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D-二聚體(D2D)等多因子檢測(cè)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:?jiǎn)未位鞙y(cè)多因子不超過(guò)8個(gè)指標(biāo) )

  • D-二聚體(D2D)等多因子檢測(cè)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(cè)試劑盒(流式熒光發(fā)光法) 產(chǎn)品包裝(模擬)
  • Certificate 通過(guò)ISO 9001、ISO 13485質(zhì)量體系認(rèn)證

特異性

本試劑盒用于檢測(cè)D-二聚體(D2D)等多因子檢測(cè)試劑盒(流式熒光發(fā)光法),經(jīng)檢測(cè)與其它相似物質(zhì)無(wú)明顯交叉反應(yīng)。
由于受到技術(shù)及樣本來(lái)源的限制,不可能完成對(duì)所有相關(guān)或相似物質(zhì)交叉反應(yīng)檢測(cè),因此本試劑盒有可能與未經(jīng)檢測(cè)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)等多因子檢測(cè)試劑盒(流式熒光發(fā)光法)(加標(biāo)樣品),重復(fù)測(cè)定并計(jì)算其均值,回收率為測(cè)定值與理論值的比率。

樣本 回收率范圍(%) 平均回收率(%)
serum(n=5) 85-105 97
EDTA plasma(n=5) 94-101 98
heparin plasma(n=5) 99-105 102
sodium citrate plasma(n=5) 85-97 90

精密度

精密度用樣品測(cè)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(duì)低、中、高值定值樣本進(jìn)行定量檢測(cè),每份樣本連續(xù)測(cè)定20 次,分別計(jì)算不同濃度樣本的平均值及SD值。
批間差:選取3個(gè)不同批次的試劑盒分別對(duì)低、中、高值定值樣本進(jìn)行定量測(cè)定,每個(gè)樣本使用同一試劑盒重復(fù)測(cè)定8次,分別計(jì)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)等多因子檢測(cè)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(cè)樣本,線性范圍即為稀釋后樣本中D-二聚體(D2D)等多因子檢測(cè)試劑盒(流式熒光發(fā)光法)含量的測(cè)定值與理論值的比率。

樣本 1:2 1:4 1:8 1:16
serum(n=5) 99-105% 78-96% 80-91% 78-103%
EDTA plasma(n=5) 83-97% 84-94% 84-103% 89-104%
heparin plasma(n=5) 84-101% 98-105% 87-94% 99-105%
sodium citrate plasma(n=5) 99-105% 78-101% 97-104% 93-104%

穩(wěn)定性

經(jīng)測(cè)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(duì)試劑盒破壞前后檢測(cè)值的影響,實(shí)驗(yàn)室的環(huán)境條件需盡量保持一致,尤其是實(shí)驗(yàn)室內(nèi)溫度、濕度及溫育條件。其次由同一實(shí)驗(yàn)員來(lái)進(jìn)行操作可減少人為誤差。

實(shí)驗(yàn)流程

1. 實(shí)驗(yàn)前標(biāo)準(zhǔn)品、試劑及樣本準(zhǔn)備;
2. 加樣(標(biāo)準(zhǔn)品、樣本、磁珠、檢測(cè)溶液A)標(biāo)準(zhǔn)品或樣本50μL及磁珠10μL,加檢測(cè)溶液A50μL,
    37°C酶標(biāo)板振蕩器孵育60分鐘;
3. 磁吸洗板3次;
4. 加檢測(cè)溶液B100μL,37°C振動(dòng)孵育30分鐘;
5. 磁吸洗板3次;
6. 加鞘液100μL,旋渦震蕩2分鐘后讀數(shù)。

實(shí)驗(yàn)原理

將D-二聚體(D2D)等多因子檢測(cè)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(biāo)準(zhǔn)品或標(biāo)本以及磁珠、標(biāo)記VEGFA,標(biāo)記的D-二聚體(D2D)等多因子檢測(cè)試劑盒(流式熒光發(fā)光法)和未標(biāo)記的D-二聚體(D2D)等多因子檢測(cè)試劑盒(流式熒光發(fā)光法)與連接于固相載體上的抗體競(jìng)爭(zhēng)結(jié)合,然后將未結(jié)合物洗凈后,加入PE標(biāo)記的親和素,再次徹底洗滌后即可上機(jī)讀數(shù)。MFI值和樣品中的D-二聚體(D2D)等多因子檢測(cè)試劑盒(流式熒光發(fā)光法)呈負(fù)相關(guān)。

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參考文獻(xiàn)

雜志 參考文獻(xiàn)
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