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预期应用
ELISA法定量测定人血清、血浆或其它相关液体中 FIX含量。
实验原理
本试剂盒应用双抗体夹心酶标免疫分析法测定标本中FIX水平。用纯化的抗体包被微孔板，制成固相抗体，往包被单抗的微孔中依次加入FIX抗原、生物素化的抗人FIX抗体、HRP标记的亲和素，经过彻底洗涤后用底物TMB显色。TMB在过氧化物酶的催化下转化成蓝色，并在酸的作用下转化成最终的黄色。颜色的深浅和样品中的FIX呈正相关。用酶标仪在450nm波长下测定吸光度（OD值），计算样品浓度。
Intended use
This immunoassay kit allows for the specific measurement of human Factor IX (FIX) concentrations in serum and plasma.
Introduction
The biological importance of Factor IX is demonstrated in Hemophilia B (Christmas disease), an X-linked congenital bleeding disease resulting from a quantitative (low activity and low antigen) or qualitative (low activity and normal antigen) defect in Factor IX function. The congenital deficiency of Factor IX may be classified as severe (<1% Factor IX activity), moderate (between 1 and 5% Factor IX activity) or mild (between 5 and 40% Factor IX activity).
Test principle
This assay employs the quantitative sandwich enzyme immunoassay technique. A monoclonal antibody specific for FIX has been pre-coated onto a microplate. Standards and samples are pipetted into the wells and any FIX present is bound by the immobilized antibody. An enzyme-linked monoclonal antibody specific for FIX is added to the wells. Following a wash to remove any unbound antibody-enzyme reagent, a substrate solution is added to the wells and color develops in proportion to the amount of FIX bound in the initial step. The color development is stopped and the intensity of the color is measured.
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