Korean J Lab Med.  2010 Dec;30(6):654-659. 10.3343/kjlm.2010.30.6.654.

Evaluation of ARCHITECT HCV Core Antigen Assay

• Song D
• Kang JE
• Kim SY
• Hwang SH
• Kim HH
• Lee EY
• Son HC

• KMID: 1781673
• DOI: http://doi.org/10.3343/kjlm.2010.30.6.654

Abstract

BACKGROUND
Hepatitis C virus (HCV) core antigen (Ag) levels are known to be well correlating with HCV RNA levels, and may be used as an alternative marker of HCV replication for monitoring the response to HCV treatment. However, the low sensitivity of HCV core Ag assay has been an obstacle for clinical use. In this study, recently developed ARCHITECT HCV Ag assay (Abbott Laboratories, USA) was evaluated for analytical performance and clinical usefulness.
METHODS
A total of 109 sera from HCV infected patients including various genotypes of HCV (1b, 2, 2a/2c, 2b, and 3a) and 20 sera from healthy donors were used for evaluating the sensitivity, precision, and linearity of the HCV core Ag assay. The cross reactivity with HIV, hepatitis B virus and myeloma proteins (N=5, each) and correlation with HCV RNA PCR assay were also evaluated.
RESULTS
The sensitivity of the HCV core Ag assay was 97.2% (106/109) and there were no false positive results and cross reactivity. The within-run, between-run and between-day CVs were 3.0%, 2.5% and 3.0%, respectively. The levels of HCV core antigen showed a good correlation with those of HCV RNA quantification (r=0.940). The HCV Ag assay showed an excellent linearity in the range from 0.63 to 17,114 fmol/L (r=0.999).
CONCLUSIONS
The ARCHITECT HCV Ag assay was good in sensitivity, precision, and linearity and its results well correlated with HCV RNA levels. This assay could be used as a good marker of viral replication for monitoring the therapy response in chronically HCV infected patients.

Keyword

HCV core antigen; Hepatitis C virus; RNA; PCR

MeSH Terms

Chemiluminescent Measurements/*methods
Cross Reactions
Genotype
Hepacivirus/genetics/*immunology
Hepatitis Antigens/*blood
Humans
Polymerase Chain Reaction/*methods
RNA, Viral/blood
Reagent Kits, Diagnostic
Sensitivity and Specificity
Viral Core Proteins/*blood

Figure

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  Fig. 1. Linearity analysis of ARCHITECT HCV Ag assay.

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  Fig. 2. Correlation between ARCHITECT HCV Ag assay and CO-BAS AmpliPrep/COBAS TaqMan HCV test.

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