| 摘要 |
1. An immunological diagnostic reagent for the determination of pregnancy by means of HCG determination and latex agglutination containing discrete particles of an immunologically inert latex polymer having a particle size of 0.01 to 0.9 mu m and a specific weight of 0.01 to 1.1, to which human choriongonadotropin (HCG) has been covalently bound via an amide bridge with a carbodiimide coupling agent at a pH of 5-8, characterized in that the HCG is used in the form of its beta-chain, whereby this beta-chain is substantially free from the alpha-chain and whereby this beta-chain has been separated from the alpha-chain by treating partially purified HCG containing 2000-5000 IU/mg of HCG for 1/2 to 2 hours at a pH of 4-5.5 and a temperature of 20-50 degrees C with a chaotropic agent, namely with a 7-10 molar aqueous solution of urea, a 7-10 molar aqueous solution of lithium bromide, a 4.5-6 molar aqueous solution of guanidine hydrochloride or a 2-3 molar aqueous solution of ammonium thiocyanate, subsequently adjusting the pH of the reaction mixture to 7.5 and separating the mixture of HCG/chaotropic agent by ion exchange and/or further conventional methods in accordance with which molecules can be separated on the basis of differences in the elektrostatic charge, and whereby neither the partially purified HCG nor the beta-chain thereof have been purified further. |
