CN105759024B - A kind of calibration method for the reading equipment for reading immunoassay device - Google Patents
A kind of calibration method for the reading equipment for reading immunoassay device Download PDFInfo
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- CN105759024B CN105759024B CN201610117982.1A CN201610117982A CN105759024B CN 105759024 B CN105759024 B CN 105759024B CN 201610117982 A CN201610117982 A CN 201610117982A CN 105759024 B CN105759024 B CN 105759024B
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
- G01N33/48771—Coding of information, e.g. calibration data, lot number
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/29—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using visual detection
- G01N21/293—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using visual detection with colour charts, graduated scales or turrets
Abstract
The present invention provides a kind of calibration method for the reading equipment for reading immunoassay device, which is characterized in that this method includes the following steps：(1), it reads at least first, second, and third color range on standard color card with standard device and obtains AOD original values；(2), it reads first, second, and third color range at least described on standard color card with the equipment for intending being calibrated and obtains AOD original values；(3), the first calibration curve is done with the AOD values of the first and second two color ranges of standard device and the AOD values of the first and second color ranges for being calibrated equipment；The value that calibration for the first time obtains the second color range for being calibrated equipment is made to the equipment being calibrated of the first calibration curve.When with such instrument come the test zone on test agent item test result when, the result of acquisition is more accurate, measuring accuracy higher.
Description
This application is Chinese patent application, the divisional application of application number 201310332981.5.
Technical field
The present invention is about a kind of calibration method of detection device, particularly, the present invention relates to immunologic function test reagent item into
The calibration method of row optical detection apparatus.
Background technology
The statement of background of the present invention is just for the sake of helping reader to understand the present invention, without forming to the prior art of the present invention
Description or elaboration.
In quick diagnosis field, exist and much detect sample (such as saliva, urine or blood using test strips or test board
Liquid etc.) in analyte device, these test strips or test board be used cooperatively with reading equipment, may be integrally incorporated to and is together
One non-removable entirety or split structure.These read equipment will be contained in the sample detected in test strips
Analyte result reflection on coupled electronic equipment, obtain the mode of resulting number, with respect to naked eyes mesh
The method of survey is more objective, and test result has many advantages, such as can to preserve, electron-transport.For example, reading equipment includes light
Element, such as CCD camera are learned, the figure in test device is obtained by optical element, installs or is connected with counting circuit, pass through
Testing result in test strips (test device) is carried out further data conversion and calculating, obtains being more easy to know by counting circuit
It is other as a result, such as patent application US 10/741, described in 416.In other embodiments, by detection device and general calculating
Machine is connected, and testing result is carried out further conversion and digital independent, this sample prescription by the relative program in setting computer
Just the larger user of usage amount, such as medical institutions.These read equipment in such as Chinese invention patent application
201210132692.6 have in 201310025671.9 and U.S. Patent application US20050168747, US20070134812
Specific description.These electronic equipments that processing is digitized to the testing result in test-strips generally comprise light-emitting device hair
Light extraction is simultaneously irradiated in test-strips and photoelectric detector detection is reflected from reagent strip or the light scattered and some central processings
Unit.Reading equipment also includes CCD or COMS image acquisition devices, image is acquired by image acquisition device, then to image
Carry out the test result in processing acquisition test-strips.
In the reading equipment for carrying out batch production reagent strip, how to realize the consistency read between equipment, reduce to the greatest extent
Error between setting is to influence an important factor of stabilization of equipment performance.Every equipment is due to each parts, such as electricity
Subcomponent, the machine error of establishment of each element installation etc. often allows the equipment of production to exist after the completion of initial equipment
Certain error, if error is more than acceptable range between these equipment, to reading the test result on immunoassay item
It can cause not prepare, the shortcomings of precision is not high.It generally requires and equipment is calibrated, every equipment is allowed all to meet unified mark
Standard, the equipment between the equipment allowed in this way between same lot number and different lot numbers are maintained at as possible in an error range, and
Meet a standard.
Invention content
The present invention provides a kind of calibration method for reading equipment, can be to the reading for the testing result for reading immunoassay item
It is calibrated between device, can allow between these equipment has preferable consistency, improves stability and the survey of detection device
The accuracy of examination.
On the one hand, the present invention provides a kind of calibration method for reading equipment, and this method includes：A kind of reading immunoassay dress
The calibration method of reading equipment put, which is characterized in that this method includes the following steps：
(1), it reads at least first, second, and third color range on standard color card with standard device and obtains AOD original values；
(2), first, second, and third color range at least described on standard color card is read with the equipment for intending being calibrated to obtain
AOD original values；
(3), the first and second color ranges of equipment are calibrated with the AOD values of the first and second two color ranges of standard device and
AOD values do the first calibration curve；The equipment being calibrated is made of the first calibration curve and is calibrated for the first time；
(4), intend being calibrated the data of the AOD values of the second color range after equipment is calibrated for the first time and original third color range
AOD data are fitted the second calibration curve with Standard Machine second and the original AOD values of third, are set with the second calibration curve to what is be calibrated
It is standby to do second of calibration.
In some preferred schemes, the second color range is between first and third color range on the colour atla.
In other preferred modes, the equipment that the marking arrangement and plan are calibrated includes optical pickup unit.
In other preferred modes, calibration method according to claim 3, which is characterized in that the light
It learns reading element and includes COMS or CCD elements.In other preferred modes, the AOD values are the average value of multiple values.
It is characterized in that, the selection of the marking arrangement carries out by the following method in other preferred modes：With the mark
First, second, and third color range on quasi- colour examining card respectively tests the reading equipment of 3 or more, the AOD for continuing at least 1 day
Value；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum be used as standard device.
In other preferred modes, the immunoassay device includes test zone and marked region.Another
In a little preferred modes, fixed antibody or antigen are included on the test zone, is included on marked region with color
Particle.In other preferred modes, the coloured particle of the band is gold colloid particles or latex colloidal solid.
In other preferred modes, the immunoassay device is further included positioned at the sample areas of marked region upstream and positioned at survey
Try the testing result control area of region downstream.In other preferred modes, wherein the test zone is located at nitric acid
On cellophane.
In other preferred modes, the color value of the first color range of the standard color card is G3, the face of the second color range
Color value is G4, and the color value of third color range is G6.
On the other hand, kind reads the calibration method of the reading equipment of immunoassay device, which is characterized in that this method includes
Following steps：
(1), it reads at least first, second, and third color range on standard color card with standard device and obtains AOD original values；
(2), first, second, and third color range at least described on standard color card is read with the equipment for intending being calibrated to obtain
AOD original values；
(3), the first and second color ranges of equipment are calibrated with the AOD values of the first and second two color ranges of standard device and
AOD values do the first calibration curve；Calibration acquisition for the first time is made to the equipment being calibrated of the first calibration curve and is calibrated equipment
The second color range value.
Preferably, if being more than the second color range value of standard device by the second color range value that step (3) obtains；Then to this
The equipment being calibrated carries out secondary calibration.Preferably, the method for secondary calibration is as follows：Be calibrated equipment by first calibration after
The AOD values of second color range and third color range are fitted the second calibration curve with Standard Machine second and the original AOD values of third；With the second school
Directrix curve does second of calibration to the equipment being calibrated.
Preferably, on the colour atla the second color range between first and third color range.
Preferably, the equipment that the marking arrangement and plan are calibrated includes optical pickup unit.Described optically reads
Element includes COMS or CCD elements.
Preferably, the AOD values are the average value of multiple values.Preferably, the selection of the marking arrangement passes through following
Method carries out：The reading equipment of 3 or more is surveyed respectively with first, second, and third color range on the standard colour examining card
Examination, the AOD values for continuing at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation most
Small is used as standard device.
Preferably, the color value of the first color range of the standard color card is G3, and the color value of the second color range is G4, third color
The color value of rank is G6.
On the other hand, the present invention provides a kind of calibration method for the reading equipment for reading immunoassay device, and feature exists
In this method includes the following steps：
The AOD values of first, second, and third original color range of standard color card are obtained with the equipment for intending being calibrated；
Bring the first calibration value that first time calibration curve obtains the machine of being calibrated into；If the second value obtained is more than standard device
Second value, the original value of acquisition is brought into the second calibration curve and is calibrated again.
In some preferred modes, the mode for obtaining the first calibration curve is：
At least first, second, and third color range on standard color card, which is read, with standard device obtains AOD original values；
First, second, and third color range at least described on standard color card, which is read, with the equipment for intending being calibrated obtains AOD originals
Initial value；With the AOD values of the first and second two color ranges of standard device and the AOD values for the first and second color ranges for being calibrated equipment
Do the first calibration curve.
In some preferred modes, the mode for obtaining the second calibration curve is：Be calibrated equipment by first calibration after
The original AOD values of AOD values and Standard Machine second and third of the second color range and third color range be fitted the second calibration curve.
In aforementioned all embodiments, at least first, second, and third color on standard color card is read with standard device
The AOD original values that rank obtains are stored in a memory carrier.It is any Jie that can be read by equipment that memory carrier, which can be,
Matter, such as disk, (2D two dimension cards, USB disk, 3 dimension cards, one-dimensional card etc. are on media.
Advantageous effect
The method of invention can effectively improve the consistency between instrument.Particularly, it is tested when with such come instrument
When the test result of test zone on reagent strip, the result of acquisition is more accurate, measuring accuracy higher.
Description of the drawings
Fig. 1 is the structure diagram of the immunochromatography reagent item in a specific embodiment of the invention
Fig. 2 is standard color card schematic diagram, and wherein Fig. 2A is the reference colour used in the present invention for not having to color range including 10
The schematic diagram of card；Fig. 2 B are the standard color card schematic diagram used in the specific embodiment of the invention；
Fig. 3 is an embodiment standard equipment 0023 and the G3, G4, G6 tri- points one of 0018 equipment being calibrated fitting
Secondary calibration curve, the calibrating curve equation formula of acquisition is y (0023)=0.1811+1.020X (0018)；
Fig. 4 is that an embodiment Plays set the 0023 standby G3, G4, G6 tri- points one of the fitting of 0021 equipment with being calibrated
Secondary calibration curve；The calibrating curve equation formula of acquisition is y (0023)=0.5113+0.9745X (0020)
Fig. 5 is that an embodiment Plays set the 0023 standby G3 of 0018 equipment fitting with being calibrated, and 2 points of G6 is primary
Calibration curve；The calibrating curve equation formula of acquisition is y (0023)=0.0.03819+1.026X (0018)
Fig. 6 is that an embodiment Plays set the 0023 standby G3 of 0018 equipment fitting with being calibrated, and 2 points of G6 is primary
Calibration curve；The calibrating curve equation formula of acquisition is y (0023)=- 0.2304+1.017X (0020)
Linear relationship charts of the Fig. 7 between the color range of colour atla used in the present invention and AOD values；
Fig. 8 is that an embodiment Plays set the 0023 standby G3, G4 2: first of the fitting of 0018 equipment with being calibrated
Secondary calibration curve；The calibrating curve equation formula of acquisition is y (0023)=0.4748+0.9365X (0018)
Fig. 9 is that an embodiment Plays set the 0023 standby G3, G4 2: first of the fitting of 0021 equipment with being calibrated
Secondary calibration curve；The calibrating curve equation formula of acquisition is y (0023)=- 0.9206+1.398X (0020)
Figure 10 is the AOD mean values and mark of the G4 values and original G6 after 0018 equipment is calibrated for the first time in embodiment
Second of calibration curve of the G4 of quasi- instrument, G6 fitting, the calibrating curve equation formula of acquisition is y (0023)=- 0.2194+
1.045X(0018)。
Figure 11 is the AOD mean values and mark of the G4 values and original G6 after 0021 equipment is calibrated for the first time in embodiment
Second of calibration curve of the AOD mean values fitting of the G4 of quasi- instrument, G6.
The G3, G4 2: first that Figure 12 is an embodiment standard equipment 0023 and the equipment 0018 being calibrated is fitted
Secondary calibration curve；
The G3, G4 2: first that Figure 13 is an embodiment standard equipment 0023 and the equipment 0021 being calibrated is fitted
Secondary calibration curve；
G4 values, the AOD mean values of G6 and standard after Figure 14 is calibrated for the first time for 0018 equipment in an embodiment are set
Second of calibration curve of the AOD mean values fitting of standby G4, G6.
Figure 15 is the AOD mean values and reference instrument of G4, G6 after 0021 equipment is calibrated for the first time in embodiment
G4, G6 fitting second of calibration curve.
Figure 16 is the flow chart that equipment Alignment obtains first time and the second calibration curve.
Figure 17 carries out the flow chart of equipment Alignment for Software for Design.
Reference sign
Test zone 30, testing result control area 40, sample absorbance region 50, carrier 20, marked region 60, sample is applied
Add region 10, color range 100.
Detailed description
Test device
" test device " described in the present invention refers to those by reaction chemically or physically, can detect or assay samples
The equipment of middle analyte, such device can be test-strips (Fig. 1), include the test device of test-strips or test examination
Agent.Some test agents are generally comprised in test device, these test agents and analyte carry out directly or indirectly
Then there are color change or other variations, thus by naked eyes or machine in test device in test device in reaction
The variation that the result of test zone is judged or test zone occurs is analyzed, and represents to be divided in sample so as to obtain
Analysis substance whether there is or existing quantity.
Many immunoassay devices are well known to those skilled in the art to be used for detecting analyte in sample.About inspection
More peptide or proteins in patient's sample are surveyed, immunoassay device and method are commonly used, and see United States Patent (USP) 6,143,576；
6,113,855；6,019,944；5,985,579；5,947,124；5,939,272；5,922,615；5,885,527；5,851,
776；5,824,799；5,679,526；5,525,524；With 5,480,792, each patent content is completely included in ginseng
It examines in document, including all tables, figure and claim.These device and method can utilize various label macromoleculars to exist
Sandwich assay is generated and the relevant signal of target analyte presence or amount with competition or non-competing test format.In addition,
Some way and equipment, such as biosensor and optics immunodetection can not need to the macromolecular of label and can detect
Presence of analyte or existing quantity.See United States Patent (USP) 5,631,171；With 5,955,377, each patent content by
In complete listed in reference, including all tables, figure and claim.Those skilled in the art think to test
Device includes but not limited to Beckman, Abbott Laboratories AxSym, the immune detection system of Roche ElecSys, Dade Behring tomographic systems
System can carry out immune detection described here.
It is preferred that immunodetection evaluation of markers object, although other methods are also well known to those skilled in the art (such as survey
Measure marker rna level), but most preferably sandwich immunoassay.Specific antibody and its inspection by correspondence markings object
It surveys specific binding and can usually detect the presence of marker or existing quantity.The immune combination of marker and specific antibody
It can be detected directly or indirect detection.Such as immunodetection, biological detection analysis needs the method detected, most common fixed
The method of amount is to combine a kind of enzyme, and fluorophor or other macromolecular complex mass-energy form antibody-label object.Detectable label object
Including the macromolecular substances (such as fluorophor, electrochemical label, metallo-chelate etc.) that can be inherently detected, also include generating
The indirect detectable molecule (such as enzyme is as horseradish peroxidase, alkaline phosphatase etc.) of detectable response product can by one
Detection binding molecule specific bond (such as biotin, digoxin, maltose, oligohistidine, 2,4- dinitrobenzenes,
Phenylarsonic acid, ssDNA, dsDNA etc.).Particularly preferred detectable marker be such as United States Patent (USP) 5,763,189,6,238,
Fluorescent latex grain described in 931 and 6,251,687 and international publication WO95/08772, above-mentioned patent and publication is all
By in complete listed in reference.Demonstration conjugation in particle can be mentioned hereinafter.Including fluorescence or the optical label that feels cold, gold
Belong to, dyestuff, the direct label of radionuclide and analog is combined with antibody, and indirect labels include various this field numerical value
Enzyme, such as alkaline phosphatase, horseradish peroxidase and analog.
The part of the present invention is also belonged to come specific detection analyte using fixed antibody.Used herein of art
Language " solid phase " is a Generalized Material, it include solid, semisolid, gel, film, film, mesh, felts, compound,
Particle, test paper and analog etc., those skilled in the art are generally used for the substance of absorption macromolecular.Solid matter can be non-porous
Or there is hole.Suitable solid phase includes those substances ripe and/or in solid phase binding detection as solid phase.For example,《It is immune
Analysis》All as the present invention reference or a part (see：Example 9 of Immunoassay of chapter,
E.P.Dianiandis and T.K.Christopoulos eds.,Academic Press:New York).Suitable solid phase
Example includes film, and filter, cellulose paper, bead (including polymerization, latex and paramagnetic particle), glass, silicon chip is micro-
Grain, nano-particle, such as Tenta gels, Agro gels, PEGA gels, SPOCC gels and porous disc (see, example, Leon et
al.,Bioorg.Med.Chem.Lett.8:2997,1998；Kessler et al.,Agnew.Chem.Int.Ed.40:165,
2001；Smith et al.,J.Comb.Med.1:326,1999；Orain et al.,Tetrahedron Lett.42:515,
2001；Papanikos et al.,J.Am.Chem.Soc.123:2176,2001；Gottschling et al.,
Bioorg.Med.Chem.Lett.11:2997,2001).Antibody can be fixed on various solid carriers, for example, it is magnetic or
The matrix granule of chromatographic grade, detection plate surface (such as microwell plate), solid substrate material or film (such as plastics, nylon, paper) etc..It is logical
The antibody that a kind of antibody or a variety of matrix arrangements are coated on solid phase carrier is crossed, forms test-strips.These test-strips are then soaked
Enter to detect in sample, then can measure signal, such as color spot by getting express developed to generate with detecting step.When using a variety of detections
During mode, many dividually addressable positions can be generated on single solid phase carrier, each position is corresponding not
Same marker, each position include the antibody combined with these markers.Term " discrete " described here, which refers to, not to be connected
Continuous surface region.That is to say, if being not belonging to the boundary in any one region entirely around each area in two regions
Domain, i.e. two pieces of surface regions are independent from each other, discrete.Terminology used here " independent address " refers to mutually discrete surface
Region can obtain nonspecific signal on these areas.
In immunoassay device is chromatographed, test zone 30, marked region 90 are generally comprised.In some modes, test
Device further includes sample applying zone 10 and suction zone 50.Include mark substance, such as colloidal gold, breast on marked region
Glue or colored particle.In other modes, test zone 30 is included on solid phase carrier 20, such as film, filter, cellulose
Paper, bead (including polymerization, latex and paramagnetic particle), glass, silicon chip, particle, on nano-particle.In other sides
In formula, solid phase carrier is film, such as nitrocellulose filter, nylon membrane etc..Participation is fixed in some modes, on test zone
The antibody of immune response.In some modes, closing on for test zone can also set control area 40, which is used for surveying
Test result on examination region can be made whether effectively to verify.
Test zone
Here say " test zone " and refer to through the reading to test zone, can obtain represent sample in be analyzed
Substance whether there is or the region there are quantity.There can be multiple test zones in test device, on each test zone
For the detection of different analytes.In some modes, different types of quilt can also be directed on a test zone
The detection of analyte.In some embodiments, test zone can be located on the solid carrier in test device.Test section
Form can be lines, point, spot, block, the pattern of geometry shape or geometry symbol, such as a length of 0.5-1.5 centimetres, wide
Spend the lines for 0.2-5 millimeters.On test zone, test result, this test can be obtained by human eye or instrument
As a result it can directly and/or indirectly represent in sample with the presence or absence of analyte or existing quantity and/or analyte
Type.Corresponding with test zone is exactly testing and control region, and whether which can effective to the result of test and surveys
Whether trial assembly is put effectively controls.
In some modes, represent a kind of in sample by variation display color chemically or physically on test zone
A variety of analytes whether there is or with existing quantity.How display color is that this field is general on these test zones
What technical staff was known.The most commonly used is occurring on test zone or fixed colored particle, for example, colloidal gold, nano particle or
Due to the accumulation or fixation of colored particle, color is occurred as soon as in test zone for latex particle.Generally, colored particle number with
There are the quantity of analyte, there are correlations in sample.Other than there is colored particle, it can also occur in test zone
It chemically reacts and generates color, such as redox reaction occurs in the case of with oxidation substrates, allow substrate that color occurs
Variation.Also there is color in test zone in this way.Equally, after chemical reaction the depth of color also with analyte in sample
Concentration have correlation.
Here correlation can be positive correlation, or it is negatively correlated.For example, color is deeper or denseer or face
Coloured particles are more or the light that sends out is stronger, and the quantity of analyte is also more in corresponding sample.On the contrary, color it is deeper or
Denseer or colored particle is more, and the light sent out is stronger, and the quantity of analyte is also deposited less or not even in corresponding sample
.
Specific embodiment
With specific embodiment, the present invention is described further below, but these explanations are not to structure of the present invention
Into any restrictions.
Material：
1. standard color card (Fig. 2A and Fig. 2 B):The application method of more than standard color card：In actual test, usually test
Shade on reagent strip on test zone 30 (passes through naked eyes) compared with being carried out qualitatively with standard color card, and in standard color card
Which color approaches, and is considered as test result is how many.Under double antibody or antigen sandwich method, if the color category in fruit test-strips
In G1-G2, it is generally recognized that it is negative, if belonging to G3, sometimes it is considered positive, is sometimes considered negative, sometimes needs
It to be tested again, if test result belongs to G4-G11, it is considered that be positive result.Certainly, if competition side
Method detects, and color value is opposite with test result.Generally, the power of color is related to concentration in sample, and color is stronger, dense in sample
Degree is bigger；If competition immunologic detection method, color is stronger, and concentration is smaller in sample.In the following all implementation of this fermentation
In example, the standard color card described is all the colour atla that number is 0123.
If when using the color value on equipment read test item on test zone 30 is read, it is also desirable to reading be allowed to set
(AOD represents the transforming numerical of the picture signal power of colored line to the AOD values of the standby test zone read, with same equipment
The basic essence of AOD values for reading same lines or color range is the same) with the value of concentration in sample it is linear relationship, it can quantify and detect
Test value, it is also desirable to by being read to color come the concentration in linear corresponding sample, it is of course also possible in qualitative detection sample
Value.It when being detected to reading equipment, is generally detected with standard color card, sees reading whether on standard color card
Colored line (color range) has good discrimination, such as can be very good to distinguish G1 and G2, such as to each face in colour atla
Color gradient has at least 99.9% differentiation, can realize that positive and negative 3SD does not have normal state intersection etc..If it realizes to each on colour atla
Lines (G1-G11) have good discrimination, then can also have to the color on the test zone in test-strips good
Discrimination.
2. read equipment：
The reading equipment of the present invention all using COMS cameras and coordinates software programming and program write-in and other hardware
Setting, allow the AOD values of colored line on COMS collecting test items, then by the conversion with concentration, finally tested
Value.All parts are all same batch used by more than equipment.
Although software and hardware is all consistent as possible used by them, however, there remains unite to reading equipment
One calibration allows the variance between the equipment after being calibrated to be less than 5% or other acceptable ranges or value.
Table 1：Definition
| With reference to | Description |
| G3,G4,G6,G8,G10 | The color range grade (Fig. 2) of standard color card |
| C.V | Coefficient of dispersion |
| SD | Standard deviation |
Examples of implementation 1：The selection of standard device
It randomly selects 5 and reads equipment (number：0023,0025,0021,0018,0020), on standard colour examining card
G3, G4, G6 respectively test 5 multifunction immunity detectors, continue to collect test data AOD values in 5 days.Pass through 5 day datas
Analysis result see that the CV values of No. 0023 machine are minimum (0.83%), and and other 4 instrument AOD mean values SD deviations it is minimum.Most
No. 0023 machine is selected afterwards as Standard Machine (specific test data summary).
Examples of implementation 2：The collection of equipment and the initial data of calibrator (-ter) unit being calibrated
3 are read equipment (standard device 0023 and the equipment 0018 and 0020 being calibrated) and are surveyed respectively using standard test panel
Block (Fig. 2) and obtain original AOD values, the raw value such as following table of acquisition：
Table 2：The original AOD values of distinct device
After being calibrated following with standard device to the equipment being calibrated, standard of comparison equipment and setting after being calibrated
The standby number of degrees to colour atla see whether they meet the requirement of setting, such as SD, CV value or differ% values.
Examples of implementation 3：Using standard device to being calibrated the three-point calibration method of equipment
1), with the G3 of Standard Machine 0023, tri- point AOD mean values of G4, G6 and the G3, G4, G6 tri- for being calibrated machine 0018 and 0020
Point AOD mean values do linear fit, obtain linear fit calibration equation (such as Fig. 3 and 4).
The data analysis of reading equipment after being calibrated by G3, G4, G6：
After 3 points of G3, G4, G6 calibration, No. 0020 equipment in G3, the AOD values of G4 and 0023 Standard Machine G3, G4AOD's
Difference (differ%) (being respectively 11.4% and 6.97%) still above 5%, calibration result is less desirable, although No. 018
The difference of test value and standard device after equipment Alignment meets the requirements.The equipment reading being obtained by after calibration of the value of AOD
The AOD values of G3, G4, G6 color ranges on unified standard colour atla are taken, as a result see the table below.
Table 3：The comparative analysis of each equipment and the AOD values of standard device after calibration
Examples of implementation 4：The comparison of two point calibration methods
One, two point calibration method of G3, G6
1), with the two point AOD mean values of G3, G6 of Standard Machine 0023 (AB130023-SET1) with being calibrated machine 0018
(AB130018-SET1) and two point AOD mean values of the G3 of 0020 (AB130020-SET1), G6 do linear fit, obtain linear fit
Calibration equation (such as Figures 5 and 6).
2), the data analysis after G3, G6 calibration：
No. 0020 equipment is in the AOD values of G4 and the difference of the G4AOD of 0023 Standard Machine after the calibration of G3, G6
For differ% still above 5% (12.62%), calibration result is less desirable.Although the numerical value after the calibration of No. 0018 equipment
Deviation (is less than 5%) within the acceptable range.The equipment reading unified standard colour atla being obtained by after calibration of the value of AOD
The AOD values of upper G3, G4, G6 color range, as a result see the table below.
Table 4：The comparison of each equipment and the AOD values of standard device after calibration
2nd, G3 and G4；Two point calibration method of G4 and G6
With reference to method identical with G6 to G3 above, to G4, G6；With 2 points of reading equipment (0020 to being calibrated of G3, G4
With 0018) calibrated, 023 be used as standard machine.
After 2 points of calibrations of G4, G6,0020 and 0018 in the AOD values of G3 and the difference of 0023 Standard Machine G3AOD
For differ% still above 5%, calibration result is less desirable.Wherein, 0018 difference differ% is in the level of G3
7.35%, 0020 difference differ% is -24.98% (specific data summary) in the level of G3, but in other color range G4
It is less than 5% with the difference in G6 levels.
After the calibration of G3, G4,0018,0020 G6AOD values and 0023 Standard Machine G6AOD difference differ% still
So it is more than 5%, calibration result is less desirable (specific data summary).Wherein, 0018 difference differ% is in the level of G6
It is 6.46%, 0020 difference differ% is -34.09% in the level of G3.
Conclusion：
By the comparison of 4 kinds of calibration methods above, we can be obtained as drawn a conclusion：
(1), G3G4G6 calibration curves -- the value of G3 and G4 is raised after calibration, big with the differ% of the mean value of adjusting machine
In 5%.
(2), after G3G6 calibrations -- the differ% of the mean value of the value and adjusting machine of the G4 of equipment is more than 5% after calibration.
(3), G4G6 is calibrated -- and the differ% of the mean value of the value and adjusting machine of the G3 of equipment is more than 5% after calibration.
(4), G3G4 is calibrated -- and the differ% of the mean value of the value and adjusting machine of the G6 of equipment is more than 5% after calibration.
Examples of implementation 5：2 points of multiple calibration methods
First, colour atla AOD values are analyzed
In order to solve problem above, we have carried out the measure of AOD to the standard color card used, we have surprisingly found that,
The AOD values of these colour atla gradients are not linear relationship.For example, in the figure 7, the color ladder distribution of G2-G3-G4-G6-G8 is originally
Body is not linear, G3 and G4 gradients are small can be fitted to linearly, and the gradient of G4 and G6, G8 can be individually for greatly linearly, so
Secondary calibration can be tried out come the problem of making up primary calibration.
2nd, second compensation is calibrated
Method one,
1), first with the G3 of standard device 0023, the AOD values of G4 are fitted school to being calibrated equipment (0018 and 0020)
Directrix curve.With data fitted calibration curve part (Fig. 8 and Fig. 9) of G3G4
2) the original G6 data of equipment are calibrated and then with the data of the AOD values for being calibrated the G4 after the calibration of equipment and
With G4, G6 fitted calibration curve of Standard Machine 0023.(such as Figure 10 and 11)：
The equipment being calibrated by G3 and G4 calibration after, then with calibration after G4 data and original G6 data and Standard Machine
0023 G4G6 data are the G3 after the calibration of fitted calibration curve acquisition, G4, G6AOD mean values and G3, the G4 of Standard Machine 0023,
The AOD values differ% of G6 is less than 2%, and calibration result is preferable, is acceptable standard.
Table 5：Equipment and comparative analysis of the standard device to the AOD of color range on each standard color card after calibration
Method two,
With by G3, the G4 after G4 fitted calibrations, G6 data with can be with after Standard Machine G4G6 fitted calibration curves-calibration
The G6 data values for the data of G6 being withdrawn into Standard Machine are realized<5%.This method is more convenient.Record standard machine G3 is needed,
The mean value of G4, G6.By being calibrated the value of machine G3, G4 and Standard Machine G3, G4 fits first curve, for the number of G4 and G6
According to being fitted a curve again.Realize panchromatic degree approximate calibration.
1) by data fitted calibration curve of G3, G4 value of standard device to the equipment being calibrated, be specifically shown in Figure 12 and
13。
2) secondary calibration does linear fit with primary standard machine G4, G6 again with the data after G4, G6 primary calibration, obtains
Standard curve such as Figure 15 and 14.
Instrument does and intends after G3 and G4 calibrations, then with G4 the and G6 data after calibration and the G4G6 data of Standard Machine 0023
The G3 after the calibration that calibration curve obtains, G4 are closed, G6AOD mean values and the differ% of Standard Machine 0023 are less than 2%, calibration result
It is preferable.Specifically it see the table below.
Table 6：Equipment and comparative analysis of the standard device to the AOD of color range on each standard color card after calibration
Embodiment 6, sensitivity analysis
The different color ranges of same group of standard color card are tested using the equipment (0018) after calibration can be to G1-G8's
6 gradients have 99.9% discrimination.Realize that +/- 3SD does not have normal state intersection.As a result it see the table below.
| G1 | G2 | G3 | G4 | G6 | G8 | |
| AVG_AOD | 0.903 | 1.554 | 2.304 | 4.930 | 17.431 | 45.892 |
| STDEV | 0.072 | 0.044 | 0.063 | 0.076 | 0.152 | 0.069 |
| CV | 7.958% | 2.799% | 2.734% | 1.540% | 0.872% | 0.150% |
| +3SD | 1.119 | 1.685 | 2.493 | 5.158 | 17.886 | 46.098 |
| -3SD | 0.688 | 1.424 | 2.115 | 4.702 | 16.975 | 45.685 |
It, can be for synthesis by the measurement of the initial data to initial 3 detectors and the data collection for continuing 5 days
Instruments of the discrete differ% within +/- 15% is calibrated.
By the foundation and verification to multifunction immunity detector calibration method model, pass through in the instrument production phase to school
Inter-instrument agreement index G3, G4, G6AOD mean value and Standard Machine 0023 are realized in the foundation of quasi- test card secondary calibration formula
G3, G4, G6AOD mean value differ% are less than 2%.It is consistent after production phase functionality detection-phase could be provided as calibration
Property be less than +/- 5%
It realizes the secondary calibration to detector, needs first to establish Standard Machine, output calibration test is stuck in Standard Machine test
G3, the AOD mean values of G4, G6.The machine that is calibrated is stuck in the calibration test when producing instruments and tests 32 acquisitions, be calibrated machine
G3, realized by calibration method model measurement software to being calibrated the secondary calibration of machine, and preserve after the aod mean values of G4, G6
Calibration parameter.
The sensitivity of multifunction immunity detector, the test for standard testing colour atla color range can be realized from G1-G8's
99.9% discrimination.
The all patents and publications mentioned in description of the invention all represents that these are the public technologies of this field, this hair
It is bright to use.All patents referred to herein and publication are all equally listed in bibliography, with each publication
It is specific to be individually referenced equally.The present invention described here can lack any element or multiple element, and one
It is realized in the case of kind limitation or a variety of limitations, this limitation here is not particularly illustrated.Such as art in each example here
Language "comprising", " essence by ... form " and " by ... form " can be replaced with remaining 2 term of one of both.Here it adopts
Describing mode carried out by terms and expressions mode, and be not limited except as, also indicate that this book describes without any intention here
These terms and explain and eliminate any equivalent feature, but it is recognised that can be in the model of the present invention and claim
Any suitable be altered or modified is done in enclosing.Preferably implement it is appreciated that examples of implementation described in the invention are all some
Example and feature, any those of ordinary skill in the art can be changed and become according to some are done under the marrow of the invention that describe
Change, these are changed and variation is recognized as belonging to the scope of the present invention and independent claims and appended claims are limited
In the range of.
Claims (38)
1. a kind of calibration method for the reading equipment for reading immunoassay device, which is characterized in that this method includes the following steps：
(1), it reads at least first, second, and third color range on standard color card with standard device and obtains AOD original values；
(2), it reads first, second, and third color range at least described on standard color card with the equipment for intending being calibrated and obtains AOD originals
Initial value；
(3), with first and second color ranges of the AOD values of the first and second two color ranges of standard device with intending being calibrated equipment
AOD values do the first calibration curve；The equipment being calibrated with the first calibration curve to plan, which is done calibration for the first time and obtained, to be intended being calibrated setting
The value of the second standby color range.
2. if according to the method described in claim 1, obtained by step (3) the second of the standard device of the second color range value
Color range value；Concentration fit equation then is carried out to the equipment being calibrated.
3. according to the method described in claim 1, the second color range is between first and third color range on the colour atla.
4. according to the method described in claim 2, the second color range is between first and third color range on the colour atla.
5. according to the method described in claim 1, the equipment that the standard device and plan is calibrated includes optical pickup unit；
The optical pickup unit includes COMS or CCD elements.
6. according to the method described in claim 2, the equipment that the standard device and plan is calibrated includes optical pickup unit；
The optical pickup unit includes COMS or CCD elements.
7. according to the method described in claim 3, the equipment that the standard device and plan is calibrated includes optical pickup unit；
The optical pickup unit includes COMS or CCD elements.
8. according to the method described in claim 4, the equipment that the standard device and plan is calibrated includes optical pickup unit；
The optical pickup unit includes COMS or CCD elements.
9. calibration method according to claim 1, which is characterized in that the AOD values are the average value of multiple values.
10. calibration method according to claim 2, which is characterized in that the AOD values are the average value of multiple values.
11. calibration method according to claim 3, which is characterized in that the AOD values are the average value of multiple values.
12. calibration method according to claim 4, which is characterized in that the AOD values are the average value of multiple values.
13. calibration method according to claim 5, which is characterized in that the AOD values are the average value of multiple values.
14. calibration method according to claim 6, which is characterized in that the AOD values are the average value of multiple values.
15. calibration method according to claim 7, which is characterized in that the AOD values are the average value of multiple values.
16. calibration method according to claim 8, which is characterized in that the AOD values are the average value of multiple values.
17. calibration method according to claim 1, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
18. calibration method according to claim 2, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
19. calibration method according to claim 3, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
20. calibration method according to claim 4, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
21. calibration method according to claim 5, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
22. calibration method according to claim 6, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
23. calibration method according to claim 7, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
24. calibration method according to claim 8, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
25. calibration method according to claim 9, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
26. calibration method according to claim 10, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
27. calibration method according to claim 11, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
28. calibration method according to claim 12, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
29. calibration method according to claim 13, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
30. calibration method according to claim 14, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
31. calibration method according to claim 15, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
32. calibration method according to claim 16, which is characterized in that the selection of the standard device passes through with lower section
Method carries out：The reading equipment of 3 or more is tested respectively with first, second, and third color range on the standard colour examining card,
Continue the AOD values of at least 1 day；By the analysis result of data, CV values it is minimum and and other equipment AOD mean values deviation it is minimum
As standard device.
33. calibration method according to claim 1, which is characterized in that the immunoassay device includes test zone
And marked region.
34. calibration method according to claim 33, which is characterized in that include on the test zone fixed anti-
Body or antigen include with coloured particle on marked region.
35. calibration method according to claim 34, which is characterized in that the coloured particle of the band is gold colloid
Grain or latex colloidal solid.
36. calibration method according to claim 33, which is characterized in that the immunoassay device is further included positioned at mark
Remember the sample areas of region upstream and positioned at the testing result control area in test zone downstream.
37. calibration method according to claim 1, which is characterized in that first, second on the standard color card and
Three color ranges correspond to G3, G4 and G6 respectively.
38. the calibration method according to claim 37, which is characterized in that the standard device read standard color card up to
The AOD original values that few first, second, and third color range obtains are stored in a storage medium.
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| CN201310332983.4A Active CN104297469B (en) | 2013-07-15 | 2013-08-01 | Immune reading device and calibration method of the same |
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| CN107525926B (en) * | 2016-05-07 | 2020-03-27 | 贵州福斯特生物科技有限公司 | Immunochromatography detection method and detection system |
| CN106053792B (en) * | 2016-05-07 | 2018-05-08 | 昆山迪安医学检验实验室有限公司 | Immunity chromatography detection test paper and kit |
| EP3685145B1 (en) | 2017-09-19 | 2024-01-03 | Beckman Coulter, Inc. | System for analog light measuring and photon counting in chemiluminescence measurements |
| CN111795959A (en) * | 2020-07-24 | 2020-10-20 | 芯动森林(重庆)医疗科技有限公司 | Colloidal gold and fluorescence two-in-one data acquisition device and method |
| CN112462078A (en) * | 2020-11-16 | 2021-03-09 | 三诺生物传感股份有限公司 | Method for calibrating inter-platform difference of fluorescence immunoassay analyzer |
| CN112101830B (en) * | 2020-11-23 | 2021-04-23 | 广州万孚健康科技有限公司 | Preparation and calibration method and system of test strip for detecting HIV antibody and storage medium |
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