Simple immunochemical semi-quantitative assay method and apparatus

• US 6,177,281 B1
• Filed: 06/11/1996
• Issued: 01/23/2001
• Est. Priority Date: 06/02/1993
• Status: Expired due to Fees

• Current Assignee: Teikoku Hormone Manufacturing Co., Ltd. (ASKA Pharmaceutical Holdings Co., Ltd.)
• Original Assignee: Teikoku Hormone Manufacturing Co., Ltd. (ASKA Pharmaceutical Holdings Co., Ltd.)
• Inventors: Manita, Hideaki
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): PORTNER, VIRGINIA ALLEN
• Application Number:
  US08/549,716
• Time in Patent Office: 1,687 Days
• Field of Search: 422/58, 422/56, 422/57, 422/60, 422/70, 422/287.1, 435/7.1, 435/7.93, 435/7.94, 435/7.95, 435/962, 435/969, 435/970, 435/287.2, 436/510, 436/518, 436/523, 436/535, 436/541, 436/65, 436/814, 436/823, 436/824, 436/225
• US Class Current: 436/518
• CPC Class Codes: A47J 27/08 Pressure-cookers; Lids or locking devices specially adapted therefor
• CPC Class Codes: G01N 2470/04 Sandwich assay format
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/54389 with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/814 Pregnancy
• CPC Class Codes: Y10S 436/818 Human chorionic gonadotropin
• CPC Class Codes: Y10S 436/829 Liposomes, e.g. encapsulation

Abstract

The present invention relates to a simple immunochemical semi-quantitative assay method according to chromatography, which comprises trapping a certain amount of an analyte in a sample with a predetermined amount of a fixed antibody for the analyte before qualitative analysis of the analyte, the certain amount corresponding to the amount of the fixed antibody, and thereby decreasing a concentration of the analyte to be subjected to subsequent immunochemical qualitative determination, and an apparatus therefor.

Claims

1. An apparatus for an immunochemical semi-quantitative assay according to immunochromatography, the apparatus comprising a plurality of units;

each unit comprising

an antibody-fixed portion (B) where an antibody for trapping an amount of an analyte in a sample is present and fixed in a predetermined amount,

a labeled substance presence portion (C) where a labeled substance as an index for detecting the presence of the analyte is present in a chromatographically mobile state, and

a detection portion (D) where a detecting substance for detecting the labeled substance is present and fixed;

the apparatus comprising

a plurality of said units,

a sample addition portion (A) for adding the sample containing the analyte, the sample addition portion (A) being common to each unit, and

an absorption portion (E) for removing the labeled substance which does not participate in the detection of the analyte, together with the added sample, by absorption, the absorption portion (E) being either common to each unit or independent for each unit;

wherein the amount of the trapping antibody fixed in the antibody-fixed portion (B) of each unit differs from one unit to another and the amounts of the trapping antibodies are consecutively varied stepwise, and

wherein the analyte is a hapten, the antibody for trapping the analyte, fixed in the antibody-fixed portion (B), is a hapten trapping antibody, the labeled substance is a hapten labeled antibody which binds to the analyte, and the detecting substance binds to the labeled hapten antibody competitively with the hapten which is the analyte.

2. The apparatus according to claim 1, wherein the analyte is an estrogen.

3. The apparatus according to claim 1, wherein the absorption portion (E) is common to each unit.