Integral multilayer analytical element for analysis of albumin

Claim 2

In an integral multilayer analytical element for the analysis of albumin in a sample containing interfering protein having, in this order, a porous spreading layer, at least one hydrophilic polymer binder layer, and a light-transmissive, water-impermeable support layer, wherein one surface of this spreading layer faces the support layer and the other surface of the spreading layer faces away from the support layer and the support layer contains an indicator compound capable of binding to albumin and the interfering protein to produce a color change, the improvement which comprises said spreading layer containing a pH buffer and said indicator in the spreading layer being dispersed in a hydrophilic polymer or a mixture of a hydrophilic polymer and a hydrophobic polymer, such that the color change due to albumin binding occurs substantially towards the surface of the spreading layer facing the support layer and the color change due to the interfering protein occurs substantially towards the surface facing away from the support layer.

Claim 3

A process for preparing the analytical element of claim 1 which comprises dissolving or uniformly suspending the indicator and the hydrophilic polymer in a liquid medium, incorporating the solution or the suspension into the spreading layer, and drying the spreading layer.

Claim 4

A process for preparing the analytical element of claim 1 which comprises dissolving or uniformly suspending the pH buffer and the hydrophilic polymer in a liquid medium, incorporating the solution or the suspension into the spreading layer, and drying the spreading layer.

Claim 5

The analytical element of claim 1 wherein the hydrophilic polymer of said hydrophilic polymer binder layer is a copolymer containing methallyl alcohol unit.

Claim 6

The analytical element of claim 1 wherein said indicator is an acid-base indicator dye indicating protein error.

Claim 7

The analytical element of claim 5 wherein said acid-base indicator dye is Bromocresol Green or Bromocresol Purple.

Claim 8

The analytical element of claim 1, 5, 6 or 4 of which the distribution ratio of the color due to albumin (K A )≧1.0, and the distribution ratio of the color due to globulin (K G )≦0.6, and K A and K G are determined by (a) preparing a phosphate buffered saline solution containing 0.70 w/v % of pH 7.0-7.2 at 25° C., samples of the buffered saline solution containing 1.0 to 8.0 g/dl of albumin and samples of the buffered saline solution containing 0.5 to 6.0 g/dl of globulin; (b) applying 10 μl of each of the above solutions individually to the multilayer analytical element; (c) incubating each element at 37° C. for 6 minutes; (d) measuring the color developed at 37° C. by reflection photometry using visible light having a wave length of about 640 nm and a half width of longer than about 10 nm from the transparent support side and from the spreading layer side; and (e) calculating K A and K G From the following formulas K.sub.A =(P.sub.SA -P.sub.PS)/(S.sub.SA -S.sub.PS) K.sub.G =(P.sub.SG -P.sub.PS)/(S.sub.SG -S.sub.PS) P SA : Optical density of albumin-containing saline solution-spotted element measured from the support side; P SG : Optical density of globulin-containing saline solution-spotted element measured from the support side; P PS : Optical density of buffered saline solution-spotted element measured from the support side; S SA : Optical density of albumin-containing saline solution-spotted element measured from the spreading layer side; S SG : Optical density of globulin-containing saline solution-spotted element measured from the spreading layer side; S PS : Optical density of buffered saline solution-spotted element measured form the spreading layer side.