J Lab Med Qual Assur.  2009 Dec;31(2):275-279.

Evaluation of Artus HBV LC PCR kit using SLAN Real-time PCR

• Kim M
• Lee DY
• Chang YH
• Lee JK
• Hong SI
• Hong YJ

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.

Keyword

SLAN real-time PCR; Artus HBV LC PCR kit; Performance evaluation; HBV DNA

MeSH Terms

Bacteria
DNA
Limit of Detection
Nucleic Acid Amplification Techniques
Polymerase Chain Reaction
Real-Time Polymerase Chain Reaction
DNA