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促甲狀腺素(TSH)檢測(cè)試劑盒(化學(xué)發(fā)光免疫分析法)

CLIA Kit for Thyroid Stimulating Hormone (TSH)

Thyrotropin

  • 促甲狀腺素(TSH)檢測(cè)試劑盒(化學(xué)發(fā)光免疫分析法) 產(chǎn)品包裝(模擬)
  • 促甲狀腺素(TSH)檢測(cè)試劑盒(化學(xué)發(fā)光免疫分析法) 產(chǎn)品包裝(模擬)
  • 促甲狀腺素(TSH)檢測(cè)試劑盒(化學(xué)發(fā)光免疫分析法) 實(shí)驗(yàn)結(jié)果圖
  • CCA463Ca.jpg 標(biāo)準(zhǔn)曲線圖
  • 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)促甲狀腺素(TSH),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促甲狀腺素(TSH)(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) 83-93 89
EDTA plasma(n=5) 81-98 90
heparin plasma(n=5) 82-90 86

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)加入適量的促甲狀腺素(TSH),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促甲狀腺素(TSH)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% 81-95% 87-98% 80-92%
EDTA plasma(n=5) 98-105% 82-102% 78-104% 97-104%
heparin plasma(n=5) 94-105% 79-102% 97-105% 80-101%

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、試劑及樣本的準(zhǔn)備;
2. 加樣(標(biāo)準(zhǔn)品及樣本)50µL,
    加入50µL檢測(cè)液A(臨用前配制);
    37°C溫育1小時(shí)。
3. 洗板3次;
4. 加檢測(cè)溶液B100µL,37°C孵育30分鐘;
5. 洗板5次;
6. 加底物100µL,37°C孵育10分鐘;
7. 讀數(shù)。

實(shí)驗(yàn)原理

本試劑盒應(yīng)用競(jìng)爭(zhēng)抑制酶聯(lián)免疫分析法測(cè)定標(biāo)本中待測(cè)物質(zhì)水平。將促甲狀腺素(TSH)單克隆抗體包被微孔板,制成固相載體,往包被抗體的微孔中同時(shí)加入生物素標(biāo)記的抗原和待測(cè)抗原(標(biāo)準(zhǔn)品或樣本),待測(cè)抗原與生物素標(biāo)記抗原對(duì)特異性抗體進(jìn)行競(jìng)爭(zhēng)結(jié)合。溫育后經(jīng)洗滌去掉未結(jié)合物,然后加入HRP標(biāo)記的親和素,再次徹底洗滌后加入底物。加入底物后會(huì)產(chǎn)生輝光型光信號(hào)。發(fā)射光強(qiáng)度和樣品中的促甲狀腺素(TSH)呈負(fù)相關(guān)。用化學(xué)發(fā)光儀測(cè)定相對(duì)光單位(RLU),計(jì)算樣品濃度。

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編號(hào) 適用物種:Canis familiaris; Canine (Dog,犬) 應(yīng)用(僅供研究使用,不用于臨床診斷!)
CEA463Ca 促甲狀腺素(TSH)檢測(cè)試劑盒(酶聯(lián)免疫吸附試驗(yàn)法) Enzyme-linked immunosorbent assay for Antigen Detection.
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