Ortho Diagnostic Systems Inc.

Jennifer A Nasser

Henry A Graham, Jr

Ernest G Schutt

Houston G Brooks, Jr

Utpal R Chakraborty

Chi-Deu Chang

Sharon R Lawler

Albert Venturini

Lloyd L Hollenbeck, Jr

Raymond P Zolton

A method and test kit useful in a wide variety of immunoassay systems. A method of producing metal sol reagents containing metal sol particles of a preselected size is provided. A metal containing solution is reduced under optimized pH conditions to produce metal sol particles of a preselected size, the particles are coated with a coupling compound and then bound with at least one selected immunochemically reactive component. Particles having different immunochemical specificities are also mixed to produce reagents having multiple selected immunochemical specificities.

Kit containing glutaraldehyde coated colloidal metal particles of a

Method of producing a metal sol reagent containing colloidal metal

Histidine-stabilized immunoglobulin preparations and a method for their manufacture are disclosed. The present invention is particularly well suited for stabilization of human gamma globulin (IgG) preparations having a relatively low protein content. Preferred stabilized human gamma globulin preparations comprise about 5 wt-% or less gamma globulin, histidine at a concentration of about 0.025M to about 0.2M, and optionally glycine at a concentration of about 0.05M to about 0.5M. The pH value of the preparations is at least 6.0 but not more than 7.0. A pH value of about 6.4 is most preferred. Conductivity of the preparations is about 2 to about 4 millisiemens at 5.degree. C., preferably about 2.5 to about 3.5 millisiemens at 5.degree. C., and most preferably about 2.7 millisiemens at 5.degree. C.

Histidine stabilized immunoglobulin and method of preparation

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Piscataway, NJ, United States of America

Jennifer A Nasser