CN201293787Y - Portable rapid joint inspection device for hepatitis and hepatic cirrhosis - Google Patents
Portable rapid joint inspection device for hepatitis and hepatic cirrhosis Download PDFInfo
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- CN201293787Y CN201293787Y CNU2008201788483U CN200820178848U CN201293787Y CN 201293787 Y CN201293787 Y CN 201293787Y CN U2008201788483 U CNU2008201788483 U CN U2008201788483U CN 200820178848 U CN200820178848 U CN 200820178848U CN 201293787 Y CN201293787 Y CN 201293787Y
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Abstract
A portable hepatitis and liver cirrhosis fast combining examination device comprises a sample suction head and an examination tube connected with the rear end of the sample suction head, wherein the front end of the sample suction head is provided with a tubule suction nozzle for sucking sample; the chamber of the sample suction head is stuffed with sample filter material and water suction material; a test paper fixing column is internally provided in the examination tube and is fixed with at least one test strips for testing various indexes of hepatitis, liver cirrhosis and liver cancer; and the tail end of the examination tube is provided with a sealing cap for sealing the wastes after examination in the examination tube. Users can realize combining examination on various indexes of hepatitis, liver cirrhosis and liver cancer in one time and can see results by eyes, via one sample suction of each test strip in the device and background test, thereby realizing simple, safe and fast examination on various indexes of venereal disease pathogen and avoiding cross interference, and the device seals the wastes after examination in the examination tube, to avoid the dissipation of pathogen and iatrogenic infection, and be beneficial for environment-friend treatment on wastes.
Description
Technical field
The utility model relates to medicine equipment and sample detection test paper, particularly a kind of can once diagnose simultaneously or predict hepatitis, the relevant many index of cirrhosis with liver cancer (comprising but be not limited to HBsAg, HCVAb, AFP, AFU, MAO, HA, LN) portable fast joint inspection device.
Background technology
Virus hepatitis is listed in legal Category B notifiable disease in China, this disease transmission is strong, the route of transmission is complicated, popular wide, the incidence of disease is high, part is B-mode, hepatitis C patients can develop into chronicly, and can develop into cirrhosis and primary hepatoma, and is very harmful to people ' s health.China is hepatitis B big country, and the hepatitis B patient in the whole world 75% concentrates on China.Statistics, China has that the people infected hepatitis B more than 600,000,000, and about 1.3 hundred million people carry hepatitis B, wherein 3,000 ten thousand people suffer from chronic hepatitis, and about 30% chronic hepatitis patient develops into cirrhosis, and wherein liver cancer can take place part, annual nearly 300,000 because of the number of hepatopathy death, wherein half is a liver cancer.That especially serious is the pregnant woman who carries hepatitis B surface antigen, and wherein about 40% can directly pass through mother and baby's vertical transmission to infections in infants, has every year 800000-1,000,000 neonates to become the hepatitis carrier approximately.
Clinically, that the biochemical indicator application of diagnosis and prediction hepatitis, cirrhosis and liver cancer is more is hepatitis b virus s antigen (HBsAg), antibody of HCV (HCVAb), alpha-fetoprotein (Alpha fetoprotein, AFP), alpha-L-fucosidase (α-L-Fucosidase, AFU), monoamine oxidase (Mono amine Oxidase, MAO), hyaluronic acid (Hyaluronic acid, HA), Laminin ELISA (LN) etc.It detects the main serum ELISA method that adopts.This method needs Medical Devices such as hydro-extractor, incubator, microplate reader, and complicated operating process, can only detect a kind of index at every turn, can not detect whenever and wherever possible, and testing process needs 40-60 minute at least.
Colloidal gold immunochromatographimethod technology (Gold-Immunochromatography Assay, GICA) be an immunolabelling technique that on the basis of ELISA adsorption analysis method (ELISA), grows up, it is carrier with the miillpore filter, utilize the capillarity of miillpore filter, dropping is slowly oozed to the miillpore filter other end at the fluid sample of film bar one side to move, if specific antigen or antibody are arranged in the liquid, they can with the immunity gold in conjunction with after again be fixed on miillpore filter on corresponding antibodies or antigen combine and show immune golden color.This technology simply, fast, does not need any instrument and equipment, and a few minutes result that just can detect by an unaided eye is called " concentrated ELISA " by praise, now be widely used in nearly all aspect of immunology detection.But present colloidal gold immunochromatographimethod is used usually and with exposed test strips form sample is detected, and mostly is single index detection, and few people use it for the sample many index and detect simultaneously.Exposed detection paper easily causes pathogen to disseminate and hospital-acquired infection, and the offal treatment after the detection pollutes the environment, and is unfavorable for environmental protection treatment.And the single index of sample detects and is unfavorable for increasing work efficiency sooner, also is unfavorable for eliminating the detection error that exists between each sample detection.
At the above-mentioned defective that prior art exists, the author formerly disclosed in the application number patent 200710050163.0 and 200720081309.3 in the recent period a kind of without any need for instrument and equipment just can detect in good time suitablely and detect be applicable to various liquid samples (as serum and blood plasma) and thick sample (as whole blood), simple to operate, Quality Control makes things convenient for, in a few minutes with regard to the transportable reaction device of the disposable parallel joint inspection sample many index of energy.The utility model is that these two disclosed devices of application number patent are used for specializing of joint inspection hepatitis, cirrhosis and liver cancer index of correlation.In the utility model, described reaction unit comprises suction head 1 and is connected the detector tube 2 of suction head 1 rear end, suction head 1 front end has tubule suction nozzle 12, suction nozzle 12 has the sample suction port 13 that is used to inhale sample, suction nozzle 12 front ends can be with rubber helmet 14, suction head inner chamber 17 is filled with sample filtering material 3 and sample absorbent material 4 from front to back respectively, built-in test paper fixed leg 5 in the detector tube 2, the shaft surface of this test paper fixed leg 5 have 1 at the most bar be used for fixing vertical scrobicula mortise 22 of sample detection test strips 6, its sample suction end of each test strips links to each other with absorbent material 4 interference in the groove, discarded object was enclosed in the detector tube 2 in case spill after the detector tube tail end had capping 7 to detect, each test strips in the described device detects colour developing district 25, it is transparent that the strong adsorptive pads of test strips tail end district 26 and test strips are installed logo area 27 pairing that part of detector tube shells, suction head 1 one ends of described device can also outer be with band and hang other 32 device headgear lid 31, be with the distinguishing characteristics of application number patent 200710050163.0 and 200720081309.3 disclosed devices: test strips fixing in each surperficial shallow grooves 22 of the test paper fixed leg 5 in the described device is a hepatitis, cirrhosis and liver cancer index of correlation test strip 6 comprise the single index hepatitis with single detection line, cirrhosis, liver cancer index of correlation test strip is or/and have many indexs hepatitis of many detection lines, cirrhosis, liver cancer index of correlation test strip.Each test strips divides groove sealing to be fixed on to carry out in the same reaction unit with the background joint inspection, can not only be in a few minutes in the detector tube clear area each test strips translocation result in the finder fast with the naked eye, and refuse still is closed in the described Device Testing pipe after detecting, and is more conducive to the environmental protection treatment discarded object.Apparatus structure is simple, and cost of manufacture is cheap, is particularly suitable for suitability for industrialized production, and the joint inspection process is quick, safety, accurate, and device also is easy to carry.
The utility model content
The technical solution of the utility model is:
Described portable hepatitis and cirrhosis fast joint inspection device comprise suction head 1 and are connected the detector tube 2 of suction head 1 rear end.Suction head 1 front end has tubule suction nozzle 12, suction nozzle 12 has the sample suction port 13 that is used to inhale sample, suction nozzle 12 front ends can be with rubber helmet 14, suction head inner chamber 17 is filled with sample filtering material 3 and sample absorbent material 4 from front to back respectively, built-in test paper fixed leg 5 in the detector tube 2, the shaft surface of this test paper fixed leg 5 is respectively applied for fixes each hepatitis, cirrhosis, vertical scrobicula mortise 22 of liver cancer index of correlation test strip 6, its sample suction end of each test strips links to each other with absorbent material 4 interference in the suction head inner chamber 17 in the groove, and the detector tube tail end has capping 7 will detect afterwards that discarded object is enclosed in the detector tube 2 in case discarded object spills.During sample detection, take off rubber helmet 14, expose sample suction port 13, suction nozzle 12 be impregnated in the inspection product can carry out the sample joint inspection.Sample filtering material 3 in the suction head inner chamber 17 can filter pre-service to the sample to be checked that sucks, sample absorbent material 4 have store and auxiliary absorbing and filtering after the function of sample.
The test paper fixed leg 5 that is arranged in detector tube inner chamber 20 constitutes one by head end colyliform spacer ring 15 with the test paper fixed leg shaft 16 that is connected head end colyliform spacer ring 15.Spacer ring 15 diameter of sections and detector tube prosopyle 10 internal diameters and suction head deutostoma 8 internal diameter fits and with the sample filtering material 3 in the suction head inner chamber 17 and 4 block of sample absorbent material in suction head inner chamber 17.The double wedge structure 18 that spacer ring week circumferentially stretched out along the oriented detector tube inwall of distance along certain week of being separated by, this double wedge structure 18 is fixed test paper fixed leg 5 in detector tube inner chamber 20 with recessed toothing 19 tablings of detector tube inwall corresponding position.Spacer ring week the edge adjacent double wedge structure 18 between radially have pass through spacer ring week along and connect detector tube inner chamber 20 and suction head inner chamber 17 1 to a plurality of test strips through holes 21, through hole 21 bores and test strips 6 width, thickness adapt.Be formed for the fixedly shallow grooves 22 of test strips separately along the extension of test paper fixed leg shaft 16 surface longitudinals in spacer ring week separately along each the test strips through hole 21 between the adjacent double wedge structure 18, each shallow grooves bottom land is fixed a test strips 6, in each groove test strips by spacer ring week the edge each corresponding test strips through hole 21 link to each other with sample absorbent material 4 interference in the suction head inner chamber 17 respectively.The inwall of detector tube inner chamber 20 rear ends is fit to locate to be provided with test paper fixed leg 5 tail ends and ends screens 30.
Divide groove to be fixed on each hepatitis in the test paper fixed leg 5 surperficial shallow grooves 22, cirrhosis, its sample suction end 23 of liver cancer index of correlation test strip, be followed successively by test strips gold mark thing pad district 24 afterwards, test strips detects colour developing district 25, the strong adsorptive pads of test strips tail end district 26 and test strips logo area 27 is installed preceding.
The detection of each test strips colour developing district 25 is separated by a distance to be provided with sample detection line 28 and sample nature controlling line 29, and detection line 28 is positioned at before the nature controlling line 29.
One of its scheme of test strips in the described device is for having single index hepatitis, cirrhosis, the liver cancer index of correlation test strip of single detection line, i.e. separated by a distancely before the nature controlling line 29 in the detection of described test strips colour developing district 25 be provided with a detection line 28.These test strips include but not limited to: HBsAg test strips, HCVAb test strips, alpha-fetoprotein (AFP) test strips, alpha-L-fucosidase (AFU) test strips, monoamine oxidase (MAO) test strips, hyaluronic acid (HA) test strips, Laminin ELISA (LN) test strips.These test strips have following characteristics:
(1) anti-HBsAg has been caught in detection line 28 positions of HBsAg test strips, HCVAg has been caught in detection line 28 positions of HCVAb test strips, anti-alpha-fetoprotein (anti-AFP) has been caught in detection line 28 positions of alpha-fetoprotein (AFP) test strips, anti-alpha-L-fucosidase (anti-AFU) has been caught in detection line 28 positions of alpha-L-fucosidase (AFU) test strips, anti-monoamine oxidase (anti-MAO) has been caught in detection line 28 positions of monoamine oxidase (MAO) test strips, anti-hyaluronic acid (anti-HA) has been caught in detection line 28 positions of hyaluronic acid (HA) test strips, and anti-Laminin ELISA (anti-LN) has been caught in detection line 28 positions of Laminin ELISA (LN) test strips;
(2) gold of HBsAg test strips mark thing pad district 24 correspondences are caught the colloid gold label thing of mouse-anti HBsAg antibody, gold mark thing pad district 24 correspondences of HCVAb test strips are caught mouse-anti people IgM or/and mouse-anti human IgG antibody's colloid gold label thing, gold mark thing pad district 24 correspondences of alpha-fetoprotein (AFP) test strips are caught the colloid gold label thing of mouse-anti alpha-fetoprotein antibody, gold mark thing pad district 24 correspondences of alpha-L-fucosidase (AFU) test strips are caught the colloid gold label thing of mouse-anti alpha-L-fucosidase antibody, gold mark thing pad district 24 correspondences of monoamine oxidase (MAO) test strips are caught the colloid gold label thing of mouse-anti monoamine oxidase antibody, gold mark thing pad district 24 correspondences of hyaluronic acid (HA) test strips are caught the colloid gold label thing of mouse-anti hyaluronic acid antibody, and gold mark thing pad district 24 correspondences of Laminin ELISA (LN) test strips are caught the colloid gold label thing of mouse-anti Laminin ELISA antibody;
(3) the Quality Control thing of one or more the above-mentioned antibody in sheep anti mouse IgM antibody, sheep anti-mouse igg antibody, the anti-mouse IgM of rabbit antibody, the rabbit anti-mouse igg antibody is caught in nature controlling line 29 positions of each test strips.
Two of its scheme of test strips in the described device also can be hepatitis, cirrhosis, the liver cancer index of correlation test strip with many detection lines, i.e. two or more detection line 28 that is provided with separated by a distance before the nature controlling line 29 in the detection of described test strips colour developing district 25.These many indexs hepatitis, cirrhosis, liver cancer index of correlation test strip with many detection lines include but not limited to be used for joint inspection HBsAg, HCVAb, alpha-fetoprotein (AFP), alpha-L-fucosidase (AFU), monoamine oxidase (MAO), hyaluronic acid (HA), Laminin ELISA (LN).These test strips with many detection lines have following characteristics:
(1) each detection line 28 position of each test strips have been caught a kind of and hepatitis, cirrhosis, liver cancer related antigen or corresponding antibody of antibody or antigen;
(2) gold of each described test strips mark thing pad district 24 catch with the antibody of the corresponding checking matter antigen of the corresponding gold mark mouse-anti of 28 capture antibodies of each detection line of place test strips and gold mark mouse-anti human IgM antibody or/and gold mark mouse-anti human IgG antibody;
(3) the Quality Control thing of one or more the above-mentioned antibody in sheep anti mouse IgM antibody, sheep anti-mouse igg antibody, the anti-mouse IgM of rabbit antibody, the rabbit anti-mouse igg antibody is caught in nature controlling line 29 positions of each test strips.
That part of detector tube shell that each test strips of the co-detection device that above-mentioned test strips scheme is constituted detects colour developing district 25, the strong adsorptive pads of test strips tail end district 26 and test strips installation logo area 27 correspondences is transparent.
The co-detection device that above-mentioned test strips scheme is constituted can be cylinder type, flat cylinder-type, rectangular build, prismatic build or other cylinder-type.
The method of manipulating of described portable hepatitis and cirrhosis fast joint inspection device is:
(1) takes out fast joint inspection device;
(2) remove the device headgear lid 31 of described device and the rubber cap bag 14 of suction head front end, expose sample suction port 13, suction nozzle 12 be impregnated in the inspection product;
(3) observing each built-in test strips detection colour developing district 25 respective detection line 28 in detector tube transparent plastic district in a few minutes has or not red line to manifest, and with reference to each test strips nature controlling line 29 chromogenic line, whether judgement sample contains HBsAg, HCVAb, AFP, AFU, MAO, HA and LN.Test strips detection line and nature controlling line show red line, and testing result is positive; Nature controlling line shows red line, and detection line redfree line shows that testing result is negative; Nature controlling line redfree line shows that testing result is invalid.
When suction nozzle 12 impregnated in sample to be checked, sample was inhaled in the suction head inner chamber 17 by the suction nozzle capillarity.Sample at first touches sample filtering material 3 and is filtered in suction head inner chamber 17.If sample is a whole blood, the red blood cell in the filtering material 3 meeting prevention blood is by allowing its serum filter.Blood serum sample after the filtration touches the sample absorbent material 4 in the suction head inner chamber 17 subsequently, and the sample after 4 pairs of filtrations of absorbent material plays auxiliary absorption on the one hand, also has on the other hand to store the function of filtering the back sample.Because each the built-in test strips 6 in the device itself is that interference is communicated with absorbent material 4 in the suction head inner chamber 17, and each test strips tail end is provided with strong adsorptive pads 26, therefore, absorbing, be stored in after the filtration in the absorbent material 4 sample just can be by the test strips siphon principle, is fixed on each test strips 6 rear end in the shallow grooves 22 of test paper fixed leg surface to minute groove smoothly and oozes and move and realize the relevant many index joint inspection with liver cancer of hepatitis, cirrhosis in the sample.
When the sample after the filtration contacts test strips, if a kind of among HBsAg, HCVAb, AFP, AFU, MAO, HA and the LN or several are arranged in sample, they just mark the corresponding colloid gold label thing combination in thing pad district 24 with corresponding test strips gold, further ooze the corresponding antibody that moves to test strips detection line 28 and contained with detection line 28 or antigen generation idiosyncrasy afterwards and make detection line 28 colour developings, can judge sample to be checked from the colour developing situation and whether contain hepatitis, cirrhosis and liver cancer index of correlation.Each test strips nature controlling line 29 of co-detection device described in the utility model is caught Quality Control thing sheep anti mouse or rabbit anti-mouse antibody (one or more in sheep anti mouse IgM antibody, sheep anti-mouse igg antibody, the anti-mouse IgM of rabbit antibody, the rabbit anti-mouse igg antibody), and this Quality Control thing itself can not react with antibody or the antigen in the human blood sample.Gold mark mouse source antibody (mouse-anti HBsAg antibody, mouse-anti people IgM are or/and mouse-anti human IgG antibody, mouse-anti AFP antibody, mouse-anti AFU antibody, mouse-anti MAO antibody, mouse-anti HA antibody, mouse-anti LN antibody) is contained in the test strips of co-detection device described in the utility model gold mark thing pad district 24, they together ooze with sample and can react with Quality Control thing sheep anti-mouse antibody or the rabbit anti-mouse antibody that nature controlling line 29 is caught when moving to nature controlling line 29, make the colour developing of nature controlling line 29 positions and are identified by naked eyes.When in the sample detection because the quality problems of certain component can't detect test the time, just can not develop the color in nature controlling line 29 positions of test strips, so the Quality Control thing of catching by this nature controlling line can carry out quality control to the sample joint inspection.
Portable hepatitis described in the utility model and cirrhosis fast joint inspection device be used for detecting simultaneously sample to be checked the relevant many index of hepatitis, cirrhosis and liver cancer (comprising but be not limited to HBsAg, HCVAb, AFP, AFU, MAO, HA, LN).
The utility model purpose:
The utility model purpose provides a kind of fast joint inspection device that can diagnose and predict hepatitis, cirrhosis and the multinomial index of correlation of liver cancer simultaneously.Test strips in the device can be single index hepatitis, cirrhosis and the liver cancer index of correlation test strip with single detection line, also can be many indexs hepatitis, cirrhosis and the liver cancer index of correlation test strip with many detection lines.
The beneficial effects of the utility model:
(1) once inhales sample and can finish the detection of sample many index.
(2) each test strip divides groove to be enclosed in the reaction unit, once inhale sample, detect with background, make the multinomial index of correlation of hepatitis, cirrhosis and liver cancer in the sample (comprising but be not limited to HBsAg, HCVAb, AFP, AFU, MAO, HA and LN) detect not only simpler, safe, quick, accurate, and the quality control and avoid detecting cross interference of being more convenient for.
(3) testing process is totally-enclosed carries out in an airtight detector tube.During detection, operating personnel only need take off the device headgear lid of described device and the rubber helmet of suction head front end exposes suction nozzle, suction nozzle be impregnated in sample, just can observe directly the every testing result on the test strips in it in a few minutes in described Device Testing pipe clear area, operating personnel do not contact the inspection product repeatedly, and detecting the back discarded object still is enclosed in the detector tube, not only avoid pathogen in the inspection product to disseminate hospital-acquired infection with operating personnel, and more helped environmental requirement and offal treatment.
(4) blood sample does not need to isolate serum or blood plasma, just can directly detect with whole blood sample.The suction head inner chamber of co-detection device described in the utility model is filled with the sample filtering material, but the red blood cell in this filtering material block blood sample pass through, but can allow the serum liquid in the sample filter.Like this, blood serum sample after the filtration not only is easier to ooze smoothly on test strips and moves, and the observation of testing result and judgement have been avoided influencing because erythrocytic existence is arranged in the sample (because in the detection, it is red that the color itself that test strips detection line and nature controlling line are manifested should be.If there is red blood cell in the sample, then the red color that manifested of red color that detection line and nature controlling line manifested and red blood cell just is difficult to differentiate.This also is that prior art needs to adopt hydro-extractor to isolate serum earlier before sample detection, afterwards the major reason that detects again with serum).The utility model does not need sample is carried out serum or separating plasma, just can directly detect with whole blood sample.
(5) apparatus structure is simple, easily makes, and is with low cost, is particularly suitable for suitability for industrialized production.
(6) described device is easy and simple to handle, and is easy to carry, without any need for instrument and equipment and reagent, suitablely all can use in good time.Its operation does not need special study and training, and professional and technical personnel and ordinary person all can operate.
(7) reagent and the material that is fixed in the device do not relate to active inactivation, and described co-detection device can be in the room temperature long preservation.
Description of drawings
Fig. 1 is the portable hepatitis that constituted of single index test strip described in the utility model and the structure side view of cirrhosis fast joint inspection device.
Fig. 2 is that portable hepatitis and the cirrhosis fast joint inspection device that single index test strip shown in Figure 1 is constituted enclosed the apparatus structure synoptic diagram that device headgear lid back forms at its suction head one end.
Fig. 3 is the portable hepatitis that constituted of many detection lines test strips described in the utility model and the structure side view of cirrhosis fast joint inspection device.
Fig. 4 is that portable hepatitis and the cirrhosis fast joint inspection device that many detection lines test strips shown in Figure 3 is constituted enclosed the apparatus structure synoptic diagram that device headgear lid back forms at its suction head one end.
In above-mentioned Fig. 1-device shown in Figure 4,1, suction head, 2, detector tube, 3, the sample filtering material, 4, the sample absorbent material, 5, the test paper fixed leg, 6, test strips, 7, the capping of detector tube tail end, 8, the suction head deutostoma, 9, the vertical flange of suction head deutostoma inwall, 10, the detector tube prosopyle, 11, the detector tube prosopyle is indulged recessed inwall, 12, suction nozzle, 13, sample suction port, 14, the rubber helmet, 15, test paper fixed leg head end colyliform spacer ring, 16, test paper fixed leg shaft, 17, the suction head inner chamber, 18, spacer ring week is along the double wedge structure, 19, the recessed toothing of detector tube inwall, 20, the detector tube inner chamber, 21, the test strips through hole, 22, test paper fixed leg post table shallow grooves, 23, the test strips sample suction end, 24, test strips gold mark thing pad district, 25, test strips detects colour developing district, 26, the strong adsorptive pads of test strips tail end district, 27, test strips is installed logo area, 28, the test strips detection line, 29, the test strips nature controlling line, 30, test paper fixed leg tail end ends screens, 31, device headgear lid, 32, hang not
Fig. 5 is the testing result synoptic diagram that the portable hepatitis that constituted with single index test strip and cirrhosis fast joint inspection device detect No. 1 blood sample.Testing result shows, No. 1 blood sample does not contain any among HBsAg, HCVAb, AFP, AFU, MAO, HA and the LN.
Fig. 6 is the testing result synoptic diagram that the portable hepatitis that constituted with single index test strip and cirrhosis fast joint inspection device detect No. 2 blood samples.Testing result shows that No. 2 blood sample contains HBsAg, AFP, AFU, MAO and HA.
Fig. 7 is the testing result synoptic diagram that the portable hepatitis that constituted with single index test strip and cirrhosis fast joint inspection device detect No. 3 blood samples.Testing result shows that No. 3 blood sample contains HCVAb, AFP, AFU, MAO and HA.
Fig. 8 is the testing result synoptic diagram that the portable hepatitis that constituted with single index test strip and cirrhosis fast joint inspection device detect No. 4 blood samples.Testing result shows that No. 4 blood sample only contains HBsAg.
Fig. 9 is the testing result synoptic diagram that the portable hepatitis that constituted with single index test strip and cirrhosis fast joint inspection device detect No. 5 blood samples.Testing result shows that No. 5 blood sample contains HCVAb, AFP, AFU, MAO, HA and LN.
Figure 10 is the testing result synoptic diagram that the portable hepatitis that constituted with many detection lines test strips and cirrhosis fast joint inspection device detect No. 1 blood sample.Testing result shows, No. 1 blood sample does not contain any among HBsAg, HCVAb, AFP, AFU, MAO, HA and the LN.
Figure 11 is the testing result synoptic diagram that the portable hepatitis that constituted with many detection lines test strips and cirrhosis fast joint inspection device detect No. 2 blood samples.Testing result shows that No. 2 blood sample contains HBsAg, AFP, AFU, MAO and HA.
Figure 12 is the testing result synoptic diagram that the portable hepatitis that constituted with many detection lines test strips and cirrhosis fast joint inspection device detect No. 3 blood samples.Testing result shows that No. 3 blood sample contains HCVAb, AFP, AFU, MAO and HA.
Figure 13 is the testing result synoptic diagram that the portable hepatitis that constituted with many detection lines test strips and cirrhosis fast joint inspection device detect No. 4 blood samples.Testing result shows that No. 4 blood sample only contains HBsAg.
Figure 14 is the testing result synoptic diagram that the portable hepatitis that constituted with many detection lines test strips and cirrhosis fast joint inspection device detect No. 5 blood samples.Testing result shows that No. 5 blood sample contains HCVAb, AFP, AFU, MAO, HA and LN.
Among above-mentioned Fig. 5-Figure 14, T represents detection line (test), and C represents nature controlling line (control), 1. represents the HBsAg detection line, 2. represent the HCVAb detection line, 3. represent the AFP detection line, 4. represent the AFU detection line, 5. represent the MAO detection line, 6. represent the HA detection line, 7. represent the LN detection line
Embodiment
Fig. 1 has the portable hepatitis that the single index test strip of single detection line constituted and the structure side view of cirrhosis fast joint inspection device, separated by a distancely before the nature controlling line 29 in the detection of test strips colour developing district 25 in the device is provided with a detection line 28.Described device comprises suction head 1 and is connected the detector tube 2 of suction head 1 rear end.Suction head 1 front end has tubule suction nozzle 12, suction nozzle 12 has the sample suction port 13 that is used to inhale sample, suction nozzle 12 front ends can be with rubber helmet 14, suction head inner chamber 17 is filled with sample filtering material 3 and sample absorbent material 4 from front to back respectively, built-in test paper fixed leg 5 in the detector tube 2, the shaft surface of this test paper fixed leg 5 has and is respectively applied for the single index hepatitis that fixedly has single detection line, vertical scrobicula mortise 22 of cirrhosis and liver cancer index of correlation test strip 6, its sample suction end of each test strips links to each other with absorbent material 4 interference in the suction head inner chamber 17 in the groove, and the detector tube tail end has capping 7 will detect afterwards that discarded object is enclosed in the detector tube 2 in case discarded object spills.During sample detection, take off rubber helmet 14, expose sample suction port 13, suction nozzle 12 be impregnated in the inspection product can carry out the sample joint inspection.Sample filtering material 3 in the suction head inner chamber 17 can filter pre-service to the sample to be checked that sucks, sample absorbent material 4 have store and auxiliary absorbing and filtering after the function of sample.
The test paper fixed leg 5 that is arranged in detector tube inner chamber 20 constitutes one by head end colyliform spacer ring 15 with the test paper fixed leg shaft 16 that is connected head end colyliform spacer ring 15.Spacer ring 15 diameter of sections and detector tube prosopyle 10 internal diameters and suction head deutostoma 8 internal diameter fits and with the sample filtering material 3 in the suction head inner chamber 17 and 4 block of sample absorbent material in suction head inner chamber 17.The double wedge structure 18 that spacer ring week circumferentially stretched out along the oriented detector tube inwall of distance along certain week of being separated by, this double wedge structure 18 is fixed test paper fixed leg 5 in detector tube inner chamber 20 with recessed toothing 19 tablings of detector tube inwall corresponding position.Spacer ring week the edge adjacent double wedge structure 18 between radially have pass through spacer ring week along and connect detector tube inner chamber 20 and suction head inner chamber 17 1 to a plurality of test strips through holes 21, through hole 21 bores and test strips 6 width, thickness adapt.Be formed for the fixedly shallow grooves 22 of test strips separately along the extension of test paper fixed leg shaft 16 surface longitudinals in spacer ring week separately along each the test strips through hole 21 between the adjacent double wedge structure 18, each shallow grooves bottom land is fixed a test strips 6, in each groove test strips by spacer ring week the edge each corresponding test strips through hole 21 link to each other with sample absorbent material 4 interference in the suction head inner chamber 17 respectively.The inwall of detector tube inner chamber 20 rear ends is fit to locate to be provided with test paper fixed leg 5 tail ends and ends screens 30.
Divide groove to be fixed on each hepatitis in the test paper fixed leg 5 surperficial shallow grooves 22, cirrhosis, its sample suction end 23 of liver cancer index of correlation test strip, be followed successively by test strips gold mark thing pad district 24 afterwards, test strips detects colour developing district 25, the strong adsorptive pads of test strips tail end district 26 and test strips logo area 27 is installed preceding.
The detection colour developing district 25 sample detection line 28 and the sample nature controlling lines 29 of being provided with separated by a distance of each test strips, wherein detection line 28 is positioned at before the nature controlling line 29.
Each test strip of dividing groove to be fixed in the described co-detection device test paper fixed leg 5 surperficial shallow grooves 22 includes but not limited to HBsAg test strips, HCVAb test strips, alpha-fetoprotein (AFP) test strips, alpha-L-fucosidase (AFU) test strips, monoamine oxidase (MAO) test strips, hyaluronic acid (HA) test strips, Laminin ELISA (LN) test strips.These test strips have following characteristics:
(1) anti-HBsAg has been caught in detection line 28 positions of HBsAg test strips, HCVAg has been caught in detection line 28 positions of HCVAb test strips, anti-alpha-fetoprotein (anti-AFP) has been caught in detection line 28 positions of alpha-fetoprotein (AFP) test strips, anti-alpha-L-fucosidase (anti-AFU) has been caught in detection line 28 positions of alpha-L-fucosidase (AFU) test strips, anti-monoamine oxidase (anti-MAO) has been caught in detection line 28 positions of monoamine oxidase (MAO) test strips, anti-hyaluronic acid (anti-HA) has been caught in detection line 28 positions of hyaluronic acid (HA) test strips, and anti-Laminin ELISA (anti-LN) has been caught in detection line 28 positions of Laminin ELISA (LN) test strips;
(2) gold of HBsAg test strips mark thing pad district 24 correspondences are caught the colloid gold label thing of mouse-anti HBsAg antibody, gold mark thing pad district 24 correspondences of HCVAb test strips are caught mouse-anti people IgM or/and mouse-anti human IgG antibody's colloid gold label thing, gold mark thing pad district 24 correspondences of alpha-fetoprotein (AFP) test strips are caught the colloid gold label thing of mouse-anti alpha-fetoprotein antibody, gold mark thing pad district 24 correspondences of alpha-L-fucosidase (AFU) test strips are caught the colloid gold label thing of mouse-anti alpha-L-fucosidase antibody, gold mark thing pad district 24 correspondences of monoamine oxidase (MAO) test strips are caught the colloid gold label thing of mouse-anti monoamine oxidase antibody, gold mark thing pad district 24 correspondences of hyaluronic acid (HA) test strips are caught the colloid gold label thing of mouse-anti hyaluronic acid antibody, and gold mark thing pad district 24 correspondences of Laminin ELISA (LN) test strips are caught the colloid gold label thing of mouse-anti Laminin ELISA antibody;
(3) the Quality Control thing of one or more the above-mentioned antibody in sheep anti mouse IgM antibody, sheep anti-mouse igg antibody, the anti-mouse IgM of rabbit antibody, the rabbit anti-mouse igg antibody is caught in nature controlling line 29 positions of each test strips.
That part of detector tube shell that each test strips of described co-detection device detects colour developing district 25, the strong adsorptive pads of test strips tail end district 26 and test strips installation logo area 27 correspondences is transparent.During sample detection, but the colour developing of the band by each test strips in this detector tube shell clear area Direct observation auto levelizer result.
Fig. 2 be shown in Figure 1, enclose device headgear lid 31 and the apparatus structure synoptic diagram that forms by portable hepatitis that single index test strip constituted and cirrhosis fast joint inspection device at its suction head 1 one ends.It is other 32 to be provided with portable extension on this device headgear lid 31, and this device headgear covers 31 can be made by plastic material, metal material or other material.
Fig. 3 is the portable hepatitis that constituted of many detection lines test strips described in the utility model and the structure side view of cirrhosis fast joint inspection device.Two or more detection line that sets up separately separated by a distance obtains before the nature controlling line 29 in its detection colour developing district 25 of the test strips in its device shown in Figure 1.These many indexs hepatitis, cirrhosis, liver cancer index of correlation test strip with many detection lines include but not limited to be used for joint inspection HBsAg, HCVAb, alpha-fetoprotein (AFP), alpha-L-fucosidase (AFU), monoamine oxidase (MAO), hyaluronic acid (HA), Laminin ELISA (LN).These test strips with many detection lines have following characteristics:
(1) each detection line 28 position of each test strips have been caught a kind of and hepatitis, cirrhosis, liver cancer related antigen or corresponding antibody of antibody or antigen;
(2) gold of each test strips mark thing pad district 24 catch with the antibody of the corresponding checking matter antigen of the corresponding gold mark mouse-anti of 28 capture antibodies of each detection line of place test strips and gold mark mouse-anti human IgM antibody or/and gold mark mouse-anti human IgG antibody;
(3) the Quality Control thing of one or more the above-mentioned antibody in sheep anti mouse IgM antibody, sheep anti-mouse igg antibody, the anti-mouse IgM of rabbit antibody, the rabbit anti-mouse igg antibody is caught in nature controlling line 29 positions of each test strips.
Can realize the more high flux joint inspection of sample index with the fast joint inspection device that many detection lines test strips shown in Figure 3 is constituted.
Fig. 4 be shown in Figure 3, enclose device headgear lid 31 and the apparatus structure synoptic diagram that forms by portable hepatitis that many detection lines test strips constituted and cirrhosis fast joint inspection device at its suction head 1 one ends.It is other 32 to be provided with portable extension on this device headgear lid 31, and this device headgear covers 31 can be made by plastic material, metal material or other material.
Its overall appearance of above-mentioned co-detection device (comprising Fig. 1-4) can be cylinder type, flat cylinder-type, rectangular build, prismatic build or other cylinder-type.
The method of manipulating of portable hepatitis described in the utility model and cirrhosis fast joint inspection device is:
(1) takes out fast joint inspection device;
(2) remove the device headgear lid 31 of described device and the rubber cap bag 14 of suction head front end, expose sample suction port 13, suction nozzle 12 be impregnated in the inspection product;
(3) observing each built-in test strips detection colour developing district 25 respective detection line 28 in detector tube transparent plastic district in a few minutes has or not red line to manifest, and with reference to test strips nature controlling line 29 chromogenic lines, whether judgement sample contains HBsAg, HCVAb, AFP, AFU, MAO, HA and LN.Test strips detection line and nature controlling line show red line, and testing result is positive; Nature controlling line shows red line, and detection line redfree line shows that testing result is negative; Nature controlling line redfree line shows that testing result is invalid.
The application in fast joint inspection hepatitis, cirrhosis and liver cancer index of correlation of embodiment 3 portable hepatitis and cirrhosis fast joint inspection device
Divide the test strips in each single groove that groove is fixed on described co-detection device test paper fixed leg 5 each surperficial shallow grooves 22, can be for having the single index test strip of single detection line, also can be for having many indexs joint inspection test strips of many detection lines.
A, with portable hepatitis and cirrhosis fast joint inspection device joint inspection outpatient blood that the single index test strip with single detection line is constituted, blood sample is provided by Chengdu clinical laboratory of infectious hospital, the method for manipulating is undertaken by embodiment 2.Testing result is as follows:
No. 1 blood sample does not contain any among HBsAg, HCVAb, AFP, AFU, MAO, HA and the LN, the results are shown in Figure 5;
No. 2 blood sample contains HBsAg, AFP, AFU, MAO and HA, the results are shown in Figure 6;
No. 3 blood sample contains HCVAb, AFP, AFU, MAO and HA, the results are shown in Figure 7;
No. 4 blood sample only contains HBsAg, the results are shown in Figure 8;
No. 5 blood sample contains HCVAb, AFP, AFU, MAO, HA and LN, the results are shown in Figure 9.
B. portable hepatitis and the cirrhosis fast joint inspection device joint inspection outpatient blood that is constituted with many detection lines test strips, (wherein the detection line of a test strips is caught anti-HBsAg and HCVAg respectively to co-detection device with built-in two test strips, the detection line of another test strips is caught anti-AFP, anti-AFU, anti-MAO, anti-HA and anti-LN respectively) be example, blood sample still adopts above-mentioned source sample to test, and the method for manipulating is undertaken by embodiment 2.Testing result is as follows:
No. 1 blood sample does not contain any among HBsAg, HCVAb, AFP, AFU, MAO, HA and the LN, the results are shown in Figure 10;
No. 2 blood sample contains HBsAg, AFP, AFU, MAO and HA, the results are shown in Figure 11;
No. 3 blood sample contains HCVAb, AFP, AFU, MAO and HA, the results are shown in Figure 12;
No. 4 blood sample only contains HBsAg, the results are shown in Figure 13;
No. 5 blood sample contains HCVAb, AFP, AFU, MAO, HA and LN, the results are shown in Figure 14.
This instructions embodiment only is for the design feature of co-detection device described in the utility model is described; manipulate method and it in quick diagnosis and prediction hepatitis; application in the relevant many index of cirrhosis with liver cancer; special needs to be pointed out is; device described in the utility model (for example can also have some modifications; hepatitis in the device; the colloid gold label thing of cirrhosis and liver cancer test strip is also replaceable to be the electroselenium label; test strips includes, but are not limited to several detection index test strips that this instructions exemplifies etc.); therefore; all to any other technical scheme that is equal to replacement or equivalent transformation formation of co-detection device employing described in the utility model, all drop in the protection domain of the utility model claim.
Claims (5)
1. portable hepatitis and cirrhosis fast joint inspection device, comprise suction head (1) and be connected the detector tube (2) of suction head (1) rear end, suction head (1) front end has tubule suction nozzle (12), suction nozzle (12) has the sample suction port (13) that is used to inhale sample, suction nozzle (12) front end can be with rubber helmet (14), suction head inner chamber (17) is filled with sample filtering material (3) and sample absorbent material (4) from front to back respectively, built-in test paper fixed leg (5) in the detector tube (2), the shaft surface of this test paper fixed leg (5) have 1 at the most bar be used for fixing vertical scrobicula mortise (22) of sample detection test strips (6), its sample suction end of each test strips links to each other with absorbent material (4) interference in the suction head inner chamber (17) in the groove, discarded object was enclosed in the detector tube (2) in case spill after the detector tube tail end had capping (7) to detect, the detection colour developing district (25) of each test strips in the described device, the strong adsorptive pads of tail end district (26) and the pairing that part of detector tube shell of installation logo area (27) are transparent, suction head (1) one end of described device can also outer be with band and hang the not device headgear lid (31) of (32), it is characterized in that: test strips fixing in each surperficial shallow grooves (22) of the test paper fixed leg (5) in the described device is a hepatitis, the test strip of cirrhosis and liver cancer index of correlation (6) comprises the single index hepatitis with single detection line, cirrhosis, liver cancer index of correlation test strip is or/and have many indexs hepatitis of many detection lines, cirrhosis, liver cancer index of correlation test strip.
2. portable hepatitis according to claim 1 and cirrhosis fast joint inspection device is characterized in that: wherein said single index hepatitis, cirrhosis, liver cancer index of correlation test strip with single detection line comprises HBsAg test strips, HCVAb test strips, alpha-fetoprotein test strips, alpha-L-fucosidase test strips, monoamine oxidase test strips, hyaluronic acid test strips, Laminin ELISA test strips.
3. portable hepatitis according to claim 2 and cirrhosis fast joint inspection device is characterized in that: anti-HBsAg, HCVAg, anti-alpha-fetoprotein, anti-alpha-L-fucosidase, anti-monoamine oxidase, anti-hyaluronic acid, anti-Laminin ELISA have been caught in detection line (28) position of (1) HBsAg test strips, HCVAb test strips, alpha-fetoprotein test strips, alpha-L-fucosidase test strips, monoamine oxidase test strips, hyaluronic acid test strips, Laminin ELISA test strips correspondence respectively; (2) HBsAg test strips, HCVAb test strips, alpha-fetoprotein test strips, alpha-L-fucosidase test strips, monoamine oxidase test strips, hyaluronic acid test strips, the gold mark thing pad district (24) of Laminin ELISA test strips is corresponding respectively to catch mouse-anti HBsAg antibody, mouse-anti human IgM antibody or/and the colloid gold label thing of mouse-anti human IgG antibody, mouse-anti alpha-fetoprotein antibody, mouse-anti alpha-L-fucosidase antibody, mouse-anti monoamine oxidase antibody, mouse-anti hyaluronic acid antibody, mouse-anti Laminin ELISA antibody; (3) the Quality Control thing of one or more the above-mentioned antibody in sheep anti mouse IgM antibody, sheep anti-mouse igg antibody, the anti-mouse IgM of rabbit antibody, the rabbit anti-mouse igg antibody is caught in the nature controlling line of each described test strips (29) position.
4. portable hepatitis according to claim 1 and cirrhosis fast joint inspection device is characterized in that: wherein said many indexs hepatitis, cirrhosis, liver cancer index of correlation test strip with many detection lines comprises many indexs hepatitis, cirrhosis, the liver cancer index of correlation test strip that is used for joint inspection HBsAg, HCVAb, alpha-fetoprotein, alpha-L-fucosidase, monoamine oxidase, hyaluronic acid, Laminin ELISA.
5. portable hepatitis according to claim 4 and cirrhosis fast joint inspection device is characterized in that: each detection line (28) position of (1) each test strips has been caught a kind of and hepatitis, cirrhosis, liver cancer related antigen or corresponding antibody of antibody or antigen; (2) gold of each described test strips mark thing pad district (24) catch with the antibody of the corresponding checking matter antigen of the corresponding gold mark mouse-anti of each detection line of place test strips (28) institute capture antibody and gold mark mouse-anti human IgM antibody or/and gold mark mouse-anti human IgG antibody; (3) each test strips nature controlling line (29) is caught the Quality Control thing of one or more the above-mentioned antibody in sheep anti mouse IgM antibody, sheep anti-mouse igg antibody, the anti-mouse IgM of rabbit antibody, the rabbit anti-mouse igg antibody.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNU2008201788483U CN201293787Y (en) | 2008-01-29 | 2008-11-12 | Portable rapid joint inspection device for hepatitis and hepatic cirrhosis |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200820062026 | 2008-01-29 | ||
| CN200820062026.9 | 2008-01-29 | ||
| CNU2008201788483U CN201293787Y (en) | 2008-01-29 | 2008-11-12 | Portable rapid joint inspection device for hepatitis and hepatic cirrhosis |
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| Publication Number | Publication Date |
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| CN201293787Y true CN201293787Y (en) | 2009-08-19 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNU2008201788483U Expired - Lifetime CN201293787Y (en) | 2008-01-29 | 2008-11-12 | Portable rapid joint inspection device for hepatitis and hepatic cirrhosis |
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| Date | Code | Title | Description |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| AV01 | Patent right actively abandoned |
Granted publication date: 20090819 Effective date of abandoning: 20081112 |