CAJ | 학술논문

目的比较全自动病毒载量检测系统(COBAS TaqMan)和国产荧光定量PCR试剂盒对血清HCV RNA载量的检测结果,探讨两种检测方法在临床诊断和治疗中的应用价值.方法收集26例慢性丙型肝炎患者抗病毒治疗前和治疗过程中2、4、8、12、24、36和48周的系列血标本,共168份,采用COBAS TaqMan 48全自动分析系统和广州某国产TaqMan实时PCR试剂盒分别检测系列血清中的HCV RNA载量.统计学处理采用x2检验和t检验.结果当血清HCV RNA≥1×104IU/mL时(0周),COBAS检测和国产试剂盒均能很好测定HCV载量,而且国产试剂盒检测值为1.35×107IU/mL高于COBAS检测值2.21×106IU/mL,差异有统计学意义(t=2.05,P<0.05);血清HCV RNA<1×104IU/mL时(2～48周),COBAS检测出的HCV阳性率为21.4%(30/140),远高于国产试剂盒的1.4%(2/140),差异有统计学意义(t=3.66,P<0.01);治疗4周时,COBAS检测26例患者中14例血清HCV为阳性,12例病毒载量低于检测下限,获得快速病毒学应答(RVR);国产试剂盒检测结果为3例血清HCV为阳性,23例获得RVR.COBAS与国产试剂盒梧比,转阴率差异有统计学意义(x2=10.575,P<0.01).治疗12周时,COBAS检测完全早期病毒学应答(cEVR)率为95.7%(22/23),国产试剂盒检测的cEVR为100%(17/17),差异无统计学意义(x2=0.726,P>0.05).结论国产荧光定量PCR试剂盒可用于HCV疑似患者的筛查和高HCVRNA载量者的确诊,对于低HCV RNA载量的疑似患者和抗病毒治疗过程中HCV载量的检测,COBAS则更为敏感.
목적 비교전자동병독재량검측계통(COBAS TaqMan)화국산형광정량PCR시제합대혈청HCV RNA재량적검측결과,탐토량충검측방법재림상진단화치료중적응용개치.방법 수집26례만성병형간염환자항병독치료전화치료과정중2、4、8、12、24、36화48주적계렬혈표본,공168빈,채용COBAS TaqMan 48전자동분석계통화엄주모국산TaqMan실시PCR시제합분별검측계렬혈청중적HCV RNA재량.통계학처리채용x2검험화t검험.결과 당혈청HCV RNA≥1×104IU/mL시(0주),COBAS검측화국산시제합균능흔호측정HCV재량,이차국산시제합검측치위1.35×107IU/mL고우COBAS검측치2.21×106IU/mL,차이유통계학의의(t=2.05,P<0.05);혈청HCV RNA<1×104IU/mL시(2～48주),COBAS검측출적HCV양성솔위21.4%(30/140),원고우국산시제합적1.4%(2/140),차이유통계학의의(t=3.66,P<0.01);치료4주시,COBAS검측26례환자중14례혈청HCV위양성,12례병독재량저우검측하한,획득쾌속병독학응답(RVR);국산시제합검측결과위3례혈청HCV위양성,23례획득RVR.COBAS여국산시제합오비,전음솔차이유통계학의의(x2=10.575,P<0.01).치료12주시,COBAS검측완전조기병독학응답(cEVR)솔위95.7%(22/23),국산시제합검측적cEVR위100%(17/17),차이무통계학의의(x2=0.726,P>0.05).결론 국산형광정량PCR시제합가용우HCV의사환자적사사화고HCVRNA재량자적학진,대우저HCV RNA재량적의사환자화항병독치료과정중HCV재량적검측,COBAS칙경위민감.
Objective To compare the plasma hepatitis C virus(HCV)RNA levels detected by the fully automated viral load detection system(COBAS TaqMan)and the national real-time quantitative polymerase chain reaction(PCR)kit,and to investigate the clinical application value of these two methods in clinical practice.Methods A total of 168 serial plasma samples collected from 26 patients with chronic hepatitis C(CHC)before and at week 2,4,12,24,36 and 48 of antiviral treatment were detected by both COBAS Taqman 48 analyzing system and the national real-time quantitative PCR kit.The results of two methods were compared by chi square test and t test.Resnlts Both COBAS and national kit showed great positive detecting results when HCV RNA≥1×104IU/mL(at week O),and the virus load value detected by national kit was significantly higher than that detected by COBAS(t=2.05,P<0.05).However,when HCV RNA<1×104(at week 2-48),the positive rate of HCV detected by COBAS was significantly higher than that detected by national kit (t=3.66,P<0.01).At week 4 of treatment,the rapid virological response(RVR)rate was 46.2 % (12/26)detected by COBAS,while that was 88.5%(23/26)detected by national kit,and the difference was significant(x2=10.575,P<0.01).At week 12 of treatment,the complete early virological response(cEVR)was 95.7%(22/23)detected by COBAS,while that was 100%(17/17)detected by national kit,and the difference was not significant(x2=0.726,P>0.05).Conclusions The national TaqMan real-time quantitative PCR kits could be used to screen the suspected cases of HCV infecrion and to diagnose CHC cases with high HCV virus load.COBAS detection is more sensitive in cases with low HCV virus load and in on-treatment monitor during anti-HCV therapy.