JP2006284279A - A method for selecting a calibration curve when measuring colored test strips. - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To solve the problem wherein the measurement of reflection using color test paper is performed in clinical examination for the purpose of quantitatively analyzing a specific component contained in a specimen such as blood or the like and a measuring item can be changed by changing the kind of the test paper but a calibration curve is required in the conversion to a quantified value and, since the calibration curve is different at every measuring item and lot of the test paper, if the test paper of a different kind (measuring item and lot) is to be continuously measured, continuous measurement is difficult because the calibration curve is different. <P>SOLUTION: The inherent calibration curve data at every measuring item and lot of the test paper is preliminarily input using a medium such as a magnetic card or the like to be stored in the memories of a plurality of calibration curve data readers. On the other hand, the marker printed on the support of the test paper is read at the time of measurement to select the kind of the test paper or a calibration curve. By using a discrimination marker, the calibration curve can be accurately selected and the test paper different in kind can be simply and continuously measured. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  For the purpose of quantitative analysis of specific components contained in specimens such as blood, use colored test paper, irradiate the color test paper with light from the light source, and analyze the specific components by measuring the reflected light The field of clinical laboratory equipment.

For the measurement of blood and urine samples, an analytical method for analyzing specific components in blood and urine by irradiating a colored test paper with light from a light source and reading reflected light is used in clinical tests.
In recent years, JP-A-2001-083153 has made it possible to use an immunochromatography method not only qualitatively or semi-quantitatively but also quantitatively. In this method, a sample such as blood is first sampled in a sampling section of a test paper by immunochromatography. Then, while the test solution develops on the test paper, it penetrates in the lateral direction while reacting with a specific antibody or dye-labeled latex antibody labeled with gold colloid. Beyond that, there is a labeled antibody-specific antibody in which a plurality of control lines and test lines are immobilized, and reacts with them to give a red color. (See Figures 1 and 2)

The test pattern and the control band of the developed pattern react with each other and light is emitted from the light source, and the reflected light is read by the CCD image sensor. The substance concentration is obtained from the amount of reflected light and the calibration curve with reference to the control line.

Since the calibration curve differs for each measurement item and lot, there is a method of reading a calibration curve suitable for each from a magnetic card attached to each lot of test paper.

JP-A-2001-083153 Fumio Yoshino and Hisao Osawa “Spectroscopic measurement method in clinical biochemical examination” Society of Science Publishing Center 1984

For example, assuming that the reaction time until the target band of the test paper is colored is 5 minutes, the time actually measured by the apparatus is about 15 seconds. Therefore, if the sampling time is shifted by, for example, about 30 seconds, it can be continuously measured. However, when different measurement items or test papers of different lots are mixed, the calibration curves are different from each other. Therefore, it is necessary to accurately select a calibration curve corresponding to each measurement item and lot number.

As described above, when measuring test items having different measurement items or different lot numbers in a short time (for example, at intervals of 30 seconds), it is difficult to perform continuous measurement because the respective calibration curves are different.

  According to the present invention, a calibration curve corresponding to a measurement item and a production lot is given in advance from a magnetic card to a test paper reader, and stored in a memory of the reader. On the other hand, the measurement item identification marker and the lot identification marker as shown in FIG. 1 are printed on the test paper support. Each time a test strip is inserted into the reader, the item identification marker and lot identification marker printed on the support containing the test strip are instantaneously read by the image sensor, and the corresponding calibration curve is displayed. The calculated value is obtained by calculating using the calibration curve (see FIGS. 4 and 5).

The marker is a unique bit pattern.

  Even with continuous measurement of test papers with different measurement items and production lots in any order, the calibration curve can be selected quickly and reliably by the marker, making it possible to measure accurately and simply.

A test paper as shown in FIG. 2 is stored in a support as shown in FIG. Then, the test paper stored in the support is read using a reading device as shown in FIG. In the reader, a plurality of calibration curve information corresponding to measurement items and test paper lots are registered in advance using a magnetic card or the like. The reading device also reads the measurement item printed on the support during measurement of the test paper and the marker of the test paper, and performs data processing using the calibration curve information that matches the marker from the registered calibration curve information. By this method, even when the types of test paper (measurement items and lots) to be measured are mixed, a calibration curve can be easily selected and continuous measurement can be performed.

As an embodiment of the present invention, an example of an immunochromatographic test paper and a color test paper reading device will be shown.
FIG. 1 shows a test paper portion stored in a support in an embodiment of the apparatus of the present invention.
Reference numeral 1 denotes a test paper support in which test paper is stored. Reference numeral 2 is a part for sampling a specimen such as blood in a specimen dropping window, and 3 is a reading window for reading a pattern developed on the test paper. 4 is a marker for identifying a measurement item, and 5 is a marker for identifying lot information.

FIG. 2 shows the test paper itself stored in the test paper support of FIG.
6 is a portion where the sample is dropped under the specimen dropping window 2, 7 is a portion for capturing a colloidal gold-labeled antibody or dye-labeled latex antibody, 8 and 10 are control bands, and 9 is a test band. Specific antibody is immobilized.

FIG. 3 shows a reading device for the color test paper of the present invention. The analyzer main body 11, the magnetic card reader unit 12, the magnetic card 13, the display unit 14, the test paper support insertion unit 15, and the printer unit 16.
When the test paper support of FIG. 1 is inserted into the test paper support insertion portion 15, after the reaction time has elapsed, measurement is automatically performed using reflected light, calculation is performed using a calibration curve, and the calculation result is displayed and printed. Out.

POCT, which has attracted attention in recent years among clinical laboratory equipment, because it can measure quickly and accurately
Can be applied in the field of (Point of care testing).

It is an example of a test paper support. Example 1 It is an example of a test paper. Example 1 It is an example of the reading device of a color test paper. Example 1 Information stored in the reader memory (example) An example of selecting a calibration curve by recognizing a measurement item code and a lot number from a marker printed on a test paper support with the apparatus of FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Test paper support body 2 Sample dropping window 3 Test paper reading window 4 Measurement item identification marker part 5 Lot identification marker part 6 Sampling part 7 Gold colloid labeled antibody part 8 Control band 1
9 Test band 10 Control band 2
DESCRIPTION OF SYMBOLS 11 Analyzer main body 12 Magnetic card reader part 13 Magnetic card 14 Liquid crystal display part 15 Test paper support insertion part 16 Printer part

Claims (3)

A plurality of calibration curves corresponding to the measurement items and lot numbers are input to the color test paper reader in advance, while the test items are read from the marker printed on the test paper support at the same time the test paper is read. A method of identifying a number and selecting a calibration curve that matches the measurement item and lot number. The method according to claim 1, wherein the items input in advance to the color test paper reader from the measurement item and lot number and selected at the time of measurement include a measurement range, unit, number of significant digits, etc. in addition to the calibration curve. 2. The method according to claim 1, wherein the search key is not limited to the measurement item and the lot number, but includes other similar numerical values and symbols.

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