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糖化血紅蛋白A1c(HbA1c)等多因子檢測試劑盒(流式熒光發(fā)光法)

Multiplex Assay Kit for Glycated Hemoglobin A1c (HbA1c) ,etc. by FLIA (Flow Luminescence Immunoassay)

Glycosylated Hemoglobin; Hemoglobin A1c; Hb1c; HbAIc; HbAIc

(注:單次混測多因子不超過8個(gè)指標(biāo) )

    • 糖化血紅蛋白A1c(HbA1c)等多因子檢測試劑盒(流式熒光發(fā)光法)產(chǎn)品包裝(模擬)
    • 糖化血紅蛋白A1c(HbA1c)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

    本試劑盒用于檢測糖化血紅蛋白A1c(HbA1c)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糖化血紅蛋白A1c(HbA1c)等多因子檢測試劑盒(流式熒光發(fā)光法)(加標(biāo)樣品),重復(fù)測定并計(jì)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)88-10191
    EDTA plasma(n=5)89-9995
    heparin plasma(n=5)90-9894

    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(jìn)行定量檢測,每份樣本連續(xù)測定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低、中、高值定值樣本進(jìn)行定量測定,每個(gè)樣本使用同一試劑盒重復(fù)測定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)加入適量的糖化血紅蛋白A1c(HbA1c)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糖化血紅蛋白A1c(HbA1c)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)98-105%96-105%92-99%81-93%
    EDTA plasma(n=5)95-105%96-104%86-93%80-91%
    heparin plasma(n=5)95-103%89-101%88-102%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(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、檢測溶液A)標(biāo)準(zhǔn)品或樣本50μL及磁珠10μL,加檢測溶液A50μL,
        37°C酶標(biāo)板振蕩器孵育60分鐘;
    3. 磁吸洗板3次;
    4. 加檢測溶液B100μL,37°C振動孵育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

    將糖化血紅蛋白A1c(HbA1c)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(biāo)準(zhǔn)品或標(biāo)本以及磁珠、標(biāo)記VEGFA,標(biāo)記的糖化血紅蛋白A1c(HbA1c)等多因子檢測試劑盒(流式熒光發(fā)光法)和未標(biāo)記的糖化血紅蛋白A1c(HbA1c)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競爭結(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值和樣品中的糖化血紅蛋白A1c(HbA1c)等多因子檢測試劑盒(流式熒光發(fā)光法)呈負(fù)相關(guān)。

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