基于连续监测法快速检测 HBsAg
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河南省中医药科学研究专项课题(2019JDZX2077)


Rapid detection of HBsAg based on continuous monitoring method
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    摘要:

    摘要:目的 建立乙型肝炎病毒表面抗原(HBsAg)定性测定的快速连续监测法。 方法 摸索均相光激化学发光免疫分析技术 检测 HBsAg 的反应时间条件,建立短时连续检测程序。 使用分类回归树(CART)算法,根据 10 个组合分类变量建立阴阳性判 断规则,同时根据阴性、阳性样本重叠区域,建立可疑判断规则。 对连续监测法进行检出限验证,并比较连续监测法和第 1 次 读数的阴性复检率。 结果 确定均相光激化学发光免疫分析技术检测 HBsAg 的 2 次温育时间分别为 9 min、4 min,之后每分 钟检测 1 次,连续 3 次,总反应时间为 15 min。 采用 CART 决策树建立了判断规则,在该规则下,样本验证阴性符合率为 100%,阳性符合率为 97.5%。 训练样本风险指数为 0.02,验证样本风险指数为 0.011,均小于 0.05。 连续监测法在 0.1 IU/ mL 时检出限验证符合要求。 连续监测法的阴性复检率为 2.55%,第 1 次读数方案的阴性复检率为 7.64%,两者差异有统计学意 义(χ2 = 4.215,P= 0.04)。 结论 连续监测法在满足定性准确性和低复检率要求下可缩短反应时间。

    Abstract:

    Abstract: Objective To establish a rapid continuous monitoring method for qualitative determination of hepatitis B virus surface antigen ( HBsAg). Methods A rapid continuous detection program was established though exploring the conditions of reaction time for HBsAg test by amplified luminescent proximity homogeneous assay linked immunosorbent assay. The judgment rules for negative and positive samples were established by using the Classification and Regression Tree ( CART) based on 10 combinatorial classification variables. The judgment rules for suspicious results were established simultaneously according to the overlapping areas of negative and positive samples. The detectable limit of continuous monitoring method was verified, and the retest rates for negative results in continuous monitoring method and the first reading were compared. Results The incubation times for HBsAg detection of by amplified luminescent proximity homogeneous assay linked immunosorbent assay were determined to be 9 and 4 min in two tests ,respectively. The detections were performed once per minute for 3 consecutive times with 15 minutes of the final total reaction time. The judgment rule was established according to CART, by which the negative coincidence rate of sample verification was 100% and the positive coincidence rate was 97.5%. The risk indexes were 0.02 and 0.011 for training samples and validated samples respectively, both of which were less than 0.05. The detectable limit of the continuous reading protocol was verified to meet the requirements at the concentration of 0.1 IU/mL.The negative retest rate of the continuous monitoring method was 2.55%, which was significantly different from the retest rate of 7.64% in the first reading value protocol (X2 =4.215, P= 0.04). Conclusion The reaction time was shortened by continuous monitoring method, and the requirements of both qualitative accuracy and low retest rate were satisfied.

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陈明心,王炜,张岱,任伟宏.基于连续监测法快速检测 HBsAg[J].临床检验杂志,2022,(05):321-325

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  • 收稿日期:2021-10-12
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  • 在线发布日期: 2022-08-09
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