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目的验证磁珠法乙型肝炎病毒核酸提取试剂盒效能,评价其临床应用价值。方法参考国家医药行业标准(YY/T 1182-2010)对该项目的定量检测下限(log)、线性范围、精密度、准确度、灵敏度和稳定性进行验证。结果(1)检测结果平均值为(60.85±20.17)IU/ml,定量偏差±lg 0.5以内,符合定量检测下限检测要求,线性关系良好(P<0.01)。(2)高浓度样本和低浓度样本或批内、批间的精密度变异系数均<5%。(3)取检测值和已知值的对数值绘制散点图,两者相关性良好(P<0.01)。(4)检测值平均值为(34.70±8.57)IU/ml时,阳性率为100%。结论磁珠法乙型肝炎病毒核酸提取试剂盒具有良好的灵敏度、线性范围、准确度、精密度和稳定性,相关指标均符合检测标准,可满足临床测试要求。
Objective To verify the efficacy of the magnetic beads method for hepatitis B virus nucleic acid extraction kit and evaluate its clinical value. Methods With reference to the national pharmaceutical industry standard (YY / T 1182-2010), the quantitative detection limit (log), linear range, precision, accuracy, sensitivity and stability of the project were validated. Results (1) The average value of test results was (60.85 ± 20.17) IU / ml and the quantitative deviation was within ± 1g 0.5. The results were in good linearity (P <0.01). (2) The coefficient of variation of precision between high-concentration samples and low-concentration samples or between batches was <5%. (3) Taking the logarithm of the measured value and the known value to draw the scatter plot, the correlation between them is good (P <0.01). (4) The average detection value (34.70 ± 8.57) IU / ml, the positive rate was 100%. Conclusion The magnetic beads nucleic acid extraction kit of Hepatitis B virus has good sensitivity, linear range, accuracy, precision and stability, and the relevant indexes meet the testing standards to meet the clinical testing requirements.