CAJ | 학술논문

目的：评估两代HCV核酸定量检测试剂的临床应用。方法收集南京市第二医院住院和门诊HCV感染者556例，采用罗氏COBAS HCV核酸定量一代和二代检测试剂检测其标本，其中HCV RNA阴性血浆93份；HCV RNA阳性血浆350份；血清血浆配对标本52份；干扰样本61份。将阳性血浆样本分为3组，低浓度（3次方及以下）61例、中浓度（4、5次方组）191例和高浓度89例（6次方及以上）。采用线性分析法，计算相关系数和回归方程，比较各组之间的关系。结果总体分析2种HCV RNA定量检测试剂的结果具有相关性（r＝0．948，P＜0．05）。低浓度组的线性回归方程y＝0．9809x＋0．1359，r2＝0．8047，P＞0．05；中浓度组的线性回归方程y＝0．8130x＋1．0727，r2＝0.6956，P＜0．01；高浓度组的线性回归方程y＝0．6746x＋1．8914，r2＝0．3088，P＜0.01。血清血浆有效对比检测结果的相关性良好（r2＝0．9698，P＜0．05），线性回归方程y＝0．9368x＋0．4469。结论两代HCV RNA定量检测试剂符合程度较好，在低浓度组中具有良好的相关性，更适用于临床HCV RNA低浓度的检测。
목적：평고량대HCV핵산정량검측시제적림상응용。방법수집남경시제이의원주원화문진HCV감염자556례，채용라씨COBAS HCV핵산정량일대화이대검측시제검측기표본，기중HCV RNA음성혈장93빈；HCV RNA양성혈장350빈；혈청혈장배대표본52빈；간우양본61빈。장양성혈장양본분위3조，저농도（3차방급이하）61례、중농도（4、5차방조）191례화고농도89례（6차방급이상）。채용선성분석법，계산상관계수화회귀방정，비교각조지간적관계。결과총체분석2충HCV RNA정량검측시제적결과구유상관성（r＝0．948，P＜0．05）。저농도조적선성회귀방정y＝0．9809x＋0．1359，r2＝0．8047，P＞0．05；중농도조적선성회귀방정y＝0．8130x＋1．0727，r2＝0.6956，P＜0．01；고농도조적선성회귀방정y＝0．6746x＋1．8914，r2＝0．3088，P＜0.01。혈청혈장유효대비검측결과적상관성량호（r2＝0．9698，P＜0．05），선성회귀방정y＝0．9368x＋0．4469。결론량대HCV RNA정량검측시제부합정도교호，재저농도조중구유량호적상관성，경괄용우림상HCV RNA저농도적검측。
Objective To evaluate the clinical application of two generations of HCV nucleic acid quantitative kits:COBAS AmpliPrep/COBAS TaqMan HCV,v2.0 and COBAS AmpliPrep/COBAS TaqMan HCV Test.Methods HCV RNA levels in 556 samples that were collected in our hospital were measured using the COBAS AmpliPrep/COBAS TaqMan HCV,v2.0 and COBAS AmpliPrep/CO-BAS TaqMan HCV Test.The samples included 93 ones that were HCV RNA negative,350 ones that were HCV RNA positive,52 paired plasma and serum samples,and 6 1 ones with previous interferon therapy.HCV RNA-positive samples were divided into low-concentration group (≤103,61 cases),medium-concentration group (104 -105,191 cases),and high-concentration group (≥106,89 cases). Comparison between groups was made by linear analysis to compute the correlation coefficient (r)and establish the regression equation.Re-sults There was a significant correlation between the two generations of HCV nucleic acid quantitative kits (r=0.948,P<0.05 ).The correlation between the two kits in the low-concentration group (y=0.9809x+0.1359,r=0.8047,P>0.06)was higher than that in the medium-concentration group (y=0.8130x+1.0727,r=0.6956,P<0.01)and that in the high-concentration group (y=0.6746x+1.8914,r=0.3088,P<0.01).A high correlation between the two kits in paired serum and plasma samples was observed (y=0.9368x+0.4469,r=0.9698,P>0.05).Conclusion The two generations of HCV RNA quantitative kits produce consistent results.A stronger correlation was shown in the low-concentration group,suggesting that the quantitative kits are more sensitive in detecting low level of HCV RNA in the clinical setting.