Immunoglobulin immunoassays with an integrated control procedure

Claim 2

In an immunoassay for the detection of an immunoglobulin in a sample utilizing one or more ligand binding partners specific thereto, at least one of said ligand binding partners having a detectable label attached for determining when a reaction between the immunoglobulin and ligand binding partner has taken place, the improvement comprising providing an immunoassay control to be performed at the time and as part of the immunoassay wherein said control confirms the procedural steps of the assay including the performance of sample addition to the ligand binding partners and the performance of requisite wash steps.

Claim 3

The method as provided in Claim 1 wherein the control portion of the readout and the test portion of the readout together combine to form a discernible pattern.

Claim 4

The method as provided in Claim 2 wherein such pattern is a "plus" and wherein the control portion is one leg of the "plus" while the test portion is the other leg of the "plus".

Claim 5

An immunoassay for the detection of immunoglobulin in a human fluid sample comprising the steps of: a) providing a first zone having a ligand for which the immunoglobuin is specific and a second zone having a binding substance capable of reacting with a component in the sample that is ubiquitously present in all human fluid samples undergoing similar immunoassay testing: b) contacting said first and second zones with the human fluid sample; c) removing unbound materials from said first and second zones; d) contacting said first and second zones with a labeling reagent comprising labeled anti-human IgG or IgM capable of reacting with both said sample immunoglobulin and said sample component; e) removing unreacted materials from said first and second zones: and f) observing said first and second zones for the presence of label wherein the presence of label in both of said first and second zones is necessary in order to obtain a positive result.

Claim 6

An immunoassay for the detection of immunoglobulin in a human fluid sample comprising the steps of: a) providing a first zone having a ligand for which the immunoglobuin is specific and a second zone having a binding substance capable of reacting with a component in the sample that is ubiquitously present in all human fluid samples undergoing similar immunoassay testing: b) contacting said first and second zones with the human fluid sample; c) removing unbound materials from said first and second zones; d) contacting said first and second zones with a labeling reagent comprising labeled anti-human IgG or IgM capable of reacting with both said sample immunoglobulin and said sample component; e) removing unreacted materials from said first and second zones: and f) observing said first and second zones for the presence of label wherein the presence of label in both of said first and second zones is necessary in order to obtain a positive result.

Claim 7

The method as provided in Claim 4 wherein said first and second zones combine to form an identifiable pattern and wherein the presence of label in either of said first or second zones alone constitutes a negative result and the absence of label in both said first and second zones constitutes a failed immunoassay and the presence of label in said zones without forming an identifiable pattern constitutes a failed immunoassay.

Claim 8

The method as provided in Claim 4 or claim 5 wherein the label is selected from the group consisting of colloidal gold, fluorescent molecules, and enzymes.

Claim 9

7 . The method of any one of claims 4 to 6 wherein said sample component is human immunoglobulin and said binding substance is anti-human immunoglobulin.

Claim 11

In an immunoassay for the detection of an immunoglobulin in a sample utilizing one or more ligand binding partners specific thereto, at least one of said ligand binding partners having a detectable label attached for determining when a reaction between the immunoglobulin and ligand binding partner has taken place, the improvement comprising a zone capable of reacting with a sample component to ensure the sample was added, said sample component further reacting with said labeled reagent.

Claim 12

In an immunoassay for the detection of an immunoglobulin in a sample utilizing one or more ligand binding partners specific thereto, at least one of said ligand binding partners having a detectable label attached for determining when a reaction between the immunoglobulin and ligand binding partner has taken place, the improvement comprising a zone capable of reacting with a sample component to ensure the sample was added, said sample component further reacting with said labeled reagent.