肿瘤标志物免疫测定的标准化.pdfVIP

1800 Ch in J Ph rm An l 20 10, 30( 9) * ** 黄杰, 曲守方, 高尚先 (, 100050) : , 4, , , , , , , : ; ; : R917 : A : 0254- 1793( 2010) 09- 1800- 04 * The standardization of tumor markers immunoassay ** HUANG Jie, QU Shou- f ng, GAO Sh ng- x i n ( N tion l Institute for the Control of Ph rm ceutic l nd B iologic l Products, Beijing 100050, Ch in ) Abstract: R eferring to the st nd rd nd docum ent tion, the v rious f ctors in the process of tumor m rkers mi muno ss ys st nd rdiz tion w ere ggreg ted. The st nd rdiz tion of clin ic l s mp le collection, tr nsport tion nd preserv tion, test re gents nd methodology, referencem teri ls pplic tionw ere four elem ents in tumor m rkers mi muno s s y st nd rd iz tion. A s to the four elem ents, referencem teri ls w s prem ise to obt in comp r ble resu lts. And itw s essenti l th t results n lysis, re gent nd m ethods, nd st nd rd iz tion of procedures. St nd rdiz tion is the prem ise to re lize comp r b ility of tumor m rkers mi muno ss y resu lts. St nd rd iz tionw s composited bym ny critic l f c tors, the core w s reference m teri ls development nd pp lic tion. By cl rifing the tumor m rkers mi muno ss y st nd rd iz tion of v rious f ctors, suggestion to mi prove tumor m rkers mi muno ss y ccur cy nd comp r bility of the results w s proposed. K ey words: tumor m rkers mi muno ss y; st nd rd iz tion; referencem teri ls , 2006 , 10 , 2 , , ( AFP) ,