# US 5,705,330 A · Chemiluminescent immunoassay for antibody detection

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- Number: US 5,705,330 A
- Document ID: US5705330A
- Status: Granted
- Kind: A
- Application number: 08/422,404
- Filed: 1995-04-14
- Granted: 1998-01-06
- Earliest claimed: 1995-04-14
- Assignees: Abbott Laboratories
- Inventors: Dinesh O. Shah; Russell B. Richerson
- Web page: https://patentgrep.com/patent/US5705330A

## CPC

- G01N 33/54306: {Solid-phase reaction mechanisms}
- G01N 33/582: {with fluorescent label}
- Y10S 435/975: Kit
- Y10S 436/805: Optical property
- Y10S 436/808: Automated or kit
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

A chemiluminescent assay utilizing a precomplex reagent of a probe comprising an enhancer compound such as a hapten and a conjugate comprising a chemiluminescent signal generating compound. Kits for performing such an chemiluminescent assay are also provided.

## Claims

### Claim 1

A method for determining the presence of a Hepatitis C Virus (HCV) analyte in a test sample by specific amplification of a chemiluminescent signal generated from a heterogeneous immunoassay, comprising:
a. incubating a test sample containing a HCV analyte with an analyte-specific binding pair member for a time and under conditions sufficient to form analyte/analyte specific binding member pair complexes;
b. contacting the analyte/analyte specific binding member pair complexes with a precomplex wherein said precomplex comprises 1) a probe comprising an enhancer compound attached to an analyte-specific binding member and 2) a conjugate comprising a chemiluminescent signal generating compound attached to an enhancer-specific binding member, and incubating said second mixture for a time and under conditions sufficient to form analyte/analyte specific binding member pair/precomplex complexes
wherein said chemiluminescent signal generating compound is an acridinium compound or a derivative thereof;
c. separating said resulting analyte/analyte specific binding member pair/precomplex complexes of step b from free, unbound precomplexes; and
d. determining the presence of the HCV analyte in the test sample by measuring the detectable signal.

### Claim 2 (depends on 1)

The method of claim 1 wherein said analyte is an antibody or an antigen.

### Claim 3 (depends on 1)

The method of claim 1 wherein said enhancer compound is selected from the group consisting of a hapten, a fluoresecent compound and di-nitrophenol.

### Claim 4 (depends on 1)

The method of claim 1 wherein said enhancer compound is biotin.

### Claim 5 (depends on 1)

The method of claim 1 wherein said acridinium compound is selected from the group consisting of an acridium ester and an acridinium sulfonamide.

### Claim 6 (depends on 1)

The method of claim 1 wherein said analyte-specific binding member is attached to a solid phase prior to step (a).

### Claim 7

A kit for detecting an HCV analyte, comprising:
an HCV antigen; and
a single container containing a precomplex reagent wherein said precomplex reagent comprises 1) a probe which comprises an enhancer compound and 2) a conjugate which comprises a chemiluminescent signal generating compound, wherein said chemiluminescent signal generating compound is an acridinium or a derivative thereof.

### Claim 8 (depends on 7)

The kit of claim 7 wherein said enhancer compound is selected from the group consisting of a hapten, a fluoresecent compound and di-nitrophenol.

### Claim 9 (depends on 7)

The kit of claim 7 wherein said acridinium compound is selected from the group consisting of an acridinium ester and an acridinium sulfonamide.