CN102164531A

CN102164531A - A universal testing platform for medical diagnostics and an apparatus for reading testing platforms

Info

Publication number: CN102164531A
Application number: CN2009801329757A
Authority: CN
Inventors: 罗杰·呐米·雅西; 安德鲁·慧列; 克里斯多佛·土蒙; 罗威·基瓦纳特; 沃夫·雷索锣其
Original assignee: Inverness Medical Switzerland GmbH
Current assignee: Alere Switzerland GmbH
Priority date: 2008-08-05
Filing date: 2009-08-05
Publication date: 2011-08-24
Also published as: IL211091A0; WO2010017299A2; WO2010017299A3; EP2346388A2

Abstract

A method and an apparatus for optically reading test devices having an identification data zone associated with the test device and test zone arranged to receive a sample. The apparatus comprises an optical sensing module, an image processing module coupled to the optical sensing module, a control module coupled to the optical sensing module and to the image-processing module. The optical sensing module is arranged to sense both the test zone and the identification data zone and deliver the sensed data to the image processing module responsive to the control module. Further, the image-processing unit is arranged to perform image processing on the sensed data from the test zone and from the identification data zone and further determine the sample according to the sensed data from the test zone in view of the sensed data from the identification data zone responsive to the control unit.

Description

The equipment of general medical diagnosis test platform and read test platform

Technical field

The present invention relates to analytic sample (for example blood, urine, saliva or the sample of signing from liniment) and test analyte, for example whether pathogen exists.

Background technology

Device for quick testing at test chemistry and biological substance is extensively quoted, and often replaces the test in some traditional laboratorys.These test sets comprise polytype test and are used to carry out the diagnosis such as the mankind, herding test and food product environment test or the like.

A lot of such test set utilizations are carried out chemical reaction and are carried out at being present on the test set material on the specific region.The material of this chemical reaction can be, for example he and sample react the back and occur representing existing of material in the sample by the parameter that sets in advance with optical form.The expression of optical form can be (for example two or centrifugal pump) or the quantitatively result of (for example by intensity, color or the shape of reaction, perhaps their combination is represented) qualitatively.

A lot of test platforms only allow to analyze the analysis of single sample and requirement to carry out manual operations and realizes test.For example, " rotation " streptococcus test box of being produced by Ai Bo/nova company has the sample treatment chamber, and this cavity allows liquid and test strip separate at the beginning, and having only by the time, terminal user just allows liquid contact with test strip after opening valve by the rotation cavity.Should " rotation " test platform be especially at swab (sample as cotton swab head) sample.Can being positioned on the circular rotatable working of plastics of valve in " rotation " test box.This valve mechanism needs manual the operation.

Concentrate on mainly that optical image handles, the digital fetch equipment (Reader) that is used for testting test set also is widely used, and they imitate the mode of for example diagnosing by craft such as bore hole, microscope or magnifieres to be designed to form.This equipment has also been used image processing technique and is tested or diagnose in order to improve human the use.This raising is by having used the sensitive of other, the technology that can realize, and for example the wavelength that can not see of naked eyes and digital result is provided has increased storage and linkage function etc.And the device for quick testing of setting the use field that has that reads for fetch equipment also is provided, and for example sample can be hidden, and simultaneously, the material of chemical reaction is placed on these device for quick testing in advance.

Some device for quick testing can be used with fetch equipment and be connected.Fetch equipment can be arranged to be connected with test set and be used for receiving some the extra data about sample, for example Ce Shi identification, the information of patient information and special lot number.These data are further processed for diagnostic test purpose subsequently.

In this field, the repeatedly design with light and handy test set that is of looking over so as to check in order to test material in the body fluid or the chemical substance in other samples is attempted.In a lot of cases, these data for unique special test set can be used for obtaining best test result and precise diagnosis process.These data are usually about technical manual, for example about the production process of special test set, and lot number for example, date of manufacture, model and type of device or the like.The device of relevant this data is used to calibrate fetch equipment and influences the processing of diagnostic procedure quality for other.

Whole United States Patent (USP) number 7,267,799, full content be cited as the application's reference.He provides a common sensed image test macro, comprises a fetch equipment and a kind of method that a kind of calibration data is provided for fetch equipment.But, this about test and data relevant with calibration by with different form transmission.This just need provide a kind of better fetch equipment, it can use identical method and identical visual response to read data relevant with sample and the peripheral data relevant with test set, ID (identity number) card No. for example, the information of name and his or her bio information stamp and the like.

Summary of the invention

In some concrete modes, the present invention relates to analytic sample (for example blood, urine, saliva or the sample of signing from liniment) and test analyte, for example whether pathogen exists.The concrete diagnostic test platform that comprises, he can directly be a test set.This platform can have or not have the correction that platform is carried out appropriateness just can analyze multiple different sample.This platform also can reduce operator's operating procedure and more accurate more sensitive test result is provided.This platform also can be combined as a whole with low-cost device the analysis of Exact Number formula is provided.

In some modes, the present invention is about a kind of equipment, fetch equipment for example, a kind of portable fetch equipment about biological or chemical sample on the read test device; For example a kind of fetch equipment, it can vision read the information data relevant with sample, for example relevant data message with test set, patient for example, the donor perhaps carries out the people's who detects information data.

In some devices, test set comprises a box.Exemplary, this box comprises a body portion, a upper cover part and a cavity.This cavity comprises a receiving unit that is used for receiving the sample application device.One test strip is between the body portion and upper cover part of box.This device can comprise the passage that connects cavity and test strip.

This device can comprise a movably valve that can move to the second position from primary importance.In primary importance, valve is blocked this passage.In the second position, this valve flows on the test strip from cavity by this passage by sample.In some modes, valve is side direction guiding valve, straight line guiding valve or rotary valve.

Upper cover part can comprise the test strip window that is used for observing the partial test bar.The upper cover part of box can also comprise a recognition data zone, for example at least one sign, for example bar code.This have to can be positioned near the test strip window in a recognition data zone.At least one sign can be, for example the bar code of an identification number bar code or a two dimension.

In some modes, cavity is round shape or circular.In a concrete mode, cavity has slick wall.In another concrete mode, cavity can comprise the ridge structure of groove or projection.

In some modes, cavity is a reaction chamber, for example in cavity, sample can with one or more reagent reactings.Exemplary, can also comprise a kind of reagent in the cavity, the antibody granule that for example is labeled.Cavity also can comprise a kind of mixing apparatus, and it comprises the Magnet and the magnetic force generator of an antibody granule that is used for mixing being labeled and sample.

In a mode, reagent strip can comprise that one or more sample reception pads receives sample; Nitrocellulose membrane and an adsorptive pads that absorbs unnecessary sample of comprising test zone.Reagent strip can also comprise a bridge pad.

In some modes, cavity can also comprise the receiving unit that receives the sample application device.This receiving unit can, for example accept applicator for taper applicator shape, the netted saliva collector of accepting can also comprise liquid filter, cushion pad or at least one blood separation pad.

In some modes, exemplary, sample is applied to the catcher receiving unit of the cavity on the checkout gear.Sample can be processed at the catcher receiving unit and handle sample.In some modes, the processing of sample can be to extract saliva from sample application device or saliva collector, also can be by sample being filtered, adds buffering liquid (for example filtering or the buffering urine specimen) or separating sample (for example separating erythrocyte from sample).

Sample, for example processed sample and reagent are mixed and prepare biased sample in cavity.In some modes, sample, for example processed sample and reagent mix with a mixing apparatus, for example a Magnet and a magnetic force generator that is arranged in cavity.

By valve is moved to the second position from primary importance the sample the cavity is transferred on the reagent strip.In a mode, the move through equipment of valve from the primary importance to the second position is finished.In a mode, valve is side direction guiding valve, straight line guiding valve or rotary valve.

In some modes, test set comprises a test zone and recognition data zone.Test zone preferably is positioned on the test strip, and the recognition data zone can be positioned at, for example on box or the test strip.

Test set and test strip can be analyzed with equipment, and for example fetch equipment reads this test set.It is the positive or negative result that test strip can analyzedly be tested, or the concentration of analyte in the working sample.Test strip and test set can be analyzed by reading the recognition data zone, for example on the reagent strip or the identified areas on the box of test set.This identified areas can be, bar code for example.

In some modes, equipment can be provided to read (for example optically) test set, and this test set comprises recognition data zone that is connected with test set and the test zone that is used to accept sample.This equipment can comprise the optical sensor module, image processing module and control module.Image processing module preferably is connected with the optical sensor module.Control module preferably is connected with image processing module with the optical sensor module.The optical sensor module is arranged to respond to test zone and recognition data zone.Response module, optical sensor module also can send induced data in image processing module.Response module, image processing element can be arranged to carry out from the data of test zone and the data of identified region carries out image processing, and, under the data of reference identified region, measure sample by processing to the sensed data of test zone.

In some modes, come biological substance in the analyzing samples by test set, also can be transferred in the device about the data of sample and about the production process data of test set.The biological specimen material can be preferably processed by optical sensor and induced data.Processed data and test set creation data can be transferred on the test set.

Description of drawings

Fig. 1 is the plan structure sketch map of the body portion of test box.

Fig. 2 is the plan structure sketch map of test box.

Fig. 3 is the upper cover part plan structure sketch map of test box.

Fig. 4 looks up structural representation for the body portion of test box.

Fig. 5 is the plan structure sketch map that has the test box of bar code.

Fig. 6 is the 3-D solid structure sketch map of applicator receiving unit.

Fig. 7 is saliva collection grid and the plan structure sketch map that filters keeper.

Fig. 8 is the plan structure sketch map that has particulate box of traget antibody and magnetic stirring apparatus.

Fig. 9 represents to have the structural representation of the motor apparatus that is connected with linear valve.

Figure 10 a is illustrated in the structural representation that sample is hatched the valve primary importance in the process.

Figure 10 b is illustrated in the structural representation of the valve second position in the sample motor process.

Figure 10 c is illustrated in the complex structural representation of valve the 3rd position in the motor process downstream.

Figure 11 a for Figure 10 a shown be the side structure sketch map of test set.

Figure 11 b for Figure 10 b shown be the side structure sketch map of test set.

Figure 11 c for Figure 10 c shown be the side structure sketch map of the test set of complex when beginning to move round about.

Figure 11 d is the side structure sketch map of the shown test set that is complex in motor process round about of Figure 10 c.

Figure 11 e reads lines and controls the structural representation that reads lines for the shown capture antigen of Figure 10 c.

Figure 12 a is presented at sample and hatches the structural representation that the linear cunning with two positions in the process is in primary importance.

Figure 12 b is presented in the sample motor process, and the linear cunning with two positions among Figure 12 a is in the structural representation of the second position.

The 3rd the structural representation that has dcq buffer liquid among linear guiding valve among Figure 12 c displayed map 12a and Figure 12 b with two positions.

Figure 13 a is presented at and oppositely applies the structural representation that linear guiding valve between the complex flow periods is in primary importance.

Figure 13 b be presented at complex downstream-the sample flow upstream during linear guiding valve be in the structural representation of the second position.

Figure 13 c is presented at the structural representation that complex linear guiding valve during the sample flow further downstream is in the 3rd position.

Figure 14 a is presented at that the biotin complex oppositely flows backwards and sample applies the structural representation that linear guiding valve between the golden compound trip flow periods in back is in primary importance.

Figure 14 b is presented at the structural representation that the linear guiding valve of sample flow disorder of internal organs is in primary importance.

Figure 14 c is presented at the structural representation that the linear guiding valve of the easy sample flow disorder of internal organs of the composite buffering that discharges biotin complex and avidin simultaneously is in primary importance.

Figure 15 a is presented at sample and hatches in the process process, oppositely applies the structural representation that linear guiding valve in the complex process is in primary importance.

Figure 15 b is presented at the sample flow upstream, oppositely applies the structural representation that linear guiding valve in the complex process is in the second position.

Figure 15 c show complex oppositely apply with two complexs flow further downstream process together in linear guiding valve be in the structural representation of primary importance.

Figure 15 d is the side structure sketch map of Figure 15 c.

Figure 16 a is the side structure sketch map that test strip has sample or erythrocyte separate blood test sample box.

Figure 16 b is the side structure sketch map that has sample or erythrocyte separate blood test sample box in the cavity.

Figure 16 c is the side structure sketch map that has buffer storage and sample/erythrocyte separate blood test sample box in the cavity.

Figure 16 d is the side structure sketch map that has the blood sample test box of buffer storage in the cavity.

Figure 17 is the roughly flow chart of the equipment work in some embodiments.

Figure 18 is the roughly flow chart of the method in some embodiments.

Figure 19 is the detailed operation flow chart of the several different methods in some embodiments.

Figure 20 is the schematic perspective view of the fetch equipment of some embodiment equal proportions.

These figure and following detailed obviously can know how the present invention is applied in the reality for one of ordinary skill in the art.

Describe in detail

In some modes, diagnostic test comprises a box, and equipment reads this box and one and is used for applying the applicator of sample to box.This diagnostic test also can and equipment, for example automatic fetch equipment uses together or uses not together.See Fig. 1-3, box preferably includes body portion 1, upper cover part 2 and cavity 3.In a mode, cavity 3 is cylindrical or barrel-shaped.This cavity 3 can comprise that the applicator that is used for accepting the sample applicator accepts part.

The body portion 1 of the box of test set preferably maintains a test strip 6.This test strip 6 is preferred between the body portion 1 and upper cover part 2 of box, and lies low on body portion 1.Upper cover part 2 can have the watch window 7 of observing a part of test strip 6.Test strip preferably includes the sample reception pad, a nitrocellulose filter and an absorption pad.In some modes, this test strip 6 can also comprise a bridge pad.In other modes, this test strip 6 can also for example on the test zone, comprise the antibody of some dry-cure on nitrocellulose membrane in some special places.Test strip 6 can have suitable dimensions to be arranged in body portion 1, for example about 1-10 mm wide, approximately 40-80 millimeters long.This box also can be designed to hold the test strip of different length and width.

In some modes, for example shown in Figure 4, can comprise a breach 8 at the body portion 1 of box, light can be from matrix irradiation and tested from the matrix down like this.This breach can be an Any shape, and is for example circular, oval or avette.In this mode, test strip preferably is made up of clean or transparent back lining materials.Allow projection light in this concrete mode or/and reflected light is tested arrives.

In Fig. 5, the upper cover part 2 of box can wrap a recognition data zone, and for example marker for example is a bar code 9.This marker or bar code can be positioned at any one side of watch window 7.Marker can for, for example one dimension (ID) or the two dimension (2D) bar code.In these modes, in order to reduce minimum error, marker or bar code and test strip have the position that same routine is focused on jointly.

Cavity preferably has an opening, and the part of for example accepting sample receives different sample applicators, and these are specifically described below.The example of sample applicator comprises swab applicator or saliva collector.The acceptance part of each applicator that is described below can be designed to enter the manipulation zone at sample and come to handle sample.For example,, filter or the buffering urine specimen, from blood sample, separate erythrocyte by extracting saliva sample from swab or saliva collector.Carry out in order to allow other be reflected at cavity bottom, allow end step of sample receiving area and cavity separate, produced two different zones like this, sample receiving area and sample treatment zone.The receptor receiving unit can be designed to allow the sample that adds cavity away from the sample process zone.

In some embodiments, the sample device receiving unit is that the shape of applicator head 10 receives the sample applicator, a swab for example, and for example throat horizontal bar in the front of a carriage used as an armrest (swab) or sample divider are such as the foam saliva collector.User can insert swab or applicator in cavity.Buffer solution be introduced in the cavity.Applicator head 10 shape receiving units can stop fluid flow before swab or applicator are left cavity.Can allow the material on swab or the applicator better be eluted like this, this is because swab or applicator are immersed in the buffer solution.Swab or applicator are removed up to them to the hole 11 of the cavity bottom of obstruction applicator head 10 shapes of small part, and swab or applicator can rely on the external wall of the cavity of swab head 10 shapes to mix with nest to revolve like this.The interior walls surface 12 of the cavity of applicator head 10 shapes allows liquid flow along wall.The width of the cavity of applicator head 10 shapes and highly allow the applicator of number of different types be inserted into, for example foam swab or polyester swab.Foam swab demonstration from Puritan can improve the susceptiveness of test.If be not used, in analytical sensitivity, test can be predicted minimizing 1A log (this point also is proved to be in below the example).Also can comprise cataphracted structure 13 outside the cavity of applicator head 10 shapes, it can be slotted or by coarse.This cataphracted structure 13 can allow be reflected at allow when carrying out air in cavity on current downflow, also help allow the bead material of Magnet or reaction be positioned at intravital suitable position, chamber.

In some modes, the receiving unit of sample applicator can also comprise a network structure 14, and for example such network structure extracts sample among Fig. 7 from catcher.This network structure 14 can allow the catcher of outside, and for example saliva collector is extruded or compresses and allows sample be extruded or compress catcher.Catcher can be made up of foam, and network structure is made up of foam plastics.Filter pad can be set on the network structure or below.Have netted structure and can only allow catcher collect a spot of sample collection on catcher, because all liquid can be directly is extruded or compresses and directly enter the sample process zone from catcher.This is very particularly useful under the dry situation to those mouths, because the people of xerostomia can only collect very a spot of sample.

In some modes, the catcher receiving unit can comprise some filter pads or cushion pad.For example, filtration or cushion pad can be placed in the chamber, perhaps can be fixed on a position on the cavity wall.Filtration or cushion pad can be made up of pore material, for example are numbered 1342 and have discoid (for example diameter is 9/16``, and thickness is 1/16``) material.This discoid material can be handled the also dry top moisture of removing through decontamination reagent.The catcher receiving unit do not need use to filter swab head or with the buffer solution dilution under just can directly allow sample, for example urine or saliva are applied on this detection platform.

In some modes, the catcher receiving unit comprises that is separated and collect a receiving unit, for example blood separation and collection receiving unit.The separating blood sample can carry out in the cavity of test set or on the test strip.For separating blood sample in cavity, the sample that can be arranged in cavity by the sample receiving pad that can separate the material of erythrocyte from sample applies on the position.Optionally, also can also have a lot of pads, they have different character can be from catcher (for example capillary cuvette) shift those and do not contain on the antibody granule of erythrocytic sample to the cavity.In order on test strip, to separate erythrocyte, being positioned at sample pad under the cavity can be formed or be had difference and can analyze the separator of erythrocyte and form by the material that separates erythrocyte, like this, shift from cavity that sample stops on test strip or fixed sample in erythrocyte on sample pad.The examples of material of forming separating pad can comprise, for example overflows the VF1 of (Whatman) from German Butterworth, VF2, MF1, and LF1 material or from the Cytosep material of precious Lay (Pall).In some modes, sample pad is that multiple erythrocyte separating pad is formed, they can work as that sample stops in flow process or fixed sample in erythrocyte and stop these erythrocyte that nitrocellulose membrane is incarnadined.In other modes, sample pad only goes up a unique mat and analyzes erythrocyte or two or more mat and be cascaded and allow erythrocyte fix.The antibody of anti-erythrocyte can be processed at the erythrocyte of assisting on one or more mats in the fixed sample.

Cavity can comprise a valve, for example linear sliding shutter or changeover valve.This valve can be operated by linear slide, and this slide block can be made of plastics.Can open a hole on valve, the body portion of box can be fit to allow the sample pad of test strip near the hole of valve.The step of opening valve can be automatic.Automatically open valve and not only can allow the user of commence operation reduce the step of operation, can also reduce some because open valve and the technical mistake that causes in incorrect time or incorrect mode.A motor of this equipment, for example stepper motor can promote slide block to certain position, allows the hole of valve align with the hole of the upper cover part of box like this.The upper cover part of box can keep this valve in a position.Place around valve is preferably sealed, for example seals with "O.Valve can be two zones separately, and one for sample applies the zone, and another is the sample process zone.

Figure 10-16 has shown the possibility of other about the test box.In these modes, valve has first and second positions.In primary importance, valve intercepts the passage between cavity and test strip.In the second position, valve flows on the test strip from cavity by this passage by sample.If have enough samples to flow on the test strip or the process time enough, valve also can move to primary importance from the second position.These can be based on what of time controlling liquid.For example, after through the testing time that needs, the motor of equipment can promote valve to the position of opening, testing time rule of thumb then, the position that promotion valve to the second is closed.

Referring to Fig. 8, cavity comprises a reagent material, and for example the reagent granule 15, and for example the antibody granule of labelling is positioned at cavity 3.Reagent granule 15 is included in sample process and goes to handle the composition of sample and the product that one of generation can be tested.This composition can comprise the antibody coupled with gold colloidal, extracts enzyme, the material of protected protein or buffer reagent.In some modes, the antibody granule of labelling is the gold grain that has antibody, and this antibody and gold colloidal and PIyC enzyme are coupled.Mix formation antibody complex with can sample on the test strip all sample of reagent granule 15 rather than the antibody that absorbs labelling with all antibody.Can improve like this and reduce because replenish excessive and kinetics is former thereby the inaccuracy reaction that causes.Reagent granule 15 can improve the accuracy and the sensitivity of test set, and this is to should be him can test low-level analyte and the availability that increases test set.This test set can be used and without any need for operator's manual operations.The reagent granule can be inserted into disclosing in 3 of box when producing.In some modes, the chemical reaction of a heat release also can be included in the reagent granule, at the liquid of coloring reaction prerequisite heat supply.In these modes, the opening and closing of valve can help attemperation.In some modes, the equipment based on testing chain coccus A (Strep A) can use quick test immunochromatographic method box and an equipment to come in the test patient sample, throat swab for example, in streptococcus A.Traditional testing chain coccus A method adopts nitric acid to extract or discharge the antigen of streptococcus A, this method (1-2 minute) not only consuming time nor can all extract (Kong De etc. " simply extract the method for the streptococcic cytolysis material of Beta serum; " applied microbiology " 836-839 page or leaf; the 5th; 28 the volume, in November, 1974).On the contrary, the antibiotics that method of the present invention adopts lysine to connect, PIyC extracts streptococcus A antigen.This material shows can provide hydrolysis substance completely in several seconds.The lysine of reorganization is provided by new height diagnostic companies (New Horizons Diagnostics.).This albumen is expressed by large intestine Citrus chachiensis Hort. bacterium and be purified (international publication number sign indicating number: WO2004/104213-Rockefeller University) on hydroxyl (base) hydroxy-apatite pillar (hydroxyl apatite column).

The present invention also can use the bubble myrrh to sign and replace traditional flocking polyester swab.Can improve sensitivity like this, reduce the inconvenience and the minimized transmission medium of user.The present invention also can use low-cost device to carry out mixing sample, hatch sample and automatic analytical reactions automatically.This equipment can reduce the step of operation, and the ambiquity of measurement result during those low signals of minimized reduction provides the error of transmission when result and minimized minimizing write down to the patient by direct test transmission result faster.

The equipment that the present invention is based on testing chain coccus A has used antibody, and the test that test is compared on the existing market is sensitive more, and specificity is stronger.The goat-anti body is processed on the nitrocellulose membrane with wide lines form, can improve in limited test like this and catch the capture rate of lines and eliminate the antibacterial that causes cross reaction in advance.The antibody of goat-anti streptococcus A can be BBA, a kind ofly uses antibody that the immunogen immune of Abbott Laboratories (ABBOTT) produces or by than blue company (Binax, Inc.) antibody of Sheng Chaning by ADAPT.Eliminate the antibody of the goat-anti streptococcus A of three kinds of different gonorrhea cross reactions and can before purification, eliminate cross reaction.The antibody (18A) of the rabbit streptococcus A that new height diagnostic companies (New Horizons Diagnostics) company provides also can be used.Label is preferably gold colloid, and sample is preferably in painted preceding and gold colloidal mixing.Coupled antibody shows the sensitiveest and the antibody of streptococcus A is had specificity most.

The sample mixing apparatus also can be arranged in cavity 3, and is shown in Figure 8.The equipment of mixing sample can be read equipment control.Mix and preferably finished by Magnet 16 and magnetic force generation motor.Magnet 16 can be inserted in process of production or be embedded in the bucket of box.The Magnet of Any shape can be used.In some modes, Magnet can be rhombus or square row.Allow sample and buffering solution, extract reagent and or the Magnet of the antibody of labelling can eliminate the inhomogeneity of sticking silk fabric sample.The mixing velocity of Magnet and the frequency of stirring can be controlled by the software of fetch equipment fully.This is useful for mixing sticking silk fabric sample and reagent granule, can improve the kinetic reaction of antigen and antibody like this.In addition, sample is prepared also can finish before painted (chromatography) reaction completely.

In case sample is mixed and hatch one suitable period with the reagent granule after, valve is pushed to by the motor of equipment and opens.In the time of valve open, liquid solution can flow on the sample receiving pad of test strip by the valve hole.Painted beginning and react detected.In some modes, one catches up with buffer solution (for example promoting buffer solution) also can be added in the cavity after cavity or incubation time are finished being entered by sample.In some modes, catch up with or promote buffer solution and can be included in the cavity; Also can, in coding, utilize the skew mouthful on the slide block be positioned at valve and second slide block allow catch up with or promote buffer solution and be applied on the test strip with sample or after sample.In some embodiments, coupled buffer solution can be contained in the blister parcel.

Equipment preferably uses signal-testing apparatus, and photographing unit for example is such as the CMOS photographing unit.Signal-testing apparatus has a lot of algorithms and the decision chart comes test signal.Equipment is analytical test strip periodically, and for example 10-15 second, up to satisfying a certain definite standard cycle, for example the positive or negative result is detected.Need not change design system, the software in the equipment can be adjusted along with the position change of test features.Equipment can with some software, bluetooth for example connects to come automatically downloading data.

Figure 17 shows high-caliber equipment workflow diagram (for example 17 for fetch equipment), 100 expressions, for example read test device 180 optically.Test set 180 preferably has a recognition data zone 195 (for example indicating the zone, such as bar code) and test zone 190.Equipment 100 comprises induction module 110, optical sensor module for example, and it comprises 120, one picture modules 130 of optical sensor module (such as the digital image module) and an image processing module 140 and a control module 150.Image processing module 140 can be connected with induction module 110.Control module 140 can be connected with image processing module 140 with the optical sensor module.

Induction module 110 can be arranged (perhaps simultaneously) induction test zone 190 and recognition data zone 195.Response module, induction module 150 can be transmitted induced data in image processing module 140.Further, response module 150, image processing module 140 can be arranged carrying out image processing from the data of the data of test zone and identified region and further by with reference to from the data in recognition data zone 195 with based on measuring sample from the sensed data of test zone 190.

In some modes, equipment 100 can be arranged to measure a plurality of test sets, and each difference that can be designed to carry out for different samples, different analytes is tested.Sample can be multiple, such as biomaterial, and body substances, chemical sample and similar with it sample.The type of test and/or other parameter can be undertaken such as test optically by induction test zone and data area.In some modes, identified region can relate to any kind of of test set itself or the data of form, and these data can be applied in the process that the image of test zone is handled.Data to identified region have no particular limits, and he can comprise the kind of test, pattern, calibration data, date of manufacture, identification number, bar shaped number, bio information (for example being arranged on the finger print image of data area) and the similar with it information of test.In some modes, test zone can be arranged to receive sample and the visual image that provides about sample.

In some embodiments, test zone 190 can receive sample and provide visual about whether there being the test result of material in the sample according to the parameter that is provided with in advance.

In some embodiments, induction module 110 can be responded to test zone 190 and recognition data zone 195 simultaneously.

In some embodiments, induction module 110 can be responded to test zone 190 and recognition data zone 195 in turn.

In some modes, equipment 100 need not scan or slave unit on the mobile test device just can the read test device.

In some modes, induction module 110 can comprise a vision element 120 and digital image module 130.Digital image module 130, image processing module 140 and control module 150 can be integrated on the same circuit board.

In some modes, equipment 100 can comprise a printed circuit board.Induction module 110, image processing module 140 and control module 150 can be integrated on the printed circuit board.

In some concrete modes, equipment 100 can comprise a power supply, for example can be again towards power supply.This power supply can comprise be positioned at test set 180 on the electromagnetism power supply that can be connected towards power on switch again.Cooperate to come with the machinery of test set by equipment battery supply is charged.

In the mode, equipment 100 can comprise the limiting module 170 that is connected with control module.Limiting module 170 can be used to store some restricting datas about restriction use test device.These control/restricting datas can be used to the response limits data and limit these equipment of use.Restricting data can be following any data, but is not limited to, the recognition data of the test set that the quantity of maximum use test device, preliminary election set and relevant therewith data.

In some embodiments, equipment 100 can also comprise subscriber interface module 160.Subscriber interface module can be connected with control module.Subscriber interface module can be arranged to allow pattern and the type of selecting suitable operation the pattern of the operation that user is provided with from preliminary election and the type.

In some embodiments, equipment 100 can also comprise abandon the part and can re-use part.Abandoning part can be arranged to be separated from from re-using part.Optionally, entire equipment can be as the part that abandons.

Figure 18 has shown the high level flow chart of describing optical sensor test set method.In some modes, this method can comprise the step (for example optical sensor) of responding to test zone 210; With the step (for example optical sensor) in induction recognition data zone 220, and by with reference to from the data in recognition data zone with based on the analyte of measuring from the sensed data of test zone in the sample 230.In some embodiments, the step in induction test zone and recognition data zone can be carried out or carry out in turn simultaneously.In some modes, this method comprises that the restricting data by preexisting in the recognition data 240 comes the use test device is limited use.

In some modes, this method comprises allows the device current starting device, and for example by manual when allowing test set and equipment cooperate, optical sensor starts 250.

Figure 19 has shown the high level flow chart of describing some embodiments of optical sensor test set.This method can comprise the step that reads data area 310; The step of test zone 320, the step 330 in read test zone are given in the restriction that handle immediately sets in advance; Handle the step of test zone 340 and response result (if there is), use the step in calibration parameter 350 read test zones.

Figure 20 shows the stereo amplification figure of the equipment behind the removal shell.Equipment 400 in the inferior embodiment can be arranged to accept test set 410, and test set has test zone 412 and identified region 414.In operation, test set is inserted in the opening of equipment, for example chute.By the lens of digital processing module 440, image and identified region 414 that mirror 420 can reflection measurement zone 412.Then, processing module is carried out Treatment Analysis, and information can be displayed on the display 450, perhaps carries out transfer of data by data transmission module.Can understand that other certain operations method and embodiment also are fine, the description here is the embodiment of an object lesson of the present invention.

In some modes, this method comprises analyzes the bio information analysis good bio information relevant with test set with storage.Bio information may reside in test set, and these information realize same test from patient or nurse to the collection of sample, perhaps biological specimen identification itself are obtained other information.Bio information can obtain from chemistry or biological respinse result, and this reaction can be read by optical system.For example, information comprises dna fingerprint information, blood type etc.Biological specimen can be photo or by ink, powder or other any directly/be printed on the finger printing on the test set indirectly.

In some modes, sample can be provided the composition in the sample by biosystem identification.In addition, bio-identification can be got in touch with test result and be pointed out and the corresponding special test result of test composition (for example drugs test).Bio information can obtain from tested biological specimen, also can obtain from coming from the sample of the same mankind or animal with test sample book.Biomaterial can be the sample that intermediate form exists, for example photo, image, leaflet or other information relevant with test.

In some modes, equipment can be arranged to encrypt or hide some test result, can allow user see test result very difficultly or test result is analyzed like this.Server or doctor that these test results can be passed through transmission channel (for example USB, the RF storage medium) person of being transferred to end analyze.

Equipment component can be implanted one or more computer programs, for example the processor that can programme at least, data-storage system, at least one input equipment and at least one outut device.At least the processor that can programme can with from data-storage system, receive data and indication, and data-storage system is given in transmission data and indication.Computer program comprises a series of operable indication, and direct or indirect carries out a certain activity or bring a certain result in computer.Computer program can be written into by language in any form, comprises original or blocky language, and this language comprises any form, comprises the program or the template of single cpu mode, composition, and subprogram, perhaps other are used in the program language of computer environment.

The program of indication can be carried out by processor, is for example carried out by common or special microprocessor.Program can be carried out by one processor, also can be carried out by a plurality of processors.Preferably, handled for one and can from memory medium, receive indication and data, read-only memory for example, flash memory or by random memory or their combination.Computer components comprise that a processor goes to carry out indication and one or more internal memory goes to store these indications and data.Usually, computer comprises or comes storing data files with one or more jumbo memory devices.Jumbo memory device comprises disk, for example in cun disk and disk movably; Magneto-optical disk or CD.Can be comprised any type of memory media by the memory device that computer program reads, including, but not limited to, semiconductor memory equipment, EPROM for example, EEPROM, and flash memory, jumbo disk can be interior cun disk and magnetic movably, magneto-optical disk or CD, for example CD-ROM and DVD-ROM dish.Processor and memorizer can be increased or appendix on ASICs (integration application).

In order to provide explanation to user, fetch equipment can show information to user with having a display device for example the computer structure of LCD detector (LCD Panel) is incompatible, keyboard and stare at point device (for example mouse or trackball) can be imported data to computer by these user.

Equipment can with the computer combination with backup functionality, data server for example, perhaps computer comprises intermediary element, for example application service or network service, perhaps computer comprises anterior member, the client computer that for example has user explanation perhaps has their bonded computer of internet browsing function or this.These assemblies of system can be communicated with by network.For example interactive network comprises telephone network, a LAN, a WAN, WLAN or bluetooth, and the Internet of computer and network composition.

Computer system can comprise client and server.A client can be connected by network with the server, an example that for example describes below.Client and server's relation relies on the computer program operation and sets up.

Specific embodiment

Examples of implementation 1-is based on the equipment of detection of streptococcus A

These examples of implementation can display-object analyte (detection of streptococcus A) at susceptiveness that is just listing exemplary and specificity.

Material:

● based on the box of detection of streptococcus A detection;

● RTG-A: equipment;

● the loam cake of RTK-box;

● RTK-" O " type ring;

● the RTK-linear valve;

● RTK-detection of streptococcus A tests strip

■ G﹠amp; L thin slice backing (GL-51954)

■ nitrocellulose filter cutting machine CN95,

◆ be numbered 1UN95ER050025WS;

◆ lot number is 0,308 19,910 0703883):

The antibody of ■ ADAPT goat-anti detection of streptococcus A

◆ 1mg/Ml (B AA#021): the trehalose that contains 4uL/cm;

■ chicken IgY (1mg/Ml; 1uL/cm)

The wide sample pad of ■ (Ahlstrom 1281) 12.5mm

The bridge pad that ■ Porex 4588 12mm are wide

The absorption pad that ■ Ahlstrom 901 18mm are wide

● the body portion of RTK-box

● RTK-Magnet

● RTK-streptococcus A gold grain (providing) by Biosite company

■ rabbit streptococcus A antibody (lot number 030948RD)

■ (hydrochloric acid 18 OD30, OD 9.375/ every test strip)

The anti-chicken complex of ■ donkey (OD 30, OD 1.4 every test strip)

◆1mg/mL?PIyC(12.5ug/test)

■ Next Gen pearl buffering liquid

◆ 9.5mg/mL boric acid

◆50mg/mL?fraction?five?bsa

◆ 300mg/mL sucrose

◆ the polymeric rabbit igg of 12.5mg/mL De-

◆ the 1mg/mL compound that dissolves

◆pH?7.2

● RTK-taper receiving unit

● washing buffer solution-research form

■ 0.025M citric acid

■ 0.25M Tris base soln

■0.025M?EGTA

■0.25％SDS

■ 0.25%P40 Nonidet

■ 0.05% Hydrazoic acid,sodium salt

■pH?7.2

● cotton swab: from supplier (Puritan pharmaceutical companies, reference number are the 25-1506IPF solid)

● streptococcus A dilution buffer liquid: Ix PBS+0.05%P40 Nonidet:

Equipment: RTG-A is numbered #6, streptococcus A program

Method

In present embodiment, comprise box, an equipment, a cotton swab and wash liquid based on the equipment of streptococcus A test strip.This box comprises test strip, Magnet, gold grain and taper receiving unit.Test strip comprises nitrocellulose filter, sample pad, bridge pad and absorption pad.The antibody of a streptococcus A who is provided by ADAPT BAA company and control antibody, chicken IgY, these raw materials are attracted on the special position of nitrocellulose filter.Fast 5 millimeters of test strip, long 59.5 millimeters.Gold grain comprises: the coupled gold grain of antibody of rabbit streptococcus A, anti-chicken antibody of donkey and PIyC enzyme.In process of production, gold grain and Magnet are inserted in the bucket of box.The taper receiving unit be inserted in the box and be positioned at gold grain and Magnet on allow them be positioned at fixed position.

Taper receives and comprises the washing zone, and the washing zone can not stop liquid flow when label also left face to face.Equipment comprises the part of acceptance test device, and mixing sample and gold grain promote valve automatically to enable position.Equipment is automatically every 10-15 analytical reactions in second and the result of report based on extreme standard.Equipment is connected to come automatically downloading data by bluetooth with PC software.

For the test of analyzing, the streptococcus A solution of 10uL is added on the cotton swab.User inserts cotton swab in patient's mouth and take a sample in the tonsil zone.User is inserted into cotton swab in the taper receiving unit of box.By discardable 200uL pipette wash solution is joined the taper receiving unit.

Analytical procedure

Box is taken out generation from packing.Box is put in the equipment, and allows testing of equipment information come open detection.Cotton swab is inserted in the taper receiving unit of box.Wash solution is joined the taper receiving unit.Cotton swab in the taper receiving unit in the rotation several times (maximum 5 times) remove then.Cotton swab is inserted in the taper receiving unit of box again and is used for removing top excess liquid with projection on the taper receiving unit.Remove and abandon inferior then.Be positioned on the equipment the test button by by and begin the test.When signal tested to or whole end product (concentration of control line or time) is tested go out after, the screen that test result can be by equipment (perhaps by Bluetooth transmission to the PC device).

Examples of implementation 2-sensitive analysis

Streptococcus A (ATCC#19615) is evaluated under study for action.The diluted two

parts solution

1,2 that is divided into of the sample that from same freezing stock, obtains.Prepare with streptococcus A dilution buffer liquid.When signal is stopped in time test.Therefore, the time (rather than signal) has the generation curve of response.If there is not signal to occur in this 1000-1200 unit (units), then total time post analysis also was stopped (340 seconds+20 seconds incubation times) at 6 minutes.The mensuration that changes for two different solution.This variation between the bottle just as solution packing bottle the time.1X10 ³There is one to stop rather than 360 seconds in the individual original test (org/test) in 326 seconds.Testing equipment can read a signal, and these data can not be by bluetooth by correct transmission.The result is presented in the following form.

Table 1: sensitive analysis

Examples of implementation 3-specificity analyses

20 negative specimen of the indoor throat swab that is assumed to be are used to assess equipment based on streptococcus A by method described above.If (not having signal to occur in 1000-1200 unit (units)), then total time post analysis was stopped (340 seconds+20 seconds deposited educating the time) at 6 minutes.The test result of 20 indoor negative sample sees Table 2.Neither one produces signal greater than the negative specimen of the throat swab of 1000-1200 unit (units).By the test of indoor negative throat swab, be considered to not have the specificity problem based on the equipment of streptococcus A.

The analysis result of the negative specimen of indoor throat swab that 2:20 in table is assumed to be

Examples of implementation 4-clinical research

Collecting 26 positives and 65 negative clinical samples during the 2007-2008 and under-80 degree, preserving.Assess equipment with these samples based on streptococcus A.These swab sample are all passed through on the cultivation plate streak culture before being frozen.Compared in the table 3 and cultivated and used BinaxNOW

Result between the streptococcus A test.If (not having signal to occur in 1000-1200 unit (units)), then total time post analysis was stopped (340 seconds+20 seconds deposited educating the time) at 6 minutes.Test result at different time is recorded.Sensitivity and specificity that table 4 is illustrated in different time points compare.Table 5 shows that sensitivity and the specificity under the reference PRC compares.The equipment of testing chain coccus A can successfully be tested clinical streptococcus A sample.And, this equipment very sensitive, he can truly reflect the sample that misses in the test by cultivating.

Table 3: the result of testing of equipment and cultivation test relatively

Table 4: the sensitivity/specificity of different time points relatively

Sensitivity/specificity under table 5 is measured with reference to PCT relatively

The comparison of examples of implementation 4-low-cost equipment of the present invention and goldstandard equipment

With Biodot XYZ the compound dilution of red pigment and be sprayed on the nitrocellulose filter.This RTG (SN2) is used for comparing with the reader (NES) that carries out QC control of unipath.The mechanical percent deviation (%CV) of machine times N=20 of same test strip (read time) compares by the variable concentrations dilute solution; Strip also compares by different concentration dilution solution with deviation between the strip.Table 6 shows the percentage deviation of RTG (SN2) machinery.Table 7 shows the mechanical percentage deviation (%CV) of the reader of unipath.Table 8 shows the percentage deviation (%CV) (SN2 is for NES) under high dose between the strip.Table 9 shows the percentage deviation (%CV) (SN2 is for NES) under moderate dosage between the strip.Table 10 shows the percentage deviation (%CV) (SN2 is for NES) under low dosage between the strip.By these data show, RTG (SN2) has identical result with the reader that carries out QC control of unipath aspect sensitivity and specificity.

The percentage deviation (%CV) of table 6:RTG (SN2) machinery.

Table 7: the mechanical percentage deviation (%CV) that shows the reader of unipath

Table 8: show the percentage deviation (%CV) (SN2 is for NES) under high dose between the strip

Table 9: show the percentage deviation (%CV) (SN2 is for NES) under middle dosage between the strip.

Table 10: show the percentage deviation (%CV) (SN2 is for NES) under low dosage between the strip.

" some embodiments " that relates in the present invention, " embodiment ", or " embodiment " or " other embodiment " meaning is meant the feature that all is described in detailed rules and regulations in the embodiment at these, it is total that structure or characteristics are included in some embodiments at least, but do not need to be included in all embodiments.

The publication that all are mentioned in the application's description comprises patent, and the full content of patent application and article is referred among the application to combine with description, independent with them or discrete quoted and combine by this description have same scope.In addition, in some embodiments, any list of references of quoting not is to think the prior art of this document for the application.

Though the present invention describes limited embodiment, this also and do not mean that limitation of the scope of the invention, but to an explanation of preferred forms.One of ordinary skill in the art can change arbitrarily within the scope of the present invention and revises him.Certainly, scope of the present invention should not limited by his described scope, but is determined by his claims or the description that is equal to of legality.

Claims

1. checkout gear, comprising: box, this box comprise a body portion, a upper cover part and a cavity, this cavity comprises a receiving unit that is used for receiving the sample application device; A test strip is between the body portion and upper cover part of box; The passage that connects cavity and test strip; With a guiding valve that can slide into second position lateral sliding from primary importance; Wherein guiding valve is in primary importance, and the guiding valve of lateral sliding is blocked this passage, and guiding valve is in the second position, and this guiding valve flows on the test strip from cavity by this passage by sample.

2. device according to claim 1, wherein upper cover part comprises the test strip window that is used for observing the partial test bar.

3. device according to claim 1, wherein cavity is columniform.

4. device according to claim 1, wherein cavity comprises that is opened a slotted wall.

5. device according to claim 1, this cavity also comprise a sample mix equipment.

6. device according to claim 1, this cavity comprise the antibody bead of labelling.

7. device according to claim 6, wherein sample mix equipment comprises that design is used for the antibody bead of mixed mark and the Magnet and the magnetic force starter of sample.

8. device according to claim 1, wherein said test strip comprises the sample reception pad, nitrocellulose filter and adsorptive pads.

9. device according to claim 5, wherein test strip also comprises a bridge pad.

10. device according to claim 1, wherein the upper cover part of box also comprises the bar code that at least one is two-dimentional.

11. device according to claim 5, wherein at least one two-dimensional bar is positioned on the side of test window.

12. device according to claim 1, wherein the receiving unit of the reception sample application device of cavity is that taper receives the cotton swab applicator.

13. device according to claim 1, wherein the receiving unit of the reception sample application device of cavity is the netted saliva collector that receives of saliva.

14. device according to claim 1, wherein the receiving unit of cavity is a liquid filter.

15. device according to claim 1, wherein the receiving unit of cavity is a cushion pad.

16. device according to claim 1, wherein the receiving unit of cavity is at least a blood separation pad.

17. device according to claim 1, wherein guiding valve is driven by motor.

18. checkout gear comprises:

Box, this box comprise a body portion, a upper cover part and a cavity, and this cavity comprises a receiving unit that is used for receiving the sample application device;

In the body portion of box and the test strip between the upper cover part;

The passage that connects cavity and test strip;

One can be from the primary importance lateral sliding to the second position guiding valve, wherein guiding valve is in primary importance, guiding valve is blocked this passage, guiding valve is in the second position, this guiding valve flows on the test strip from cavity by this passage by sample.

19. a method comprises:

Receiving unit to the reception sample application device that installs upper cavity applies sample; In receiving unit, handle sample;

Sample that mixed processing is crossed in cavity and reagent form biased sample;

By coming from primary importance lateral sliding guiding valve to the second position on the test strip from cavity transmission biased sample auto levelizer.

20., handle sample and comprise from applicator or saliva collector and extract saliva sample according to the method for claim 19.

21., handle sample and comprise filtration or buffering urine specimen according to the method for claim 19.

22. according to the method for claim 19, the processing sample comprises isolates erythrocyte from sample.

23. according to the method for claim 19, biased sample and reagent also comprise with the Magnet and the magnetic force initiating device that are arranged in cavity.

24., the lateral sliding guiding valve is moved to the second position from primary importance by an equipment according to the method for claim 19.

25., also comprise with an equipment and analyze this test strip according to the method for claim 19.

26., analyze this test strip and comprise that measuring is positive findings or negative findings according to the method for claim 25.

27., analyze the concentration that this test strip comprises analyte in the specimen according to the method for claim 25.

28., analyze this test strip and comprise and read bar code according to the method for claim 25.

29. a method comprises:

Receiving unit to the reception sample application device that installs upper cavity applies sample;

In receiving unit, handle sample; Sample that mixed processing is crossed in cavity and reagent form biased sample;

By coming from primary importance shifted laterally guiding valve to the second position on the test strip from cavity transmission biased sample auto levelizer.

30. read the visual apparatus of the checkout gear that has data identification zone and test zone, comprising:

The optical sensor module;

The image processing module that is connected with the optical sensor module; With

The control module that is connected with image processing module with the optical sensor module;

Wherein the optical sensor module is used to respond to test zone and data identification zone, and response module is transmitted induced data in image processing module; With

Wherein image processing module is used to handling from the data in test zone and data identification zone; the also further specimen of image processing mould; this specimen is based on response module, and reference is simultaneously carried out from the data in recognition data zone.

31. equipment according to claim 30, wherein control module also comprises the data that are used for storing all sensed data or the analyzed mistake related with recognition data.

32. equipment according to claim 30, wherein sample is a biomaterial; Material on the health, chemical sample or any other one of the chemical reaction that can be read by visual apparatus.

33. equipment according to claim 30, wherein recognition data is the type of test, the pattern of test; Normal data, the generation of data, the numeral that can be identified, lot number or any other can be the data that visual form is described.

34. equipment according to claim 30, wherein recognition data comprises the test that forms graphics standard, for example comprises the master scale of a plurality of parameters, and these master scales are used to by different function calibration testing results.

35. equipment according to claim 30, wherein recognition data comprises about following one or more biological information: test, patient, nurse or tester.

36. equipment according to claim 30, wherein test zone is arranged to receive sample and relevant with sample, as to be set an in advance visible symbols is provided.

37. equipment according to claim 30, wherein the optical sensor module is arranged to respond to optically test zone and recognition data zone.

38. equipment according to claim 30, wherein the optical sensor module comprises a vision element and digital image-forming module, wherein digital image-forming module, image processing module and control module are integrated and are arranged on the single integrated circuit, on the one medium or their combination.

39. equipment according to claim 30, this equipment comprise that also a print circuit pulls, optical sensor module wherein, and image-forming module and control module are integrated in one print circuit and pull.

40. equipment according to claim 30, this equipment also comprise the power supply that can be recharged; A kind of in battery or the outside power supply.

41. equipment according to claim 30, wherein the power-supply device that can be recharged comprises that a charging that is connected with Electromagnetic generation and is positioned on the test set opens switch, wherein cooperates with test set by equipment to start charging.

42. equipment according to claim 30, wherein also comprise the limiting module that is connected with control module, limiting module is arranged to the restricting data of stored limit use test device, and wherein the control data of corresponding restricting data further is arranged to restriction and uses this equipment.

43. equipment according to claim 30, the startup of equipment rely on the insertion of test set to start.

44. according to the described equipment of claim 39, wherein restricting data is one of following: the maximum upper limit of test set number, set in advance the recognition data on test set, the lot number of test set, the transmission number of test set, the sequence number of test set, the expired time of test set, the type of test set.

45. equipment according to claim 30 also comprises the parameter module of user, wherein parameter module is connected with control module, and wherein parameter module is used for allowing preference pattern and action type model that user is provided with from preliminary election and the action type.

46. equipment according to claim 30 also comprises the parameter module of user, wherein parameter module is connected with control module, and wherein parameter module is used for allowing preference pattern and action type model that user is provided with from preliminary election and the action type.

47. equipment according to claim 30, this equipment also comprise a part that can abandon and the part that can be used again, wherein discardable part can break away from from the part that is re-used.

48. an optical sensor has the recognition data zone and is used for receiving the method for test set of the test zone of sample, this method comprises: the optical sensor test zone; Optical sensor recognition data zone; With, with reference to the data of handling from the data of identified region from test zone, thus the material in the test sample book.

49. according to the described method of claim 48, wherein visual response test zone and visual response identified region carry out simultaneously.

50. according to the described method of claim 48, wherein visual response test zone and visual response identified region carry out in turn.

51. according to the described method of claim 48, also comprise be present in recognition data in the corresponding restriction use test device of restricting data.

52., wherein handle sensed data sampling supplier's biometric information according to the described equipment of claim 48.

53. according to the described equipment of claim 48, wherein test result conceals to direct tester, uses as further analysis but be transferred to far end system.