• 主题
高级搜索  >
历史搜索 清空历史
首页> 中文期刊> 《首都医科大学学报》 >应用CNAS CL-36标准评估 HBV DNA定量检测试剂的抗干扰能力

应用CNAS CL-36标准评估 HBV DNA定量检测试剂的抗干扰能力

         
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Objective To evaluate the anti-interference capability of hepatitis B virus ( HBV ) deoxyribonucleic acid ( DNA ) quantitative reagents. Methods HBV DNA positive serum samples with critical concentrations, low, medium and high were collected. The analysis of interference was performed in four HBV DNA positive samples with hemoglobin ( Hb) ranging from 1. 63 to 17. 25 g/L or total bilirubin ( TBIL ) ranging from 26. 55 to 497. 50 μmol/L by quantitative real-time polymerase chain reaction ( q-RT-PCR ) . According to criterion of China National Accreditation Service for Conformity Assessment ( CNAS) CL-36, if the bias is higher than and equal to ± 7. 5%, there will be interference with the detection of HBV DNA. Results All of the HBV DNA positive sample were subjected to interference with Hb ranging from 7. 75 to 17. 25g/L, and were not subjected to interference with Hb less than or equal to 3. 50 g/L. For TBIL ranging from 274. 60 to 399. 15 μmol/L, the sample with HBV DNA viral load 2. 24 × 108 IU/mL was the only one without interference. For TBIL = 153. 55μmol/L, only the sample with HBV DNA viral load 4. 62 × 102 IU/mL was subjected to interference. None of the HBV DNA positive sample were subjected to interference with TBIL less than or equal to 26. 55μmol/L. Conclusion The HBV DNA quantitative reagent has certain anti-interference capability: there was no interference effect on HBV DNA results when Hb is less than or equal to 3. 50 g/L and TBIL is less than or equal to 26. 55 μmol/L.%目的：评估乙型肝炎病毒( hepatitis B virus,HBV)脱氧核糖核酸( deoxyribonucleic acid,DNA)定量检测试剂的抗干扰能力。方法选择临界值、低值、中值和高值HBV DNA阳性血清样本,采用实时荧光定量 PCR ( quantitative real-time polymerase chain reaction, q-RT-PCR)技术检测1.63~17.25 g/L的血红蛋白( hemoglobin, Hb)或26.55~497.50μmol/L的总胆红素( total bilirubin, TBIL)对HBV DNA阳性样本检测结果的干扰,依据中国合格评定国家认可委员会( China National Accreditation Service for Conformity Assessment,CNAS) CL-36中的评价标准：偏差大于等于±7.5％时,判断检测结果受到干扰。结果当Hb浓度为7.75~17.25 g/L时,各样本均受到干扰；当Hb≤3.50 g/L时,各样本均未受到干扰。当TBIL浓度为274.60~399.15μmol/L时,仅HBV DNA＝2.24×108 IU/mL的样本检测未受到干扰；当TBIL＝153.55μmol/L时,仅HBV DNA＝4.62×102 IU/mL的样本检测受到干扰；当TBIL＝26.55μmol/L时,各样本均未受到干扰。结论该HBV DNA定量检测试剂具有一定的抗干扰能力：Hb≤3.50 g/L、TBIL≤26.55μmol/L对检测结果没有影响。

著录项

相似文献

  • 中文文献
  • 外文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号