CAJ | 학술논문

比较两种国产不同核酸提取方法定量检测乙型肝炎病毒（HBV）核酸试剂的检测效能。方法选择经抗病毒治疗且HBV DNA 载量在﹤1x104 IU/ml的乙型肝炎患者血清标本36份，采用两种国产HBV核酸定量检测试剂盒平行检测HBV DNA，对阳性血清进行梯度稀释后再检测，从定量线性范围、准确性、灵敏度、特异性等方面比较两种试剂的差异。结果在36例临床血清中，14份经科华试剂检测的结果为﹤500 IU/ml，而圣湘试剂检测的结果仍﹥1.00×103 IU/ml；对其中获得检测数据的31份标本进行两种试剂检测结果的相关性分析，发现一致性较好（r=0.817，P﹤0.05）；两种方法检测乙型肝炎患者血清HBV DNA的阳性率分别为55.6％和94.4％，差异具有统计学意义(x2=12.07，P=0.000)；对强阳性血清进行梯度稀释后定量检测显示，两种试剂检测水平的平均值与理论水平的线性相关性较好（湖南圣湘r=0.999，上海科华r=0.992），但圣湘所有检测的相对偏差均在±0.3logIU/ml之内，而科华有两次检测的相对偏差超出了±0.3logIU/ml范围，提示圣湘试剂检测结果更稳定，使用纳米磁珠核酸提取法的检测结果较煮沸法更加准确。结论以纳米磁珠为提取核酸方法不仅具有更广的线性范围，同时可显著提高国产HBV DNA检测试剂的灵敏度和准确性。
비교량충국산불동핵산제취방법정량검측을형간염병독（HBV）핵산시제적검측효능。방법선택경항병독치료차HBV DNA 재량재﹤1x104 IU/ml적을형간염환자혈청표본36빈，채용량충국산HBV핵산정량검측시제합평행검측HBV DNA，대양성혈청진행제도희석후재검측，종정량선성범위、준학성、령민도、특이성등방면비교량충시제적차이。결과재36례림상혈청중，14빈경과화시제검측적결과위﹤500 IU/ml，이골상시제검측적결과잉﹥1.00×103 IU/ml；대기중획득검측수거적31빈표본진행량충시제검측결과적상관성분석，발현일치성교호（r=0.817，P﹤0.05）；량충방법검측을형간염환자혈청HBV DNA적양성솔분별위55.6％화94.4％，차이구유통계학의의(x2=12.07，P=0.000)；대강양성혈청진행제도희석후정량검측현시，량충시제검측수평적평균치여이론수평적선성상관성교호（호남골상r=0.999，상해과화r=0.992），단골상소유검측적상대편차균재±0.3logIU/ml지내，이과화유량차검측적상대편차초출료±0.3logIU/ml범위，제시골상시제검측결과경은정，사용납미자주핵산제취법적검측결과교자비법경가준학。결론이납미자주위제취핵산방법불부구유경엄적선성범위，동시가현저제고국산HBV DNA검측시제적령민도화준학성。
To evaluate the efficacy of two domestic kits using different nucleic acid extraction methods for quantitative detection of serum hepatitis B virus (HBV) nucleic acids. Methods Thirty-six serum samples from hepatitis B patients with HBV DNA levels ﹤1x104 IU/ml after antiviral treatment were collected and HBV DNA was detected by kits from two pharmaceutical Co..The quantitative linear range,accuracy,sensitivity and specificity of each kits were evaluated and compared. Results Out of 36 serum samples,the HBV DNA levels in 14 were ﹤500 IU/ml by KELONG reagent,while they were﹥1.00× 103 IU/ml by San Xiang reagent;There was a good correlation in 31 samples by the two reagents (r=0.817,P﹤0.05 );The positive rates of serum HBV DNA were 55.6% and 94.4%,respectively,by the two kit detection(x2=12.07,P=0.000);We detected serum HBV DNA in some strong positive samples after serial dilution and the results showed a good linear correlation (San Xiang: r=0.999,KELONG:r=0.992);The relative deviations by San Xiang kit repetition was within ±0.3logIU/ml,while it was beyond ±0.3logIU/ml in two detections by KELONG. Conclusions The findings in this study suggests that the San Xiang reagent is more stable as it use nanometer magnetic extraction, which might be superior to boiling method for DNA extraction because the magnetic nanoparticle has wider liner ranger and significantly improves the sensitivity and accuracy of HBV DNA detection.