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KMID : 0375319940160010097
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Journal of Clinical Pathology and Quality Control
1994 Volume.16 No. 1 p.97 ~ p.102
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Evaluation of the Automated Chemiluminescence System ACS: 180TM for the Determination of tumor Markers (AFP, CEA and PSA)
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Abstract
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Background :
the ACSTM tumor marker assay has been developed using a fully automated random-access immunoassay system, the Ciba-Corning Diagnostics ACS:180TM system. The ACS tumor marker assay is a poly/monoclonal immunochemiluminometric assay, that
utilizes a
polyclonal antibody labeled with acridinium ester as the tracer reagent and monoclonal antibody immobilized on paramagnetic particles.
Methods:
We evaluated the technical performance of the ACS:180 system for tumor markers such as α-fetoprotein(AFP), carcinoembryonic antigen(CEA), and prostate specific antigen(PSA). Serum specimens and control materials are used for this study.
Results :
all tests studied had within-run CVs below 5% for the three control sera concentrations. In the between-run precision study CVs were below 5% for the three control sera concentration except for CEA and PSA tests that in certain control sera
concentration the CV's were 14.4% and 8.6%, respectively. the linearity was statistically acceptable (p<0.001) for AFP, CEA, and PSA. Method comparison of ACS: 180 with RIA(Hybritech Tandem-R) assay results in the follwing regression: ACS
AFP=0.91×(Tandem)+33.28, R=0.998, N=54; ACS CEA=0.72×(Tandem)+1.50, R=0.971, N=64;ACS PSA=2.74×(Tandem)-4.94, R=0.001, N=48. Dilution of control material of AFP, CEA, and PSA=2.74(Tandem)-4.94, R=0.991, N=48. Dilution of control material of
AFP,
CEA,
and PSA gave mean recovery of 104.8%, 99.0%, and 105.9%, respectively. No significant carryover effect was observed for all the tests studied. The detection limits for AFP, CEA, and PSA were 0.56g/L, 0.50g/L, and 0.02g/L, respectively.
Conclusions:
Development of tumor marker assay on the ACS:180 system allows a fully automated, rapid, accurate, and precise nonisotopic determination of these tumor markers.
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