PMID- 22386211
OWN - NLM
STAT- MEDLINE
DCOM- 20120803
LR  - 20191210
IS  - 1873-264X (Electronic)
IS  - 0731-7085 (Linking)
VI  - 64-65
DP  - 2012 May
TI  - Development and validation of an alpha fetoprotein immunoassay using Gyros 
      technology.
PG  - 8-15
LID - 10.1016/j.jpba.2012.02.001 [doi]
AB  - Circulating alpha fetoprotein (AFP) is a diagnostic and prognostic biomarker for 
      hepatocellular carcinoma (HCC) with potential utility as a pharmacodynamic 
      endpoint in rodent tumor models. This application is limited, however, by low 
      sample volumes, highlighting the need for sensitive, sample-sparing biomarker 
      assay methods. In order to improve the utility of AFP as an oncology biomarker, 
      we developed a method for AFP using the Gyrolab, an automated microimmunoassay 
      platform. Commercially available antibodies were screened to identify optimal 
      combinations that were then used in a multi-factorial design of experiments (DOE) 
      to optimize reaction conditions. Analytical validation included assessments of 
      accuracy and precision (A&P), and dilutional linearity/hook effect, as well as 
      reagent and sample stability. The method is reliable, with total error, a measure 
      of accuracy and precision, less than 30% for all concentrations tested. AFP 
      concentrations were measurable in diseased mice and undetectable in normal mice. 
      Therefore, this novel, low volume AFP immunoassay is suitable for pre-clinical 
      drug development, where its miniaturized format facilitates serial sampling in 
      rodent models of cancer.
CI  - Copyright (c) 2012 Elsevier B.V. All rights reserved.
FAU - Given, Allison M
AU  - Given AM
AD  - Pfizer Worldwide Research & Development, Pharmacodynamics, Metabolics and 
      Dynamics, La Jolla, CA 92121, United States.
FAU - Whalen, Pamela M
AU  - Whalen PM
FAU - O'Brien, Peter J
AU  - O'Brien PJ
FAU - Ray, Chad A
AU  - Ray CA
LA  - eng
PT  - Journal Article
PT  - Validation Study
DEP - 20120211
PL  - England
TA  - J Pharm Biomed Anal
JT  - Journal of pharmaceutical and biomedical analysis
JID - 8309336
RN  - 0 (Antibodies)
RN  - 0 (alpha-Fetoproteins)
SB  - IM
MH  - Animals
MH  - Antibodies/chemistry
MH  - Automation, Laboratory/*methods
MH  - Blood Chemical Analysis/methods
MH  - Immunoassay/*methods
MH  - Mice
MH  - Mice, Inbred ICR
MH  - Mice, SCID
MH  - Reproducibility of Results
MH  - alpha-Fetoproteins/*analysis
EDAT- 2012/03/06 06:00
MHDA- 2012/08/04 06:00
CRDT- 2012/03/06 06:00
PHST- 2011/12/15 00:00 [received]
PHST- 2012/02/01 00:00 [revised]
PHST- 2012/02/03 00:00 [accepted]
PHST- 2012/03/06 06:00 [entrez]
PHST- 2012/03/06 06:00 [pubmed]
PHST- 2012/08/04 06:00 [medline]
AID - S0731-7085(12)00063-5 [pii]
AID - 10.1016/j.jpba.2012.02.001 [doi]
PST - ppublish
SO  - J Pharm Biomed Anal. 2012 May;64-65:8-15. doi: 10.1016/j.jpba.2012.02.001. Epub 
      2012 Feb 11.