Korean J Blood Transfus.  2013 Aug;24(2):161-174.

Performance Evaluation of LG AdvanSure HBV Real-Time QPCR Kit

Affiliations
  • 1Department of Laboratory Medicine, College of Medicine, Korea University, Seoul, Korea. malarim@korea.ac.kr
  • 2Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Abstract

BACKGROUND
Accurate quantitative testing of HBV DNA is very important for choosing antiviral treatment targets and evaluating treatment response in chronic HBV patients. We evaluated the performance of LG AdvanSure HBV Real-Time QPCR kit (LG) utilizing real-time quantitative PCR.
METHODS
The LG kit was conducted for 201 chronic hepatitis patients undergoing treatment at the Korea University Ansan hospital and 48 normal control volunteers. The precision, limit of detection, sensitivity, and specificity of LG Kit were evaluated. Correlation analysis was done with Abbott Real Time HBV kit (Abbott) and the Cobas Amplicor HBV Monitor kit (Cobas) and the concordances rate of the three methods were calculated.
RESULTS
The LG assay showed linear range of detection from 10(2) to 10(6) and coefficient of variation (CV) was 1.10~0.52% at > or =1,000 IU/mL and 1.19% at 100 IU/mL. The coefficient of determination for precision analysis was 0.997. The limit of detection for detection of 95% of positive samples was 9.71 IU/mL (54.4 copies/mL). In 201 clinical samples, the log HBV DNA/ml showed good correlation between Roche vs Abott, Roche vs LG and Abott vs LG, respectively (n=105, 108, 133, r2=0.91, 0.89, 0.94, P<0.0001). The overall concordance rate of three methods were 79.1% (159/201), 82.1% (165/201), and 85.1% (171/201), respectively, showing no stastically significant difference (P>0.05).
CONCLUSION
LG AdvanSure HBV Real-Time QPCR kit showed outstanding precision, linearity, limit of detection, good correlation with previous methods, and is a valuable tool in treatment monitoring of chronic HBV infections.

Keyword

AdvanSure HBV Real-Time QPCR; Hepatitis B; HBV quantitation; Performance evaluation
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