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摘要: 目的：分析酶联免疫吸附试验（ELISA）即刻法存在质控图警告点偏多的问题，改进即刻法前两板次的检测条件，使绘制的质控图精准并更具监测意义。方法：ELISA法进行乙型肝炎病毒表面抗原（HBsAg）和人类免疫缺陷病毒抗体（HIV Ab）检测，更换新的批号试剂盒时预做两个板次，然后进行常规标本的检测，依据前三板次的质控值绘制ELISA即刻法质控图。绘制20个点后对质控图进行数据处理分析，分别将去除预做两点和保留预做两点的手工加样与仪器加样两种操作方式绘制的即刻法质控图进行比较，验证ELISA即刻法质控图的影响因素。结果：HBsAg和HIV Ab的检测结果均显示仪器加样与手工加样绘制的去除预做两点的即刻法质控图差异有统计学意义（P<0.01），且仪器加样的稳定性均优于手工加样。不去除预做两点的仪器加样与手工加样检测HIV Ab所绘制的即刻法质控图差异无统计学意义（P>0.05），但检测HBsAg绘制的质控图仪器加样优于手工加样（P<0.01）。结论：仪器加样对检测HBsAg和HIV Ab均较手工法更稳定。预做两点可提高手工加样即刻法质控图的稳定性，减少警告点数量，降低操作方式对质控图造成的系统误差。Abstract: Objective: To analyze several problems in the instant method of enzyme-linked immunosorbent assays(ELISA), such as multiple warming points in the quality control chart and how to improve the detection conditions of the instant method, so that the quality control chart we made can be more accurate.Method: We used ELISA to detect the titer of HBsAg and HIV Ab two times before replacing the new batch number, after that detected the routine sample.The ELISA "instant method" quality chart was made according to the quality control value of the first three times.After added 20 points into the chart, we processed and analyzed the data in the chart.We compared the difference between the chart that add samples by instrument or by handcraft, and verified the influence of the first two points in the chart.Result: The result of the detection of HBsAg and HIV Ab showed that the chart of added samples by instrument had significant differences between the chart of added samples by handcraft without put first two points in the chart(P<0.01).While put first two points in the chart, we found that different methods to add sample had no significant difference in the detection of HIV Ab(P>0.05).But in the detection of HBsAg, added samples by instrument was better than by handcraft(P<0.01).Conclusion: In the detection of either HBsAg or HIV Ab, the instrument operation was more stable than handmade operation.Added first two points in quality chart could improve stability, reduce the number of warming points and system error caused by operating mode.
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Key words:
- enzyme-linked immunosorbent assays /
- instant method /
- quality control
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