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：單次混測(cè)多因子不超過8個(gè)指標(biāo) ）
- 編號(hào)LMA506Po
- 物種Sus scrofa; Porcine (Pig，豬) 相同的名稱，不同的物種。
- 實(shí)驗(yàn)方法競(jìng)爭抑制
- 反應(yīng)時(shí)長1.5h
- 檢測(cè)范圍4.88-5000ng/mL
- 靈敏度最小可檢測(cè)劑量小于等于1.627 ng/mL.
- 樣本類型plasma
- 下載 英文說明書 中文說明書
- 規(guī)格 8指標(biāo)數(shù) 7指標(biāo)數(shù) 6指標(biāo)數(shù) 5指標(biāo)數(shù) 4指標(biāo)數(shù) 3指標(biāo)數(shù) 2指標(biāo)數(shù)1指標(biāo)數(shù)
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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(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(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) | 84-95 | 90 |
| EDTA plasma(n=5) | 96-105 | 101 |
| heparin plasma(n=5) | 93-101 | 98 |
| sodium citrate plasma(n=5) | 86-101 | 91 |
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) | 90-97% | 79-103% | 90-101% | 79-90% |
| EDTA plasma(n=5) | 80-88% | 85-101% | 92-101% | 87-101% |
| heparin plasma(n=5) | 86-104% | 94-103% | 84-104% | 94-102% |
| sodium citrate plasma(n=5) | 83-95% | 79-103% | 95-104% | 98-105% |
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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| 編號(hào) | 適用物種：Sus scrofa; Porcine (Pig，豬) | 應(yīng)用(僅供研究使用，不用于臨床診斷！) |
| CEA506Po | D-二聚體(D2D)檢測(cè)試劑盒(酶聯(lián)免疫吸附試驗(yàn)法) | Enzyme-linked immunosorbent assay for Antigen Detection. |
| LMA506Po | D-二聚體(D2D)等多因子檢測(cè)試劑盒(流式熒光發(fā)光法) | FLIA Kit for Antigen Detection. |
參考文獻(xiàn)
| 雜志 | 參考文獻(xiàn) |
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