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免疫球蛋白M(IgM)等多因子检测试剂盒(流式荧光发光法)

Multiplex Assay Kit for Immunoglobulin M (IgM) ,etc. by FLIA (Flow Luminescence Immunoassay)

IGHM; Immunoglobulin Heavy Constant Mu; Ig mu chain C region

（注：单次混测多因子不超过8个指标 ）

  • 免疫球蛋白M(IgM)等多因子检测试剂盒(流式荧光发光法) 产品包装(模拟)
  • 免疫球蛋白M(IgM)等多因子检测试剂盒(流式荧光发光法) 产品包装(模拟)
  • Certificate 通过ISO 9001、ISO 13485质量体系认证

特异性

本试剂盒用于检测免疫球蛋白M(IgM)等多因子检测试剂盒(流式荧光发光法)，经检测与其它相似物质无明显交叉反应。
由于受到技术及样本来源的限制，不可能完成对所有相关或相似物质交叉反应检测，因此本试剂盒有可能与未经检测的其它物质有交叉反应。

回收率

分别于定值血清及血浆样本中加入一定量的免疫球蛋白M(IgM)等多因子检测试剂盒(流式荧光发光法)（加标样品），重复测定并计算其均值，回收率为测定值与理论值的比率。

样本 回收率范围(%) 平均回收率(%)
serum(n=5) 79-91 82
EDTA plasma(n=5) 84-93 88
heparin plasma(n=5) 82-93 87
sodium citrate plasma(n=5) 94-105 101

精密度

精密度用样品测定值的变异系数CV表示。CV(%) = SD/mean×100
批内差：取同批次试剂盒对低、中、高值定值样本进行定量检测,每份样本连续测定20 次，分别计算不同浓度样本的平均值及SD值。
批间差：选取3个不同批次的试剂盒分别对低、中、高值定值样本进行定量测定，每个样本使用同一试剂盒重复测定8次，分别计算不同浓度样本的平均值及SD值。
批内差： CV<10%
批间差： CV<12%

线性

在定值血清及血浆样本内加入适量的免疫球蛋白M(IgM)等多因子检测试剂盒(流式荧光发光法)，并倍比稀释成1:2，1:4，1:8，1:16的待测样本，线性范围即为稀释后样本中免疫球蛋白M(IgM)等多因子检测试剂盒(流式荧光发光法)含量的测定值与理论值的比率。

样本 1:2 1:4 1:8 1:16
serum(n=5) 78-89% 93-105% 79-102% 87-101%
EDTA plasma(n=5) 80-102% 78-93% 97-104% 86-102%
heparin plasma(n=5) 93-102% 94-105% 80-93% 91-99%
sodium citrate plasma(n=5) 78-98% 82-93% 90-102% 95-104%

稳定性

经测定，试剂盒在有效期内按推荐温度保存，其活性降低率小于5%。
为减小外部因素对试剂盒破坏前后检测值的影响，实验室的环境条件需尽量保持一致，尤其是实验室内温度、湿度及温育条件。其次由同一实验员来进行操作可减少人为误差。

实验流程

1. 实验前标准品、试剂及样本准备；
2. 加样（标准品、样本、磁珠）标准品或样本100μL及磁珠10μL，
    37°C酶标板振荡器孵育90分钟；
3. 磁吸甩干，加检测溶液A100μL，37°C酶标板振荡器孵育60分钟；
4. 磁吸洗板3次；
5. 加检测溶液B100μL，37°C振动孵育30分钟；
6. 磁吸洗板3次；
7. 加鞘液100μL，旋涡震荡2分钟后读数。

实验原理

将免疫球蛋白M(IgM)等多因子检测试剂盒(流式荧光发光法)抗体包被于磁珠，制成固相载体，向微孔中分别加入标准品或标本以及磁珠，其中的免疫球蛋白M(IgM)等多因子检测试剂盒(流式荧光发光法)与连接于固相载体上的抗体结合，然后加入生物素化的免疫球蛋白M(IgM)等多因子检测试剂盒(流式荧光发光法)抗体，将未结合的生物素化抗体洗净后，加入PE标记的亲和素，再次彻底洗涤后即可上机读数。MFI值和样品中的免疫球蛋白M(IgM)等多因子检测试剂盒(流式荧光发光法)呈正相关。

赠品

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