JP2000346847A - Method and device for detecting organism-derived material - Google Patents

Abstract

PROBLEM TO BE SOLVED: To make detectable a signal value without preparing a new template when detecting the signal value generated from a spot position of a test piece using a template, even if a test piece with a different spot position is used. SOLUTION: Plural kinds of templates T are stored on a template storing means 12 corresponding to a plurality of kinds of test pieces with different spot position arrangements. For performing analysis with an analyzing means 11, the template T where ROI is placed at a position corresponding to the spot position of a used test piece is read out from the template storing means 12, this template T is set to an image shown by marking data S1, S2, and a signal value at a position corresponding to the ROI of the template T is detected for evaluation.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method and an apparatus for detecting a substance derived from a living body using a test piece used for DNA analysis or immunological analysis.

[0002]

2. Description of the Related Art In recent years, the technology in the field of genetic engineering has rapidly developed, and the human genome project has been developed with one object of decoding the base sequence of the human genome, which is thought to reach 100,000. .

On the other hand, enzyme immunoassays and fluorescent antibody methods utilizing antigen-antibody reactions have been used for diagnosis and research, and research has been advanced to search for DNAs affecting various genetic diseases. Array technology has attracted attention as one of the methods.

This array technique uses a large number of different known cDNAs that have already been decoded, as shown in FIG.
An array chip (an example of a specific binding substance) is arranged in a matrix at a high density on a carrier 2 such as a membrane filter or a slide glass in advance. Is used as the test piece 1. For example, a DNA (an example of a biological substance) derived from cells of a healthy individual A, which is labeled with a labeling substance composed of a fluorescent dye or a radioisotope, and labeled with the above labeling substance The DNA derived from the cells of the specimen B having the genetic disease is dropped on separate array chips, and the cDNAs of the specimens A and B are hybridized with the cDNA on the array chip. Each cDN
A is scanned with laser light to excite each labeling substance,
Fluorescence and radiation emitted for each NA are detected with a photodetector,
A label signal representing this detection result associated with the light emission position (spot position) on the array chip is obtained, and to which cDNA the cDNA of each sample is hybridized, a label signal obtained between both samples is obtained. This is a technique of comparing the cDNAs hybridized between the two specimens by determining the ratio or difference between the two, and specifying the gene expressed or deleted due to the above-mentioned disease (hereinafter referred to as a change in expression). At this time, a change in expression can be specified by outputting two images represented by the marker signal to a printout or a monitor and visually confirming them. On the other hand, since the ratio of the label signals obtained from both samples becomes larger (or smaller) at the position where the expression change occurs, the ratio of the label signals between the samples becomes larger (or smaller). ) Sequentially output, for example, a ratio of signal values at 50 spot positions as a measurement result table showing the measurement result in association with the position where the signal was obtained, and output the measurement result table and the image displayed on the monitor. , The position where the signal value is obtained is obtained, and the change in expression can be specified.

At this time, the signal value corresponding to each spot position is set to a template in which a circular ROI corresponding to the spot position is arranged for an image represented by the beacon signal, and the position of the ROI of this template is set. Is obtained by detecting a signal value at a location corresponding to.

[0006]

However, the arrangement of the spot positions in the test piece described above varies depending on the manufacturer of the test piece, the purpose of the test, and the like. When only the template corresponding to the test piece to be used is used, if another test piece is used, the spot value and the ROI position do not correspond to each other, so that the signal value cannot be detected. In this case, the signal value can be detected by creating a new template in which the ROI is arranged at a position corresponding to the spot position of the test piece to be used. However, the number of spot positions on the test piece is as small as 500 and as many as tens of thousands, and the arrangement of the spot positions is variously different for each test piece, so that the operation of creating a template becomes very troublesome. .

The present invention has been made in view of the above circumstances, and provides a method and an apparatus for detecting a substance derived from a living body which can detect a signal value at a spot position even when test pieces having different spot position arrangements are used. It is intended to provide.

[0008]

According to the present invention, there is provided a method for detecting a substance derived from a living body, the method comprising the steps of: A substance is bound to a biological substance labeled with a labeled substance of a specimen, and an image represented by a label signal released from the bound labeled substance of the biological substance is obtained, and the specific binding in the test piece is obtained. In a method for detecting a substance derived from a living body, in which a template on which an ROI corresponding to an arrangement position of a substance is arranged is set on the image, and a signal value of the label signal is detected at a position corresponding to the ROI of the image, A template of a type corresponding to the test piece is read out from the template storage means storing the template, and the signal is read based on the read template. It is characterized in that for detecting a value.

[0009] Here, the "ROI" is arranged according to the arrangement position of the specific binding substance in the test piece to be used, and "reads out the type of template corresponding to the test piece".
"Reading out a template in which the ROI is arranged corresponding to the arrangement position of the specific binding substance of the test piece to be used."

"Detecting a signal value based on a template" means that a template is set on an image represented by a beacon signal, and a signal value of the beacon signal at a position corresponding to the ROI of the image is detected. That means.

The "carrier" is not particularly limited as long as it is capable of stably binding and spotting a specific binding substance, and examples thereof include a membrane filter and a slide glass plate. These carriers may be pretreated in order to stably bind the specific binding substance.

"Specific binding substance" refers to hormones, tumor markers, enzymes, antibodies, antigens, abzymes, other proteins, nucleic acids, cDNAs, DNAs, RNAs, etc., which specifically bind to biological substances. Mean possible substance. The term "known" means that the nucleotide sequence and length of a nucleic acid are known for a nucleic acid, and the composition of amino acids and the like are known for a protein. Here, the specific binding substance disposed at a plurality of predetermined positions on the carrier means that one type of specific binding substance is disposed at each position.

The term "substance derived from a living body" refers to a substance that specifically binds to a known specific binding substance placed at a predetermined position on a carrier, and is extracted and isolated from a living body. However, not only those directly extracted from a living body but also those obtained by chemically treating or chemically modifying these are included. For example, hormones, tumor markers, enzymes, antibodies, antigens, abzymes, other proteins, nucleic acids, cDNA, DNA,
It is a substance such as mRNA.

"Labeled substance" means information derived from a biological substance.
Modify some of them to obtain
It refers to a substance that is directly added and serves as a mark. Labeling substance
Can detect the label signal emitted from the labeling substance, and
Predetermined regularity incorporated into biological substances
It is not particularly limited as long as it is one. For example, rhino
Bargreen II, Cy5, fluorescein isothiocyan
Fluorescent dyes such as ³²P,³³Radioactive isotopes such as P
It is preferable to use

The term "label signal" refers to a signal emitted from or output from a labeling substance, such as fluorescence when the labeling substance is a fluorescent dye and radiation when the labeling substance is a radioisotope. A signal obtained by detecting with a light detector or a radiation detector.

"Binding a biological substance to a specific binding substance"
For example, when a stable double strand is formed between complementary nucleotide sequences found in DNA or RNA (hybridization), or when a specific nucleotide such as an antigen and an antibody or biotin and avidin is used. Means a highly specific binding that selectively reacts only with the substance.

In the method for detecting a substance derived from a living body according to the present invention, it is preferable that a new template is created and the new template is stored in the template storage means.

An apparatus for detecting a biological substance according to the present invention comprises:
A plurality of known specific binding substances, which are different from each other, are arranged at predetermined plural positions on a carrier, and the specific binding substance is bound to a biological substance labeled with a labeling substance of a specimen. An image represented by a labeling signal emitted from the labeled substance of the biological substance is obtained, and R corresponding to the position of the specific binding substance on the test piece is obtained.
Setting a template on which the OI is arranged on the image,
In a biological substance detection apparatus including an analysis unit that detects a signal value of the label signal at a position corresponding to the ROI of the image, a template storage unit that stores a plurality of types of templates; and Reading means for reading a template of a type corresponding to the test piece, wherein the analyzing means is means for detecting the signal value based on the read template.

It is preferable that the apparatus for detecting a substance derived from a living body according to the present invention further includes a template creating means for creating a new template and storing the new template in the template storage means.

[0020]

According to the present invention, a template of a type corresponding to a test piece is read out from the template storage means storing a plurality of types of templates to detect a signal value, so that there is a possibility of use. If the template corresponding to the test piece is stored in the template storage means, no matter what kind of test piece is used, the signal at the position where the specific binding substance is located can be obtained from the label signal without creating a new template. The value can be detected.

Further, even if the arrangement of the specific binding substance in the test piece is not in the template stored in the template storage means, the new template can be created so that the specific binding can be performed from this test piece. The signal value at the position where the substance is located can be detected. In this case, it takes time to create a template, but if the newly created template is stored in the template storage means, the signal value can be immediately detected from this test piece when the same test piece is used. Can be.

[0022]

Embodiments of the present invention will be described below with reference to the drawings.

FIG. 1 is a view showing a test piece used in the embodiment of the present invention. As shown in FIG. 1, a test piece 1 used in the present embodiment has a plurality of known cDNAs (as specific binding substances) different from each other at predetermined positions on a carrier 2 such as a membrane filter or a slide glass. It has been done. The cDNAs arranged on the carrier 2 are different DNAs whose base sequences have already been decoded.
And the arrangement position on the carrier 2 is predetermined. Further, the position of the cDNA (hereinafter referred to as a spot position) arranged on the carrier 2 is different for each manufacturer of the test piece 1.

Next, referring to FIG. 2, the test piece 1 shown in FIG.
Will be described. The illustrated reading device 100
Is an embodiment of an apparatus for reading two types of test strips 1 and 1 ', which will be described later.
On each of the two test strips 1 and 1 'on which NA is arranged, a sample obtained by hybridizing cDNA (as a biological substance) labeled with a fluorescent dye of two different specimens A and B is placed. A transparent sample stage 20 installed at a predetermined position, a laser light source 21 emitting a laser beam L1 having an emission wavelength suitable for exciting a fluorescent dye,
A photomultiplier (hereinafter referred to as PMT) 90 for photoelectrically detecting fluorescence emitted by excitation of the 1 'fluorescent dye.
And the laser beam L1 emitted from the laser light source 21 is applied to the test pieces 1, 1 'mounted on the sample table 20, and the fluorescent light K1, K2 emitted from the test pieces 1, 1' by this irradiation is emitted. Optical head 50 for guiding light to PMT 90
Main scanning means 60 for moving the optical head 50 at a constant speed in the direction of the arrow X, and sub-scanning for integrally moving the laser light source 21, the optical head 50 and the PMT 90 in the direction of the arrow Y (the direction perpendicular to the direction of the arrow X). Means 70; an amplifier 91 for logarithmically amplifying the detection signal detected by the PMT 90;
The amplified detection signal is A / D-converted and labeled data S
A / D converter 92 that obtains S1 and S2, analysis device 93 that compares label data S1 and S2 at spot positions corresponding to each other between test pieces 1 and 1 ′ and calculates a comparison result, and laser beam L1 And a control unit 95 for controlling emission of light. Note that the label data S1 and S2 collectively refer to the entire signal value obtained at each spot position where the specimens A and B in the test pieces 1 and 1 'are hybridized.

Sample A is a healthy person, and sample B is a person having a predetermined genetic disease. As described above, a number of known and different cDNAs are arranged at predetermined spot positions on each test piece 1, 1 '.
1 ′, each cDNA derived from the cells of the above-mentioned specimens A and B is spotted with a pipette or the like, and a large number of cD
Among the NAs, cDNAs (complementary) corresponding to the cDNAs of the specimens A and B are hybridized with these cDNAs. Then, with a predetermined solution, c
The cDNA not hybridized with the cDNA of any sample, except for the cDNA hybridized with the DNA
DNA has been washed.

The laser light source 21 has a wavelength of, for example, 633n.
A He-Ne laser that emits a laser beam L1 of m, an SHG laser that emits a laser beam L1 of a wavelength of 532 nm, and an SHG laser that emits a laser beam L1 of a wavelength of 473 nm can be used. The laser beam L1 having a wavelength of 633 nm is suitable for exciting a fluorescent dye such as Cy5, and the laser beam L1 having a wavelength of 532 nm.
1 is suitable for exciting, for example, a fluorescent dye called Cy3, and the laser beam L1 having a wavelength of 473 nm is suitable for, for example, exciting a fluorescent dye called Florescein.

Next, the operation of the reading apparatus 100 according to this embodiment will be described.

The test piece 1 on which the cDNA labeled with the fluorescent dye of the sample A is hybridized is placed on the sample table 20, and the control unit 95 controls the laser light source 21 so as to emit the laser light L1. Thus, the laser light L1 is emitted from the laser light source 21. The laser light L1 emitted from the laser light source 21 travels in the direction of the arrow X. The laser beam L1 incident on the plane mirror 51 of the optical head 50 is reflected upward in the drawing, passes through the small hole 52a of the perforated mirror 52, enters the lens 53, passes through the lens 53, and is placed on the sample stage 20. A small area of the test piece 1 is irradiated. At this time, the optical head 50 is moved at high speed and at a constant speed in the arrow X direction by the main scanning means 60, and the laser beam L1 main-scans the test piece 1 in the arrow X direction. The fluorescent dye is excited by the irradiated laser light L1 for the cDNA existing in the minute region irradiated with the laser light L1, and emits the fluorescent light K1.

The fluorescent light K1 emitted by the laser light L1 spreads out from the lower surface of the test piece 1 and is emitted. The emitted fluorescent light K1 is converted into a lower beam in the figure by the lens 53 of the optical head 50. The light enters the mirror 52. The fluorescence K1 is reflected by the reflection surface of the perforated mirror 52,
It proceeds in the direction along the arrow X direction. The fluorescence K1 that has progressed in the direction of the arrow X enters the PMT 90. The fluorescence K1 incident on the PMT 90 is amplified by the PMT 90, photoelectrically detected, and read as a corresponding electric signal,
The signal is amplified by a logarithmic amplifier 91 and converted into a digital signal by an A / D converter 92.

When reading by one main scanning is completed in this way, the optical head 50 is returned to the original position by the main scanning means 60, while the sub-scanning means 70 is operated by the laser light source 21, the optical head 50 and the PMT 90. Are integrally sub-scanned in the arrow Y direction. By repeating the main scanning and the sub-scanning described above, the entire surface of the test piece 1 is irradiated with the laser light L1, the fluorescence K1 corresponding to each spot position on the test piece 1 is converted into a digital signal, and the label data S
1 and input to the analyzer 93.

After the main scan and the sub-scan are completed and the label data S1 is obtained from the test piece 1, the optical head 50 is returned to the initial position, and then the cDN labeled with the fluorescent dye of the specimen B
The test piece 1 ′ hybridized with A is placed on the sample table 20, read in the same manner as the test piece 1, and the label data S 2 is obtained and input to the analyzer 93.

FIG. 3 is a schematic block diagram showing the configuration of the analyzer 93. As shown in FIG. 3, the analyzing device 93 reads the sign data S1 and S2, the analyzing means 11 which analyzes the sign data S1 and S2 and outputs the measurement result table H, and the analyzing means 11 A template storage means 12 storing a plurality of templates T required for the execution according to the types of the test pieces 1 and 1 'to be used, and marker data S1 and S2 associated with addresses by the templates T as described later. Image storing means 1 for storing
3 and a measurement result storage means 14 for storing a measurement result table H
A monitor 15 for displaying the measurement result table H and an image,
Input means 16 comprising a keyboard and a mouse for performing various inputs, and reading means 17 for reading an image of a spot position corresponding to the selected measurement result from the image storage means 13 as image data S4 and S5 as described later. Prepare.

The template storage means 12 stores a plurality of circular ROIs corresponding to the spot positions of the test pieces 1 and 1 '.
Are stored. That is, the arrangement of the spot positions on the test pieces 1 and 1 'varies depending on the manufacturer of the test pieces 1 and 1', the purpose of the test, and the like, and depends on the type of the test pieces 1 and 1 'used. For example, as shown in FIGS. 4 to 6, a plurality of templates T are stored in the template storage unit 12. In the template T shown in FIGS. 4 to 6, a circular portion is an ROI corresponding to a spot position.

An address number is assigned to each ROI of the template T. For example, in the template shown in FIG. 4, the template T is divided into six fields of Fields 1 to 6, and each field has 16 × 24 4 × 4 ROI blocks. This ROI block has a to a in both XY directions.
p, 1 to 24 are assigned.
The position of the OI block is, for example, a-
It can be represented as 1. Further, one set of eight types of cDNAs is arranged in the ROI block, and the same pattern number is assigned to the spot position where the same cDNA is arranged. Therefore, for example, when the pattern number in the ROI block is “2”, FIG.
In the template shown in FIG.
The position can be specified using “d1, a-1, 2” as the address number.

The template shown in FIG.
The field is divided into two fields of 1 and 2, and each field is further divided into eight areas A to H. In each region, there are 12 × 30 ROIs. The ROI has al to l, 1 to 3 in both XY directions.
0 is assigned, and in the template shown in FIG. 5, the ROI is, for example, “Field1, B, a-
The position can be specified by using "1" as the address number.

Further, the template shown in FIG.
F is divided into six areas, and in each area, 2
There are seven sets of × 14 ROI blocks in the X direction. R
In the OI block, address numbers a to m are assigned in the Y direction, and in the ROI block, address numbers 1 to 7 are assigned in the X direction. In the template shown in FIG. 6, when the numbers of the ROI blocks are the same, the same cDNA is arranged there. Therefore, in the template shown in FIG.
The OI can specify its position using, for example, “A, 1-a” as an address number.

Next, the operation of the analyzer 93 will be described. First, when the type of the used test piece 1, 1 'is input from the input means 16 to the analysis means 11, the analysis means 11 outputs a ROI corresponding to the spot position of the test piece 1, 1'.
Is stored in the template storage means 1
2 and the template T is arranged on the image represented by the sign data S1 and S2. In this embodiment, the test pieces 1 and 1 'corresponding to the template shown in FIG. 4 will be described. However, when the test pieces corresponding to the template The template T corresponding to the test piece is read from the template storage unit 12. Then, fitting is performed to adjust the position of the template T so that the circular ROI of the template T matches the spot position on the image. That is, spots are formed on the test pieces 1 and 1 'so as to correspond to the spot positions, but a slight displacement may occur for each spot.
Therefore, an operation for adjusting the ROI to the spot position is performed in order to accurately measure at each spot position. Specifically, the template T is rotated, moved left, right, up and down,
By scaling, the position of the ROI and the spot position are matched. This fitting may be performed automatically, or may be performed manually by displaying the sign data S1 and S2 and the template T on the monitor 15 and operating the mouse of the input means 16. Before this fitting,
The label data S1 and S2 are displayed on the monitor 15, and the samples A and
B spots when spots B were spotted on the test pieces 1 and 1 ', each spot caused by a large amount of fluorescence emission, and unevenness of the specimen remaining when washed with a predetermined solution as described above. It is preferable to remove an abnormal part having an abnormality in the signal value of the position. By this fitting, an address number corresponding to the address number of the template is assigned to each spot position.
Further, in the image represented by the sign data S1 and S2, since the position of each pixel can be represented as a coordinate value, the address number is associated with the coordinate value on the image representing the center position of the address number. The association information indicating the association result is added to the sign data S1 and S2.

When the fitting is performed as described above, the density at each spot position is measured according to an instruction from the input means 16. Specifically, the signal values in an area surrounded by the ROI are integrated, and the integrated signal value is detected as a density value at the spot position. At this time, it is preferable to remove the density value of the background, that is, the density value of the carrier 2 of the test pieces 1 and 1 'from the detected density values. When the density values are detected in all the ROIs set in the label data S1 and S2, the label data S
The ratio of density values obtained at spot positions corresponding to each other between S1 and S2 is determined. Here, the sign data S
The density value obtained at one specific spot position is N1,
Assuming that the density value obtained at the spot position corresponding to the specific spot position in the marker data S2 is N2, this ratio is obtained as N2 / N1. Then, a measurement result table H is created in which the address numbers of the 50 spot positions and the values of the ratios are associated with each other, for example, in descending order of the ratio, and stored in the measurement result storage means 14. The sign data S1 and S2 are stored in the image storage unit 13 with the above-mentioned association information added thereto.

Next, when an instruction to display the measurement result table H and the sign data S1 and S2 is given from the input means 16, the measurement result table H is sent from the measurement result storage means 14 and the sign data S1 and S2 are sent from the image storage means 13. Is read out and displayed on the monitor 15. FIG. 7 is a diagram showing a display state of the measurement result table H and the label data S1 and S2. As shown in FIG. 7, the top seven lists of the measurement result table H are displayed in the window 40 of the monitor 15, and all the lists can be displayed in the window 40 by operating the scroll bar 40 </ b> A. In the measurement result table H, the number (No.) of the list and the field number (Fi
eld), an address number in both XY directions (X, Y), a pattern number (Pattern), an obtained ratio (Ratio), and a judgment (Judge) are provided. The item of Judge is blank, and the operator's evaluation is input here. In the windows 41 and 42, images G1 and G2 of spot positions corresponding to the list selected in the measurement result table H are displayed. Note that in FIG. The list of No. 3 is selected, and the image of the spot block corresponding to the ROI block at the position of Field 2, n-13, which is the spot position in this list, is displayed in the windows 41, 42.

The operator observes the measurement result table H and the images G1 and G2 displayed as described above, and inputs the evaluation into the Judge column of the measurement result table H. In this evaluation, “Good” indicating that the target gene is expressed, “NG” indicating that the target gene is not expressed, and “No judgment” are given based on the measurement result and the state of the image. This is performed by inputting the character "?" Here, it is preferable that the input of the evaluation is such that, for example, when "G" on the keyboard is pressed, "Good" is input, and when "N" is pressed, "NG" is input. Then, by sequentially selecting the list, the evaluation is performed with reference to the images G1 and G2 and the measurement result table H.

As described above, according to the present embodiment, the template storage means 12 storing a plurality of types of templates.
, The template T in which the ROIs corresponding to the spot positions of the used test pieces 1 and 1 ′ are read out, so that a plurality of types of templates corresponding to the test pieces that may be used are stored in the template storage unit 12. , It is possible to detect the density value at the spot position from the label data S1 and S2 without newly creating a template T, no matter what test piece is used.

In the above embodiment, the template in which the ROIs corresponding to the spot positions of the test pieces 1 and 1 'used are not stored in the template storage means 12 in some cases. Therefore, a template creating means for creating a new template may be provided in the template storage means 12 to create a new template in which the ROIs are arranged according to the spot positions of the test pieces 1 and 1 '. In this case, as the attributes of the spot position, the number of layers such as one layer in which spots are arranged in a matrix or two layers in which a plurality of 4 × 4 spot blocks are arranged as shown in FIG. 4, the number of spots, the number of spot blocks, and the address Expression method, number of fields, Fie
The number of spots in ld, the presence or absence of spots to be paired as shown in FIG. 6, the number of paired spots, whether the spots are for signal value detection, positioning, spots are not formed, etc. There are various types such as a measurement attribute for each spot, and this attribute differs depending on the manufacturer of the test piece. Therefore, it is preferable that the template creating means can create a template in consideration of these attributes.

In the above embodiment, cDNA was used as a specific binding substance, and cDNA extracted from cells was used as a biological substance. However, the present invention is not limited to this.

Further, in the above-described embodiment, the ratio between the marker data S1 and S2 is determined by the analyzer 93. The difference between the marker data S1 and S2 is determined, and the spot positions of 50 spots are determined in the descending order of the difference. The measurement result table H in which the difference values are associated with each other may be created.

Further, in the above embodiment, 2
Although analysis is performed using one test piece 1 and 1 ′, analysis is performed on two types of specimens A and B using one test piece in which a large number of two sets of known and different cDNAs are arranged. You may.

In the above embodiment, two types of specimens A and B are analyzed. However, for three or more types of specimens, the reading of test pieces 1 and 1 'is performed in the same manner as described above.
It is possible to display the analysis and measurement result table H and the image.

In the above embodiment, a fluorescent dye is used as a labeling substance, but a radioactive isotope can be used.

[Brief description of the drawings]

FIG. 1 shows a test piece used in the present embodiment.

FIG. 2 is a diagram showing a configuration of a reading device used in the embodiment.

FIG. 3 is a schematic block diagram showing a configuration of an analyzer.

FIG. 4 shows a template (part 1).

FIG. 5 shows a template (part 2).

FIG. 6 shows a template (part 3).

FIG. 7 is a view showing a display state of a measurement result table and an image.

[Explanation of symbols]

 Reference Signs List 1, 1 'test piece 2 carrier 10 reading means 11 analysis means 12 template storage means 13 image storage means 14 measurement result storage means 15 monitor 16 input means 17 reading means 93 analysis device 100 reading device

──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI Theme coat ゛ (Reference) G01N 33/53 G01N 33/53 MD 33/543 501 33/543 501D 521 521 35/00 35/00 A 35/02 35/02 F // C12N 15/09 C12N 15/00 A

Claims (4)

[Claims] 1. A test specimen in which a plurality of known specific binding substances different from each other are arranged at a plurality of predetermined positions on a carrier, a biological substance labeled with a labeling substance of a specimen is added to the specific binding substance. After binding, an image represented by a labeling signal released from the bound labeling substance of the biological substance is obtained, and the template on which the ROI corresponding to the location of the specific binding substance in the test strip is placed is described. In a method for detecting a biological substance, which is set on an image and detects a signal value of the label signal at a position corresponding to the ROI of the image, a template storage unit storing a plurality of types of templates corresponds to the test piece. Detecting a signal value based on the read template, and detecting the signal value based on the read template. 2. The method according to claim 1, wherein a new template is created and the new template is stored in the template storage unit. 3. A test strip having a plurality of known specific binding substances different from each other arranged at a plurality of predetermined positions on a carrier, wherein a bio-derived substance labeled with a labeling substance of a sample is added to the specific binding substance. After binding, an image represented by a labeling signal released from the bound labeling substance of the biological substance is obtained, and the template on which the ROI corresponding to the location of the specific binding substance in the test strip is placed is described. In a biological substance detection apparatus, which is provided on an image and includes an analysis unit configured to detect a signal value of the label signal at a position corresponding to the ROI of the image, a template storage unit storing a plurality of types of templates, Reading means for reading a template of a type corresponding to the test piece from the template storage means, wherein the analyzing means comprises: An apparatus for detecting a substance derived from a living body, which is means for detecting the signal value based on a signal. 4. The apparatus according to claim 3, further comprising a template creating unit that creates a new template and stores the new template in the template storage unit.