Apparatus and method for providing assay calibration data

• US 5,311,426 A
• Filed: 10/27/1992
• Issued: 05/10/1994
• Est. Priority Date: 08/02/1988
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Bailey, Mark W., Mattimiro, Christopher N., Donohue, Joseph P.
• Primary Examiner(s): Envall, Jr., Roy N.
• Assistant Examiner(s): Brutman, Laura
• Application Number:
  US07/967,946
• Time in Patent Office: 560 Days
• Field of Search: 435/810, 422/102, 364/413.02, 364/413.07, 364/413.09, 364/413.11, 356/39
• US Class Current: 73/1.02
• CPC Class Codes: B01L 3/545 for laboratory containers
• CPC Class Codes: G01N 2021/478 Application in testing analytical test strips
• CPC Class Codes: G01N 2035/00752 bar codes
• CPC Class Codes: G01N 2035/00762 magnetic code
• CPC Class Codes: G01N 2035/1025 Fluid level sensing
• CPC Class Codes: G01N 2035/1086 Cylindrical, e.g. variable angle
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/12753 and storage
• CPC Class Codes: G01N 35/00712 Automatic status testing, e.g. at start-up or periodic
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G01N 35/1009 Characterised by arrangements for controlling the aspiration or dispense of liquids

Abstract

A semi-automated biological sample analyzer and subsystems are provided to simultaneously perform a plurality of enzyme immuno assays for human IgE class antibodies specific to a panel of preselected allergens in each of a plurality of biological samples. A carousel is provided to position and hold a plurality of reaction cartridges. Each reaction cartridge includes a plurality of isolated test sites formed in a two dimensional array in a solid phase binding layer contained within a reaction well which is adapted to contain a biological sample to be assayed. The carousel and cartridges contain structures which cooperate to precisely position the cartridges in each of three separate dimensions so that each cartridge is positioned uniformly. An optical reader operating on a principle of diffuse reflectance is provided to read the results of the assays from each test site of each cartridge. Also provided is a subsystem which provides predetermined lot-specific assay calibration data which is useful for normalizing the results of various assays with respect to predetermined common standard values.

Claims

1. Apparatus for providing assay information useful for calibration or normalization of data obtained from a panel of assays for a plurality of selected test sample binding components performed on a biological sample, comprising:

predetermined assay calibration data for calibrating or normalizing the results of a preselected panel of assays for a plurality of selected test sample binding components with respect to at least one predetermined standard value for each said binding component;

data providing means for providing said predetermined assay calibration data, wherein said data providing means contains predetermined assay calibration data for said panel of assays and first code means for identifying said predetermined assay calibration data of said preselected panel of assays;

storage means for storing said calibration data and said first code means;

entering means for entering said calibration data and said first code means from said data providing means to a location in said storage means without performing an assay;

assay means for simultaneously carrying out a preselected panel of assays on a single aliquot of a biological sample, wherein said assay means contains a preselected panel of assay reagents wherein each assay reagent is bound to its own discrete test site in an array of isolated test sites and second code means for identifying said panel of assays; and

correlation means for correlating assay results for said panel of assays of said assay means with said predetermined assay calibration data for said panel of assays in said storage means using said first code means and said second code means.

2. The apparatus defined in claim 1 wherein:

said predetermined assay calibration data and said first code means of said data providing means is provided in a machine-readable format; and

said entering means includes reader means for reading said machine-readable calibration data and first code means.

3. The apparatus defined in claim 1 including a plurality of said data providing means for providing said predetermined assay calibration data, where each said data providing means contains predetermined assay calibration data for a different preselected panel of assays and a different first code means for identifying said predetermined assay calibration data of said preselected panel of assays.

4. The apparatus defined in claim 1 wherein said assay means comprises disposable reaction cartridge means having bound thereto said array of isolated test sites a plurality of preselected capture reagents for a preselected panel of assays.

5. The apparatus defined in claim 1 wherein:

said second code means of said assay means is provided in a machine-readable format; and

said correlation means includes reader means for reading said machine-readable second code means.

6. The apparatus defined in claim 1 including:

controlling means for controlling said entering means to cause said entering means to enter said predetermined assay calibration data and first code means in a selected available storage location of said storage means;

first associating means for associating said first code means and said predetermined assay calibration data with said selected available storage location of said storage means; and

second associating means for associating said second code means with said selected available storage location of said storage means for accessing said calibration data stored in said location.

7. Apparatus for providing assay information useful for calibration or normalization of data obtained from panels of assays for a plurality of selected test sample binding components performed on a plurality of biological samples, comprising:

predetermined machine-readable assay calibration data for calibrating or normalizing the results of preselected panels of assays for a plurality of selected test sample binding components with respect to at least one predetermined standard value;

data providing means for providing said predetermined machine-readable assay calibration data, wherein said data providing means contains said predetermined machine-readable assay calibration data for said panels of assays and first code means for identifying said predetermined assay calibration data of said preselected panels of assays;

storage means for storing said calibration data for a plurality of said preselected panels of assays and said first code means;

user-operable reader means for reading said calibration data and said first code means from said data providing means;

entering means for entering said calibration data and said first code means read by said user-operable reader means in selected available storage locations in said storage means without performing an assay;

associating means for associating said predetermined assay calibration data and said first code means read from said data providing means with said selected available storage location of said storage means;

a plurality of disposable reaction cartridge means each designed for simultaneously carrying out a preselected panel of assays on a single aliquot of a biological sample wherein each said reaction cartridge means contains a preselected panel of assay reagents wherein each assay reagent is bound to its own discrete test site in an array of isolated test sites, and machine-readable second code means for identifying said panel of assays;

reader means for reading said second code means from each said reaction cartridge means;

associating means for associating said second code means with said selected available storage location of said storage means for accessing said calibration data stored in said location; and

correlation means for correlating assay results for said panel of assays of each said reaction cartridge means with said predetermined assay calibration data for each said panel of assays in said storage means using said first code means and said second code means.

8. A method for providing assay calibration data to an instrument capable of simultaneously assaying a single aliquot of a biological sample with a panel of assays of preselected test sample binding, components comprising the steps of:

providing predetermined assay calibration data for calibrating or normalizing the results of said panel of assays with respect to at least one predetermined standard value for each said binding component and first code means for identifying said calibration data;

entering said calibration data into a location in a data storage means of said instrument;

providing assay means for carrying out said panel of assays with said instrument, wherein said assay means comprises an array of isolated test sites wherein each assay reagent is bound to its own discrete test site, and second code means for identifying said panel of assays; and

accessing said calibration data in said data storage means using said first code means and said second code means.

9. The method defined in claim 8 wherein:

said predetermined assay calibration data is provided in a machine-readable format; and

said predetermined assay calibration data is entered into said data storage means with a reader means for reading said machine-readable predetermined assay calibration data.

10. The method defined in claim 8 wherein said assay means comprises disposable reaction cartridge means having bound to said array of isolated test sites a plurality of preselected capture reagents for carrying out a preselected panel of assays with said instrument.

11. The method defined in claim 8 wherein:

said second code means is machine-readable; and

the step of accessing said calibration data in said data storage means includes reading said machine-readable second code means.

12. The method defined in claim 8 including the steps of:

associating said first code means and said location in said storage means, where said location in said storage means is a selected available storage location, and

accessing said calibration data in said storage means using said selected available storage location associated with said first code means and said second code means.