Verification device for optical clinical assay systems

• US 20050206875A1
• Filed: 03/23/2005
• Published: 09/22/2005
• Est. Priority Date: 09/04/1997
• Status: Active Grant

• Current Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Original Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Inventors: Zweig, Stephen E., Meyer, Benjamin G., Downey, Thomas D.
• Granted Patent: US 7,072,035 B2
• Time in Patent Office: Days
• US Class Current: 356/42
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 21/64 Fluorescence; Phosphorescence
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• 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

Abstract

A device and method for verifying correct performance of an optical clinical assay system is provided.

Claims

1. A reference device useful for verification of a clinical analytical system having an optical detection apparatus, the reference device comprising:

an opaque optical reference;

an optical shutter;

means for controlling the percent exposure of the optical reference to the optical detection apparatus;

optionally, a means to monitor the temperature of a reaction stage of the clinical analytical system; and

an algorithm or method that controls the rate at which the optical reference is selectively revealed to the optical detection apparatus, said algorithm or method being selected as to simulate the reaction rates of one or more levels of clinical analytes reacting with a test reagent.

2. The reference device of claim 1, wherein the optical shutter comprises a fluorescent backing on one side of the optical shutter.

3. The reference device of claim 1, wherein the opaque optical reference comprises a fluorescent or luminescent reagent test strip.

4. The reference device of claim 1, wherein the opaque optical reference comprises a fluorescent target so that any fluorescent intensity of light detected by the system varies as a function of the optical shutter.

5. The reference device of claim 4, wherein the fluorescent target comprises a fluorescent compound incorporated into a support matrix.

6. The reference device of claim 1, wherein the device provides a means to monitor a reagent present sensor and/or a blood present sensor, wherein a stimulus to the sensors is provided to signal readiness of a meter for testing a clinical sample.

7. The reference device of claim 1, wherein the clinical analytical system is an assay system.

8. The reference device of claim 1, wherein the reference device is selected from the group consisting of test strip emulator, a control test simulator, and an electronically controlled optical reference device.

9. The reference device of claim 1, wherein the clinical analytes are enzymatic.