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免疫球蛋白E(IgE)等多因子檢測試劑盒(流式熒光發(fā)光法)

Multiplex Assay Kit for Immunoglobulin E (IgE) ,etc. by FLIA (Flow Luminescence Immunoassay)

IGHE; Immunoglobulin Heavy Constant Epsilon; Ig epsilon chain C region

(注:單次混測多因子不超過8個指標 )

  • 免疫球蛋白E(IgE)等多因子檢測試劑盒(流式熒光發(fā)光法)產(chǎn)品包裝(模擬)
  • 免疫球蛋白E(IgE)等多因子檢測試劑盒(流式熒光發(fā)光法)產(chǎn)品包裝(模擬)
  • Certificate通過ISO 9001、ISO 13485質(zhì)量體系認證

特異性

本試劑盒用于檢測免疫球蛋白E(IgE)等多因子檢測試劑盒(流式熒光發(fā)光法),經(jīng)檢測與其它相似物質(zhì)無明顯交叉反應(yīng)。
由于受到技術(shù)及樣本來源的限制,不可能完成對所有相關(guān)或相似物質(zhì)交叉反應(yīng)檢測,因此本試劑盒有可能與未經(jīng)檢測的其它物質(zhì)有交叉反應(yīng)。

回收率

分別于定值血清及血漿樣本中加入一定量的免疫球蛋白E(IgE)等多因子檢測試劑盒(流式熒光發(fā)光法)(加標樣品),重復(fù)測定并計算其均值,回收率為測定值與理論值的比率。

樣本回收率范圍(%)平均回收率(%)
serum(n=5)98-105101
EDTA plasma(n=5)88-10194
heparin plasma(n=5)82-9791
sodium citrate plasma(n=5)85-10189

精密度

精密度用樣品測定值的變異系數(shù)CV表示。CV(%) = SD/mean×100
批內(nèi)差:取同批次試劑盒對低、中、高值定值樣本進行定量檢測,每份樣本連續(xù)測定20 次,分別計算不同濃度樣本的平均值及SD值。
批間差:選取3個不同批次的試劑盒分別對低、中、高值定值樣本進行定量測定,每個樣本使用同一試劑盒重復(fù)測定8次,分別計算不同濃度樣本的平均值及SD值。
批內(nèi)差: CV<10%
批間差: CV<12%

線性

在定值血清及血漿樣本內(nèi)加入適量的免疫球蛋白E(IgE)等多因子檢測試劑盒(流式熒光發(fā)光法),并倍比稀釋成1:2,1:4,1:8,1:16的待測樣本,線性范圍即為稀釋后樣本中免疫球蛋白E(IgE)等多因子檢測試劑盒(流式熒光發(fā)光法)含量的測定值與理論值的比率。

樣本1:21:41:81:16
serum(n=5)85-97%81-95%98-105%78-101%
EDTA plasma(n=5)96-104%90-104%88-96%93-101%
heparin plasma(n=5)89-101%96-104%81-93%81-89%
sodium citrate plasma(n=5)96-105%86-94%90-97%93-101%

穩(wěn)定性

經(jīng)測定,試劑盒在有效期內(nèi)按推薦溫度保存,其活性降低率小于5%。
為減小外部因素對試劑盒破壞前后檢測值的影響,實驗室的環(huán)境條件需盡量保持一致,尤其是實驗室內(nèi)溫度、濕度及溫育條件。其次由同一實驗員來進行操作可減少人為誤差。

實驗流程

1. 實驗前標準品、試劑及樣本準備;
2. 加樣(標準品、樣本、磁珠)標準品或樣本100μL及磁珠10μL,
    37°C酶標板振蕩器孵育90分鐘;
3. 磁吸甩干,加檢測溶液A100μL,37°C酶標板振蕩器孵育60分鐘;
4. 磁吸洗板3次;
5. 加檢測溶液B100μL,37°C振動孵育30分鐘;
6. 磁吸洗板3次;
7. 加鞘液100μL,旋渦震蕩2分鐘后讀數(shù)。

實驗原理

將免疫球蛋白E(IgE)等多因子檢測試劑盒(流式熒光發(fā)光法)抗體包被于磁珠,制成固相載體,向微孔中分別加入標準品或標本以及磁珠,其中的免疫球蛋白E(IgE)等多因子檢測試劑盒(流式熒光發(fā)光法)與連接于固相載體上的抗體結(jié)合,然后加入生物素化的免疫球蛋白E(IgE)等多因子檢測試劑盒(流式熒光發(fā)光法)抗體,將未結(jié)合的生物素化抗體洗凈后,加入PE標記的親和素,再次徹底洗滌后即可上機讀數(shù)。MFI值和樣品中的免疫球蛋白E(IgE)等多因子檢測試劑盒(流式熒光發(fā)光法)呈正相關(guān)。

贈品

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參考文獻

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