CAJ | 학술논문

目的：分析国产和进口实时荧光定量聚合酶链反应（PCR）试剂检测乙型肝炎病毒（HBV）‐DNA的相关性，探讨国产和进口试剂在临床应用中的差异。方法使用国产和进口试剂平行检测262例乙型肝炎（乙肝）患者血浆当中的HBV‐DNA水平，国产试剂采用手工提取标本，罗氏LightCycler480Ⅱ（LC480Ⅱ）进行核酸扩增；进口试剂则采用罗氏COBAS AmpliPrep（CAP）和COBAS Taqman48（CTM ）进行标本提取和扩增；对 HBV‐DNA病毒载量数据进行对数转换（log10），并将两组数据进行相关分析。结果国产和进口试剂检测结果，经线性拟合， R2＝0．8143。HBV‐DNA浓度在10～103 IU／mL 的标本，R2＝0．3006；浓度在104～105 IU／mL 的标本，R2＝0．4118；浓度在106～108 IU／mL的标本，R2＝0．8017。进口试剂阳性检出率为75．57％（198／262），明显高于国产试剂阳性检出率[65．65％（172／262）]。结论国产试剂和进口试剂相比，相关性良好。HBV‐DNA浓度在106～108 IU／mL时，相关性最高；浓度在104～105 IU／mL时，相关性一般；浓度在10～103 IU／mL时相关性较差，国产试剂与进口试剂有明显差异，灵敏度有待进一步提高。
목적：분석국산화진구실시형광정량취합매련반응（PCR）시제검측을형간염병독（HBV）‐DNA적상관성，탐토국산화진구시제재림상응용중적차이。방법사용국산화진구시제평행검측262례을형간염（을간）환자혈장당중적HBV‐DNA수평，국산시제채용수공제취표본，라씨LightCycler480Ⅱ（LC480Ⅱ）진행핵산확증；진구시제칙채용라씨COBAS AmpliPrep（CAP）화COBAS Taqman48（CTM ）진행표본제취화확증；대 HBV‐DNA병독재량수거진행대수전환（log10），병장량조수거진행상관분석。결과국산화진구시제검측결과，경선성의합， R2＝0．8143。HBV‐DNA농도재10～103 IU／mL 적표본，R2＝0．3006；농도재104～105 IU／mL 적표본，R2＝0．4118；농도재106～108 IU／mL적표본，R2＝0．8017。진구시제양성검출솔위75．57％（198／262），명현고우국산시제양성검출솔[65．65％（172／262）]。결론국산시제화진구시제상비，상관성량호。HBV‐DNA농도재106～108 IU／mL시，상관성최고；농도재104～105 IU／mL시，상관성일반；농도재10～103 IU／mL시상관성교차，국산시제여진구시제유명현차이，령민도유대진일보제고。
Objective To analyze the correlation between the domestic and imported real‐time fluorescent quantitative PCR reagents for detecting HBV‐DNA and to explore their difference in clinical application .Methods The domestic and imported reagents were used to parallelly detect the plasma HBV‐DNA content in 262 cases of hep‐atitis B .The domestic reagent adopted the sample extracting by adopting the manual method and the amplification for nucleic acid was performed by the Roche LightCycler480 Ⅱ (LC480 Ⅱ );the imported reagent used the Roche CO‐BAS AmpliPrep (CAP) and COBAS Taqman48(CTM ) for conducting the sample extracting and amplification;the HBV DNA viral load data (log10) was performed the logarithmic transformation and the 2 sets of data were conduc‐ted the correlation analysis .Results The detection results of the domestic and imported reagents were performed the linear fitting ,R2 =0 .814 3 .The sample with the concentration range of 10 -103 IU/mL ,R2 = 0 .300 6 ;the sample with the concentration range of 104 -105 IU/mL ,R2 = 0 .411 8 ;the sample with the concentration range of 106 -108 IU/mL ,R2 =0 .801 7 .The positive detection rate of the imported reagent was 75 .57% (198/262) ,which was signifi‐cantly higher than 65 .65% (172/262) of the domestic reagent .Conclusion There is a good correlation between the domestic reagent and imported reagent .The correlation is the highest when the HBV‐DNA concentration in the range of 106 -108 IU/mL ;the correlation is general when the concentration in the range of 104 -105 IU/mL ;the correlation is lowest when the concentration in the range of 10-103 IU/mL ,there is a significant difference between the domes‐tic reagent and imported reagent and the sensitivity of the domestic reagent remains to be further improved .