CN104076031A - Test piece for point inspection and analyzing device - Google Patents
Test piece for point inspection and analyzing device Download PDFInfo
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- CN104076031A CN104076031A CN201410123021.2A CN201410123021A CN104076031A CN 104076031 A CN104076031 A CN 104076031A CN 201410123021 A CN201410123021 A CN 201410123021A CN 104076031 A CN104076031 A CN 104076031A
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Abstract
The invention provides a test piece for point inspection and an anaalyzing device, which can restrain color change of a color identification and a reference area along with time on condition that a surface that is utilized in point inspection is exposed to atmophere. Furthermore the test piece prevents dirt adhesion on the surface that is utilized in point inspection when inspection is performed on the color identification and the reference area. Therefore easy disposition is realized and furthermore inspection with high reliability can be performed. Furthermore, the invention provides an analyzing device which can use the test piece for point inspection for easily performing point inspection. The test piece for point inspection is provided with a light-penetratable substrate which is made of a non-hygroscopic material. On the light-penetratable substrate, a color identification is formed on one part of a surface of the light-penetratable substrate, and one surface of the light-penetratable substrate including the color identification is provided with a reference area with a color which is different from that of the color identification.
Description
Technical field
The present invention relates to the spot check test film for analytical equipment being carried out to spot check and use test film by the analytical equipment of spot check by this spot check, this analytical equipment detects this analyte with having the test film that the conversion zone of chromogenic reaction occurs by analyte, in more detail, the present invention relates to for example having utilized on the analytical equipment using in the detection of analyte of immunochromatography or quantitative test, for this analytical equipment being carried out to the spot check test film of spot check and using test film by the analytical equipment of spot check by spot check.
Background technology
For example, as some analytical equipment that blood, urine etc. is examined to the analyte in liquid and analyzes, disclosed the device (referring to patent documentation 1) of the formation of having utilized immunochromatography (immunologic chromatography).
In the analytical equipment of this patent documentation 1, service test sheet (below also referred to as " analysis test film ") is analyzed, and this test film has the conversion zone that produces chromogenic reaction by analyte in a part for a face.As shown in Figure 4, this analysis is used under the state that is incorporated in housing (below also referred to as " analysis housing ") 63 with test film example., be set up in parallel to be useful on to make to analyze and be exposed to outside opening 64A and for the opening 64B analyzing with the position of leaving from the conversion zone R dropping analytic liquid on test film 61 with the conversion zone R of test film 61 with on housing 63 in this analysis.
Specifically, the analytical equipment of patent documentation 1 possesses to analyzing with the illumination part of the conversion zone R light irradiation of test film 61 and to the photography portion in being taken by the conversion zone R of the state of this illumination part light irradiation.And, according to the photographed data information of the conversion zone R being obtained by photography portion, detect analyte by the colour developing degree on this conversion zone R.
In Fig. 4, for convenience's sake, analyzing with affix oblique line on test film 61.
In this analytical equipment, as analyzing with test film 61, use is formed with the test film of conversion zone R in a part for a face of the base material being for example made up of porous plastid, this conversion zone R has the coloured moiety 62 fixedly being formed by the immobilized antibody of being distinguishingly combined with analyte (antigen).By from opening 64B to test film 61 analytic liquid that drips for this analysis, this analytic liquid moves to conversion zone R by capillarity.With respect to being examined liquid, in this analytic liquid, be added with and the labelled antibody of analyte (antigen) singularity ground combination, so along with the movement of the analytic liquid dripping, analyte and labelled antibody move to conversion zone R.Then, analyte and labelled antibody arrive conversion zone R, thereby on coloured moiety 62, analyte and immobilized antibody and labelled antibody carry out antigen-antibody reaction, the painted or quality of coloured moiety 62 and become color status.As the concrete example of analyzing with test film 61, for example can enumerate in the some of a face of the base material of the rectangle being formed by nitrocellulose, be formed with the banded coloured moiety 62 extending along the short side direction of this base material, and be provided with conversion zone R, above-mentioned coloured moiety 62 becomes color status and painted (for example, referring to patent documentation 2) by gold colloid (gold colloid).
And, in this analytical equipment, on illumination part, use lighting device, and use camera in photography portion, so need to check termly whether these devices suitably play a role, specifically, need to check termly the illumination that produced by lighting device whether fully, whether the sensitivity of the photographic element of camera deteriorated etc.
So, the inventor is studied, use the following spot check forming to carry out the spot check of analytical equipment with test film: in a part for a face of the base material of the rectangular flat shape for example being formed by nitrocellulose, be formed with the banded colour code extending along the short side direction of this base material, this colour code is made up of the gold colloid of color status.That is to say, studied with analyzing and formed spot check test film with the constituent material of test film.
As concrete spot check gimmick, measure the colour developing degree of the colour code of spot check on test film, the i.e. known color depth of colour code (colour developing concentration) by analytical equipment, when in the scope of the reference value of obtained measured value in predetermining, be judged as device in normal condition, on the other hand, outside the scope of this reference value time, being judged as device has extremely.
But, in analytical equipment, taking the color of base material as benchmark, according to the colour developing degree of the poor coloured moiety of obtaining test film of the optical concentration of coloured moiety and base material, so with on test film, there is variety of issue in the constituent material using porous plastids such as nitrocelluloses as base material while use at spot check.At this, about the colour developing degree of the coloured moiety on test film, analyzing by the colour developing degree that refers to conversion zone on test film, or in the colour developing degree (color depth of colour code) that refers to colour code on test film for spot check.
Specifically, the porous plastids such as nitrocellulose have the characteristic that can utilize capillarity that liquid is moved, therefore have high-hygroscopicity.Therefore,, the in the situation that of keeping its state to take care of under atmospheric environment with test film spot check, along with the moisture absorption of base material, the color rheological parameters' change with time of the color of base material or the colour code that forms on base material, so can not obtain correct spot check result.Therefore,, even untapped spot check test film also needs for example to put into together with drying agent in the airtight bag of aluminum and takes care of, if strictly do not preserve in the mode that can not be exposed to atmosphere like this, can not use.Certainly, can not recycle with test film spot check.
In addition, on the face that is formed with colour code on base material, owing to measuring the colour developing degree (color depth of colour code) of colour code, so be not between maintaining period, in spot check action, also should be noted that use.That is to say, in spot check action, at the face that is formed with colour code of test film for spot check, especially in the situation that having adhered to dirt around colour code and this colour code, this dirt can not be removed, so likely cannot obtain correct spot check result.
Patent documentation 1: TOHKEMY 2012-225864 communique
Patent documentation 2: No. 2009/145250th, International Publication
Summary of the invention
The present invention In view of the foregoing makes, its object is, a kind of spot check test film is provided, even if the face utilizing in the time of spot check is exposed under the state of atmosphere, the color rheological parameters' change with time of colour code and reference area is still inhibited, and the face utilizing can prevent the spot check on colour code and reference area time adheres to dirt, so easily dispose, can carry out reliably the spot check of analytical equipment.
In addition, another object of the present invention is to, a kind of analytical equipment that can use spot check test film easily to carry out spot check is provided.
Spot check of the present invention is used for analytical equipment to carry out spot check with test film, this analytical equipment uses the test film with conversion zone, detect this analyte by the colour developing degree on the conversion zone of this test film, described conversion zone produces chromogenic reaction by analyte, this spot check is characterised in that with test film, possesses the light-transmitting substrate being formed by non-absorbent material, on described light-transmitting substrate, in a part for a face of this light-transmitting substrate, be formed with colour code, on a face of this light-transmitting substrate that comprises this colour code, be formed with the reference area with this colour code different colours.
At spot check of the present invention, with in test film, preferred described reference area is made up of the clad that described colour code is covered.
At spot check of the present invention, with in test film, preferred described colour code is made up of gold colloid.
At spot check of the present invention, with in test film, preferred described light-transmitting substrate is made up of glass.
At spot check of the present invention, with in test film, preferred described reference area is white.
At spot check of the present invention, with in test film, 2 different above belt courses of color depth that preferred described colour code forms material by same mark form.
With in test film, preferably on described light-transmitting substrate, be provided with the code region of reveal codes at spot check of the present invention, this code packages is containing the information of the reference value of the color depth of described colour code.
Spot check test film of the present invention, preferred described spot check uses under the state that is accommodated in housing with test film, is provided with the code region of reveal codes on described housing, and this code packages is containing the information of the reference value of the color depth of described colour code.
Analytical equipment of the present invention, uses described spot check test film to carry out spot check, it is characterized in that, described analytical equipment possesses: illumination part, colour code and reference area light irradiation to described spot check with test film; Photography portion, photographs to colour code and the reference area of the state that has been irradiated light by this illumination part; And control part, this illumination part and this photography portion are controlled, described control part has following function: according to the photographed data information of the described spot check test film obtaining in described photography portion, obtain this spot check poor with the optical concentration of the colour code on test film and reference area, poor this optical concentration and reference value that predetermine are compared.
Invention effect
Spot check of the present invention is configured to test film, is formed with colour code and reference area at a face of the light-transmitting substrate being made up of non-absorbent material, measures the color depth of colour code at the another side of this light-transmitting substrate.Therefore, the face for measuring on colour code and reference area becomes the state of being protected by light-transmitting substrate, thus can not be exposed to atmosphere, and do not have dirt and adhere to., even if be exposed at the another side of light-transmitting substrate under the state of atmosphere, can not there are not the such evils of the color rheological parameters' change with time of colour code and reference area and take care of in its result.In addition, medium in spot check action, even adhered to dirt at the another side of light-transmitting substrate, also can on colour code and reference area, not adhere to dirt.
Therefore, according to spot check test film of the present invention, even if the face utilizing in the time of spot check is exposed under the state of atmosphere, still can suppress the color rheological parameters' change with time of colour code and reference area, and adhere to dirt on the face utilizing while preventing the spot check on colour code and reference area, so obtain disposing easiness, carry out the spot check of analytical equipment with high reliability.
According to analytical equipment of the present invention, control part has following function: the photographed data information according to spot check with test film, obtain this spot check colour code of test film and the optical concentration of reference area poor, poor this optical concentration and reference value that predetermine are compared, so can use spot check of the present invention test film easily to carry out spot check.
Brief description of the drawings
Fig. 1 represents that spot check of the present invention test film is incorporated in the explanation front view of the state of housing.
Fig. 2 is the explanation cut-open view that represents the cross section of the spot check test film of the state of the housing that is accommodated in Fig. 1.
Fig. 3 is the key diagram of a face in test film, that measure for carrying out the color depth of colour code for spot check of presentation graphs 1.
Fig. 4 is the key diagram that represents the main composition for the test film analyzed in analytical equipment to be accommodated in the state of housing.
Fig. 5 is the key diagram that represents an example of the manufacture method of spot check of the present invention test film.
Fig. 6 is the explanation stereographic map that represents the outward appearance of an example of the formation of analytical equipment of the present invention.
Fig. 7 is the explanation stereographic map of the summary of the formation of the analysis spot check mechanism in the analytical equipment of presentation graphs 6.
Fig. 8 is the action flow chart of the analytical equipment of Fig. 6.
Fig. 9 obtains in experimental example 1, the absorbance of high concentration belt course in test film (1) and the curve map through the relation between number of days.
Figure 10 obtains in experimental example 1, the absorbance of low concentration belt course in test film (1) and the curve map through the relation between number of days.
Figure 11 obtains, relatively uses the absorbance of the high concentration belt course in test film (1) and the curve map through the relation between number of days in experimental example 1.
Figure 12 obtains, relatively uses the absorbance of the low concentration belt course in test film (1) and the curve map through the relation between number of days in experimental example 1.
Description of reference numerals
10 spot check test films; 11 light-transmitting substrates; 11A glass plate; 14 colour codes; 15,16 belt courses; 15A, 16A gold colloid film; 17A, 17B end face; 18 clads; 18A coating film; 30 housings (spot check housing); 31 upper casing bodies; 31A opening; 33 lower casing bodies; 34 hinge parts; 36 Quick Response Codes; 40 analytical equipments; 41 frameworks; 42 test film insert ports; 43 power switches; 44 touch panels; 50 analyze spot check mechanism; 51 test film detecting sensors; 52 lighting devices; 53LED; 54 cameras; 55CMOS imageing sensor; 61 test films (analysis test film); 62 coloured moieties; 63 housings (analysis housing); 64A, 64B opening; 65 codes (Quick Response Code)
Embodiment
The following describes embodiments of the present invention.
Fig. 1 represents that spot check of the present invention test film is accommodated in the explanation front view of the state of housing, Fig. 2 is the explanation cut-open view that represents the cross section of the spot check test film of the state of the housing that is accommodated in Fig. 1, and Fig. 3 is the key diagram of a face in test film, that measure for the color depth of colour code for the spot check of presentation graphs 1.
This spot check with test film 10 for analytical equipment is carried out to spot check, this analytical equipment uses the test film (analysis test film) with conversion zone, detect analyte by this analysis by the colour developing degree on the conversion zone of test film, the analyte that above-mentioned conversion zone is examined in liquid by such as blood, urine etc. produces chromogenic reaction.In this analytical equipment, as shown in Figure 4, analysis is used under the state that is incorporated in the housing (analysis housing) 63 with the flat face shaping of essentially rectangular with test film 61.Use on housing 63 in this analysis, code region C and be exposed to outside opening 64A with the conversion zone R of test film 61 and be set up in parallel for making to analyze, this code region C shows the code (for example Quick Response Code) 65 that comprises the information relevant to the chromogenic reaction producing on conversion zone R.
Spot check possesses the light-transmitting substrate 11 of rectangular flat shape with test film 10, at the lower surface (lower surface on Fig. 2) of this light-transmitting substrate 11, be formed with colour code 14 in a part for this lower surface.In addition, at the lower surface of light-transmitting substrate 11, to cover the mode of colour code 14, be formed with the clad 18 with this colour code 14 different colours.And, form the reference area on test film 10 for spot check by this clad 18.
In the example of this figure, spot check has the face shaping substantially same with the analysis using in the analytical equipment as spot check object test film 61 with test film 10.In addition, colour code 14 is formed on and analyzes the position corresponding with the conversion zone R of test film 61.
In addition, at the lower surface of light-transmitting substrate 11, the whole region that spreads all over this lower surface is formed with clad 18.That is to say, clad 18 is formed as at the lower surface of light-transmitting substrate 11, and colour code 14 is covered, and will not form this colour code 14 and the whole covering in region that the lower surface of this light-transmitting substrate 11 exposes simultaneously.
Light-transmitting substrate 11 is made up of non-absorbent material, has non-hygroscopic, and has the light transmission of the light transmission that makes the illumination part from analytical equipment (referring to Fig. 7).
In addition, on light-transmitting substrate 11, need to be formed at the colour code 14 of lower surface and the difference of the color of reference area depending on identification from upper surface (upper surface of Fig. 2) sidelong glance.
At this, in this manual, " non-absorbent material " represents be not easy to absorb moisture and keep, and do not have in fact hygroscopic material.
In addition, the preferred upper surface of light-transmitting substrate 11 is smooth.
Have fluctuating in the upper surface unevenness of light-transmitting substrate 11, in the time that the upper surface of light-transmitting substrate 11 adheres to dirt or moisture, likely adsorb this dirt and moisture.
The thickness of light-transmitting substrate 11 is preferably 0.5～1mm.
Be greater than 1mm at the thickness of light-transmitting substrate 11, in the photography portion (referring to Fig. 7) of analytical equipment, while shooting being irradiated by light the spot check test film 10 of state of portion's light irradiation, this shooting environmental is because the refraction of light is to analyze shooting environmental with test film 61 different.Therefore, likely cannot carry out suitable spot check.On the other hand, be less than 0.5mm at the thickness of light-transmitting substrate 11, likely damaged.
As the material of light-transmitting substrate 11, can enumerate such as glass and styrene resin " CLEAPACT " (DIC(strain) system) etc. resin etc.
And based on from the colour code 14 of upper surface side and the visibility of reference area, environment resistant and manufacture the viewpoint of the thermotolerance that needs etc., light-transmitting substrate 11 is preferably made up of glass.
Colour code 14 forms material by mark and forms.
And as shown in FIG. 1 to 3, colour code 14 forms material by same mark and forms, preferably this mark forms the concentration of material, the deep or light belt course 15,16 by different 2 above (in the example of figure being 2) of color forms.
In the example of this figure, 2 belt courses 15,16 are formed as the linearly extension of short side direction along this light-transmitting substrate 11 at the lower surface of light-transmitting substrate 11.In addition, 2 belt courses 15,16 are separated from each other and form on the long side direction of light-transmitting substrate 11.
Colour code 14 forms by same mark 2 above belt courses 15,16 that the concentration of material is different and forms, thus the precision of whole measurement range that can confirmation analysis device, so can carry out with higher reliability the spot check of analytical equipment.
Specifically, in the situation that colour code 14 is made up of 1 belt course, in analytical equipment, can only be confirmed whether the concentration (hereinafter referred to as " mark color depth ") of the mark formation material that can normally measure (detection) this 1 belt course.That is to say, use mark color depth known spot check to carry out spot check with test film 10, for demonstrate with the belt course of spot check test film 10 on the analysis test film 61 of the equal colour developing of mark color depth be confirmed whether to measure normally (detection).Therefore,, in the time that analysis is different with the mark color depth of spot check on the belt course of test film 10 by the colour developing degree on the conversion zone R of test film 61, cannot be confirmed whether to measure normally (detection).Like this, the mark color depth that according to 1 spot check data, whether the state of analytical equipment judgement (being normal condition or the judgement of abnormality) only can normally be measured on (detection) 1 belt course carries out.
But, different more than 2 belt course 15,16 of concentration that forms material by same mark at colour code 14 forms, in analytical equipment, can be confirmed whether normally to measure the mark color depth on (detection) these 2 above belt courses 15,16 and the concentration in addition of the mark color depth on this belt course 15,16.That is to say, can be confirmed whether normally to measure each mark color depth on (detection) 2 above belt courses 15,16.On this basis, according to obtained multiple spot check data, can obtain the different estimation data of mark color depth on the belt course 15,16 above from 2 of spot check test film 10, so use the known spot check of mark color depth to carry out spot check with test film 10, not just for demonstrating and analysis for the test film 61 of spot check with the equal colour developing of the mark color depth on 2 belt courses of test film 10, for the test film 61 for analysis that demonstrates different colour developings, also can infer and whether can measure normally (detection).The state that the tentative data that can obtain according to multiple spot check data and by the plurality of spot check data like this, carries out analytical equipment judges.Specifically, for example, can all measure normally (detection) such spot check data more than 2 belt courses 15,16 in the case of having obtained, be speculated as on the whole region of measurement range of analytical equipment can+normally measure (detection), carry out the state judgement of analytical equipment according to this estimation data.In addition, obtain estimation data according to multiple spot check data, this estimation data and the reference value predetermining are compared, thereby carry out the state judgement of analytical equipment.
Therefore, 2 different above belt courses 15,16 of concentration that colour code 14 forms material by same mark form, can obtain estimation data from multiple spot check data, so the precision in the whole region of measurement range that can confirmation analysis device, so can carry out with high reliability the spot check of analytical equipment.Therefore, spot check with test film 10 not just for the daily spot check of the analytical equipment that carries out termly, also can be suitable for manufacturing time, the calibration in the time of maintenance.
For the mark color depth in 2 above belt courses 15,16 of formation colour code 14, the viewpoint of the reliability judging from the state of analytical equipment, the belt course that preferred identity color depth is the highest has and roughly equal concentration of the concentration of the higher limit of the measurement range of analytical equipment, and mark color depth minimum belt course has and roughly equal concentration of the concentration of the lower limit of the measurement range of analytical equipment.
In the example of this figure, one side's belt course (hereinafter referred to as " high concentration belt course ") 15 is compared with the opposing party's belt course (hereinafter referred to as " low concentration belt course ") 16, mark color depth is high, and its mark color depth is made as the concentration of the higher limit of the measurement range of analytical equipment.In addition, the mark color depth of low concentration belt course 16 is made as the concentration of the lower limit of the measurement range of analytical equipment.
In addition, forming in more than 2 belt course 15,16 of colour code 14, the distance of separation between width (size of the left and right directions on Fig. 1～Fig. 3) and belt course adjacent one another are etc. can suitably determine.
Specifically, the width of 2 belt courses 15,16 is respectively for example 1mm.In addition, the distance of separation of 2 belt courses 15,16 is for example 3～4mm.
Form material as mark, with in test film 61, preferably use the material for antibody mark in order to allow the coloured moiety 62 of conversion zone R become color status in general analysis.
Form the concrete example of material as this mark, can enumerate such as gold colloid and blue latex etc.
At spot check, with in test film 10, reference area has non-transparency, and has the color different from colour code 14.
At this spot check, with in test film 10, the color of reference area is preferably white.
The color of reference area is made as to white, and the color of this reference area becomes the color roughly the same with the base material of general analysis test film 61.That is to say, become with for to analyzing roughly equal color of the reference color that detect by the colour developing degree on the conversion zone R of test film 61.Therefore, in the control part of analytical equipment, by a part for the spot check operation program for controlling spot check action and the routine analyzer communization moving for control analysis, so can simplify spot check program.
The clad 18 that preferably forms this reference area has tack to light-transmitting substrate 11, and also has tack for the belt course 15,16 that forms colour code 14.
In addition, clad 18 preferably has non-hygroscopic.
Clad 18 has non-hygroscopic, thereby even if be exposed at clad 18 under the state of atmosphere, also can prevent or suppress the color rheological parameters' change with time of colour code 14 and reference area.
As the concrete example of the constituent material of clad 18, can enumerate the pigment ink of for example white etc.
The thickness of clad 18 is preferably 50～100 μ m.
The spot check of this formation can be manufactured by various gimmicks with test film 10.
Specifically, for example, first, on a face of the glass plate of rectangular flat shape, the colour code being made up of is formed to the mode that the coating fluid of material extends with the short side direction at this glass plate be coated with the shape that is in line gold colloid, form 2 gold colloid films.Then, be formed with 2 gold colloid films glass plate a face on the whole, with by the mode of the surface coverage of exposing face (not forming the region of gold colloid film) and 2 gold colloid films on a face of this glass plate, form the coating film of Chinese white ink by silk screen print method.Like this, obtain being formed with at the lower surface of the light-transmitting substrate 11 being formed by glass the test film 10 for spot check of the colour code 14 being formed by belt course 15,16 and the reference area being formed by clad 18, belt course 15,16 is made up of gold colloid, and clad 18 is made up of Chinese white ink.
In addition, a large amount of make spot checks test film 10 in the situation that, example as shown in Figure 5, can adopt following gimmick: the glass plate 11A for preparing elongated rectangular shape, formed gold colloid film 15A, 16B on this rectangular glass plate 11A after, form the coating film 18A being formed by Chinese white ink, then by its disjunction.
Specifically, first, as shown in Fig. 5 (A), on a face of the glass plate 11A of elongated rectangular shape, the coating fluid that the colour code being made up of gold colloid is formed to material is coated with in the mode of the long side direction extension along this glass plate 11A the shape that is in line, thereby forms gold colloid film 15A, 16A.Then, be formed with 2 gold colloid film 15A, 16A glass plate 11A a face on the whole, with by the mode of the surface coverage of exposing face (not forming the region of gold colloid film 15A, 16A) and 2 gold colloid film 15A, 16A on a face of this glass plate 11A, form the coating film 18A of Chinese white ink by silk screen print method.And then, as shown in Figure 5 (B), be to make each point of part become required size by the glass plate 11A disjunction that is formed with gold colloid film 15A, 16A and coating film 18A.Like this, obtain being formed with at the lower surface of the light-transmitting substrate 11 being formed by glass the test film 10 for spot check of the colour code 14 being formed by belt course 15,16 and the reference area being formed by clad 18, belt course 15,16 is made up of gold colloid, and clad 18 is made up of Chinese white ink.
At this, according to above-mentioned gimmick,, can become by clad 18 state of whole the covering in surface of 2 belt courses 15,16 of formation colour code 14 with in test film 10 at obtained spot check.On the other hand, in gimmick described later, with on test film 10, become the end face 17A of 2 belt courses 15,16, the state that 17B exposes at the spot check obtaining.
As depicted in figs. 1 and 2, this spot check also can be received to housing (being called again " spot check housing " below) 30 with test film 10.
By spot check is accommodated in to housing 30 for spot check with test film 10, even if light-transmitting substrate 11 is made up of glass, the also easily keeping of test film 10 for spot check.
In addition, spot check is large with the surface area ratio spot check of housing 30 test film 10, and institute is for showing the design freedom increase of code region C of the code that comprises spot check information needed.Specifically, can show various information at code region C.
In addition, can be made as the state of using housing 30 that the major part of spot check test film 10 is covered by spot check, so spot check increases with the design freedom of test film 10.Specifically, even if for example clad 18 does not have non-hygroscopic, or with forming on test film 10 under the end face 17A, state that 17B exposes of belt course 15,16 of colour code 14, spot check can not be exposed to atmosphere with end face 17A, the 17B of the clad 18 on test film 10 and the belt course 15,16 in exposing state yet at spot check.
Formed by for example upper casing body 31 and lower casing body 33 for the spot check housing 30 of receiving spot check test film 10, mark the space for receiving spot check test film 10 in inner area, there is the flat face shaping of essentially rectangular.At this spot check, with on housing 30, upper casing body 31 and lower casing body 33 can openedly and closedly link mutually via hinge part 34.
In addition, at spot check, with on housing 30, (specifically, lower surface is formed with a part for colour code 14 and reference area to be formed with a part for making the spot check upper surface of the light-transmitting substrate 11 on test film 10 at the middle body of upper casing body 31.Below be called again " upper surface exposed portions serve ".) be exposed to outside opening 31A.Like this, spot check is configured to the part beyond the upper surface exposed portions serve of spot check test film 10 is covered with housing 30, and the part beyond this upper surface exposed portions serve can not be exposed to atmosphere.
And,, be exposed to outside upper surface exposed portions serve by the opening 31A that uses housing 30 by spot check and form identified areas S with in test film 10 at the spot check that is accommodated in spot check housing 30.
In the example of this figure, spot check has with housing 30 and analyzes the face shaping roughly the same with the analysis housing 63 of test film 61 for receiving.Specifically, have and can insert the shape being installed to analytical equipment from test film insert port (referring to Fig. 6).
In addition, at spot check, with on housing 30, opening 31A is rectangle, is formed at and analyzes the position corresponding with the opening 64A of housing 63.
In addition, at spot check, with on test film 10, identified areas S is made up of the middle body of the upper surface of light-transmitting substrate 11, does not comprise the peripheral part of this upper surface.Therefore, spot check is incorporated in housing 30 for spot check with test film 10, even if thereby under the end face 17A, state that 17B exposes of 2 belt courses 15,16 that forms colour code 14, this end face 17A, 17B are also covered with housing 30 by spot check, therefore can not be exposed to atmosphere.
In addition, at the upper surface (upper surface of Fig. 2) of upper casing body 31, be provided with the Quick Response Codes 36 such as such as QR code (registered trademark) in the position of leaving from opening 31A, form thus code region C.
As the information that is contained in Quick Response Code 36, for example can enumerate the information etc. that represents the relevant reference value of the color depth of the intrinsic colour code of the essential information of the spot check such as identifying information, the product batch number test film 10 that is spot check test film and the such as reference area reference value (be below again called " optical concentration poor reference value ") poor with the optical concentration of colour code 14 etc. and spot check use test film 10.
In the example of this figure, Quick Response Code 36 is formed on and analyzes the position corresponding with the code region C of housing 63.Specifically, be positioned at an one end side portion (the right one end side portion of Fig. 1 and Fig. 2) at spot check by the mode that the long side direction of housing 30 is arranged with opening 31A.
Material as spot check with housing 30, can enumerate the resins such as such as ABS resin.
In addition, the viewpoint reflecting from the light that suppresses to send from the illumination part of analytical equipment, spot check is preferably black with housing 30.Especially, spot check preferably has scattering surface with the surface of housing 30, makes the light scattering from the illumination part of analytical equipment.
Above spot check is configured to test film 10, is formed with colour code 14 and reference area at the lower surface of light-transmitting substrate 11, measures the color depth (degree of the colour developing of colour code 14) of colour code 14 at the upper surface of this light-transmitting substrate 11.Therefore, the state in being protected by light-transmitting substrate 11 for the face (upper surface of Fig. 2) measured of colour code 14 and reference area, thus can not be exposed to atmosphere, and do not have dirt and adhere to.Its result even if be exposed at the upper surface of light-transmitting substrate 11 under the state of atmosphere, also can be taken care of under the state of the such evils of the color rheological parameters' change with time that there will not be colour code 14 and reference area.But also can recycle.In addition, even medium in spot check action, adhere to dirt at the upper surface of light-transmitting substrate 11, also can not adhere to dirt at colour code 14 and reference area, and can be by this dirt wiped clean.
Therefore, according to test film 10 for spot check, even if the one side of utilizing in the time of spot check is exposed under the state of atmosphere, also can suppress the color rheological parameters' change with time of colour code 14 and reference area, and prevent that the face utilizing from adhering to dirt in the time of the spot check of colour code and reference area, so can easily dispose, and can carry out with high reliability the spot check of analytical equipment.
In addition, use in test film 10 at spot check, colour code 14 is made up of 2 belt courses 15,16,2 belt courses 15,16 form material by same mark and form, and this mark forms the concentration difference of material, so the precision in the whole region of measurement range that can confirmation analysis device, so can carry out with higher reliability the spot check of analytical equipment.
In addition, spot check uses under the state that is incorporated in spot check housing 30 with test film 10, and this spot check is configured to the identified areas S(upper surface exposed portions serve on spot check test film 10 with housing 30) part in addition can not be exposed to the structure of atmosphere.Therefore, the spot check test film 10 that is accommodated in the state of spot check housing 30 can not produce the such evils of color rheological parameters' change with time of colour code 14 and reference area, can under this state, directly under atmospheric environment, take care of.
At this spot check with in test film 10, can using the material that produces characteristic variations because of moisture without evils form materials'use as mark.Therefore, form material as mark, can use well gold colloid.And this gold colloid is to identify widely used material in analysis conduct on test film 61 for the antibody that makes conversion zone R become color status.Therefore, the color of colour code 14 becomes and analyzes by roughly equal color of the color of the coloured moiety 62 of the color status of the conversion zone R in test film 61.Its result, in the control part of analytical equipment, can be by a part for the spot check operation program for controlling spot check action and the routine analyzer communization moving for control analysis, so can simplify spot check program.
Fig. 6 is the explanation stereographic map that represents the outward appearance of an example of the formation of analytical equipment of the present invention, and Fig. 7 is the explanation stereographic map that represents the summary of the formation of the analysis spot check mechanism of the analytical equipment of pie graph 6.
This analytical equipment 40 is for analyzing by test film (specifically, analyze with test film 61 and spot check test film 10) or the analysis spot check mechanism 50 of spot check is incorporated in the interior and formation of framework 41.In this framework 41, be provided with test film insert port 42, this test film insert port 42 is for inserting the test film of the state in being received into housing (specifically, be incorporated in the analysis test film 61 of analysis housing 63 and be incorporated in the test film 10 for spot check of spot check housing 30).In this test film insert port 42, be incorporated in the spot check test film 10 of spot check housing 30 to there is inserting facing to the state of top and the posture of level of identified areas S and code region C.In addition, being incorporated in the analysis test film 61 of analyzing with housing 63 inserts with the state facing to top and the flat-hand position with conversion zone R and code region C.
In Fig. 6, the 43rd, power switch, the 44th, input and the relevant information of analysis and the touch panel of relevant information etc. input action command signal with spot check.
The analysis spot check mechanism 50 of analytical equipment 40 possesses: detect the test film detecting sensor 51 that has or not test film; The illumination part being made up of lighting device 52, is arranged at test film under the state of suitable position, and lighting device 52 is to test film light irradiation; And the photography portion being formed by camera 54, camera 54 is taken for the test film that has been irradiated the state of light by this illumination part.In addition, be provided with the control part (not shown) that each action of the illumination part forming to test film detecting sensor 51, by lighting device 52 and the photography portion being made up of camera 54 is controlled in spot check mechanism 50 analyzing.
As test film detecting sensor 51, can use such as optical chopper etc.
Be arranged at test film under the state of appropriate location, the camera 54 that forms photography portion is included in area of visual field (representing with double dot dash line in Fig. 1 and Fig. 4) I by analyzing with the spot check region that comprises identified areas S and code region C in the analyzed area that comprises conversion zone R and code region C and spot check test film 10 in test film 61 (below they being generically and collectively referred to as to " analyzing spot check region ").
This camera 54 is accepted the reflected light being produced by the analysis spot check region of test film, the analysis spot check region of test film light intensity distributions is on the whole looked like to take, is preferably configured to and possesses for example by CMOS(Complementary Metal-Oxide Semiconductor) photographic element that forms of imageing sensor 41.
The lighting device 52 that forms illumination part throws light on to region (region dotting in Fig. 1 and Fig. 4 is called " field of illumination " below) L that at least comprises the area of visual field I on test film.
As this lighting device 52, for example, the in the situation that of having used gold colloid with test film 10 as mark formation material at spot check, the color of the belt course 15,16 of colour code 14 is pink colour, so preferably possess as light source the LED53 that for example sends near the green light of peak luminous wavelength 525nm.At this, as the light source of lighting device 52, as long as can irradiate with the coloured moiety of test film (specifically, analyze with the coloured moiety of the conversion zone R on test film 61 and the colour code 14 on test film 10 for spot check) the color of light that increases of the contrast of colour developing concentration, also can combine the device that forms etc. by such as semiconductor laser, lamp and bandpass filter and form.
The size of field of illumination L can be adjusted with respect to the allocation position (distance of separation) on test film surface by for example lighting device 52.
Control part has following function: the photography conditions to camera 54 is adjusted, obtain photograph with the 1st mutually different photography conditions and the 2nd photography conditions, for 2 view data in the analysis spot check region of test film, wherein, read the view data based on the 1st photography conditions as code and obtain by view data, detect with view data or unit state and judge and obtain by view data the view data based on the 2nd photography conditions as analyte, and analyze each view data.
Code reads image data, analyte detect and judges the shading image performance with for example 0～255 256 gray scales by view data with view data and unit state, for example use on test film 10 at spot check, the maximum gray scale portion of identified areas S and code region C is as long as respectively in from 200 to 250 scope for example, can suitably carry out reading of the information that shows on the C of code region and reading of the color status of identified areas S.
In addition, control part has following function: according to the optical concentration information that is judged optical concentration information that obtain by view data, colour code 14 and reference area by unit state, calculate spot check poor with the optical concentration of reference area with the colour code 14 in test film 10, and reference value (optical concentration poor reference value) that predetermine poor to this optical concentration compares.
In the example of this figure, as the optical concentration information of colour code 14, obtain the value of the optical concentration of 2 belt courses 15,16 that form colour code 14.And, poor with the optical concentration of reference area as colour code 14, obtain for 2 belt courses 15,16 poor value of optical concentration separately, specifically, obtain poor value and low concentration belt course 16 value poor with the optical concentration of reference area of optical concentration of high concentration belt course 15 and reference area.In addition, as the poor reference value of optical concentration, determine and the poor relevant reference value of 2 belt courses 15,16 optical concentration separately.
The poor reference value of optical concentration has scope, specifically, for example, represents the value in the scope in ± 10% with respect to the poor true value of colour code 14 and the optical concentration of reference area.
In addition, control part also has concentration calculation mechanism, and this concentration calculation mechanism, according to reading by code the lubber-line information obtaining by view data, detects the concentration of calculating analyte by view data according to analyte.
As the gimmick that the photography conditions of camera 54 is adjusted, for example preferably use the shutter speed (aperture time) of the electronic shutter by the cmos image sensor 55 to camera 54 to control and adjust the time shutter, adjust thus the method for exposure (light quantity of the light that cmos image sensor 55 receives), or the luminous quantity of the LED53 of illumination apparatus 52 is controlled method of adjusting exposure etc.At this, adjust the method for exposure as the adjustment time shutter, also the method that has for example gain to cmos image sensor 55 (sensitivity) or aperture degree to adjust, but due in the gain that increases cmos image sensor 55 to increase when exposure, noise increases, and when change aperture is spent, style of shooting changes, so preferably control to adjust the method for time shutter by the shutter speed (aperture time) of the electronic shutter to cmos image sensor 55.
The 1st photography conditions of camera 54 is set to, and the shooting of the code region C in the analysis spot check region of test film becomes optimal brightness.Specifically, for example, use in test film 10 at spot check, be no more than the mode of the maximum gray scale of cmos image sensor 55 with the brightest position of the periphery of Quick Response Code 36, the size of the luminous quantity of the LED53 on shutter speed (time shutter) and/or the lighting device 52 of the electronic shutter to cmos image sensor 55 is controlled, thereby sets the size of the exposure to cmos image sensor 55.
The 2nd photography conditions of camera 54 is configured to, conversion zone R on the analysis spot check region of test film and the shooting of identified areas S become optimal brightness, specifically, be set as following condition: for example, in exposure than the large condition of the 1st photography conditions, be no more than in the scope of maximum gray scale of cmos image sensor 55 with the brightest position except colour code 14 of the identified areas S on test film 10 at spot check, the size of the luminous quantity of the LED53 in shutter speed (time shutter) and/or the lighting device 52 of the electronic shutter of cmos image sensor 55 is larger than the 1st photography conditions.
The exposure to cmos image sensor 55 in the 2nd photography conditions is for example 1.3 times of left and right of the exposure to cmos image sensor 55 in the 1st photography conditions.
In the above description, the adjustment of the shutter speed of the electronic shutter of cmos image sensor 55 can be by for example changing to carry out to the operation condition of CMOS camera module.
In addition, the adjustment of the luminous quantity of LED53 can be undertaken by the size that for example changes the electric current that is supplied to LED53.
The following describes an example of the spot check action of above-mentioned analytical equipment 40.
When the power switch 43 of analytical equipment 40 is switched on, display menu picture on touch panel 44, in the state that can measure.
As shown in Figure 8, on touch panel 44, press while measuring button (S1), analyze the LED53 of the lighting device 52 in spot check mechanism 50 in illuminating state (S2).Then, the spot check test film 10 of the state that is accommodated in spot check housing 30 is inserted into test film insert port 42 from code region C side.
When (S3) while being provided with test film being detected by analyzing test film detecting sensor 51 in spot check mechanism 50, be adjusted into by control part under the state of the 1st photography conditions, take the image of spot check with the spot check region on test film 10 by camera 54, this image reads and is obtained by view data as the code of the information showing on the Quick Response Code 36 for detection of being arranged at code region C.Then, by control part, obtained code is read and carries out suitable image analysis with the code region C in view data, thereby read the information etc. of relevant reference value such as the color depth of the colour code intrinsic with spot check test film 10 such as the spot check test film 10 that shows on Quick Response Code 36 intrinsic information, the such as poor reference value of optical concentration etc. and be recorded to storer (S4).
Then, detect as test film and be provided with spot check (S5) when the test film 10 by control part, the photography conditions of camera 54 is changed to the 2nd photography conditions, take the image of spot check with the spot check region on test film 10 by camera 54, this image judges and obtains by view data as the unit state of the state for discriminatory analysis device 40, and lighting device 52 is in extinguishing state (S6).
In addition, be provided with (S5) analyze with test film 61 in the situation that being detected by control part as test film, pattern changes to and analyzes pattern (S7) from spot check pattern.
Judge with the identified areas S in view data for obtained unit state, carry out suitable image analysis by control part, thereby calculate the optical concentration poor (S8) of colour code on identified areas S 14 and reference area.
Then, to poor the comparing of optical concentration on the poor reference value of the optical concentration of obtaining and identified areas S, according to this result relatively, the state of discriminatory analysis device.
Specifically, first, to poor the comparing of optical concentration (S9) of the poor reference value of optical concentration and high concentration belt course 15, while confirming the poor scope that is positioned at the poor reference value of optical concentration of optical concentration of high concentration belt course 15, next poor the comparing of optical concentration (S10) to the poor reference value of optical concentration and low concentration belt course 16.And, confirming in the situation of the poor scope that is positioned at the poor reference value of optical concentration of optical concentration of low concentration belt course 16, discriminatory analysis device 40 is normal condition, its result is shown to touch panel 44(S11 as spot check result).On the other hand, poor not in the case of in the scope of the poor reference value of optical concentration at the optical concentration that confirms low concentration belt course 16, be judged as analytical equipment 40 in abnormality, its result is shown to touch panel 44(S13 as spot check result).
In addition, by the poor comparison (S9) of the optical concentration of the poor reference value of optical concentration and high concentration belt course 15, the optical concentration that confirms high concentration belt course 15 is poor not in the case of in the scope of the poor reference value of optical concentration, further poor the comparing of optical concentration (S12) to the poor reference value of optical concentration and low concentration belt course 16.Then, in the case of the poor scope that is positioned at the poor reference value of optical concentration of optical concentration of low concentration belt course 16 and be not positioned at the scope of the poor reference value of optical concentration, all be judged as analytical equipment 40 in abnormality, its result is shown to touch panel 44(S13 as spot check result).
Like this, on analytical equipment 40, control part has that to calculate this spot check according to the photographed data information of spot check test film 10 poor with the optical concentration of reference area with the colour code 14 on test film 10, and the function that with optical concentration reference value that predetermine compare poor to this optical concentration, so can use spot check of the present invention test film easily to carry out spot check.
The invention is not restricted to above-mentioned embodiment, can carry out various changes.
For example, use in test film, as long as reference area is formed on a face that is formed with colour code of light-transmitting substrate at spot check.Specifically, needn't be formed on light-transmitting substrate be formed with whole of colour code upper, in addition, also can not be formed as colour code to cover.
In addition, spot check is with test film as long as being provided with the code region of reveal codes, and this code comprises the information of the reference value relevant with the color depth of colour code.This code region preferably at spot check be formed as on test film can be from the upper surface side identification of light-transmitting substrate.
In addition, the structure of analytical equipment entirety is not limited to the structure shown in Fig. 6 and Fig. 7, can adopt various formations.
The experimental example carrying out in order to confirm action effect of the present invention is below described.
(experimental example 1)
According to the formation of Fig. 1～Fig. 3, be produced on the test film (hereinafter referred to as " test film (1) ") that is formed with the colour code (14) being formed by gold colloid and the clad (18) being formed by Chinese white ink on a face of the light-transmitting substrate (11) being formed by glass.
Specifically, first, on a face of the glass plate of rectangular flat shape, the coating fluid that the colour code being made up of gold colloid is formed to material is coated with in the mode of extending on the short side direction of this glass plate the shape that is in line, thereby has formed 2 gold colloid films.Then, be formed with 2 gold colloid films glass plate a face on the whole, with by the mode of the surface coverage of exposing face (not forming the region of gold colloid film) and 2 gold colloid films of a face of this glass plate, form the coating film of Chinese white ink by serigraphy.Like this, obtain being formed with at the lower surface of the light-transmitting substrate being formed by glass (11) test film (1) that the colour code 14 being made up of belt course (15,16) and the reference area that formed by clad 18 form, colour code 14 is made up of gold colloid, and clad 18 is made up of Chinese white ink.
On the test film obtaining (1), colour code (14) is made up of the high belt course (hereinafter referred to as " high concentration belt course ") (15) of mark color depth and the low belt course (hereinafter referred to as " low concentration belt course ") (16) of mark color depth, the width of these belt courses (15,16) is respectively 1mm, in addition, high concentration belt course 15 is 3mm with the distance of separation of low concentration belt course 16.
In addition, the states that the whole surface of 2 belt courses (15,16) of formation colour code (14) covers in being wrapped by layer 18.That is to say, the end face (17A, 17B) of 2 belt courses (15,16) do not expose and be wrapped by layer 18 cover.
In addition, made on the face of base material forming at nitrocellulose, be provided with that the colour code that is made up of gold colloid forms relatively use test film (hereinafter referred to as " relatively using test film (1) ").
Relatively use in test film (1) at this, the light-transmitting substrate (11) of instead of glass system and adopt the base material of nitrocellulose system, a face at the base material of this nitrocellulose system does not arrange clad (18), in addition, has the formation identical with test film (1).Relatively use in test film (1) at this, form reference area by the base material of nitrocellulose system.
By the test film of producing (1) and relatively use test film (1) under the environment of humidity 90RH%, room temperature (25 DEG C), test film (1) keeping 60 days, relatively uses test film (1) keeping 240 days.When keeping, test film (1) maintains the original state and takes care of, and on the other hand, relatively uses test film (1) keeping under the state that is put into aluminum bag.Between maintaining period, the absorbance (poor with the optical concentration of reference area) of 2 belt courses that form colour code is measured.Show the result in Fig. 9～Figure 12.At this, Fig. 9 represents the absorbance of the high concentration belt course (15) in test film (1) and the curve map through the relation between number of days, and Figure 10 represents the absorbance of the low concentration belt course (16) in test film (1) and the curve map through the relation between number of days.In addition, Figure 11 represents relatively to use the absorbance of the high concentration belt course in test film (1) and the curve map through the relation between number of days, and Figure 12 represents relatively to use the absorbance of the low concentration belt course in test film (1) and the curve map through the relation between number of days.
As can be known from the above results, the test film of embodiments of the invention (1) even if be exposed under the state of atmosphere under atmospheric environment, and the absorbance (poor with the optical concentration of reference area) that forms the belt course of colour code does not almost change.
On the other hand, relatively using in test film (1), although under the state of putting into aluminum bag, take care of, form colour code belt course absorbance (poor with the optical concentration of reference area) through time change large.
Therefore,, according to test film of the present invention (1), even if confirm the in the situation that of keeping, also can carry out with high reliability the spot check of analytical equipment under atmospheric environment.
Claims (9)
1. a spot check test film, for analytical equipment is carried out to spot check, this analytical equipment uses the test film with conversion zone, detect this analyte by the colour developing degree on the conversion zone of this test film, described conversion zone produces chromogenic reaction by analyte, this spot check is characterised in that with test film
Possess the light-transmitting substrate being formed by non-absorbent material,
On described light-transmitting substrate, in a part for a face of this light-transmitting substrate, be formed with colour code, on a face of this light-transmitting substrate that comprises this colour code, be formed with the reference area with this colour code different colours.
2. spot check test film according to claim 1, is characterized in that,
Described reference area is made up of the clad that described colour code is covered.
3. spot check test film according to claim 1, is characterized in that,
Described colour code is made up of gold colloid.
4. spot check test film according to claim 1, is characterized in that,
Described light-transmitting substrate is made up of glass.
5. spot check test film according to claim 1, is characterized in that,
Described reference area is white.
6. spot check test film according to claim 1, is characterized in that,
2 different above belt courses of color depth that described colour code forms material by same mark form.
7. spot check test film according to claim 1, is characterized in that,
On described light-transmitting substrate, be provided with the code region of reveal codes, this code packages is containing the information of the reference value of the color depth of described colour code.
8. spot check test film according to claim 1, is characterized in that,
Described spot check uses under the state that is accommodated in housing with test film,
On described housing, be provided with the code region of reveal codes, this code packages is containing the information of the reference value of the color depth of described colour code.
9. an analytical equipment, right to use requires the spot check described in 1～8 any one to carry out spot check with test film, it is characterized in that,
Described analytical equipment possesses:
Illumination part, colour code and reference area light irradiation to described spot check with test film;
Photography portion, photographs to colour code and the reference area of the state that has been irradiated light by this illumination part; And
Control part, controls this illumination part and this photography portion,
Described control part has following function: according to the photographed data information of the described spot check test film obtaining in described photography portion, obtain this spot check poor with the optical concentration of the colour code on test film and reference area, poor this optical concentration and reference value that predetermine are compared.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2013068517A JP5821885B2 (en) | 2013-03-28 | 2013-03-28 | Inspection specimen and analyzer |
| JP2013-068517 | 2013-03-28 |
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| CN104076031A true CN104076031A (en) | 2014-10-01 |
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| CN109916657A (en) * | 2019-04-25 | 2019-06-21 | 天津益三友色母料有限公司 | Color masterbatch sampling detecting device |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| JP6567698B2 (en) | 2015-03-10 | 2019-08-28 | セル アイディー ピーティーイー リミテッドＣｅｌｌ Ｉｄ Ｐｔｅ Ｌｔｄ | Disposable inspection kit |
| EP4023338A1 (en) | 2016-04-14 | 2022-07-06 | Roche Diagnostics GmbH | Cartridge and optical measurement of an analyte with said cartridge |
| WO2020137532A1 (en) * | 2018-12-28 | 2020-07-02 | テルモ株式会社 | Test strip and component measurement system |
| JP7273631B2 (en) * | 2019-06-26 | 2023-05-15 | 株式会社日立製作所 | Specimen property identification device, specimen property identification method, and specimen transport system |
| WO2021166471A1 (en) * | 2020-02-20 | 2021-08-26 | テルモ株式会社 | Component measurement device, component measurement device set, and information processing method |
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| JP5821885B2 (en) | 2015-11-24 |
| JP2014190926A (en) | 2014-10-06 |
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Application publication date: 20141001 |