B형 간염 바이러스 실시간 정량법(RealArt HBV LC PCR)의 평가
Evaluation of a Quantitative RealArt HBV LC PCR Assay for Hepatitis B Virus by Real-time PCR
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배경: 경구용 B형 간염 바이러스 치료제가 널리 사용됨에 따라 혈중 HBV 정량은 환자의 진단과 치료에 필수적이며, 최근 real-time PCR법은 102～109copies/mL 구간에 이르는 직선성과 예민도를 나타내어 사용이 증가되고 있다. 방법: RealArt HBV LC PCR Reagents (Artus GmbH, Hamburg, Germany)의 성능(재현성, 직선구간 및 예민도 ) 및 COBAS AMPLICOR HBV MONITOR Test (Roche Diagnostics, Mannheim, Germany)와의 상관성, HBeAg과 항바이러스제 치료와 관련된 환자 혈청 내 HBV DNA 농도의 분포를 조사하였다. 결과: RealArt법은 농도에 따라 검사 내 및 검사 간 변이가 104copies/mL에서 각각 18.1%, 73.2%, 103copies/mL에서 39.7%, 78.1% 및 105～109copies/mL에서 ＜10%, ＜15% 였으며, 직선구간 5×103～2.3×109copies/mL, Amplicor법과 상관관계 y=0.9211x+0.607 (R2=0.7801, P＜0.001)이었으며, 치료력이 없는 검체에서 중앙값 농도는 HBeAg (+) 검체 6.3×107 copies/mL 및 HBeAg (－) 검체 3.1×103 copies/mL였다. 결론: Real-time PCR 원리를 이용한 RealArt HBV 정량 방법은 직선구간, 예민도 및 재현성에서 B형 간염의 관리에 적절 할 것으로 생각한다.
Abstract
Background: As oral antiviral treatment for chronic hepatitis B increases, quantitation of viral load has become an essential test for HBV management, and assays using real-time PCR principles have been introduced recently. Methods: We analysed the analytical performance(precision, linear range, and sensitivity) of RealArt HBV LC PCR Reagents (Artus GmbH, Hamburg, Germany), its correlation with COBAS AMPLICOR HBV MONITOR Test (Roche Diagnostics, Mannheim, Germany), and distribution of viral load in the patients’sera according to antiviral treatment and presence of HBeAg. Results: Variation of intra-assay and inter-assay were 39.7% and 78.1% at 103 copies/mL of viral load, 18.1% and 73.2% at 104 copies/mL, and below 10% and below 15% between 105～109 copies/mL. Linear range was with 5×103～2.3×109 copies/mL. Correlation with Amplicor was y=0.9211x+0.607 (R2=0.7801, P＜0.001) and the median concentration in the patients without any treatment was 6.3×107 copies/mL (HBeAg positive) and 3.1×103 copies/mL (HBeAg negative). Conclusion: RealArt reagent using principles of real-time PCR, would be an appropriate laboratory method for HBV management.
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