Assay Analysis

Abstract

System, apparatus, and assemblies for the detection of at least one analyte in a sample are shown and described. The system may be an onboard vehicle system to generate an antibiotic test result from an antibiotic analyte assay.

Description

[0001] This application is a Continuation of U.S. application Ser. No. 13/819,064 filed Nov. 11, 2013; and is based on and claims priority to PCT/US2011/49170 filed Aug. 25, 2011; U.S. Provisional Application No. 61/454,771 filed Mar. 21, 2011; and U.S. Provisional Application 61/377,287 filed Aug. 26, 2010, all of which are incorporated herein by reference in their entireties.

FIELD OF THE TECHNOLOGY

[0002] The present disclosure relates generally to analytical testing, and more particularly to improved test strips for the detection of an analyte.

BACKGROUND

[0003] Reagent strips and films are often a helpful analytical tool in the fields of clinical chemistry, analytical medicine, and food sanitation diagnostics. For example, it is advantageous to determine or to test, through quantitative or qualitative methods, various matrices, including body fluids such as serum and urine, and food, such as meat products, fruit, vegetables, milk, honey and the like. Such matrices can be tested for a variety of analytes including a variety of chemicals, biochemicals and biological molecules such as bacteria, antibiotics, for example, sulfa drugs, tetracyclines, beta-lactam drugs; toxins, such as aflatoxin, zearalonone, ochratoxin, T-2, and vomitoxin, pesticides such as organophosphates and carbamates, and active metabolites, either in materials or on the surface of materials or a combination thereof.

[0004] Generally, lateral flow assays are membrane-based test devices in which a sample that is suspected of containing the analyte of interest is placed at or near one end of the membrane strip. The sample is carried to the opposite end of the membrane strip by mobile phase that traverses the membrane strip, for example by capillary action. While traversing the membrane strip, the analyte in the test sample, if any, encounters one or more reagents. The reagents can include binders for the analyte. Binders can be mobile and, therefore, flow with the sample, or be immobilized on the test strip as a capture agent. Depending on the test configuration, either the analyte binder, the analyte itself, or some other reagent in the test system will be captured by the immobilized capture agent and, thereby, produce a detectable signal. The signal can be generated by a label provided within the assay. The detectable signal can be measured, such as by an optical reader.

[0005] The presence and, in some cases, the concentration, of an analyte on a reagent strip may be determined by measuring the optical reflectance from an area of development on the strip. For example, the area of development on the strip may be an area of color development. Percent reflectance can be used to determine the result.

[0006] Testing commonly occurs in a controlled environment, such as a laboratory, but testing in non-laboratory settings is also common. In some applications speed and ease of use is particularly important. For example, in food processing it would be advantageous for tests to be run in non-laboratory settings because processors must wait for results. Further, it would also be advantageous for tests to be run on trucks during transport of the items. For that reason, it would be advantageous to accelerate the speed of testing, reduce the cost of equipment and tests, improve the ruggedness of the apparatus, and enhance the ease of use and simplicity of operation. In addition, it is advantageous to have confidence that test results are valid. Therefore, systems, methods and devices herein also assist in preventing fraudulent use of pre-run, known negative assays in place of true samples or use of assays pre-marked to provide a negative result that does not reflect the true nature of the sample. It is also desirable to increase the ruggedness of the assays, systems and test procedures.

[0007] Therefore, Applicants desire systems and methods for analyte detection without the drawbacks presented by traditional lateral flow assay systems and methods.

SUMMARY

[0008] This disclosure provides improved test strips for analyte detection. In one embodiment, a lateral flow assay for the detection of an analyte includes a surface reflectance profile that is generally adapted to enable monitoring

Claims

1. An onboard vehicle system to generate an antibiotic test result from an antibiotic analyte assay, said system comprising: an optical detector reader in communication with a vehicle assembly to synchronize transmissions of light on said antibiotic analyte assay, when contacted with a sample, with development of said antibiotic test result in an onboard vehicle testing environment.

2. The system of claim 1, including a user interface adapted to display said antibiotic test result.

3. The system of claim 2, wherein said user interface communicates said antibiotic test result to alert a user on said vehicle.

4. The system of claim 1, wherein said optical detector reader performs a plurality of image detections of said antibiotic analyte assay.

5. The system of claim 1, wherein said onboard vehicle testing environment comprises an incubation environment.

6. The system of claim 5, wherein said system synchronizes incubation of said incubation environment with optical detection on said antibiotic analyte assay.

7. The system of claim 1, wherein said system synchronizes a test progress with optical detection.

8. An onboard vehicle system to generate an antibiotic test result from an antibiotic analyte assay, said system comprising: an optical detector reader in communication with a vehicle assembly to detect transmissions of light on said antibiotic analyte assay when contacted with a sample to generate said antibiotic test result.

9. The system of claim 8, including a user interface adapted to display said antibiotic test result.

10. The system of claim 9, wherein said user interface communicates said antibiotic test result to alert a user on said vehicle.

11. The system of claim 8, wherein said optical detector reader performs a plurality of image detections of said antibiotic analyte assay.

12. The system of claim 8, wherein said onboard vehicle testing environment comprises an incubation environment.

13. The system of claim 8, wherein said optical detector reader performs a continuous image detection of said antibiotic analyte assay.

14. The system of claim 8, wherein said antibiotic analyte assay comprises a test strip having at least one test line and at least one control line, and whereby a theoretical reflectance value is a comparison between a reflectance value at said test line and a reflectance value at said control line.

15. An onboard vehicle system to generate an antibiotic test result from an antibiotic analyte assay, said system comprising: an optical detector reader in communication with a vehicle assembly to synchronize progression of said antibiotic test result development with optical detection when contacted with a sample in an onboard vehicle testing environment.

16. The system of claim 15, wherein said optical detector reader performs a plurality of image detections of said antibiotic analyte assay.

17. The system of claim 15, wherein said system synchronizes test progress with an image detection on said antibiotic analyte assay.

18. The system of claim 15, wherein said onboard vehicle testing environment comprises an incubation environment.

19. The system of claim 15, wherein said optical detector detects a transmission of light passed through said antibiotic analyte assay.

20. The system of claim 15, including a user interface to communicate said antibiotic test result to alert a user on said vehicle.

Images