游離-前列腺特異抗原酶免定量檢測(cè)試劑盒【生產(chǎn)廠(chǎng)家】上海科華生物工程股份有限公司 【批準(zhǔn)文號(hào)】國(guó)藥準(zhǔn)字S20010067 【劑 型】檢測(cè)試劑盒 【規(guī) 格】48人份 【醫(yī)保類(lèi)型】 【國(guó)家基本藥物】否 【藥品名稱(chēng)】 游離-前列腺特異抗原酶免定量檢測(cè)試劑盒 【主要成分】 【化學(xué)名】 【正文】 PSA（前列腺特異抗原）是由前列腺上皮細(xì)胞產(chǎn)生的一種大分子糖蛋白，它具有極高的組織器官特異性。正常人體內(nèi)PSA<4ng/ml。約有63%-70%的早期前列腺癌病人血清PSA濃度高于正常值。然而，血清PSA濃度升高并非總是提示前列腺癌，事實(shí)上，約有25%組織學(xué)檢查證實(shí)的前列腺增生（BPH），其血清PSA值高于正常范圍。盡管Pca患者血清PSA濃度較BPH患者高，但PSA值的分布有相當(dāng)?shù)慕徊娌糠�。�?dāng)正常PSA的上限值為4ng/ml時(shí)，應(yīng)用PSA來(lái)區(qū)別Pca和BPH的敏感性為71%，特異性?xún)H為49%。 血清中PSA有不同的分子形式。PSA能與血清中一些絲氨酸蛋白酶抑制劑形成復(fù)合物（如PSA-ACT，PSA-AMG等），游離-PSA（Free-PSA）不能與蛋白抑制劑絡(luò)合，而以游離的形式循環(huán)于血液中。研究證實(shí)，Pca患者血清中Free-PSA/t-PSA(血清中總PSA)比值明顯較BPH患者低。當(dāng)PSA值為4-15ng/ml時(shí)，應(yīng)用Free-PSA/t-PSA比值來(lái)區(qū)別Pca和 BPH的特異性增加到90%（單用PSA約為49%）。 本品采用酶聯(lián)免疫法，雙抗體夾心定量檢測(cè)血清中Free-PSA的含量，用于前列腺癌的輔助診斷。 一、試劑盒的內(nèi)容物 mso-table-layout-alt:fixed;border:none;mso-border-alt:solid windowtext 1.5pt; mso-padding-alt:0cm 7.1pt 0cm 7.1pt"> 1.5pt;border-bottom:.75pt;border-right:.75pt;border-color:windowtext; border-style:solid;padding:0cm 7.1pt 0cm 7.1pt"> mso-hansi-font-family:"Times New Roman"">已包被抗體的酶標(biāo)反應(yīng)板（48 "Times New Roman"">孔） border-left:none;border-bottom:solid windowtext .75pt;border-right:solid windowtext 1.5pt; mso-border-left-alt:solid windowtext .75pt;padding:0cm 7.1pt 0cm 7.1pt"> 1 mso-ascii-font-family:"Times New Roman";mso-hansi-font-family:"Times New Roman"">塊 solid windowtext 1.5pt;border-bottom:solid windowtext .75pt;border-right: solid windowtext .75pt;mso-border-top-alt:solid windowtext .75pt;padding: 0cm 7.1pt 0cm 7.1pt"> mso-hansi-font-family:"Times New Roman"">濃縮洗滌液（用時(shí)蒸餾水1 "Times New Roman"">:25 宋體;mso-ascii-font-family:"Times New Roman";mso-hansi-font-family:"Times New Roman"">稀釋?zhuān)?br> none;border-bottom:solid windowtext .75pt;border-right:solid windowtext 1.5pt; mso-border-top-alt:solid windowtext .75pt;mso-border-left-alt:solid windowtext .75pt; padding:0cm 7.1pt 0cm 7.1pt"> 1 mso-ascii-font-family:"Times New Roman";mso-hansi-font-family:"Times New Roman"">瓶 solid windowtext 1.5pt;border-bottom:solid windowtext .75pt;border-right: solid windowtext .75pt;mso-border-top-alt:solid windowtext .75pt;padding: 0cm 7.1pt 0cm 7.1pt"> mso-hansi-font-family:"Times New Roman"">酶結(jié)合物 none;border-bottom:solid windowtext .75pt;border-right:solid windowtext 1.5pt; mso-border-top-alt:solid windowtext .75pt;mso-border-left-alt:solid windowtext .75pt; padding:0cm 7.1pt 0cm 7.1pt"> 1 mso-ascii-font-family:"Times New Roman";mso-hansi-font-family:"Times New Roman"">瓶 solid windowtext 1.5pt;border-bottom:solid windowtext .75pt;border-right: solid windowtext .75pt;mso-border-top-alt:solid windowtext .75pt;padding: 0cm 7.1pt 0cm 7.1pt"> FREE-PSA 宋體;mso-ascii-font-family:"Times New Roman";mso-hansi-font-family:"Times New Roman"">校準(zhǔn)品S0 mso-hansi-font-family:"Times New Roman"">（0ng/ml "Times New Roman"">）兼樣品稀釋液 none;border-bottom:solid windowtext .75pt;border-right:solid windowtext 1.5pt; mso-border-top-alt:solid windowtext .75pt;mso-border-left-alt:solid windowtext .75pt; padding:0cm 7.1pt 0cm 7.1pt"> 1 mso-ascii-font-family:"Times New Roman";mso-hansi-font-family:"Times New Roman"">瓶 solid windowtext 1.5pt;border-bottom:solid windowtext .75pt;border-right: solid windowtext .75pt;mso-border-top-alt:solid windowtext .75pt;padding: 0cm 7.1pt 0cm 7.1pt"> FREE-PSA 宋體;mso-ascii-font-family:"Times New Roman";mso-hansi-font-family:"Times New Roman"">校準(zhǔn)品系列 S1(0.5);S2(1);S3(2.5);S4(5);S5(10);S6(15)ng/ml mso-hansi-font-family:"Times New Roman"">（經(jīng)HBsAg "Times New Roman"">，抗HCV "Times New Roman"">，抗HIV "Times New Roman"">－1/2 宋體;mso-ascii-font-family:"Times New Roman";mso-hansi-font-family:"Times New Roman"">檢測(cè)為陰性） none;border-bottom:solid windowtext .75pt;border-right:solid windowtext 1.5pt; mso-border-top-alt:solid windowtext .75pt;mso-border-left-alt:solid windowtext .75pt; padding:0cm 7.1pt 0cm 7.1pt">  |