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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=2.24×108IU/m L的样本检测未受到干扰;当TBIL=153.55μmol/L时,仅HBV DNA=4.62×102IU/m L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。
Objective To evaluate the anti-interference ability of quantitative detection reagents of hepatitis B virus (HBV) deoxyribonucleic acid (DNA). Methods HBV DNA positive serum samples were selected for detection of serum HBV DNA levels from 1.63 to 17.25 g / L by quantitative real-time polymerase chain reaction (q-RT-PCR) (hemoglobin, Hb) or total bilirubin (TBIL) of 26.55 ~ 497.50μmol / L on the detection of HBV DNA positive samples, according to the China National Accreditation Service for Conformity Assessment (CNAS) CL-36 in the evaluation criteria: deviation of greater than or equal to ± 7.5%, determine the test results are disturbed. Results When the concentration of Hb was 7.75 ~ 17.25 g / L, all samples were interfered; when Hb was less than 3.50 g / L, the samples were not disturbed. When TBIL concentration was 274.60 ~ 399.15μmol / L, only HBV DNA = 2.24 × 108IU / m L samples were not interfered; when TBIL = 153.55μmol / L, only HBV DNA = 4.62 × 102IU / mL samples Detection was disturbed; when TBIL = 26.55μmol / L, the samples were not disturbed. Conclusion The HBV DNA quantitative detection reagent has a certain anti-interference ability: Hb≤3.50 g / L, TBIL≤26.55μmol / L has no effect on the test results.