Evaluation of Artus HBV LC PCR kit using SLAN Real-time PCR.
- Author:
Minki KIM
1
;
Dong Young LEE
;
Yoon Hwan CHANG
;
Jin Kyung LEE
;
Seok Il HONG
;
Young Joon HONG
Author Information
1. Department of Laboratory Medicine, Korea Cancer Center Hospital, Seoul, Korea, clinchem@hotmail.com
- Publication Type:Original Article
- Keywords:
SLAN real-time PCR;
Artus HBV LC PCR kit;
Performance evaluation;
HBV DNA
- MeSH:
Bacteria;
DNA;
Limit of Detection;
Nucleic Acid Amplification Techniques;
Polymerase Chain Reaction;
Real-Time Polymerase Chain Reaction
- From:Journal of Laboratory Medicine and Quality Assurance
2009;31(2):275-279
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUND: Real-time PCR has been widely used not only for quantification?of disease-related genes but also for detection of bacteria or viruses. In this study, we evaluated the performance of Artus HBV LC PCR kit (Qiagen, Hilden, Germany) using recently developed SLAN real-time PCR detection system (Shanghai Hongshi Medical Technology Co., Shanghai, China) to assess clinical relevance of the new instrument. METHODS: Precision, linearity and detection limit of Artus HBV LC PCR kit were evaluated using SLAN real-time PCR detection system. We also compared the SLAN real-time PCR detection system with LightCycler 1.5 (Roche Molecular System, Branchburg, NJ, USA) and ABI PRISM 7500 (Applied Biosystems, Foster City, CA, USA). WHO International Standard for HBV DNA Nucleic Acid Amplification Techniques (NIBSC code:97/750) and 40 HBV DNA positive sera were tested for this evaluation. RESULTS: Within-run and between-day coefficients of variation were 5.63%, 4.01% at 6.2x10(3) IU/mL and 1.12%, 0.80% at 2.1x10(1) IU/mL, respectively. Linearity was verified from 1.0x10(1) to 1.0x10(5) IU/mL (r(2)=1.000; slope=1.1412). Detection limit for HBV DNA was verified to be 7.54 IU/mL. It showed a good correlation with LightCycler 1.5 (r=0.9723) and ABI PRISM 7500 (r=0.9768). CONCLUSIONS: Artus HBV LC PCR kit using SLAN real-time PCR detection system showed a good precision, linearity and assay sensitivity. It correlated well with LightCycler 1.5 and ABI PRISM 7500. We conclude that it can be used in clinical laboratories for nucleic acid quantification.
