CAJ | 학술논문

目的比较5种国内外HBV DNA定量检测试剂盒的灵敏度、特异度和符合率.方法分别应用A、B、C、D 4种国产和德国Roche公司生产的荧光定量试剂盒检测国家HBV DNA标准品、7份灵敏度稀释血浆(15.6～1 000 IU/mL)、15份健康献血者和45份慢性乙型肝炎患者血浆.统计学分析采用平行性检验.结果 5种试剂盒对9份阳性和8份阴性国家标准品均能正确检出,并能准确定量标准品中的灵敏度样本;对灵敏度稀释血浆,Roche试剂盒和国产试剂盒C、D均能检出最高稀释度样本(15.6 IU/mL),而试剂盒A和B检测限分别为125 IU/mL和500 IU/mL,Roche试剂盒及C试剂盒的定量检测结果与理论值的符合率高,两者检测结果经平行性检验存在线性相关(r>0.98);检测15份健康献血者血浆,试剂盒D有2份假阳性;检测慢性乙型肝炎患者血浆,Roche试剂盒对1×102～1×108 IU/mL范围的样本检测的变异系数均<15%,而国产试剂盒变异系数较大.4种国产试剂盒与Roche试剂盒的符合率为50%～96 %,其中A为61%,B为50%,C为96%,D为83%,试剂盒C符合率显著高于试剂盒D、A和B(X2=5.62,P<0.05;X2=28.93,P<0.01;X2=44.31,P<0.01).各种试剂盒符合率最高的区段均在1×104～1×108 IU/mL.结论国产HBV DNA定量试剂盒质量差异较大,试剂盒c与Roche试剂盒定量检测HBV DNA的符合率最高,国产试剂盒质量有待进一步提高.
목적 비교5충국내외HBV DNA정량검측시제합적령민도、특이도화부합솔.방법 분별응용A、B、C、D 4충국산화덕국Roche공사생산적형광정량시제합검측국가HBV DNA표준품、7빈령민도희석혈장(15.6～1 000 IU/mL)、15빈건강헌혈자화45빈만성을형간염환자혈장.통계학분석채용평행성검험.결과 5충시제합대9빈양성화8빈음성국가표준품균능정학검출,병능준학정량표준품중적령민도양본;대령민도희석혈장,Roche시제합화국산시제합C、D균능검출최고희석도양본(15.6 IU/mL),이시제합A화B검측한분별위125 IU/mL화500 IU/mL,Roche시제합급C시제합적정량검측결과여이론치적부합솔고,량자검측결과경평행성검험존재선성상관(r>0.98);검측15빈건강헌혈자혈장,시제합D유2빈가양성;검측만성을형간염환자혈장,Roche시제합대1×102～1×108 IU/mL범위적양본검측적변이계수균<15%,이국산시제합변이계수교대.4충국산시제합여Roche시제합적부합솔위50%～96 %,기중A위61%,B위50%,C위96%,D위83%,시제합C부합솔현저고우시제합D、A화B(X2=5.62,P<0.05;X2=28.93,P<0.01;X2=44.31,P<0.01).각충시제합부합솔최고적구단균재1×104～1×108 IU/mL.결론 국산HBV DNA정량시제합질량차이교대,시제합c여Roche시제합정량검측HBV DNA적부합솔최고,국산시제합질량유대진일보제고.
Objective To compare the sensitivity, specificity and consistency of five kits for quantitative detection of hepatitis B virus (HBV) DNA. Methods Four domestic fluorescence kits, A, B, C, and D, and Roche Cobas Ampliprep/Cobas TaqMan HBV test for quantitation of HBV DNA in serum, were applied to detect the National Standards, an additional plasma for sensitivity (7 times dilution), 15 plasma samples from healthy blood donor and 45 plasma samples from chronic hepatitis B patients. Results All five kits showed the correct results for the 9 positive specimens and 8 negative specimens from the National Standards. The quantitative results of specimens for sensitivity met requirements of the National Standards. The lowest concentration of HBV DNA by these three kits was 15.6 IU/mL. The lowest detection level of HBV DNA for domestic kit B was ≤500 IU/mL. There was linear correlation between the results by Roche kit and domestic kit C (r> 0.98). Kit D showed 2 false-negatives results in the 15 healthy blood donor samples. The coincidence rates between 4 domestic kits and the Roche kit ranged from 50% to 96% (A: 61%, B: 50%, C: 96%, D: 83 %). The consistency rate of kit C with the Roche kit was significantly higher than those of kit D, A and B (X2=5.62, P<0.05, X2=28. 93, P<0.01, X2=44.31,P<0.01, respectively). The consistency rates among these 5 kits were highest when testing samples with HBV DNA levels between 1×104-1×107 IU/mL. Conclusions The qualities of domestic kits vary remarkably and kit C has the greatest consistency rate with the Roche kit. Therefore, the qualities of domestic kits need to be further improved.