Abstract

We conducted a multicenter evaluation of the analytical and clinical features of the automated Bayer Immuno 1(TM) CA 15-3(TM) assay and compared assay performance to two manual tests. Results of the 10-day imprecision study of the Bayer Immuno 1 assay pooled across four evaluation sites and three lots of reagent produced total CV ≤4%. Lot-to-lot reproducibility for 26 different lots of reagents and calibrators manufactured over a 2-year period was demonstrated (CV, 1.1%). Results for the Bayer Immuno 1 assay correlated well with the Biomira TRUQUANT® BR(TM) 27.29 and Centocor® CA 15-3 RIAs (r ≤0.94). The upper limit of the reference interval for the Bayer Immuno 1 assay was 35.9 kilounits/L (35.9 units/mL); values were similar for all methods. Longitudinal monitoring of healthy women yielded assay values with an average CV of 11% and 21% for the Bayer Immuno 1 and Biomira assays, respectively. The Bayer Immuno 1 assay demonstrated the analytical features, intermethod correlation, and long-term performance characteristics that are essential for longitudinal monitoring of breast cancer patients.

Original language	English (US)
Pages (from-to)	765-772
Number of pages	8
Journal	Clinical chemistry
Volume	44
Issue number	4
DOIs	https://doi.org/10.1093/clinchem/44.4.765
State	Published - 1998

ASJC Scopus subject areas

General Medicine

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title = "Multicenter evaluation of the Bayer Immuno 1(TM) CA 15-3(TM) assay",

abstract = "We conducted a multicenter evaluation of the analytical and clinical features of the automated Bayer Immuno 1(TM) CA 15-3(TM) assay and compared assay performance to two manual tests. Results of the 10-day imprecision study of the Bayer Immuno 1 assay pooled across four evaluation sites and three lots of reagent produced total CV ≤4%. Lot-to-lot reproducibility for 26 different lots of reagents and calibrators manufactured over a 2-year period was demonstrated (CV, 1.1%). Results for the Bayer Immuno 1 assay correlated well with the Biomira TRUQUANT{\textregistered} BR(TM) 27.29 and Centocor{\textregistered} CA 15-3 RIAs (r ≤0.94). The upper limit of the reference interval for the Bayer Immuno 1 assay was 35.9 kilounits/L (35.9 units/mL); values were similar for all methods. Longitudinal monitoring of healthy women yielded assay values with an average CV of 11% and 21% for the Bayer Immuno 1 and Biomira assays, respectively. The Bayer Immuno 1 assay demonstrated the analytical features, intermethod correlation, and long-term performance characteristics that are essential for longitudinal monitoring of breast cancer patients.",

author = "Cheli, {Carol D.} and Morris, {Deborah L.} and Linda Kish and Joan Goldblatt and Irene Neaman and Allard, {W. Jeffrey} and Yeung, {Kwok K.} and Wu, {Alan H.B.} and Robert Moore and Chan, {Daniel W.} and Fritsche, {Herbert A.} and Schwartz, {Morton K.} and Very, {Donald L.}",

year = "1998",

doi = "10.1093/clinchem/44.4.765",

language = "English (US)",

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pages = "765--772",

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AU - Cheli, Carol D.

AU - Morris, Deborah L.

AU - Kish, Linda

AU - Goldblatt, Joan

AU - Neaman, Irene

AU - Allard, W. Jeffrey

AU - Yeung, Kwok K.

AU - Wu, Alan H.B.

AU - Moore, Robert

AU - Chan, Daniel W.

AU - Fritsche, Herbert A.

AU - Schwartz, Morton K.

AU - Very, Donald L.

PY - 1998

Y1 - 1998

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AB - We conducted a multicenter evaluation of the analytical and clinical features of the automated Bayer Immuno 1(TM) CA 15-3(TM) assay and compared assay performance to two manual tests. Results of the 10-day imprecision study of the Bayer Immuno 1 assay pooled across four evaluation sites and three lots of reagent produced total CV ≤4%. Lot-to-lot reproducibility for 26 different lots of reagents and calibrators manufactured over a 2-year period was demonstrated (CV, 1.1%). Results for the Bayer Immuno 1 assay correlated well with the Biomira TRUQUANT® BR(TM) 27.29 and Centocor® CA 15-3 RIAs (r ≤0.94). The upper limit of the reference interval for the Bayer Immuno 1 assay was 35.9 kilounits/L (35.9 units/mL); values were similar for all methods. Longitudinal monitoring of healthy women yielded assay values with an average CV of 11% and 21% for the Bayer Immuno 1 and Biomira assays, respectively. The Bayer Immuno 1 assay demonstrated the analytical features, intermethod correlation, and long-term performance characteristics that are essential for longitudinal monitoring of breast cancer patients.

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Multicenter evaluation of the Bayer Immuno 1(TM) CA 15-3(TM) assay

Abstract

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