TY - JOUR
T1 - Evaluation of automated serum des-gamma-carboxyprothrombin (DCP) assays for detecting hepatocellular carcinoma
AU - Choi, Jonghyeon
AU - Park, Yongjung
AU - Kim, Jeong Ho
AU - Kim, Hyon Suk
PY - 2011/12
Y1 - 2011/12
N2 - Objectives: We evaluated two new autoanalyzers, μTAS and Lumipulse for des-γ-carboxyprothrombin (DCP) assay. Material and methods: Analytical performance was evaluated, and the upper reference limit of the 97.5th percentile for DCP was re-established using sera from 140 healthy individuals. DCP levels were determined by the two autoanalyzers and EIA in a total of 239 sera from HCC patients (n = 120) and those without HCC (n = 119). Results: Total imprecision of the two automated assays was < 5% CV. Analytical measurement ranges (AMRs) were verified to be linear. The new reference limits were 29.5. mAU/mL for μTAS and 35.0. mAU/mL for Lumipulse. There were proportional and constant biases between the results from the autoanalyzers and those from EIA. Conclusion: The two newly developed DCP assays showed high analytical performance, but re-establishment of reference limits would be necessary. The new analyzers could be useful for clinical laboratories because of convenience of operation and wide AMRs.
AB - Objectives: We evaluated two new autoanalyzers, μTAS and Lumipulse for des-γ-carboxyprothrombin (DCP) assay. Material and methods: Analytical performance was evaluated, and the upper reference limit of the 97.5th percentile for DCP was re-established using sera from 140 healthy individuals. DCP levels were determined by the two autoanalyzers and EIA in a total of 239 sera from HCC patients (n = 120) and those without HCC (n = 119). Results: Total imprecision of the two automated assays was < 5% CV. Analytical measurement ranges (AMRs) were verified to be linear. The new reference limits were 29.5. mAU/mL for μTAS and 35.0. mAU/mL for Lumipulse. There were proportional and constant biases between the results from the autoanalyzers and those from EIA. Conclusion: The two newly developed DCP assays showed high analytical performance, but re-establishment of reference limits would be necessary. The new analyzers could be useful for clinical laboratories because of convenience of operation and wide AMRs.
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U2 - 10.1016/j.clinbiochem.2011.08.1144
DO - 10.1016/j.clinbiochem.2011.08.1144
M3 - Article
C2 - 21939644
AN - SCOPUS:81555219222
SN - 0009-9120
VL - 44
SP - 1464
EP - 1468
JO - Clinical Biochemistry
JF - Clinical Biochemistry
IS - 17-18
ER -