CN1773288A - Sidestream analytic system and method - Google Patents
Sidestream analytic system and method Download PDFInfo
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- CN1773288A CN1773288A CN 200410052202 CN200410052202A CN1773288A CN 1773288 A CN1773288 A CN 1773288A CN 200410052202 CN200410052202 CN 200410052202 CN 200410052202 A CN200410052202 A CN 200410052202A CN 1773288 A CN1773288 A CN 1773288A
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Abstract
The present invention relates to a side-flow analysis system for quick diagnosis and its method. Said detection system includes 1 main unit and 1-20 test modules, they are connected to computer main machine by means of USB or blue tooth wireless receiver, said computer main machine can utilize related software to control operation of said detection instrument. It adopts a bio-chemical reaction platform to implement various detection items. Said invention also provides its concrete operation method and its concrete application range.
Description
Technical field
The present invention relates to a kind of method and medicine equipment of quick diagnosis, be specially adapted to a kind of method and system that can carry out fast quantification or qualitative immunology detection simultaneously to a plurality of samples, multiple test item simultaneously.
Background technology
Sensitive, convenient, quantitatively, diagnostic method is current " care diagnostic before the bed " (Point of care test, the POCT) developing direction of medical diagnosis system of popularizing day by day fast.Come out from the beginning of the eighties, popularize gradually (as Eisinger based on the tachysynthesis detection method (quick detection test paper bar) of capillary chromatography principle; Robert W, US patent 4,943,522, Pawlaketal, US patent 5,770,460, Charlton; David E., UA patent5714389), be widely used in the early diagnosis of early pregnancy, drug abuse, hormone, infectious disease, painstaking effort disease.These quick detection test paper bars are generally used heavy metal (as gold, silver etc.) or dye marker, utilizing the optical density of bands visible that material to be checked presents or spot to carry out naked eyes judges, thereby bring the error of subjective judgement inevitably, and can not carry out quantitative test thing to be checked.U.S. Biosite Inc. releases the mini-plant that can be used for brain natriuretic peptide miocardial infarction quick diagnosis such as (BNP) recently, utilize fluorescein-labelled---BNP or Pro-NBNP among the immunological method detection by quantitative patients serum, but only limit to the several projects relevant, and can only measure single patient at every turn with coronary heart disease.U.S. Praxsys Biosystems Inc. has developed a kind of qualitative and quantitative tachysynthesis detection system (Relia based on capillary chromatography principle and optoelectronic scanning principle that can be used for
TM, US patent 6,136,610).This system is made up of detector and supporting with it detection paper box.Detect paper box and be used to carry out the colloid gold label immune response.Bag is by one or two contrast band on the test strip, the ratio of the optical density between band to be checked and the wherein arbitrary contrast band (or average of two contrast bands) is the relative optical density (RI) that sample to be checked produced, detector obtains the optical density that contrast is with and the detection band is produced on the test strip by optoelectronic scanning, and its relative optical density analyzed, through software processes, draw quantitatively or qualitative conclusions.Relia
TMSystem uses single channel, promptly once only can detect single patient's sample.Owing to catch optical density value by optoelectronic scanning, be subject on the test-strips in the sample and the influence that detects irrelevant impurity, the optical density value that must make mistake, thus the RI analysis precision is affected.
Summary of the invention
The objective of the invention is to provide a kind of energy multiple detection content quick, high flux liquid towards biological sample relatively to carry out accurately quantitative detection system and method.
Lateral flow assays method of the present invention is achieved by the following technical solution: with the platform of biochemical reaction, implement various test items, the required temperature conditions of one or more biochemical reactions is provided and hatches with detector, but it is characterized in that the detectable region (colour band or color dot) that biochemical reaction produces being measured with photometry, calculating and analysis by optical density value ratio between tester and the determinand, by detector to being used for liquid biological sample, the project to be checked that is not limited to human sample to be checked is made quantitatively or judgement qualitatively, by pre-set programs testing result is stored in database.
One or above tester zone being provided with in the biochemical reaction of the present invention, the used material of this control zone are non-existent material in the human body, as using DNP (dinitrophenol dinitrophenolate).
Detector of the present invention links to each other with computing machine by communication interface, and by this system operating software project category to be detected is discerned.Described detection realizes treating this biochemical reaction of sample: utilize the capillary chromatography effect, make liquid sample to be checked directed flow on holder, meet with corresponding detection thing and biochemical reaction takes place.Described sample to be checked is artificial or natural liquid sample, as whole blood, serum, blood plasma, urine, saliva or other body fluid.
Biochemical reaction of the present invention can utilize colloid gold particle or silver or fluorescent dye or C
14Or the information that can be detected by light reflection principle that produces of other metal or dyestuff, will detect information after testing instrument system feed back on the Computerized analysis system.Described colloid gold particle or silver or fluorescent dye or C
14Or the colour band that can be detected by light reflection principle that produces of other metal or dyestuff, with detection information after testing the optical density capture systems of instrument feed back on the Computerized analysis system.Described optical density capture systems can be an optical scanner, CCD pickup system, or fluorescence spectrometry system.
Biochemical reaction of the present invention is treated finished item by physical mechanical movement and electronic circuit and is carried out detection time and temperature controlling, reflects the Acquisition Detection result and feeds back to the computing machine presetting database by optical density.The relative optical density that described database root is produced according to catching densitometric analysis sample to be checked, and, draw qualitative or quantitative testing result according to predetermined threshold value or typical curve analysis.The systemic presupposition program is carried out the optical density value analysis to survey district band, calculates the relative optical density ratio of band to be checked with measuring tape optical density value to be checked/contrast band optical density value; And with what preset in this relative optical density ratio and the computer, detection relative optical density ratio threshold value or the typical curve relative optical density ratio relevant with this test item carry out correlation analysis, draw qualitative or quantitative testing result.
Qualitative or the quantitative testing result of described sample to be checked stores automatically by system operating software, and can be downloaded or print.
Detector of the present invention passes through the contained detection content of this testing cassete of the bar code recognition on the testing cassete shell, and passes through the corrected value of this bar code recognition institute test item difference between batch.Testing cassete is formed by shell with by the test-strips of ad hoc structure.The ad hoc structure of test-strips provides capillary chromatography required pressure reduction.After liquid sample added described testing cassete window A, by the high what A end of what B end capillary chromatography pressure reduction, liquid sample flowed to the B end from A; By way of the detection of wrapping quilt in advance with on, the antigen or the antibody that can produce biochemical reaction with material to be checked, form immune complex (horizontal flow measurement for the first time).Described test-strips B end is coated with the collaurum coupling, can with material to be checked, or detection with on formed immune complex produce the antigen or the antibody of biochemical reaction; And coupling, can wrap the antigen or the antibody of the tester qualitative response of quilt with the view window district in advance.This moment, test-strips was soaked by the liquid of horizontal flow measurement for the first time, and the suction pad that is placed in the A end makes the high what B end of capillary chromatography pressure reduction of A end.Add B end with liquid sample or damping fluid this moment, and dissolving should be wrapped in advance by conjugates, flows (horizontal flow measurement for the second time) approach view window district to the A end from B by capillarity; Can be deposited on the reaction initial point with the contrast material of pre-bag quilt or the immune complex generation biochemical reaction that has produced in the B that dissolved the end material.Biochemical reaction takes place for the second time and is deposited on reaction place in the anti-detection band material of described collaurum coupling, or established biochemical complexes is met on the anti-established immune complex of collaurum coupling and the detection zone band.The redness of collaurum forms visible band or zone at the deposition place; The suction pad of test-strips A end is to absorb excess liquid in for the second time horizontal flow measurement reaction.
The present invention overcomes with the difference of the described testing cassete of batch difference to same pattern detection result, and bag is by two contrast bands of high and low concentration on the NC Nitroncellulose film; Make after the optical density in detector Acquisition Detection district directly with the optical density value sentence read result that obtains, and come sentence read result than the relative optical density value (being the relative optical density value, the RI value) of last preassigned high concentration contrast band or low concentration contrast band with district to be detected band optical density value.In the production of qualitative test box, calibrating threshold values (the Cut-off value of each particular detection project, for judging the boundary of positive or negative) determine via the certain criteria flow process, should examine and determine the variation of threshold value between every series-produced product, to be incorporated into bar code and be delivered to instrument, and understand in correcting determination result's the process.In the production of quantitative test box, adjust the parameter value commonly used of typical curve and relative optical density value (RI value) to reach the purpose that reduces difference between batch by changing information that the different batches bar code contains.Typical curve is determined by the RI value that concentration known and its of known standard product produces in native system.Behind every batch of production test box, use the standard items with the same series concentration of the first series-produced testing cassete, record corresponding RI value, obtain adapting to the typical curve of this batch of what product.New curve and former default curve ratio are, calculate the error slope and the intercept of two curves by the Excel form with the RI value, obtain adjusting the parameter of new curve, make it consistent, thereby reach the purpose of the correctly interpretation batch different identical product that just do not need to rectify an instrument with former default curve.Behind described parameter information Input Software, software compiles all these information for digital, in the software that can make bar code that these numbers are input to, can translate into bar code by software then, be made into the steel plate die with this bar code, be printed on the testing cassete lid by screen printer or pad printer.Instrument by to the identification of bar code from the criterion of normal moveout correction to the survey project.
Lateral flow assays of the present invention system, comprise 1 master unit and 1～20 test module, and be connected to host computer by USB or blue teeth wireless receiver, host computer is by the operation of related software control detection instrument, the identification test item, obtain and the analyzing and testing result, store sample information to be checked and testing result.
The master unit of system of the present invention is connected by cable with test module, and one or more test modules can be selected to use by system, is designed to relatively independent relation between master unit and the test module.Detection module comprises an available motor and controls forward and backward mobile pallet, the bearing test box, and the tray bottom ad-hoc location is equipped with capacitive transducer, with the application of sample process in the monitoring and detection operation; The privileged site returning apparatus temperature control system of tray bottom is realized heating with resistance thermometer clement, realizes cooling with peltier-element.Master unit is chemically examined module for power supply to each, coordinates the activity of a plurality of chemical examination modules, and provides communication to be connected with the computing machine that links to each other.Master unit receives the image information that receives test item and reaction band and feeds back to the enterprising line data of continuous computing machine and handles from the chemical examination module.The function software control detection module operation that moves on the computing machine comprises temperature control, tray motion, illumination, shooting etc.
The module of respectively chemically examining in the system of the present invention all contains 1 microprocessor, illumination, position, monitoring environment temperature and the heating plate temperature of monitoring pallet, the monitoring application of sample that can carry out such as the control test strip are detected capacitive transducer, are passed through I2C interface and master unit communication, also can monitor the temperature of Pa Er card hot receiver and the rotating speed of fan in refrigeration unit, the chemical examination module is collected the image information of test item and is uploaded to master unit.System can utilize CCD imaging identification test item, and Acquisition Detection result draws the detection conclusion by the relative optical density analysis.The zone of CCD shooting comprises the bar code area and the testing window district of testing cassete loam cake; The image that CCD camera picked-up testing window district presents, system measures the optical density of colour band, and carries out band relative optical density to be checked analysis according to pre-set programs, draws quantitatively or detect qualitatively conclusion with preset parameter after relatively.
Detection system of the present invention and method are compared with prior art, measure by the detected optical density (colour band or color dot) that biochemical reaction produces at the reaction zone band by the liquid towards biological sample, calculating and analysis by optical density value ratio between tester and the determinand, by pre-set programs testing result is stored in database by detector, thereby energy is quick, high flux accurately detects quantitatively to the multiple detection content of clinical liquid sample relatively.
Description of drawings
Fig. 1 is the composition structural drawing of lateral flow assays of the present invention system.
Fig. 2 is the structural drawing of the present invention as the testing cassete of the carrying platform of immune detection.
Fig. 3 is the identification curve map of detector of the present invention to bar code.
Fig. 4 is the vertical view of test-strips in the testing cassete of the present invention.
Fig. 5 is the side view of test-strips in the testing cassete of the present invention.
Fig. 6 is the schematic diagram of two-way horizontal sidestream immune of the present invention testing.
Fig. 7 produces the red zone synoptic diagram that is presented by collaurum for the present invention directly adds the B end with sample.
Fig. 8 is the synoptic diagram of the picked-up of the CCD camera in the detector of the present invention image.
Fig. 9 is the default linear diagram of TSH of the present invention.
Figure 10 is the structural drawing of system works of the present invention.
Figure 11 is the structural drawing of system of the present invention master unit and detection module.
Figure 12 is the structural drawing of detection module of the present invention.
Figure 13 is the theory diagram of master unit functional block of the present invention.
Figure 14 respectively chemically examines the theory diagram of functions of modules piece for system of the present invention.
Figure 15 is the FB(flow block) of software control of the present invention and management data.
Figure 16 is the schematic diagram in the zone of system of the present invention pickup image.
Figure 17 is the schematic diagram of the photoelectricity reverse shot approach of system of the present invention pickup image.
Figure 18 is the structure design principle figure of camera system of the present invention and section being shot.
Figure 19 detects the linear diagram of the linear concentration of precision experiment to PSA for the different detectors of the present invention.
Figure 20 is A of the present invention, the RI curve map of B two BT(batch testing) boxes.
Figure 21 is A of the present invention, the curve map of the correlativity of B two BT(batch testing) box RI.
Figure 22 is A of the present invention, the curve map of B two BT(batch testing) box concentration correlativitys.
Embodiment
The present invention's usefulness detection paper box as shown in Figure 1 is as immunoreactive platform, carry various test items, the required temperature conditions of one or more immune responses is provided and hatches platform with detector, and with the CCD camera system on the testing cassete since visible colour band or color dot that immune response produces take pictures, calculating and analysis by the relative optical density value, the project to be checked of sample to be checked is made quantitatively or judgement qualitatively by detector, and testing result is stored in database by pre-set programs.Printable or the download of testing result.
Principle of work flow process of the present invention:
Detector links to each other with computing machine by USB interface, and by this system operating software the project category that detects paper box is discerned; Treat finished item by physical mechanical movement and electronic circuit and carry out detection time and temperature controlling, reflect the Acquisition Detection result and feed back to the computing machine presetting database by optical density; Database root divides according to catching optical density surveys the relative optical density that sample to be checked produced, and according to predetermined threshold value or typical curve analysis, draws qualitative or quantitative testing result.The information of sample to be checked and detection data store automatically by system operating software, and can be downloaded or print.
Detect paper box and realize treating sample biochemical reaction originally.Utilize the capillary chromatography effect, make liquid sample to be checked directed flow on solid support, meet with corresponding detection thing and immune response takes place.The colour band (or color dot) that can be detected by visible light that utilizes that colloid gold particle produces, the optoelectronic scanning or the CCD camera system of instrument feed back on the Computerized analysis system after testing with detection information.
Technical scheme of the present invention is as follows:
Detector of the present invention as shown in Figure 3, is discerned the contained detection content of this testing cassete by to the bar code on the testing cassete shell.
Testing cassete of the present invention is the carrying platform of immune detection.This testing cassete is made up of test-strips and shell thereof.As shown in Figure 2, three windows are arranged on the outer casing upper cover: application of sample window A, the B at two ends and middle view window 1.According to detecting content and requirement, sample to be checked can be by application of sample in application of sample window A or application of sample window B, or adds application of sample window A and B simultaneously.Testing result is presented in the view window 1.
Shown in Fig. 4～6, immune response occurs on the test strip, and this test-strips comprises the colloid gold label thing pad 7 corresponding with application of sample window B, is with 4,6 and calibration tape 5, NC Nitroncellulose film 11 and supporting pad 12 with application of sample window A corresponding sample absorption pad 8 and liquid absorption pad 9 and contrast.After liquid sample adds application of sample window A, flow to the B end through sample absorbent 8 and by the capillary chromatography effect.Can produce immunoreactive antigen or antibody by way of the detection of wrapping quilt in advance with material to be checked (big molecule such as albumen, polysaccharide, polypeptide, nucleic acid) on 5, form immune complex.Collaurum labeling pad 7 is coated with collaurum (or other can produce the big molecule that can detect optical density) coupling on the test-strips B end, can be with that formed immune complex produces immunoreactive antigen or antibody on 5 with material to be checked or in detection; And coupling, can with the antigen or the antibody of the tester qualitative response of view window 1 district pre-bag quilt.Liquid sample or damping fluid are added the B end, and dissolving should be wrapped in advance by conjugates, flowed approach view window 1 district by capillarity to the A end.Can produce the anti-tester of immunoreactive collaurum coupling with the contrast material of pre-bag quilt in the B end material that has dissolved produces immune complex and is deposited on the reaction initial point with the contrast material; Immune response for the second time takes place and is deposited on reaction place in established immune complex on 5 and the anti-detection band material of collaurum coupling (or anti-established immune complex) is with detection.Because the redness of collaurum (or other can produce the big molecule that can detect optical density) forms visible band at the deposition place: contrast be with 4,6 and detection be with for 5 (if containing this material to be checked in the sample).The liquid absorption pad 9 that the A end of test-strips is settled is with excess liquid in the absorption reaction.
If sample directly adds application of sample window B, then can add damping fluid with the reaction zone of prewetting at the A end.In such cases, sample directly with the corresponding antigens/antibody response of B end collaurum coupling, and when flowing through detection zone, produce immune response once more and deposit, the red zone that generation is presented by collaurum, as shown in Figure 7.Here, can be with reference to the related content described in the Chinese patent literature ZL0045278.2.
The solution of difference experiment in testing cassete of the present invention is criticized:
Difference shows as with the difference of batch different testing cassetes to same pattern detection result in batch.The variation that batch interpolation different time is equal trend is appearring in three bands (HC, LC and measuring tape to be checked) that are coated in theory on the same test-strips, thereby the ratio of optical density just should be tending towards a stable scope between them between each calibration tape of same batch.By this principle, as shown in Figure 5, we wrap on NC Nitroncellulose film 11 by two contrast bands of high and low concentration (HC, LC band).Directly do not use optical density value (the being the absolute light density value) sentence read result that obtains after making detector scanning, and come sentence read result than the optical density value (relative optical density value) of last preassigned high concentration contrast band or low concentration contrast band with measuring tape optical density value to be checked, can make batch interpolation of product reduce to minimum like this.For example, use same sample, choosing detects with a HCV antibody positive sample, testing result such as table 1 with 10 of batch HCV testing cassetes
Batch interpolation of table 1 HCV testing cassete
| HC | LC | HCV calibration tape optical density | HC/LC | HCV/HC | HCV/LC | |
| Optical density | Optical density | (absolute light density value) | (relative optical density value) | (relative optical density value) | ||
| Test-strips A | 0.3250 | 0.2682 | 0.0402 | 1.2118 | 0.1237 | 0.1499 |
| Test-strips B | 0.3108 | 0.2625 | 0.0381 | 1.1840 | 0.1226 | 0.1451 |
| Test-strips C | 0.3652 | 0.3024 | 0.0455 | 1.2077 | 0.1246 | 0.1505 |
| Test-strips D | 0.3375 | 0.2668 | 0.0428 | 1.2650 | 0.1268 | 0.1604 |
| Test-strips E | 0.3547 | 0.2634 | 0.0384 | 1.3466 | 0.1083 | 0.1458 |
| Test-strips F | 0.2683 | 0.2248 | 0.0335 | 1.1935 | 0.1249 | 0.1490 |
| Test-strips G | 0.2931 | 0.2318 | 0.0341 | 1.2645 | 0.1163 | 0.1471 |
| Test-strips H | 0.3172 | 0.2546 | 0.0378 | 1.2459 | 0.1192 | 0.1485 |
| Test-strips I | 0.3663 | 0.2988 | 0.0392 | 1.2259 | 0.1070 | 0.1312 |
| Test-strips J | 0.3142 | 0.2727 | 0.0402 | 1.1522 | 0.1279 | 0.1474 |
| AV | 0.3252 | 0.2646 | 0.0390 | 1.2297 | 0.1201 | 0.1475 |
| SD | 0.0316 | 0.0246 | 0.0036 | 0.0544 | 0.0074 | 0.0071 |
| CV％ | 10％ | 9％ | 9％ | 4％ | 6％ | 5％ |
As can be seen from the above table: the CV% of 10 HCV testing cassete calibration tape absolute light density values is 9%, and the CV% of relative optical density value is respectively HCV/LC=5%, HCV/HC=6%, and these two relative optical density values are all little than the variation of absolute light density value.
Simultaneously, limit a variation range (for example 0.8～1.5) for HC and LC Reinhoit Zahl, exceed this setup parameter scope, illustrate that the wrong or testing process of test-strips quality makes mistakes, further guarantee to drop to batch interior difference minimum.
The present invention is to the correction of the qualitative product difference between batch of testing cassete:
Differences between batches are a kind of system difference, show as the identical product different batches detection reading of same standard items (is the relative optical density value at this, RI) is the rising or the decline of same trend.During qualitative detection, the RI that sample to be checked produces is positive, and ratio with threshold value (cut off value) RI is called signal to noise ratio (S/N ratio) (S/CO), and S/CO＞1 is judged to the positive.Because during the instrument sentence read result, whether the cut off value of having set when dispatching from the factory according to instrument is positive as judging sample to be checked, instrument will be proofreaied and correct by the bar code that identification is printed on the testing cassete shell the error between this batch.Detailed process is: every series-produced testing cassete, all will measure the cut off value of this batch products with the clinical negative serum of some examples of this production rules defined, this new cut off value that gets is compared with the cut off parameter of importing instrument, and the different information that obtains (for example new cut off value exceeds 10% than default cut off value) will be incorporated into bar code and be delivered to instrument to be understood in correcting determination result's the process.For example, the cut off value that HCV detection paper box A criticizes product is 0.25, the cut off value that B criticizes product is 0.275, cut off value is changed to 10% between two batches, this information is input in the bar code of B BT(batch testing) box, relatively two BT(batch testing) boxes see Table 2 to the testing result of same example negative (Y) or positive (X) sample.
As shown in table 2, to same sample, two BT(batch testing) boxes obtain different RI values, but the no significant difference of its S/CO value.
Table 2:
| Sample | A criticizes (cut off=0.25) | B criticizes (cut off=0.275) | ||
| RI | S/CO | RI | S/CO | |
| X | 0.3125 | 1.25＝0.3125÷0.25 | 0.3548 | 1.29＝[0.3548÷(0.25+0.25×10％)] |
| Y | 0.238 | 0.952＝0.238÷0.25 | 0.2640 | 0.96＝[0.2640÷(0.25+0.25×10％)] |
Sample Y (negative standard items) criticizes product at B, and to obtain RI be 0.2640, if the cut off value 0.25 calculating S/CO that criticizes product with A will obtain S/CO=0.2640/0.25=1.056, false positive results promptly＞1; By the correction to not batch cut off value difference between batch, instrument is discerned the cut off value that B criticizes automatically and be should be 0.275, then obtains S/CO=0.2640/0.275=0.96, i.e. the negative correct result of S/CO＜1.
The present invention is to the correction of the quantitative product difference between batch of testing cassete:
During detection by quantitative, the RI value that sample to be checked produces obtains quantitative judgement (concentration or unit) through the known standard curve calculation.Behind every batch of production test box, use with the standard items of the same series concentration of the first series-produced testing cassete and detect, obtain corresponding RI value, promptly adapt to the typical curve of this batch of what product.New curve and former default curve ratio are calculated the error slope and the intercept of two curves with the RI value by the Excel form, obtain adjusting the parameter (correction parameter) of new curve, make the curve after the correction consistent with former default curve.In the software that can make bar code that this correction parameter is input to, can translate into bar code by software, be made into the steel plate die with this bar code, be printed on the testing cassete lid by screen printer, just do not need to rectify an instrument correctly interpretation batch different identical product to reach, effectively control the purpose of difference between batch.
For example: produce two batches of TSH testing cassetes of A, B, criticize as first with A, B criticizes as second batch, with the standard items of two BT(batch testing) boxes detection with a series of gradients, different RI values can be obtained between the two BT(batch testing) boxes,, then different concentration will be obtained if the typical curve of criticizing with A calculates, but after with said method the typical curve (slope and intercept) of B BT(batch testing) box being proofreaied and correct, B BT(batch testing) box will obtain not having with A BT(batch testing) box the concentration value of significant difference to same sample.Detection and trimming process are as follows:
1., the two batches of TSH testing cassetes of A, B detect with the series of standards product, obtain RI value and difference thereof:
Table 3
| Standard items concentration | A criticizes the RI average | B criticizes the |
| 0 | 0.004 | 0.004 |
| 0.5 | 0.067 | 0.074 |
| 1 | 0.081 | 0.090 |
| 2 | 0.120 | 0.132 |
| 5 | 0.280 | 0.305 |
| 10 | 0.497 | 0.547 |
| 15 | 0.745 | 0.817 |
| 25 | 0.875 | 0.960 |
| 50 | 1.348 | 1.470 |
| 100 | 1.887 | 2.114 |
By Figure 20, there are differences between two curves, need to proofread and correct what A curves such as making the B curve, otherwise instrument will criticize that product surveys that the RI value is calculated and the concentration information that must make mistake to B according to default A curve.According to curvilinear correlation analysis as shown in figure 21, calculated correction value (slope and intercept) is as follows:
Slope=1/1.111=0.90009; Intercept=0.0048
2., with above corrected value input B curve, and be made into bar code after this corrected value information transformed, make the instrument that has dispatched from the factory can discern the concentration computing formula of the B BT(batch testing) box of having proofreaied and correct automatically.Table 4 show calibrated after, to same gradient series standard items, B criticize product obtain with instrument in criticize the default consistent concentration results of typical curve of product with A:
Table 4
| Standard items concentration | A criticizes the concentration average | B criticizes the |
| 0 | 0.046 | 0.083 |
| 0.5 | 0.742 | 0.797 |
| 1 | 0.946 | 1.002 |
| 2 | 1.512 | 1.569 |
| 5 | 4.506 | 4.503 |
| 10 | 10.011 | 10.005 |
| 15 | 18.415 | 18.232 |
| 25 | 23.363 | 23.097 |
| 50 | 50.814 | 49.337 |
| 100 | 101.632 | 103.895 |
Above result is made correlation analysis, be highly linear fruit (R mutually with B opisometer standard items concentration of calculating and the standard items concentration of calculating with the A opisometer after proofreading and correct
2＞0.999).
Above data and Figure 22, curve error slope by proofreading and correct B BT(batch testing) box and intercept can be so that A, B two BT(batch testing) boxes do not have significant difference to the result of same sample detection by quantitative.Promptly solved the difference between batch between the different batches testing cassete in this way.
As shown in Figure 8, test strip is thrown light on, image of formed bands visible reflexes to the CCD camera picked-up image that is preset in detector through the eyeglass that built-in being arranged in of instrument detects box view window top on it.
As shown in Figure 2: this systemic presupposition program is carried out the optical density value analysis to taking the photograph band, calculates the relative optical density ratio (RI) of band to be checked with measuring tape optical density value to be checked/contrast band optical density value; And with what preset in this RI value and the computer, detection RI threshold value or the typical curve RI value relevant with this test item are carried out correlation analysis, draw qualitative or quantitative testing result.With thyrotropic hormone (TSH, middle inspection institute, 600uIU/ml, lot number: 150530-0308) be example: with concentration known TSH standard items, with damping fluid (the PBS phosphate buffers of 5 ‰ BSA) serial dilution concentration gradient; Every concentration application of sample 150 μ l, the colloid gold label that usefulness has prepared (three hydroxyl tetrachloro aurin acid, Tetrachloroauric Acid Trihydrate, Sigma., USA, Cat#) the TSH testing cassete detects in native system, testing result such as table 5:
Table 5
| TSH standard items concentration (uIU/ml) | The contrast optical density value | The measured light density value | RI | Measured concentration uIU/ |
| 0 | 0.2506 | 0.0020 | 0.0080 | 0.000 |
| 1 | 0.2409 | 0.0143 | 0.0594 | 0.980 |
| 2 | 0.2473 | 0.0267 | 0.1080 | 1.828 |
| 5 | 0.2197 | 0.0512 | 0.2330 | 4.530 |
| 10 | 0.2258 | 0.1315 | 0.5824 | 9.389 |
| 15 | 0.2106 | 0.1811 | 0.8599 | 15.950 |
| 25 | 0.2288 | 0.2505 | 1.0948 | 23.490 |
| 50 | 0.2160 | 0.3587 | 1.6606 | 50.410 |
| 100 | 0.2645 | 0.5475 | 2.0699 | 96.310 |
With the RI value mapping of actual measurement TSH series gradient standard items, presenting with concentration increases and the linear (see figure 9) of RI value increase
Show as Figure 10: this system comprises 1 master unit and 1～20 test module, and is connected to host computer by USB or blue teeth wireless receiver.Host computer is by the operation of related software control detection instrument, and the identification test item obtains and the analyzing and testing result, stores sample information to be checked and testing result.
As Figure 11: the master unit of system is connected by cable with test module, and system can select to use one or more test modules 13 arbitrarily.Be designed to relatively independent relation between master unit 14 and the test module 13, that is: (1) arbitrary test module 13 breaks down does not influence other test module operation; When (2) master unit 14 broke down, all test cells can be disassembled and ressemble with another master unit.
Show as Figure 12: test is carried out in detection module.
Detection module comprises an available motor and controls forward and backward mobile pallet, the bearing test box.The tray bottom ad-hoc location is equipped with capacitive transducer, with the application of sample process in the monitoring and detection operation.The privileged site returning apparatus temperature control system of tray bottom is realized heating with resistance thermometer clement, realizes cooling with peltier-element.
Show as Figure 13: master unit is chemically examined module for power supply to each, coordinates the activity of a plurality of chemical examination modules, and provides communication to be connected with the computing machine that links to each other.Master unit receives the image information that receives test item and reaction band and feeds back to the enterprising line data of continuous computing machine and handles from the chemical examination module; Also can be according to the function software control requirement that moves on the computing machine, as shown in figure 16, the control detection module is moved (comprising temperature control, tray motion, illumination, shooting etc.).
Show as Figure 14 and Figure 15, the module of respectively chemically examining in the system all contains 1 microprocessor, illumination, position, monitoring environment temperature and the heating plate temperature of monitoring pallet, the monitoring application of sample that can carry out such as the control test strip are detected capacitive transducer, are passed through I2C interface and master unit communication, also can monitor the temperature of Pa Er card hot receiver and the rotating speed of fan in refrigeration unit.The chemical examination module is collected the image information of test item and is uploaded to master unit.
As Figure 16～shown in Figure 180, native system utilizes the CCD shooting to the identification test item, and Acquisition Detection result draws the detection conclusion by the relative optical density analysis.The zone of CCD shooting comprises the bar code area and the testing window district of testing cassete loam cake.The correcting parameter of the title of test item and product difference between batch is embodied in the bar code.The image that CCD camera picked-up testing window district presents (contrast band and detection band), system measures the optical density of colour band, and carry out band relative optical density to be checked (RI) according to pre-set programs and analyze, draw quantitatively or detect qualitatively conclusion with preset parameter after relatively.For reducing the cross reaction between sample to be checked and the mensuration reagent, (DNP-X-SE6-(2 to have selected the interior non-existent small-molecule substance dinonyl phthalate (DNP) of human body for use, 4-dinitrophenyl) aminohexanoic acid, N-hydroxy succinimide esterMW 394.34, Molecular Probe, USA, catalog number (Cat.No.) A-23018) be with in contrast.
The design of native system implementation data management from the software is improved and is increasingly automated very much.
Enforcement of the present invention:
Example 1 is to the detection by quantitative of thyrotropic hormone (TSH)
To collaurum (the three hydroxyl tetrachloro aurin acid that prepared of the clinical serum of TSH, Tetrachloroauric Acid Trihydrate) mark TSH testing cassete detects in native system, and with enzyme joint inspection survey method (ELISA, Biocheck lot number: RN-17790) comparison and detection, testing result such as table 6.
The clinical serum specimen testing result of table 6 TSH (uIU/ml)
| Catalogue number(Cat.No.) | Concentration that native system is surveyed | Concentration that ELISA surveys |
| 1 | 0.00 | 0 |
| 2 | 0.00 | 0 |
| 3 | 1.28 | 1.1 |
| 4 | 1.77 | 1.27 |
| 5 | 2.21 | 1.99 |
| 6 | 4.58 | 4.18 |
| 7 | 7.18 | 7.05 |
| 8 | 8.71 | 8.62 |
| 9 | 18.86 | 18.51 |
| 10 | 22.70 | 22.46 |
Above testing result is made paired t-test with preparation standard items concentration
The comparing result of collaurum TSH testing cassete and ELISA paper box
1, suppose that collaurum TSH testing cassete is identical with the comparing result of ELISA paper box, the population mean that then differs is 0, i.e. H0=u=u0; U ≠ u0
2, make significance level a=0.05,, look into critical value t0.05=2.262 (bilateral) by this routine v=10-1=9
3, ask sample completely to measure standard deviation Sd, standard error Sd and the test statistics t value of average phase difference d, difference
d
-＝-0.0240 S
d＝0.1669 S
d-＝0.0528 t＝|-0.4547|＝0.4547
4, make t=0.4547＜t0.05=2.262, so at a=0.05
Refuse H1 and accept H0 at the level place.The comparing result of collaurum TSH testing cassete and ELISA paper box does not have significant difference
The qualitative detection of 2 pairs of antibody to hepatitis C of example (anti-HCV)
With the anti-HCV testing cassete of the colloid gold label that has prepared, detect Chinese food and the anti-HCV standard diagnosing reagent of Drug Administration (known HCV antibody positive or negative serum), judge with signal to noise ratio (S/N ratio) (S/CO), and with (Abbott Laboratories of the same trade, OrthoDiagnostics) HCV detects the ELISA method relatively, confirm reagent (RIBA) as criterion with Chiron third generation HCV, testing result such as table 5 and table 6:
Table 7.HCV antibody colloidal gold diagnostic reagent examination criteria product: positive series
| Serum number | Native system HCV testing cassete | ABBOTT ELISA | Ortho ELISA | Chiron RIBA3.0 | ||||||
| The S/CO value | The result | OD | The result | OD | The result | c100 | | C22 | NS5 | |
| 1 | 4.56 | + | 1.702 | + | 1.925 | + | 1+ | 2+ | - | - |
| 2 | 5.46 | + | 1.811 | + | 1.557 | + | 1+ | ± | ± | - |
| 3 | 4.66 | + | 2.381 | + | 0.832 | + | ± | ± | 2+ | - |
| 4 | 4.38 | + | 1.209 | + | 1.39 | + | 1+ | 1+ | - | - |
| 5 | 2.88 | + | 1.793 | + | 1.184 | + | ± | ± | 2+ | - |
| 6 | 2.34 | + | 2.776 | + | 1.747 | + | ± | ± | 2+ | - |
| 7 | 4.34 | + | 2.7 | + | 1.395 | + | ± | ± | 2+ | - |
| 8 | 1.40 | + | 1.766 | + | 1.759 | + | 1+ | 2+ | - | - |
| 9 | 2.15 | + | 3.112 | + | 3.171 | + | 4+ | 4+ | 4+ | 4+ |
| 10 | 5.14 | + | 3.112 | + | 3.066 | + | 1+ | 2+ | 2+ | - |
| 11 | 2.09 | + | 3.191 | + | 3.309 | + | 4+ | 4+ | 4+ | 4+ |
| 12 | 2.25 | + | 3.077 | + | 3.309 | + | 1+ | 4+ | 4+ | 4+ |
| 13 | 5.26 | + | 3.15 | + | 3.258 | + | 1+ | 4+ | 4+ | 2+ |
| 14 | 1.73 | + | 3.191 | + | 3.309 | + | 3+ | 4+ | 4+ | - |
| 15 | 2.44 | + | 1.958 | + | 1.393 | + | ± | 1+ | - | - |
| 16 | 2.41 | + | 3.191 | + | 3.309 | + | 2+ | 3+ | 4+ | ± |
| 17 | 3.57 | + | 3.198 | + | 3.44 | + | ± | 2+ | 4+ | - |
| 18 | 2.55 | + | 3.163 | + | 1.488 | + | - | 2+ | - | - |
| 19 | 1.41 | + | 0.523 | - | 0.865 | + | 2+ | 3+ | - | - |
| 20 | 6.04 | + | 2.484 | + | 2.507 | + | 4+ | 4+ | - | - |
Table 8 HCV antibody diagnosing reagent examination criteria product: negative series
| Serum number | Native system HCV testing cassete | ABBOTT ELISA | Ortho ELISA | Chiron RIBA3.0 | ||||||
| The S/CO value | The result | OD | The result | OD | The result | c100 | C33C | C22 | NS5 | |
| 1 | 0.12 | - | 0.142 | - | 0.007 | - | - | - | - | - |
| 2 | 0.11 | - | 0.404 | - | 0.101 | - | - | ± | - | - |
| 3 | 0.81 | - | 0.206 | - | 0.014 | - | - | ± | - | - |
| 4 | 0.87 | - | 0.144 | - | 0.003 | - | - | - | - | - |
| 5 | 0.62 | - | 0.133 | - | 0.106 | - | - | - | - | - |
| 6 | 0.25 | - | 0.106 | - | 0.005 | - | - | - | - | - |
| 7 | 0.51 | - | 0.146 | - | 0.009 | - | - | - | - | - |
| 8 | 0.14 | - | 0.113 | - | 0.003 | - | - | - | - | - |
| 9 | 0.23 | - | 0.105 | - | 0.004 | - | - | - | - | - |
| 10 | 0.30 | - | 0.194 | - | 0.005 | - | - | - | - | - |
| 11 | 0.26 | - | 0.427 | - | 0.12 | - | - | - | - | - |
| 12 | 0.28 | - | 0.345 | - | 0.012 | - | - | - | - | - |
| 13 | 0.29 | - | 0.4 | - | 0.01 | - | - | - | - | - |
| 14 | 0.19 | - | 0.169 | - | 0.03 | - | - | - | - | - |
| 15 | 0.28 | - | 1.069 | + | 0.066 | - | - | - | - | - |
| 16 | 0.32 | - | 0.148 | - | 0.003 | - | - | - | - | - |
| 17 | 0.20 | - | 0.443 | - | 0.241 | - | - | - | - | - |
| 18 | 0.14 | - | 0.116 | - | 0.005 | - | - | - | - | - |
| 19 | 0.14 | - | 0.104 | - | 0.003 | - | - | - | - | - |
| 20 | 0.23 | - | 0.178 | - | 0.006 | - | - | - | - | - |
The result shows: utilize the HCV detection paper box of native system that the anti-HCV standard diagnosing reagent of Chinese food and medicine Surveillance Authority is carried out qualitative detection, the result meets the requirements.Compare with the corresponding enzyme connection of international esbablished corporation (ABBOTT and Ortho) (ELISA) diagnostic products, its sensitivity and specificity all reach the ELISA standard.
The experiment of example 3 single machine test module precision
Different test modules with same detector repeat the same project standard items (hepatitis B surface antigen HBsAg, 1ng/ml, 20ng/ml, 60ng/ml) that (10 times) detect variable concentrations, obtain its RI value.Through adding up, compare, analyze the coefficient of variation (CV) that draws the RI value of surveying between a plurality of test modules, result such as table 10:
Table 10 HBsAg detection by quantitative precision testing result
| Same detection module | With 6 different detection modules of machine | |||
| RI (10 times) average | CV | RI (10 times) average | CV | |
| 5ng | 0.0912 | 7.95％ | 0.0934 | 8.22％ |
| 20ng | 0.33791 | 0.79％ | 0.34184 | 0.97％ |
| 60ng | 1.03965 | 0.37％ | 1.04028 | 0.77％ |
The result shows, the same detection module of native system, and different detection module that the detection by quantitative of the HBsAg of variable concentrations is tested result repeatability is high, even its coefficient of variation of detectable minimum (1ng/ml) of national regulation still is lower than 10%.
Example 4 different detector precision experiments
In the test module of different detectors, with colloid gold label (three hydroxyl tetrachloro aurin acid, Tetrachloroauric Acid Trihydrate, Sigma., USA,) prostate specific antigen (PSA) testing cassete, the PSA standard items of duplicate detection variable concentrations (2ng/ml, 4ng/ml, 15ng/ml, 30ng/ml, middle inspection institute, lot number: 544-0004), obtain its RI value and measured concentration, the detection linearity between the more different detectors the results are shown in Figure 19.
Figure 19 platform detector is to the RI linear diagram of the PSA detection by quantitative of identical gradient concentration.By Figure 19, different detectors presents high performance reproducibility to the detection by quantitative of the PSA of same concentration.
Appendix
One, damping fluid
1, Tris (trishydroxymethylaminomethane) damping fluid, PH7.5
Contain 10mM trishydroxymethylaminomethane-hydrochloric acid (Tris.Cl)
1mM EDTA
2, PBS phosphate buffer, PH7.0
Contain potassium chloride 0.02%
Sodium chloride 0.8%
Dipotassium hydrogen phosphate 0.02%
Sodium hydrogen phosphate 0.215%
3, chemical coupling thing pad, sample absorbent sheet and damping fluid absorbent patch confining liquid, PH7.0
The PBS damping fluid contains following reagent:
1% bSA
1％Triton X-100
0.3% PVP (polyvinyl pyrrolidone)
1.5% sucrose
2mg/ml rabbit gamma globulin
4, chemical coupling thing buffer release liquid
10 times of concentrated PBS damping fluids
Casein 0.1%
Tween-20 1％
EDTA 2mM
Sodium azide 0.1%
5, chemical coupling thing bag is cushioned liquid
5.5 concentration PBS damping fluid doubly
Casein 0.05%
Tween-20 0.5％
EDTA 2mM
Sodium azide 0.1%
Claims (33)
1, a kind of lateral flow assays method, in order to the anti-platform of biochemistry, implement various test items, the required temperature conditions of one or more biochemical reactions is provided and hatches with detector, but it is characterized in that detected colour band or color dot that biochemical reaction produces being measured with photometry, calculating and analysis by optical density value ratio between tester and the determinand, by detector to being used for liquid biological sample, the project to be checked that is not limited to human sample to be checked is made quantitatively or judgement qualitatively, by pre-set programs testing result is stored the what database.
2, lateral flow assays method according to claim 1 is characterized in that or above tester zone being provided with in the described biochemical reaction, the used material of this control zone are non-existent material in the human body, as using the DNP dinitrophenol dinitrophenolate.
3, lateral flow assays method according to claim 1 is characterized in that described detector links to each other with computing machine by communication interface, and by this system operating software the project category that detects examination is discerned.
4, lateral flow assays method according to claim 3, it is characterized in that described detection realizes treating sample biochemical reaction originally: utilize the capillary chromatography effect, make liquid sample to be checked directed flow on holder, meet with corresponding detection thing and biochemical reaction takes place.
5, lateral flow assays method according to claim 4 is characterized in that described sample to be checked is artificial or natural liquid sample, as whole blood, serum, blood plasma, urine, saliva or other body fluid.
6, lateral flow assays method according to claim 4 is characterized in that described biochemical reaction utilizes colloid gold particle or silver or fluorescent dye or C
14Or the colour band that can be detected by light reflection principle that produces of other metal or dyestuff, will detect information after testing instrument system feed back on the Computerized analysis system.
7, lateral flow assays method according to claim 6 is characterized in that described colloid gold particle or silver or fluorescent dye or C
14Or the colour band that can be detected by visible light that produces of other metal or dyestuff, with detection information after testing the optoelectronic scanning system feedback of instrument to Computerized analysis system.
8, lateral flow assays method according to claim 6 is characterized in that described colloid gold particle or silver or fluorescent dye or C
14Or the colour band that can be detected by visible light that produces of other metal or dyestuff, with detection information after testing the CCD pickup system of instrument feed back on the Computerized analysis system.
9, according to claim 7 or 8 described lateral flow assays methods, it is characterized in that described biochemical reaction treats finished item by physical mechanical movement and electronic circuit and carry out detection time and temperature controlling, by optical density reflection Acquisition Detection result and feed back to the computing machine presetting database.
10, lateral flow assays method according to claim 9, it is characterized in that described database root divides the survey relative optical density that sample to be checked produced according to catching optical density, and, draw qualitative or quantitative testing result according to predetermined threshold value or typical curve analysis.
11, lateral flow assays method according to claim 10 is characterized in that the systemic presupposition program carries out the optical density value analysis to the survey band, calculates the relative optical density ratio of band to be checked with measuring tape optical density value to be checked/contrast band optical density value; And with what preset in this relative optical density ratio and the computer, detection relative optical density ratio threshold value or the typical curve relative optical density ratio relevant with this test item carry out correlation analysis, draw qualitative or quantitative testing result.
12, lateral flow assays method according to claim 11 is characterized in that the qualitative or quantitative testing result of described sample to be checked stores automatically by system operating software, and can be downloaded or print.
13, lateral flow assays method according to claim 12 is characterized in that described detector passes through the contained detection content of this testing cassete of the bar code recognition on the testing cassete shell, and passes through the corrected value of this bar code recognition institute test item difference between batch.
14, lateral flow assays method according to claim 13, it is characterized in that liquid sample adds described testing cassete window A after, flow to B end by the capillary chromatography effect; By way of the detection of wrapping quilt in advance with on the antigen or the antibody that can produce biochemical reaction with material to be checked, form immune complex.
15, lateral flow assays method according to claim 11 is characterized in that what described test-strips B end was coated with the collaurum coupling, can with material to be checked or detection with on formed immune complex produce the antigen or the antibody of biochemical reaction; And coupling, can wrap the antigen or the antibody of the tester qualitative response of quilt with the view window district in advance.
16, lateral flow assays method according to claim 15 is characterized in that liquid sample or damping fluid are added the B end, and dissolving should be wrapped in advance by conjugates, flowed approach view window district by capillarity to the A end; The anti-tester of collaurum coupling that can produce biochemical reaction in the B end material that has dissolved with the contrast material of pre-bag quilt produces biochemical complexes and is deposited on the reaction initial point with the contrast material.
17, lateral flow assays method according to claim 16 is characterized in that the anti-detection band material of described and collaurum coupling or anti-established immune complex and detects band or zone and go up established biochemical complexes and biochemical reaction takes place for the second time and be deposited on reaction place.
18, lateral flow assays method according to claim 17 is characterized in that the redness of described collaurum forming visible band or zone at the deposition place; The A end of test is mounted with the suction pad with excess liquid in the absorption reaction.
19, lateral flow assays method according to claim 18 is characterized in that bag is by two contrast bands of high and low concentration on the NC Nitroncellulose film in order to overcome with the difference of the described testing cassete of batch difference to same pattern detection result; Directly do not use the optical density value sentence read result that obtains after making detector scanning, and come sentence read result than the relative optical density value of last preassigned high concentration contrast band or low concentration contrast band with measuring tape optical density value to be checked.
20, lateral flow assays method according to claim 19, the calibrating threshold values that it is characterized in that each particular detection project is determined via the certain criteria flow process, variation that should the calibrating threshold values between every series-produced product will be incorporated into bar code and is delivered to instrument and understands in correcting determination result's the process.
21, lateral flow assays method according to claim 20, it is characterized in that in the production of quantitative test box, adjust the parameter value commonly used of typical curve and relative optical density value (RI value) to reach the purpose that reduces difference between batch by changing information that the different batches bar code contains.
22, lateral flow assays method according to claim 21, after it is characterized in that every batch of production test box, make standard items with the same series concentration of the first series-produced testing cassete, and record corresponding high-band optical density value (HC), low strap optical density value (LC), measuring tape optical density value to be checked (TD), obtain corresponding RI value by calculating (TEST (DR)/HC (DR) or TEST (DR)/HC (DR)) again.
23, lateral flow assays method according to claim 22, it is characterized in that the RI value of a series of concentration standard product that will obtain and the concentration of standard items makes a standard lines with software, new curve and former default curve ratio are, calculate the error slope and the intercept of two curves by the Excel form with the RI value, adjust the parameter of new curve, make the curve and the typical curve of optical density approaching, from adjusted curve, the adjustment parameter that draws in the bar code to be contained.
24, lateral flow assays method according to claim 23, it is characterized in that behind the described parameter information Input Software, software compiles all these information for digital, then in the software that can make bar code that these numbers are input to, can translate into bar code by software, be made into the steel plate die with this bar code, be printed on the testing cassete lid by screen printer or pad printer.
25, a kind of lateral flow assays system, comprise 1 master unit and 1～20 test module, and be connected to host computer by USB or blue teeth wireless receiver, host computer is by the operation of related software control detection instrument, the identification test item, obtain and the analyzing and testing result, store sample information to be checked and testing result.
26, lateral flow assays according to claim 25 system, the master unit that it is characterized in that described system is connected by cable with test module, one or more test modules can be selected to use by system, are designed to relatively independent relation between master unit and the test module.
27, lateral flow assays according to claim 26 system, it is characterized in that described detection module comprises an available motor and controls forward and backward mobile pallet, the bearing test box, the tray bottom ad-hoc location is equipped with capacitive transducer, with the application of sample process in the monitoring and detection operation; The privileged site returning apparatus temperature control system of tray bottom is realized heating with resistance thermometer clement, realizes cooling with peltier-element.
28, lateral flow assays according to claim 27 system is characterized in that master unit is given respectively to chemically examine module for power supply, coordinates the activity of a plurality of chemical examination modules, and provides communication to be connected with the computing machine that links to each other.
29, lateral flow assays according to claim 28 system is characterized in that described master unit receives the image information that receives test item and reaction band and feeds back to the enterprising line data of continuous computing machine from the chemical examination module to handle.
30, lateral flow assays according to claim 29 system, it is characterized in that the function software control that moves on the brown computing machine require the operation of control detection module, comprise temperature control, tray motion, illumination, shooting etc.
31, lateral flow assays according to claim 30 system, it is characterized in that the module of respectively chemically examining in the system all contains 1 microprocessor, illumination, position, monitoring environment temperature and the heating plate temperature of monitoring pallet, the monitoring application of sample that can carry out such as the control test strip are detected capacitive transducer, are passed through 12C interface and master unit communication, also can monitor the temperature of Pa Er card hot receiver and the rotating speed of fan in refrigeration unit, the chemical examination module is collected the image information of test item and is uploaded to master unit.
32, lateral flow assays according to claim 31 system is characterized in that system utilizes the CCD shooting to the identification test item, and Acquisition Detection result draws the detection conclusion by the relative optical density analysis.
33, lateral flow assays according to claim 32 system, the zone that it is characterized in that described CCD shooting comprises the bar code area and the testing window district of testing cassete loam cake; The image that CCD camera picked-up testing window district presents, system measures the optical density of colour band, and carries out band relative optical density to be checked analysis according to pre-set programs, draws quantitatively or detect qualitatively conclusion with preset parameter after relatively.
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