Chemistry: analytical and immunological testing – Involving an insoluble carrier for immobilizing immunochemicals
Reexamination Certificate
2001-05-01
2004-08-03
Nguyen, Bao Thuy L. (Department: 1641)
Chemistry: analytical and immunological testing
Involving an insoluble carrier for immobilizing immunochemicals
C435S007100, C435S002000, C435S005000, C435S007210, C435S007320, C435S239000, C435S287200, C435S207000, C435S805000, C435S810000, C435S970000, C436S513000, C436S512000, C436S518000, C436S531000, C436S526000, C436S806000, C422S051000
Reexamination Certificate
active
06770487
ABSTRACT:
FIELD OF THE INVENTION
The invention is in the field of in vitro diagnostics, and specifically “dip stick” type diagnostic strip tests.
BACKGROUND OF THE INVENTION
So called “strip tests” are used for a wide variety of diagnostic applications. A strip test consists of an elongated rectangular component, often of paper, nitrocellulose or other porous inert material, upon which are printed stripes or layers of chemical compounds. It is generally used with a body fluid sample, e.g., urine or blood. One end of the strip is dipped into the sample, and the fluid is drawn along the strip by capillary action. As the sample passes the zones of chemical compounds, chemical reactions occur which may result in a color change, thus causing the appearance of one or more stripes. Often, a further stripe of color is used as quality control to indicate that the reaction has proceeded to completion.
The technology for such strip tests is well known in the art, and includes immunodiagnostic, enzymatic, lateral flow immunochromatography, or chemistry type reactions. Examples of strip test applications include single tests such as pregnancy (see, for example, U.S. Pat. No. 5,602,040 “Assays” by May et al., 1997); multiple simultaneous tests on a single strip such as for diagnosing patients with chest pain of suspected cardiac origin (see for example U.S. Pat. No. 5,710,008 “Method and Device for Diagnosing and Distinguishing Chest Pain in Early Onset thereof” by Jackowski, 1998); and apparatus for performing simultaneous single tests on multiple strips such as for drugs of abuse (see for example U.S. Pat. No. 5,976,895 “Device for the Collection, Testing and Shipment of Body Fluid Samples” by Cipkowski, 1999).
Strip tests can be used for qualitative yes
o results (such as a pregnancy test), or may be used to provide quantitative information, such the strip tests for blood glucose commonly used by diabetic patients. A quantitative test may use the intensity of generation of a color, or the color itself to indicate the result, or perhaps the generation of a different number of optically readable bands to indicate the result. The results can be read by a human operator by comparing the color to a printed reference, or a better quantitative result can be obtained by using an instrument to precisely determine the intensity or color of the test band. See for example U.S. Pat. No. 4,509,859, “Apparatus for the Optoelectronic Evaluation of Test Strips,” E. Markart et al., Apr. 9, 1985.
It is important in clinical applications of strip tests to include with the strip information about the lot number, calibration constants, date of expiry and the like. This may be printed in text on the strip or package and read by a human operator. However, it is also possible to encode much of this information in a bar code which is printed onto the front or back of the strip test. See, for example, U.S. Pat. No. 4,592,893, “Analysis Test Strip”, Poppe et al., Jun. 3, 1986. Such information can be read using a conventional bar code scanner, or by a special purpose device such as described by Ruppender in U.S. Pat. No. 4,510,383 “Device for Optical Identification of a Coding on a Diagnostic Test Strip”, Apr. 9, 1985.
Such information might be useful when the test is done as part of a hospital environment and the calibration and other data as well as the results must be entered into a hospital Laboratory Information System (LIS). Many hospitals now have some sort of LIS to allow hospital wide ready access to laboratory and other diagnostic tests on the hospital computer network. Most modem laboratory based IVD instruments include hardware and software for automatic communication of test results to the hospital wide LIS. Strip test results, if required to be included in the LIS, currently suffer from the disadvantage that such results must be entered into the LIS manually. Manual entry of test results can potentially be time-consuming, limiting the efficiency of clinical personnel who must enter the data. Manual entry also introduces an opportunity for error or even the possibility the results are not entered at all. These errors can compromise a patient's safety or clinical outcome because of missing diagnostic data which could be used to affect clinical medical care. Accordingly, there remains a need for improved entry of test data into LIS-type systems.
SUMMARY OF THE INVENTION
The present invention provides a diagnostic test device comprising at least one flow path, each flow path comprising a sample zone for application of a fluid sample, at least one test zone in fluid communication with the sample zone, the test zone of each flow path providing reagents necessary for performing an assay for the presence of an analyte, whereby an analyte assay result may be obtained, and machine-readable information comprising identifying information and said analyte assay result.
The present invention also provides a diagnostic strip test comprising at least one flow path, each flow path comprising a sample zone for application of a fluid sample, at least one test zone in fluid communication with the sample zone, the test zone of each flow path providing reagents necessary for performing an assay for the presence of an analyte, whereby an analyte assay result may be obtained, and machine-readable information comprising identifying information and said analyte assay result, wherein the test zone comprises a portion of the machine-readable information.
The present invention provides strip tests for a single analyte or multiple analytes. The strip tests are suitable for the semi-quantitative detection of an analyte if a plurality of test zones indicates a positive result only in the presence of a given concentration or amount of analyte. The bar code may be a standard barcode which is a series of vertical bars, or a two-dimensional barcode, or other technology for optically encoding information. Furthermore, the bar code may be visible or invisible.
The invention also provides a method for obtaining identifying information and the analyte assay result of a diagnostic test, comprising the steps of providing a diagnostic test device comprising: a sample zone for application of a fluid sample, at least one test zone providing reagents necessary for performing an assay for the analyte, whereby the analyte assay result may be obtained, and machine-readable information comprising identifying information and the analyte assay result; performing the analyte assay, and machine reading the machine-readable information, whereby the identifying information and analyte assay result may be obtained.
The present invention further provides a method for obtaining identifying information and the analyte assay result of a diagnostic strip test, comprising the steps of providing a diagnostic strip test of the present invention, performing the analyte assay, and machine reading the machine-readable information, whereby the diagnostic strip test identifying information and analyte assay result may be obtained.
Each reference cited herein is incorporated in its entirety by reference.
REFERENCES:
patent: 4509859 (1985-04-01), Markart et al.
patent: 4510383 (1985-04-01), Ruppender
patent: 4592893 (1986-06-01), Poppe et al.
patent: 5569608 (1996-10-01), Sommer
patent: 5602040 (1997-02-01), May et al.
patent: 5710008 (1998-01-01), Jackowski
patent: 5976895 (1999-11-01), Cipkowski
patent: 6036092 (2000-03-01), Lappe
patent: 6087184 (2000-07-01), Magginetti et al.
patent: 6136549 (2000-10-01), Feistel
patent: 6149719 (2000-11-01), Houle
patent: 6171870 (2001-01-01), Freitag
patent: 6203069 (2001-03-01), Outwater et al.
patent: 6335205 (2002-01-01), Bausback
patent: 6394952 (2002-05-01), Anderson et al.
patent: 6410341 (2002-06-01), Freitag et al.
Ischemia Technologies, Inc.
Nguyen Bao Thuy L.
Swanson & Bratschun LLC
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