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D-二聚體(D2D)等多因子檢測試劑盒(流式熒光發(fā)光法)

Multiplex Assay Kit for D-Dimer (D2D) ,etc. by FLIA (Flow Luminescence Immunoassay)

D 2 Dimer

(注:單次混測多因子不超過8個指標(biāo) )

  • D-二聚體(D2D)等多因子檢測試劑盒(流式熒光發(fā)光法)產(chǎn)品包裝(模擬)
  • D-二聚體(D2D)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(rèn)證

特異性

本試劑盒用于檢測D-二聚體(D2D),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D-二聚體(D2D)(加標(biāo)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)88-10192
EDTA plasma(n=5)92-104101
heparin plasma(n=5)86-9794
sodium citrate plasma(n=5)90-9794

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D-二聚體(D2D),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D-二聚體(D2D)含量的測定值與理論值的比率。

樣本1:21:41:81:16
serum(n=5)80-92%98-105%80-101%91-99%
EDTA plasma(n=5)87-104%85-94%78-94%88-102%
heparin plasma(n=5)79-102%92-105%92-99%80-99%
sodium citrate plasma(n=5)83-97%89-103%80-101%80-90%

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、向?qū)嶒灠迕靠變?nèi)加入200μL分析緩沖液以預(yù)濕;
2、實驗前標(biāo)準(zhǔn)品、試劑及樣本準(zhǔn)備;
3、加樣(標(biāo)準(zhǔn)品、樣本、磁珠、檢測溶液A),標(biāo)準(zhǔn)品或樣本50μL,加檢測溶液A 50μL,及磁珠10μL,25°C酶標(biāo)板振蕩器孵育90分鐘;
4、磁吸甩干,加檢測溶液B 100μL,25°C振動孵育30分鐘;
5、磁吸洗板1次;
6、加鞘液100μL,旋渦震蕩10分鐘后讀數(shù)。

實驗原理

將D-二聚體(D2D)抗體包被于磁性微球表面,制成固相載體。在微孔中同時加入待測抗原(標(biāo)準(zhǔn)品或樣本)、生物素標(biāo)記的抗原和微球。待測抗原與生物素標(biāo)記抗原對特異性抗體進行競爭結(jié)合。加入PE標(biāo)記的鏈霉親和素,上機讀數(shù)。MFI值(Median Fluorescence Intensity)和樣品中的D-二聚體(D2D)濃度呈負(fù)相關(guān)。

贈品

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