Protein free solution for stabilizing immunoassay calibrators

The composition of any one of the preceding claims, wherein the calibrator remains stable after at least one freeze-thaw cycle, alternatively after at least two freeze-thaw cycles, alternatively after at least three freeze-thaw cycles, alternatively after at least four freeze-thaw cycles, alternatively after at least five freeze-thaw cycles, alternatively after at least six freeze-thaw cycles, alternatively after at least seven freeze-thaw cycles.

The composition of any one of the preceding claims, wherein the D-Sorbitol and DEAE-dextran are in a weight ratio from about 1:1 to about 2:3, alternatively from about 3:1 to about 5:2, alternatively from about 1.8:1 to about 2.2:1, alternatively about 1.9:1, alternatively about 2:1, alternatively about 2:3, alternatively about 5:2.

The composition of any one of the preceding claims, wherein the stabilizer comprises about 0.5 wt. % to about 4 wt. % D-Sorbitol, alternatively about 1 wt. % to about 3.5 wt. % D-Sorbitol, alternatively about 1.5 wt. % to about 2.5 wt. % D-Sorbitol, alternatively about 1.6 wt. % D-Sorbitol, alternatively about 1.7 wt. % D-Sorbitol, alternatively about 1.8 wt. % D-Sorbitol, alternatively about 1.9 wt. % D-Sorbitol, alternatively about 2.0 wt. % D-Sorbitol, alternatively about 2.1 wt. % D-Sorbitol, alternatively about 2.2 wt. % D-Sorbitol, alternatively about 2.3 wt. % D-Sorbitol, alternatively about 2.4 wt. % D-Sorbitol, or alternatively about 2.5 wt. % D-Sorbitol.

The composition of any one of the preceding claims, wherein the stabilizer comprises about 0.25 wt. % to about 2.5 wt. % DEAE-dextran, alternatively about 0.5 wt. % to about 2 wt. % DEAE-dextran, alternatively about 0.5 wt. % to about 1.5 wt. % DEAE-dextran, alternatively about 0.6 wt. % DEAE-dextran, alternatively about 0.7 wt. % DEAE-dextran, alternatively about 0.8 wt. % DEAE-dextran, alternatively about 0.9 wt. % DEAE-dextran, alternatively about 1.0 wt. % DEAE-dextran, alternatively about 1.1 wt. % DEAE-dextran, alternatively about 1.2 wt. % DEAE-dextran, alternatively about 1.3 wt. % DEAE-dextran, or alternatively about 1.4 wt. % DEAE-dextran.

The composition of any one of the preceding claims, wherein the buffer is a citrate buffer, an acetate buffer, a phosphate buffer, or combinations thereof.

The composition of any one of the preceding claims, wherein the stabilizer comprises at least about 0.0025 M buffer, alternatively at least about 0.001 M buffer, alternatively at least about 0.002 M buffer, alternatively at least about 0.003 M buffer, alternatively at least about 0.004 M buffer, alternatively at least about 0.005 M buffer, alternatively at least about 0.006 M buffer, or alternatively at least about 0.007 M buffer.

The composition of any one of the preceding claims, wherein the non-ionic surfactant is a secondary alcohol ethoxylate, a polyether, a poly(ethylene glycol) derivative, or combinations thereof.

The composition of any one of the preceding claims, wherein the non-ionic surfactant is selected from the group consisting of Alkyl polyglycoside, Cetomacrogol 1000, Cetostearyl alcohol, Cetyl alcohol, Cocamide DEA, Cocamide MEA, Decyl glucoside, Decyl polyglucose, Glycerol monostearate, IGEPAL CA-630, Isoceteth-20, Lauryl glucoside, Maltoside, Monolaurin, Mycosubtilin, Narrow-range ethoxylate, Nonidet P-40, Nonoxynol-9, Nonoxynols, NP-40, Octaethylene glycol monododecyl ether, N-Octyl beta-D-thioglucopyranoside, Octyl glucoside, Oleyl alcohol, Pentaethylene glycol monododecyl ether, Polidocanol, Poloxamer, Poloxamer 407, Polyethoxylated tallow amine, Polyglycerol polyricinoleate, Polysorbate, Polysorbate 20, Polysorbate 80, Sorbitan, Sorbitan monolaurate, Sorbitan monostearate, Sorbitan tristearate, Stearyl alcohol, Surfactin, Tergitol, Triton X-100, Tween 80, and combinations thereof.

The composition of any one of the preceding claims, wherein the stabilizer is free of bovine serum albumin.

The composition of any one of the preceding claims, wherein the composition is essentially free of bovine serum albumin, alternatively free of bovine serum albumin.

The composition of any one of the preceding claims, wherein the composition is essentially free of protease inhibitors, preferably free of protease inhibitors.

The composition of any one of the preceding claims, wherein the composition is a liquid or a solution.

The composition of any one of the preceding claims, wherein the composition has a pH of from about 3.5 to about 6.5, alternatively about 3.5 to about 4.5, alternatively about 4.5 to about 5, alternatively about 3.5, alternatively about 4, alternatively about 4.5, alternatively about 5, alternatively about 5.5, alternatively about 6.5.

The composition of any one of the preceding claims, wherein the calibrator is an immunoassay calibrator.

The composition of any one of the preceding claims, wherein the calibrator is substantially similar to a target analyte.

The composition of any one of the preceding claims, wherein the calibrator is a protein, peptide, or amino acid.

The composition of any one of the preceding claims, wherein the calibrator is recombinantly or synthetically produced.

The composition of any one of the preceding claims, wherein the calibrator comprises a post-translational modification.

A kit comprising at least a first composition according to any one of the preceding claims and a second composition according to any one of the preceding claims and instructions for use, wherein the immunoassay calibrator concentration in the first composition and the second composition are different.