为评价RNA实时荧光恒温扩增试验（simultaneous amplification testing，SAT）与定量反转录-聚合酶链反应（quantitative reverse transcription-polymerase chain reaction，qRT-PCR）检测血清样本中乙型肝炎病毒(hepatitis B virus，HBV) RNA的相关性与一致性，本研究收集了在复旦大学附属公共卫生临床中心就诊的212例患者的血清样本,其中慢性乙型肝炎（chronic hepatitis B，CHB）患者HBV DNA≥100 IU/mL 81例、HBV DNA＜100 IU/mL 76例，以及作为对照的非HBV感染患者55例。采用SAT和qRT-PCR方法分别检测所有血清样本中的HBV RNA，对检测结果进行统计学分析。在HBV DNA≥100 IU/mL 的CHB患者中，SAT和qRT-PCR的HBV RNA阳性检出率均为95.06%(77/81)。2种方法具有较好的相关性与一致性（R2=0.803和CCC=0.882）。Bland Altman分析显示绝对偏倚为0.1 log copies/mL，相对偏倚为0.97%。配对t检验显示，结果无统计学差异(t =1.617，P =0.110)。在HBV DNA＜100 IU/mL的CHB患者中，HBV RNA阳性检出率，SAT技术为98.68%(75/76), qRT-PCR方法为88.16%(67/76), 2种方法相关性与一致性较差（R2=0.326和CCC=0.438）。Bland Altman分析显示绝对偏倚为0.5 log copies/mL，相对偏倚为0.86%。配对t检验显示，结果有统计学差异(t =3.654，P<0.001)。在非HBV感染对照患者中，SAT技术和qRT-PCR方法均未检出HBV RNA阳性。结果提示，在HBV DNA≥100 IU/mL的CHB患者中应用SAT与qRT-PCR检测血清HBV RNA，其相关性与一致性较好，在HBV DNA＜100 IU/mL 的CHB患者中相关性与一致性存在一定差异。

The purpose of the current study is to evaluate the correlation and consistency of simultaneous amplification testing (SAT) and quantitative reverse transcription-polymerase chain reaction (qRT-PCR) for quantitative detecting serum hepatitis B virus RNA. 212 serum samples from Shanghai Public Health Clinical Center including 81 CHB patients with HBV DNA≥100 IU/mL, 76 CHB patients with HBV DNA 100 IU/mL and 55 patients without HBV infection were detected by SAT and qRT-PCR methods. In HBV DNA≥100 IU/mL CHB patients, 95.06% (77/81) samples were positive both in SAT and qRT-PCR method. SAT showed a relevantly good correlation and comparability with qRT-PCR (R2=0.803, CCC=0.882). Bland Altman analysis shows absolute bias was 0.1 log10 copies/mL and relative bias was 0.97%. The paired T test analysis of test results had no difference (t =1.617，P =0.110). In HBV DNA 100 IU/mL CHB patients, 98.68% (75/76) samples were positive in SAT method and 88.16% (67/76) samples were positive in qRT-PCR method. The statistical analysis of test results had difference (P<0.001). SAT showed a relevantly bad correlation and comparability with qRT-PCR (R2=0.326, CCC=0.438). Bland Altman analysis shows absolute bias was 0.5 log10 copies/mL and relative bias was 86%. The paired T test analysis of test results had difference (t =3.654，P<0.001). In 55 patients without HBV infection, all samples were negative in SAT method and qRT-PCR method. Correlation analysis shows strong correlation and consistency between SAT and qRT-PCR for CHB patients with HBV DNA≥100 IU/mL. Difference was found in the measurement of RNA using SAT and qRT-PCR for CHB patients with HBV RNA 100 IU/mL.