Test carrier analysis system

• US 5,281,395 A
• Filed: 12/18/1991
• Issued: 01/25/1994
• Est. Priority Date: 12/27/1990
• Status: Expired due to Term

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Schreiber, Jorg, Markart, Ernst, Bolduan, Franz
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Cano, Milton I.
• Application Number:
  US07/808,808
• Time in Patent Office: 769 Days
• Field of Search: 422/56, 422/57, 422/58, 422/63, 422/67, 422/68.1, 422/82.01, 422/82.02, 422/82.05, 436/44, 436/46, 436/95, 436/47, 436/48, 436/524, 235/462, 235/375, 356/446, 356/36, 356/39, 356/243, 356/402
• US Class Current: 422/82.05
• CPC Class Codes: G01N 2035/00752 bar codes
• 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 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence
• CPC Class Codes: G01N 35/00693 Calibration
• CPC Class Codes: G01N 35/00712 Automatic status testing, e.g. at start-up or periodic
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/114165 with step of insertion or removal from test line

Abstract

Test carrier analysis system for analyzing a constituent of a body fluid, consisting of test carriers (2), code carriers (3) and an evaluation device (4). The test layers (5) of the test carrier (2) contain reagents whose reaction with the sample leads to a color change characteristic of the analysis in a detection layer. The code carriers (3) contain in machine-readable form an evaluation code with an evaluation curve required for the evaluation of the test carriers. The evaluation device (4) comprises a measuring device, a code reading device and evaluation electronics. Possible operating errors are eliminated, almost without additional expenditure, by the fact that single code reader containing two reading units offset relative to one another both laterally and in the reading direction is positioned on a common insertion path (28) both for the test carriers (2) and for the code carriers (3), the test carriers (2) possess a batch-specific identification code in the form of continuous strips, the evaluation code on the code carriers (3) is a two-track code and contains a batch identification, and the evaluation device (4) comprises a comparison unit for checking the correlation of the batch of the respective test carrier (2) to be evaluated with the stored evaluation information.

Claims

1. A test carrier analysis system comprising a test carrier, a code carrier, and an evaluation apparatus, for analyzing a constituent of a body fluid sample through the reaction of the body fluid with a reagent to produce a physically detectable change in a detection layer of the test carrier, where the change follows a particular relationship to a concentration of the constituent, in accordance with an evaluation curve which is dependent upon a particular manufacturing batch of a test carrier, said analysis being based on information supplied from the code carrier, and said physically detectable change being readable by the evaluation apparatus,

said test carrier comprising reagents in at least one layer for reacting with the body fluid component to produce said physically detectable change in said detection layer, and a batch specific identification code in a form of a bar code with code bars running across a width of said test carrier;

said code carrier including an evaluation code on a surface thereof, said evaluation code containing an item of evaluation information including batch-specific information for forming a batch-specific evaluation curve, and wherein said evaluation code is a two-track bar code with separate clock track and data track, and said evaluation information contains a batch identification, said evaluation information being provided in a bar-code format;

said evaluation apparatus comprising test carrier receiver means for positioning said test carrier in a measuring position, measuring means for measuring said physically detectable change and for generating a measurement signal, said evaluation apparatus further comprising

a) code reading means for reading said identification code of said test carrier and said evaluation code of said code carrier, said code reading means being arranged on said test carrier receiver means such that said test carrier or said code carrier can be inserted and their codes read by said code reading means, said code reading means comprising two reading units offset relative to each other laterally and longitudinally, with the longitudinal offset being in a direction of relative movement of said code carrier or said test carrier, said two reading units being laterally offset such that one of said units reads the clock track and another of said reading units reads the data track, and wherein said tracks of the evaluation code are offset in a longitudinal direction corresponding to the longitudinal offset of the reading units, and wherein a width and sequence of the code bars of the test carrier and the code carrier are coordinated with the longitudinal spacing of the reading units, whereby each of said test carrier and said code carrier are read individually by said code reading means,

b) storage means for storing said evaluation information, and

c) electronic evaluation means for converting said measurement signal in accordance with the stored items of information regarding said batch-specific evaluation curve, into an analysis result,

wherein said evaluation apparatus also has comparison means for comparing the identification code of said test carrier with the batch identification of the evaluation curve, and for checking a correlation of the batch information of said test carrier to be evaluated with said evaluation information stored in said storing means.

2. A test carrier analysis system according to claim 1, wherein said test carriers and said code carriers are provided in a strip form.

3. A test carrier analysis system according to claim 1, wherein physical dimensions of said test carrier and said code carrier are coordinated in such a way that they can be packaged together.

4. A test carrier analysis system according to claim 2, wherein physical dimensions of said test carrier and said code carrier are coordinated in such a way that they can be packaged together.

5. A test carrier analysis system according to claim 1, wherein said test carrier further includes a mark for checking a correct positioning of said test carrier, said mark being arranged opposite to said code reading means when said test carrier is in said measuring position.

6. A test carrier analysis system according to claim 1, wherein said test carrier receiver means further comprises:

a removable test carrier support having a recess into which said code reading means penetrates when said test carrier support is in an inserted position, such that an upper surface of said code reading means and a surface of said test carrier support are approximately aligned.

7. A test carrier analysis system according to claim 1, further comprising a plurality of different types of test carriers containing different reagents for determining different sample constituents, and

a plurality of code carrier types respectively correlated with the plurality of test carrier types,

wherein the identification code on the test carriers and the evaluation code on the code carriers each contain information on the type of test carrier.