CN1455242A - Quantitative measuring apparatus and method of gold colloid immuno chromatography - Google Patents
Quantitative measuring apparatus and method of gold colloid immuno chromatography Download PDFInfo
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- CN1455242A CN1455242A CN 03137101 CN03137101A CN1455242A CN 1455242 A CN1455242 A CN 1455242A CN 03137101 CN03137101 CN 03137101 CN 03137101 A CN03137101 A CN 03137101A CN 1455242 A CN1455242 A CN 1455242A
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Abstract
The detecting device comprises of the reagent strip, the reagent plate, the scanner, the data processing device, the output device and IC card. The reagent strip with the quality control strip and the detection strip being coated is stuck on the reagent plate fixedly. The density and the scanning time are stored on the IC card. With the parameters on the IC card being read out, the data processing device control the scanner to scan the reagent strip and the signals collected are transferred back to the data processing device. After the optical density value of the quality control strip and the detection strip being recognized, calculated and analyzed, the result is transferred to the output device. The invented detecting device provides the quantified detection with the precision and the accuracy accorded with the requirement.
Description
One, affiliated technical field
The present invention relates to a kind of clinical medicine detection and use device, specifically relate to a kind of colloidal gold immunochromatographimethod pick-up unit that can carry out quantitatively complete and half-quantitative detection, the invention still further relates to a kind of detection method that is used for this pick-up unit.
Two, background technology
Colloidal gold immunity chromatography (GICA) is a kind of quick clinical diagnosis technology of foreign medical science circle rise in recent years, its feature is single part mensuration, and is simple, fast, except that commercially available reagent without any need for instrument and equipment, a few minutes result that can detect by an unaided eye, the holding time is long.The varieties of reagent of GICA is also abundant day by day, tens of kinds have been reached at present, comprise alpha-fetoprotein (AFP), human chorionic gonadotrophin (hCG), luteinizing principle (LH), hepatitis B surface antibody (HBsAg), cocaine (Cocaine), hemp (Maruuana) etc., and the trend that continues development is arranged.
Because present clinical examination only depends on range estimation, so colloidal gold immunity chromatography measures and generally can only be used for qualitatively judging, and range of application has been subjected to very big restriction.Because the improvement of the selected and manufacture craft of raw material can have been prepared the GICA reagent that can be used for sxemiquantitative and full quantitative measurement, make detection by quantitative become possibility recently.
Yet up to the present, also do not have a kind of colloidal gold immunochromatographimethod device that can be used for automatic ration to come out, more do not have a kind of colloidal gold immunochromatographimethod quantitative detecting method that matches with it.And existing reagent strip can not be directly used in and carry out detection by quantitative because the concentration of quality control band bag quilt is uncertain.
Three, summary of the invention
Purpose of the present invention just provide a kind of can be suitable for complete quantitatively and the colloidal gold immunochromatographimethod detection by quantitative device of half-quantitative detection use.
A kind of colloidal gold immunochromatographimethod quantitative detecting method that is used for this detection by quantitative device is provided, and is another goal of the invention of the present invention.
Colloidal gold immunochromatographimethod detection by quantitative device of the present invention is made up of several parts of colloidal gold immunochromatographimethod reagent strip, agent plate, scanister, data processing equipment, output unit and IC-card.
The colloidal gold immunochromatographimethod reagent strip fixedly sticks on the agent plate, constitute the reagent card that uses for detection by quantitative jointly with agent plate, the past backward on reagent strip, head and the tail are aligned in sequence with sample application zone, glass fibre membrane district, nitrocellulose filter district and thieving paper district with overlapping between the each several part, be adsorbed with dry gold mark antigen in the glass fibre membrane district, be coated with the quality control band and the detection band that is widened to 1～6mm of known gold labeling antibody concentration in the nitrocellulose filter district.
Can on agent plate, paste a reagent strip and make the standard reagent card, also can be on agent plate two reagent strips of parallel stickup, make the bigeminy reagent card.Can wrap on the reagent strip by a quality control band and make simple substance control reagent strip, also can wrap by two quality control bands and make two quality control reagent bars.
Storage has the quality control band bag by the concentration of golden labeling antibody on IC-card, and the scanister parameters such as time that begin to scan, and data processing equipment can read the parameter on the IC-card and be stored in the memory.
Data processing equipment gated sweep device scans the reagent strip on the reagent card, and with the light signal that collects through photoelectricity and mould/number conversion, be converted to digital signal, transmit back data processing equipment by interface, data processing equipment is discerned and is calculated and technical Analysis by the concentration that concentration detects band according to the quality control band bag of storing the optical density value at quality control band and detection band place automatically, gives output unit with result transmission.
Scanister is the CIS contact-type image sensor.The CIS contact-type image sensor is a kind of new optical sampling technology, its luminophor is made up of 300～600 compact arranged red, blue, green three-color LED lamp banks, the light that these LED lamps are sent mixes the white light source that has just produced standard, light source shines directly into quality control band and detection is with, its reflected light is directly received by polycrystalline sheet sensor by light pipe, produces the sampled signal of high-fidelity.Therefore, CIS belongs to point-to-point sample mode, can not produce owing to optics repeatedly reflect the distorted signals of bringing, simultaneously, CIS does not still have the plane picture sampling of the depth of field, problems such as caused background interference can not occur sampling yet.
The detection band of colloidal gold immunochromatographimethod reagent strip is because of the difference of gold particle diameter size, the corresponding wavelength of its color is greatly between 600～700nm and 400～450nm scope, at the wavelength coverage that detects band, usually the wavelength set of LED lamp in the scope of 625～430nm.
The light signal that is collected by scanister is after photoelectricity and mould/number conversion, digital signal is transmitted back data processing equipment by interface, data processing equipment is at first discerned the optical density value of quality control band 450nm wavelength under the unified management of CPU automatically, and with optical density value OD
Quality ControlBe stored in the memory, then be with the optical density value that is in the 450nm wavelength to discern automatically detecting, and with optical density value OD
DetectBe stored in the memory.
Because material prices such as the employed antigen of GICA, antibody and collaurum are all very expensive, what therefore the area of detection band can only be done is very little, almost be bordering on straight line, on the spuious background of moulding materials formation such as the end and nitrocellulose filter, have the dynamic infiltration of dilution, sample liquid and collaurum etc. simultaneously again, make whole chromogenic reaction be in all the time among uneven, the dynamic process that do not have to stop, detect the optical density value of band and the relation between the concentration and change in time and taking place to change.By a large amount of experimental observations, developing the color 5 minutes later particular moments, satisfy linear relationship substantially between the optical density value of detection band and the concentration, it is more suitable that this section period is scanned.The concentration value that detect band this moment can calculate according to following formula:
So far finish the colloidal gold immunochromatographimethod reagent strip and detected the full detection by quantitative of being with.Data processing equipment can also carry out technical Analysis to testing result according to full detection by quantitative result, and the analysis and judgement report is flowed to output unit.
Because the difference of the raw material of production reagent strip and the difference on the controlling of production process, the time that is the optimum linear relation between the detection band optical density value of each batch colloidal gold immunochromatographimethod reagent strip product and the concentration also can slightly have any different, therefore, the optimum linear that need all measure this batch product when each batch product export concerns the time, and with its as be identified at sweep time with IC-card that reagent strip matches on.
The interface of transmission signals can adopt multiple modes such as serial, parallel or network connection, and the present invention has adopted the protocol mode of USB, can save the external power source of sampling with scanister like this, thus carrying device and use when being convenient to go out at OIR.
Colloidal gold immunochromatographimethod quantitative detecting method of the present invention may further comprise the steps:
A) Quality Control of quality control band gold labeling antibody concentration C, the scanister with the colloidal gold immunochromatographimethod reagent strip bag quilt stored on the IC-card begins to import sweep time in the data processing equipment;
B) there is some the reagent strip of detected sample to put into scanister, and picks up counting automatically;
When c) arriving sweep time, data processing equipment driven sweep device CIS contact-type image sensor scans reagent strip, and the light signal that scanning is obtained is converted to digital signal after photoelectricity and mould/number conversion, is transferred to data processing equipment;
D) optical density value is with in quality control band optical density value in the automatic discriminating digit signal of data processing equipment and detection, and obtains being positioned at the quality control band optical density value OD at 450nm wavelength place
Quality ControlBe with optical density value OD with detecting
Detect
E) according to OD
Quality Control, OD
DetectAnd C
Quality ControlNumerical value, calculate and detect the band concentration C
Detect, and and then obtain the technical Analysis data;
F) analysis result is transferred to output unit, the output result.
Colloidal gold immunochromatographimethod detection by quantitative device provided by the invention, can carry out detection by quantitative to the detection band concentration of colloidal gold immunochromatographimethod reagent strip easily, investigate by a large amount of clinical trials, the result shows that its precision and accuracy all meet the quantitative measurement requirement.
The present invention adopts the CIS contact-type image sensor to sample to detecting band, reflected light directly is converted to analog electrical signal, owing to be close touch sampling, simulating signal seldom has decay and distortion, and reagent strip mould the inhomogeneous background noises that produce such as the end and nitrocellulose filter, also by quality control band sampling post-processed has been obtained good restraining and elimination, sampling precision greatly improves.
Adopt colloidal gold immunochromatographimethod detection by quantitative device, can reach 0.195mIU/mL by detected detection band minimal detectable concentration, be better than the minimal detectable concentration of traditional enzyme linked immunosorbent assay 0.5mIU/mL, detection sensitivity obviously improves.
Four, description of drawings
Fig. 1-1 is to Fig. 1-the 8th, when detection by quantitative device of the present invention is applied to a kind of Prenatal Screening check, and each operation interface synoptic diagram of the detection system of installing in the data processing equipment.
Five, embodiment embodiment 1:
Colloidal gold immunochromatographimethod detection by quantitative device is made up of human chorionic gonadotrophin (hCG) colloidal gold immunochromatographimethod reagent strip, fixing several parts of agent plate, scanister, data processing equipment, output unit and IC-card of pasting reagent strip.
The past backward on the reagent strip, head and the tail are aligned in sequence with sample application zone, glass fibre membrane district, nitrocellulose filter district and thieving paper district with overlapping between the each several part, be adsorbed with dry gold mark antigen in the glass fibre membrane district, be coated with Free β-hCG quality control band and detection band that 5mm is wide of 50mIU/mL concentration in the nitrocellulose filter district.Linear relationship is best when detecting this reagent strip at 7.5 minutes through dispatching from the factory, and is defined as sweep time.With above-mentioned quality control band concentration and sweep time parameter write in the IC-card, with the supporting use of reagent strip.
Scanister is the CIS contact-type image sensor, and its luminophor is made up of 300～600 compact arranged red, blue, green three-color LED lamp banks, and wavelength coverage 625～430nm is connected with data processing equipment by USB interface.
The workstation that is used to carry out technical Analysis is installed in the data processing equipment, and connects an output unit.
Quality control band Free β-hCG concentration C Quality Control, the scanister of the colloidal gold immunochromatographimethod reagent strip bag quilt stored on the IC-card are begun to read in sweep time in the data processing equipment, and also import in the data processing equipment patient's essential information, the point sample district of detected sample point at reagent strip, reagent strip is put into scanister, and the log-on data treating apparatus, pick up counting automatically.
7.5 minute the time, data processing equipment drives the CIS contact-type image sensor, begins reagent strip is scanned, the light signal that scanning obtains is a digital signal through photoelectricity and mould/number conversion, is transferred to data processing equipment through USB interface.
Data processing equipment is discerned automatically to the optical density value of quality control band 450nm, obtains OD
Quality Control, then the optical density value that detects band 450nm is discerned automatically, obtain OD
Detect, according to OD
Quality Control, OD
DetectAnd C
Quality ControlNumerical value, calculate and detect the band concentration C
Detect, and and then the concentration determination result by Free β-hCG, calculate corresponding M oM value by analytic system, result transmission is exported to output unit.Embodiment 2:
Present embodiment is to use the concrete application examples of operation interface that colloidal gold immunochromatographimethod detection by quantitative device carries out the detection system of Prenatal Screening.
One, SYSTEM SUMMARY
Down syndrome (Down ' s Syndrome) be modal chromosome abnormality disease, account for 1% of the number of becoming pregnant, in per 700 natuses 1 Down syndrome infant is just arranged.Because Down syndrome also can't be treated at present, so only carry out early diagnosis, terminal pregnancy just can reach eugenic purpose.Native system adopts comprehensive screening method, according to multinomial data such as the concentration of the alpha-fetoprotein (AFP) in age of parent, conceived time, parent body weight, the maternal blood, human chorionic gonadtropin (hCG) and other recessive factors, adopt academia to generally acknowledge assessment algorithm more accurately, be used for the pregnant woman of second trimester of pregnancy (14 to 23 week) is assessed, calculate the probability that fetus suffers from Down syndrome, to reach the purpose of prevention.
Native system can be set up a plurality of case databases, and the user can search pregnant woman's information easily in each case database.Native system can draw assessment report according to pregnant woman's information, calculates every test rating and supplies doctor's reference and provide final assessment result.Each part assessment report can be printed or preserve separately.
Fig. 1-the 1st, the beginning interface of native system.
Two, operation instruction
Native system uses very simple.The user will enter the system master interface shown in Fig. 1-2 after selecting [continuation].
1, medical record information:
Comprise alpha-fetoprotein (AFP) concentration and human chorionic gonadtropin (hCG) concentration in numbering, Date of Sampling, name, body weight, date of birth, age, last menstruation date, conceived time, the maternal blood.
Numbering is the case history numbering of being filled in by the check doctor, and system also shows the case history total quantity in the current database.Before preparing each medical record data of input, must select [newly-built] button earlier, otherwise all inputs can't be preserved.
Native system can only be used to detect the pregnant woman in conceived 14 thoughtful 23 weeks, and for less than 14 weeks or greater than 23 weeks, system will enter the alarm of Fig. 1-3 or Fig. 1-4 automatically.
2, case history is handled
Examining report: the examining report that generates current case history.
Newly-built: newly-built case history.
Preserve: preserve current case history in database.If the user uses hold function under the state of [new record], system will preserve this record and enter [new record] state automatically so.
Deletion: delete current case history.
Last one: check a case history.
Next bar: check next bar case history.
3, examining report
When the user clicked [examining report] button, system generated the examining report of the current case history shown in Fig. 1-5.
System according to every information of pregnant woman calculate automatically MoM value, the hCG of MS-AFP the MoM value, suffer from the risk and provide assessment result (negative or positive) in female age of Down syndrome.Negative expression fetus unlikely suffers from Down syndrome, and positive expression fetus might suffer from Down syndrome.As be that 18 trisomes or the 13 trisome positives, neural tube defects, hCG single index are too high unusual etc., all will in [special suggestion], point out.
Close: close examining report.
Preserve: examining report is saved as text.
Print: print examining report.
4, the database of case history is handled
Menu provides the processing capacity to the database of case history, and each database of case history can hold 10000 above medical record informations.The title block of system's window shows the filename of current database, and its interface is shown in Fig. 1-6.
Newdata storehouse: set up a new database of case history.
Open database: open an existing database of case history.
Preserve database: preserve the current database of case history.
Save as: the copy of making the current database of case history.
Press name look-up: by pregnant woman's name look-up case history.
By record search: search case history by record number.
5, other
Withdraw from: withdraw from native system.
Help: check operation instruction (Fig. 1-7).
About: about the technology consultation information (Fig. 1-8) of native system.
Claims (7)
1, colloidal gold immunochromatographimethod detection by quantitative device, include the colloidal gold immunochromatographimethod reagent strip, be used for fixing the reagent card of pasting reagent strip, scanister, data processing equipment and output unit, it is characterized in that: on the colloidal gold immunochromatographimethod reagent strip, be coated with the quality control band that detects band and known gold labeling antibody concentration, data processing equipment gated sweep device scans reagent strip, and with the light signal that collects through photoelectricity and mould/number conversion, be converted to digital signal, transmit back data processing equipment by interface, data processing equipment is discerned the optical density value at quality control band and detection band place automatically, and carry out densimeter and calculate and technical Analysis, give output unit with result transmission.
2, colloidal gold immunochromatographimethod detection by quantitative device according to claim 1, it is characterized in that: described scanister is the CIS contact-type image sensor, its luminophor is made up of 300-600 compact arranged red, blue, green three-color LED lamp bank.
3, colloidal gold immunochromatographimethod detection by quantitative device according to claim 2, it is characterized in that: the wavelength coverage of LED lamp is 625～430nm.
4, colloidal gold immunochromatographimethod detection by quantitative device according to claim 1 is characterized in that: data processing equipment is with the optical density value that is in the 450nm wavelength to discern to quality control band and detection automatically.
5, colloidal gold immunochromatographimethod detection by quantitative device according to claim 1 is characterized in that: the width of the detection band of bag quilt is 1～6mm on the reagent card.
6, colloidal gold immunochromatographimethod detection by quantitative device according to claim 1, it is characterized in that: pick-up unit also include one with the supporting IC-card of reagent card, storing on the IC-card has the quality control band bag by the concentration data of golden labeling antibody and beginning parameter sweep time.
7, colloidal gold immunochromatographimethod quantitative detecting method is characterized in that may further comprise the steps:
A) with the quality control band gold labeling antibody concentration C of the colloidal gold immunochromatographimethod reagent strip bag quilt stored on the IC-card
Quality Control, scanister begins to read in sweep time in the data processing equipment;
B) there is some the reagent strip of detected sample to put into scanister, and picks up counting automatically;
When c) arriving sweep time, data processing equipment driven sweep device CIS contact-type image sensor scans reagent strip, and the light signal that scanning is obtained is converted to digital signal after photoelectricity and mould/number conversion, is transferred to data processing equipment;
D) optical density value is with in quality control band optical density value in the automatic discriminating digit signal of data processing equipment and detection, and obtains the quality control band optical density value OD at 450nm wavelength place respectively
Quality ControlBe with optical density value OD with detecting
Detect
E) according to OD
Quality Control, OD
DetectAnd C
Quality ControlNumerical value, calculate and detect the band concentration C
Detect, and and then obtain the technical Analysis data;
F) analysis result is transferred to output unit, the output result.
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| CN 03137101 CN1198134C (en) | 2003-06-04 | 2003-06-04 | Quantitative measuring apparatus and method of gold colloid immuno chromatography |
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| CN 03137101 CN1198134C (en) | 2003-06-04 | 2003-06-04 | Quantitative measuring apparatus and method of gold colloid immuno chromatography |
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| CN101915832A (en) * | 2010-07-29 | 2010-12-15 | 陈晓汀 | Colloidal gold and double-flow enzyme-linked immunosorbent rapid detection all-in-one machine |
| CN101975852A (en) * | 2010-09-16 | 2011-02-16 | 高翔 | Rapid detection device, detection test strip and detection method for bacterial vaginosis |
| CN102253038A (en) * | 2011-04-21 | 2011-11-23 | 福州大学 | Gold immune quantitative detection method and device on basis of embedded type charge coupled device (CCD) image acquisition |
| CN102279263A (en) * | 2011-05-06 | 2011-12-14 | 杭州顿力医疗器械股份有限公司 | CCD-type quantitative analysis system of colloidal gold immunity chromatography diagnosis test papers |
| CN102384972A (en) * | 2010-10-19 | 2012-03-21 | 刘江 | Machine vision-based immunochromatography result interpretation method |
| CN102590518A (en) * | 2012-02-08 | 2012-07-18 | 上海交通大学 | Immune colloidal gold test paper and method for quantitatively detecting configurable logic block (CLB) by matching with photoelectric sensor thereof |
| CN102680680A (en) * | 2006-04-12 | 2012-09-19 | 艾博生物医药(杭州)有限公司 | Detecting device containing non-protein capturing substance on control region |
| CN102778455A (en) * | 2012-07-26 | 2012-11-14 | 杭州华光光电有限公司 | Detection system for colloidal gold immunochromatographic assay (GICA) test paper |
| CN101509925B (en) * | 2009-03-02 | 2013-03-20 | 苏州市玮琪生物科技有限公司 | Chromatography type total cholesterol self-measuring instrument |
| CN103076449A (en) * | 2013-01-21 | 2013-05-01 | 中国检验检疫科学研究院 | Colloidal gold label detector |
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| WO2021180442A1 (en) | 2020-03-07 | 2021-09-16 | Immundiagnostik Ag | Calibration of a digital camera for use as a scanner |
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- 2003-06-04 CN CN 03137101 patent/CN1198134C/en not_active Expired - Fee Related
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| CN102680680A (en) * | 2006-04-12 | 2012-09-19 | 艾博生物医药(杭州)有限公司 | Detecting device containing non-protein capturing substance on control region |
| CN102680680B (en) * | 2006-04-12 | 2015-03-18 | 艾博生物医药(杭州)有限公司 | Detecting device containing non-protein capturing substance on control region |
| CN101509925B (en) * | 2009-03-02 | 2013-03-20 | 苏州市玮琪生物科技有限公司 | Chromatography type total cholesterol self-measuring instrument |
| CN101915832A (en) * | 2010-07-29 | 2010-12-15 | 陈晓汀 | Colloidal gold and double-flow enzyme-linked immunosorbent rapid detection all-in-one machine |
| CN101915832B (en) * | 2010-07-29 | 2013-07-17 | 陈晓汀 | Colloidal gold and double-flow enzyme-linked immunosorbent rapid detection all-in-one machine |
| CN101975852A (en) * | 2010-09-16 | 2011-02-16 | 高翔 | Rapid detection device, detection test strip and detection method for bacterial vaginosis |
| CN102384972B (en) * | 2010-10-19 | 2013-09-11 | 刘江 | Machine vision-based immunochromatography result interpretation method |
| CN102384972A (en) * | 2010-10-19 | 2012-03-21 | 刘江 | Machine vision-based immunochromatography result interpretation method |
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| CN102253038B (en) * | 2011-04-21 | 2013-07-03 | 福州大学 | Gold immune quantitative detection method and device on basis of embedded type charge coupled device (CCD) image acquisition |
| CN102279263A (en) * | 2011-05-06 | 2011-12-14 | 杭州顿力医疗器械股份有限公司 | CCD-type quantitative analysis system of colloidal gold immunity chromatography diagnosis test papers |
| CN102590518A (en) * | 2012-02-08 | 2012-07-18 | 上海交通大学 | Immune colloidal gold test paper and method for quantitatively detecting configurable logic block (CLB) by matching with photoelectric sensor thereof |
| CN102778455B (en) * | 2012-07-26 | 2014-12-10 | 杭州华光光电有限公司 | Detection system for colloidal gold immunochromatographic assay (GICA) test paper |
| CN102778455A (en) * | 2012-07-26 | 2012-11-14 | 杭州华光光电有限公司 | Detection system for colloidal gold immunochromatographic assay (GICA) test paper |
| CN103076449A (en) * | 2013-01-21 | 2013-05-01 | 中国检验检疫科学研究院 | Colloidal gold label detector |
| CN103698323A (en) * | 2013-08-24 | 2014-04-02 | 管义东 | Colloidal gold immunochromatographic test paper detection system |
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| CN104239707A (en) * | 2014-09-03 | 2014-12-24 | 贾明宏 | Rapid disease detection and information acquisition method |
| CN104634747B (en) * | 2015-02-06 | 2017-05-10 | 深圳市贝沃德克生物技术研究院有限公司 | Biomarker concentration measurement device and method based on spiral resistor |
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| WO2019215199A1 (en) | 2018-05-07 | 2019-11-14 | Immundiagnostik Ag | System for analysing quantitative lateral flow chromatography |
| WO2020165456A1 (en) | 2019-02-15 | 2020-08-20 | Immundiagnostik Ag | Rapid test for diagnosis of bacterial infections in neonates |
| WO2021180442A1 (en) | 2020-03-07 | 2021-09-16 | Immundiagnostik Ag | Calibration of a digital camera for use as a scanner |
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