全段甲狀旁腺測(cè)定試劑盒直接化學(xué)發(fā)光免疫分析法2.說明書

1、全段甲狀旁腺激素測(cè)定試劑盒（直接化學(xué)發(fā)光免疫分析法】【格】100測(cè)證號(hào)】 國(guó)食藥監(jiān)械（進(jìn)）字 2013 第 2403567 【全段甲狀旁腺激素測(cè)定試劑盒（直接化學(xué)發(fā)光免疫分析法】【格】100測(cè)證號(hào)】 國(guó)食藥監(jiān)械（進(jìn)）字 2013 第 2403567 【第一層 Q1 部位機(jī)Healthcare Diagnostics 10591,USA 02032,USA【全段甲狀旁腺激素測(cè)定試劑盒（直接化學(xué)發(fā)光免疫分析法）說明學(xué)信（RLUs）數(shù)量呈正相關(guān)英文名稱 ： act或06587575 5ADVIA CentauriPTH(129502) ReadyPackADVIA Centaur iPTH 或043

2、85983 1ADVIA CentauriPTH (129501) ReadyPackADVIA Centaur iPTH ADVIA Centaur ADVIA Centaur XP 5.0mL/瓶生物素結(jié)合的多克PTH(39-84抗體 多克隆抗人PTH(N端1-34) 抗體 (1g/mL)，置ADVIA Centaur 試劑中，是由吖啶酯標(biāo)記 多克隆抗人甲狀旁腺激素（N 20.0mL/與磁乳膠顆粒共價(jià)結(jié)合的鏈霉親和素 04mgmL，置于含Ig、牛球蛋白牛 白白防腐劑的酸緩沖中。1-34）激素（39-84 區(qū)域）抗體。固相試劑中的鏈霉親和素與順磁乳定貨描 再加入50 L 標(biāo)記試劑，在 37C

3、下孵育5 分鐘。 06441090 （570404）或 警告 ADVIA 5mL/ 10mL/ 11,2,3ADVIA Centaur 23 2814將試于 2-8C，并保持豎直向上 警告 ADVIA 5mL/ 10mL/ 11,2,3ADVIA Centaur 23 2814將試于 2-8C，并保持豎直向上 警告當(dāng)使用新批號(hào)的標(biāo)記試劑和固相試劑ADVIA Centaur 全段甲狀旁腺激素測(cè)定項(xiàng)目進(jìn)行重新定標(biāo)。對(duì)每一新將定標(biāo)曲線數(shù)值輸入系統(tǒng)中。定標(biāo)曲線數(shù)值 在定標(biāo)曲線卡品測(cè)定的每一天同時(shí)對(duì)兩個(gè)水平的質(zhì)控品定。當(dāng)進(jìn)行ADVIA Centaur ADVIA Centaur XPEDTA下面有以 1

4、000g 的轉(zhuǎn)速離心樣品1520 分鐘。對(duì)。使用至少有兩級(jí)的（高級(jí)和低級(jí)）可靠的 iPTH 商在72進(jìn)行該項(xiàng)目的一次單項(xiàng)測(cè)定需要 200L 樣品。該量不包括樣ADVIA Centaur 參考手冊(cè)中樣品系以（質(zhì)）或pmoL/L（國(guó)）1pg/mL0.106pmoL/L干擾體免疫測(cè)定。15 經(jīng)常接觸動(dòng)物或動(dòng)時(shí)1900 pg/mL的樣品必須進(jìn)行 11）并按如下參數(shù)設(shè)置系統(tǒng)參數(shù) ： （質(zhì)）或pmoL/L（國(guó)）1pg/mL0.106pmoL/L干擾體免疫測(cè)定。15 經(jīng)常接觸動(dòng)物或動(dòng)時(shí)1900 pg/mL的樣品必須進(jìn)行 11）并按如下參數(shù)設(shè)置系統(tǒng)參數(shù) ： 200 3000 40將下列 PTH 片段和化合物按

5、提示濃度加入樣品， 測(cè)定要進(jìn)行稀釋，則采用多項(xiàng)稀釋液（Multi-Diluent 11）手工稀PTH(1-34)片段 PTH(53-84) 片0 0 0 遵ADVIACentaur全段甲狀旁腺激素測(cè)試法對(duì)全段甲狀旁腺激素水平的最低檢測(cè)濃度 2.5 pg/mL（0.265pmoL/L），檢測(cè)范圍上 激素標(biāo)準(zhǔn)品進(jìn)30 次重復(fù)測(cè)定，所得平RLUs 2 個(gè)標(biāo)準(zhǔn)RLUs值相對(duì)應(yīng)的全段甲狀旁腺激素濃度值，即被15.01908.4 pg/mL（1.58202.3 pmoL/L）185份樣品進(jìn) 定，ADVIA Centaur 全段甲狀旁腺激素測(cè)試法與配對(duì)ACS:180 全段甲狀旁腺激素檢測(cè)法的關(guān)系，通過公式表

6、ADVIACentaur = 0 95（ACS:180全段甲狀旁腺激素）+ 6.48 pg/mL用多項(xiàng)稀釋液（Multi-Diluent11）5份全段甲狀旁腺激素水平范圍在 1040.21824.1pg/mL (110.3193.4 pmoL/L) 的人血漿樣1:2、1:4 和 1:8 倍比稀釋，測(cè)定回收率和平行對(duì)照值。所得回收率范圍從 91.3% 到 116.3%，均值為 99.8%【參考值( 參考范圍)正常參 考范圍已經(jīng)由 ACS:180 建立。對(duì)142鈣水平在 8 010 3mg/dL 的明顯健康的 EDTA 血漿樣品的檢測(cè)后建激素水平的95%這些結(jié)果在 ADVIA Centaur 全段

7、甲狀旁腺激素檢測(cè)法得到了評(píng)價(jià)甲狀旁腺素檢驗(yàn)的價(jià)值應(yīng)該考慮血鈣的濃度以及PTH 和必預(yù)計(jì)值 測(cè)定值 預(yù)計(jì)(pg/mL)pmoL/LpmoL/L) 足以作為惡性高鈣血癥的 依據(jù)。最為重要的是保證 血樣能夠被正確的處理和保存。不恰當(dāng)使用的樣本類型（ EDTA 血漿）可能影響到全段甲狀旁為避免發(fā)生此現(xiàn)象建議在整個(gè)的 過程中采用相同的樣本稀1787 2362 186 19 預(yù)計(jì)值 測(cè)定值 預(yù)計(jì)(pg/mLpmoL/LpmoL/L) 稀3122 3141165 2 4 4219) gnostics上查詢預(yù)計(jì)值 測(cè)定值 預(yù)計(jì)(pg/mLpmoL/LpmoL/L) 稀3122 3141165 2 4 4219

8、) gnostics上查詢5101 （4.019.0pmoL/L）5份樣品中加入不同量的全段甲狀旁腺激素?；厥章史秶鷱?91.0% 123.6%，均值為 105.0%。Mundy GR, Guise TA. Hormonal control of calcium homeostasis. Clin Chem 1999; 45:13471352.Marx SJ. Hyp arathyroid and hypoparathyroid disorders. New England Journal of Medicine 2000; FriedmanPA.Mechanismsofrenalcalciu

9、mtransport.Exp Nephrol 2000; 8(6):343350.Akizawa T, Fukagawa M. Modulation of parathyroid cell function by calcium ion in heal nd uremia. Am J Med Sci1999;317(6):358362.Itani O, Tsang RC. Bone disease. In: Kaplan LA, 12 5 3116 AJ, Clinical chemistry: ysis, and 22 5 3119 3rded.St.Louis:CVMosby, Endre

10、s DB, Rude RK. Mineral and bone metabolism. In: Burtis CA, Ashwood, ER, Tietz textbook of clinical chemistr y, 2 nd ed. Philadelphia: WB Saunders, Casez JP, Pfammatter R, et al. Diagnostic approach to hypercalcemia: relevance of parathyroid hormone and parathyroidhormone-relatedprote easurements.Eur

11、o Jour of Med 2001;12(4) 344349.Johnson LR, Doher ty G, et al. Evaluation of 96 3492 13 2 5 31123 performance and clinical impact of a parathyroid hormone assay in conjunction with preoperativeimagingandconciseparathyroidectomy.Clin Chem 2001;47 919925.Lepage R, Roy L, Brossard JH, et al. A non-(1 c

12、irculating parathyroid hormone ( PTH) f 47712 2 5 3195 erferes significantly act PTH commer assay measurements in uremic s les. Clin Chem Bilezikian JP, Silverberg SJ. Parathyroid hormone. Does i ve a role he pathogenesis of osteoporosis? Clin LabMed 2000, 20(3):559567.Raisz LG. Physiology and patho

13、physiology of rem ing. Clin Chem 53982 5 3112. Morley P, Whitfield JF, Willick GE. Parathyroid an anabolic t reatment for osteoporosis. Current Pharmaceutical Design 2001, 7(8) 671687.13. Reagent wanter Technical 14. Clinical and Laboratory Standards Institute (formerly NCCLS). Procedures for12. Mor

14、ley P, Whitfield JF, Willick GE. Parathyroid an anabolic t reatment for osteoporosis. Current Pharmaceutical Design 2001, 7(8) 671687.13. Reagent wanter Technical 14. Clinical and Laboratory Standards Institute (formerly NCCLS). Procedures for the Handling and Pro sing of Blood Specimens; Approved G

15、uideline - Third Wayne, PA: Clinical and Laboratory Standards 2004. GlendenningP,LafferLLA,WeberHK,MuskAA,Vasikaran SD.Parathyroid Hormone ex Vivo in Serum and EDTA Plasma n in Serum.Clin Chem.2004;50:1713-1714.Teal TK, Wood JL,Stevens PE,Lamb EJ.Stability of Bio- act(1- 84)Parathyroid Hormone ex Vi

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