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Research ArticleReports and Reviews

Method Comparison Studies for Prostate Specific Antigen and Unconjugated Estriol Immunoassays

Mary E Koenn and Boniface V Ndah
American Society for Clinical Laboratory Science April 2003, 16 (2) 94-98; DOI: https://doi.org/10.29074/ascls.16.2.94
Mary E Koenn
is in the Medical Technology Program, West Virginia University, Morgantown WV
MS CLS(NCA)
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  • For correspondence: MKoenn@hsc.wvu.edu
Boniface V Ndah
is in the Department of Pathology, West Virginia University, Morgantown WV
MD
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  1. Mary E Koenn, MS CLS(NCA)⇑
    1. is in the Medical Technology Program, West Virginia University, Morgantown WV
  2. Boniface V Ndah, MD
    1. is in the Department of Pathology, West Virginia University, Morgantown WV
  1. Address for correspondence: Mary Ellen Koenn MS, Medical Technology Program, West Virginia University, Room 2163C, PO Box 9211, Morgantown WV 26506-9211. (304) 293-1632, (304) 293-6249 (fax). MKoenn{at}hsc.wvu.edu

Abstract

OBJECTIVE: Method comparison studies were performed in order to move a semi-automated prostate specific antigen (PSA) immunoassay and a manual unconjugated estriol (uE3) immunoassay to an automated chemistry immunoassay analyzer. The results of the two method comparison studies are compared.

DESIGN: Serum samples collected on patients with physician orders for PSA or uE3 were assayed by both methods. PSA samples were assayed on a Hybritech Tandem Photon ERA and on two Beckman Coulter Access instruments. UE3 samples were assayed by RIA and on two Beckman Coulter Access instruments. Linear regression analysis was performed on both sets of data and within-run precision and dilution studies were performed on the PSA Access method.

SETTING: Clinical chemistry laboratory, West Virginia University Hospitals Inc, Morgantown WV.

RESULTS: PSA linear regression analysis for the two methods (ERA and Access 1) were y = 1.0008x + 0.0393, r = 0.9976, SE = 0.1319, n = 37 and (ERA and Access 2), y = 1.0019x + 0.0486, r = 0.9964, SE = 0.1632, n = 37. Within-run precision studies for both Access instruments produced acceptable coefficient variations and dilution study results were in PSA reportable range. uE3 linear regression analysis for the two methods (RIA and Access 1) were y = 1.4105x - 0.3741, r = 0.8696, SE = 0.8330, n = 33 and (RIA and Access 2) were y = 1.315x - 0.2292, r = 0.8643, SE = 0.7964, n = 33.

CONCLUSION: The results of the method comparison studies for PSA were acceptable and the automated PSA immunoassay method was adopted. The results of the uE3 comparison studies did not show good correlation; the automated method was not adopted.

ABBREVIATIONS: CV = coefficient of variation; MoM = multiple of the median; PSA = prostate specific antigen; r = correlation coefficient; RIA = radioimmunoassay; SE = standard error; uE3 = unconjugated estriol.

    INDEX TERMS
  • immunoassay
  • method comparison studies
  • prostate specific assay
  • unconjugated estriol
  • © Copyright 2003 American Society for Clinical Laboratory Science Inc. All rights reserved.
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American Society for Clinical Laboratory Science: 16 (2)
American Society for Clinical Laboratory Science
Vol. 16, Issue 2
Spring 2003
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Method Comparison Studies for Prostate Specific Antigen and Unconjugated Estriol Immunoassays
Mary E Koenn, Boniface V Ndah
American Society for Clinical Laboratory Science Apr 2003, 16 (2) 94-98; DOI: 10.29074/ascls.16.2.94

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Method Comparison Studies for Prostate Specific Antigen and Unconjugated Estriol Immunoassays
Mary E Koenn, Boniface V Ndah
American Society for Clinical Laboratory Science Apr 2003, 16 (2) 94-98; DOI: 10.29074/ascls.16.2.94
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Keywords

  • Immunoassay
  • method comparison studies
  • prostate specific assay
  • unconjugated estriol

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