CN206330983U - A kind of two-in-one CRP Test papers of new saliva blood - Google Patents

Abstract

The utility model is related to a kind of two-in-one CRP Test papers of new saliva blood, with saliva, whole blood or serum are used as detection sample, when using saliva as detection sample, use spittle collector collecting sample, when using whole blood or serum as sample, whole blood sampling device collecting sample is quantified using disposable, including Test paper, spittle collector, disposably quantify whole blood sampling device and detection means, wherein, described Test paper includes sample pad, hemofiltration film, gold conjugation pad, NC nitrocellulose filters, water sucting plate and PVC board, described sample pad, hemofiltration film, gold conjugation pad, nitrocellulose filter, water sucting plate is pasted on described PVC board surface；Described hemofiltration film and the gold conjugation pad of its underpart are connected.The utility model detected using saliva or blood sample, with reference to more ripe colloidal gold immunochromatographimethod technology at present, can it is easy, quick, to completion CRP detection of the patient without any injury.

Description

A kind of two-in-one CRP Test papers of new saliva blood

Technical field

The utility model is related to medical Test paper field, more particularly to a kind of two-in-one CRP detections of new saliva blood Test paper.

Background technology

((C-reactive protein, CRP) is that one kind can be with streptococcus pneumonia C polysaccharide precursor reactant shapes to c reactive protein Into the Acute reaction protein of compound, 19 hours half-life period；Serum CA125 is synthesized by liver, interleukin 1 b, 6 and TNF is the most important regulatory factor of its synthesis；CRP molecular weight is 105 500, by containing five identicals Not glycosylated polypeptide sub-units composition, each subunit is contained to be bonded between 187 amino acid, these subunits by non-covalent Form the pentamer of ring-type, and have an interchain disulfide bond.CRP can trigger the immuno-recuperative function and phagocytosis to invading cell Effect, and show inflammatory reaction.CRP is as an extremely sensitive index of acute-phase response, and CRP concentration is acute in blood plasma Significantly increase rapidly when myocardial infarction, wound, infection, inflammation, surgical operation, cancer infiltration, up to the 2000 of normal level Times.With reference to clinical medical history, contribute to the follow-up course of disease.It is follow-up rheumatism, systemic loupus erythematosus, white especially in inflammatory process Blood disease etc..

Method and instrument at present to c reactive protein quick detection is more, mainly has colloidal gold immunity chromatography, fluorescence to exempt from The detection methods such as epidemic disease chromatography, immunoturbidimetry, chemoluminescence method, ELISA, detection sample mostly be people's Venous serum, blood Slurry or whole blood.Need health care professional to gather blood sample, result interpretation and rely on the reasons such as professional detecting instrument.Patient can not complete Family tests oneself.

The shortcoming of prior art mainly includes：

1st, venous blood sample, including whole blood, blood plasma, serum can only be detected.The shortcoming of the collection of blood sample has：(1) Sample collection can bring certain pain, be that many sample collection persons are difficult to receive；(2) specialty is needed when gathering blood sample Medical personnel, and wound can be caused during collection blood sample, potential danger is produced, it is very inconvenient, it is impossible to gather and detect at any time, no Tested oneself suitable for patient home；

2nd, prior art products do not carry out half-quantitative detection；

3rd, quantitatively detected without special supporting smart mobile phone APP, realize that individual tests oneself and retained and detect CRP knots Really.

Due to not above-mentioned 1,2,3 functions, therefore can not realize, be controlled in addition in continuous detection in the popularization that individual tests oneself In the monitoring of therapeutic effect, it has not been convenient to, cost is higher, and the report testing result time is also longer.

In view of drawbacks described above, the utility model creator obtains this creation finally by prolonged research and practice.

The content of the invention

The utility model purpose is to provide a kind of new two-in-one CRP Test papers of saliva blood and preparation method thereof, To overcome above-mentioned technological deficiency.

To achieve the above object, the utility model employs following technical scheme：A kind of new two-in-one CRP of saliva blood Test paper, detection sample, including Test paper, detection means and sample collection cartridge are used as using saliva, whole blood or serum Put；

Wherein, described Test paper includes sample pad, hemofiltration film, gold conjugation pad, nitrocellulose filter, water sucting plate And PVC board, described sample pad, hemofiltration film, gold conjugation pad, nitrocellulose filter, water sucting plate are pasted on described PVC board Surface；

Described sample pad and its underpart hemofiltration film, described hemofiltration film and the gold conjugation pad of its underpart, it is described Gold conjugation pad and the nitrocellulose filter of its underpart, described nitrocellulose filter and the water sucting plate on its top, difference portion Divide overlapping handing-over；

Described gold conjugation pad is sprayed with the CRP- alpha monoclonal antibodies of colloid gold label；

Two parallel antibody capture lines are drawn on described nitrocellulose membrane respectively, close to one of gold conjugation pad Containing CRP- β monoclonal antibodies, as detection line, another contains the sheep anti-mouse igg polyclonal antibody through concentration is determined, and makees For normal concentration colour developing nature controlling line.

Further, saliva is detection sample, and described sample collection cartridge is set to spittle collector.

Further, described spittle collector is wound packages spittle collector, and it includes collection handle frame, container cartridge, adopted Market-head and cylinder cap, described collection handle frame are arranged on the top of collection head, and both are connected as a single entity；Gather handle frame and collection head It is arranged on inside container cartridge.

Further, whole blood or serum are sample, and described sample collection cartridge, which is set to, disposably quantify whole blood sampling dress Put.

Further, it is described disposably to quantify whole blood sampling device, including be arranged on the block of upper end, 10uL and quantitatively inhale Sample device, suction nozzle and bottom cylinder, the bottom of 10uL quantitative sample-sucking devices set suction nozzle, and 10uL quantitative sample-sucking device suction nozzles are arranged in the cylinder of bottom.

Further, described detection means is supporting color chart, and it is provided with T line colors and corresponding concentration value.

Further, described detection means is APP softwares, is stored with corresponding detectable concentration value.

Compared with prior art, the utility model is detected using saliva sample, with reference to more ripe colloid at present Golden immunochromatography technique, easy, fast, to completion CRP of the patient without any injury can detect that it can be used for medical institutions Quick detection, it more difficult to can it is valuable be that consumer can be allowed to be tested oneself.

1st, saliva sample is easy to get, and can gather at any time；

2nd, blood sample makes quantitative sampling and dilution device by oneself, and professional testing agency's venous blood samples detection is not spent；

3rd, collecting sample is simple to operate, easy to use, i.e. operable to specifications, it is not necessary to tediously long professional training；

4th, with extensive value for applications, you can for specialty detection, it can also be used to which personal or family tests oneself；

5th, it is easy to detect quick, result can be obtained within 10 minutes；

6th, it can be combined with personal mobile phone, not only result can also be preserved with testing result, personal detection can be set up With diagnosis archives, individual electronic medical record, and Family health files can be set up；

7th, due to easy to use, it can be promoted as the method for detection treatment effectiveness evaluation at any time.Continuously use, disappear Expense person, which tests oneself, could be aware that therapeutic effect, instruct the guidance of The Illustrated Family Doctor, and doctor can adjust therapeutic scheme according to testing result.

Brief description of the drawings

Fig. 1 is the structural representation of wound packages spittle collector of the present utility model；

Fig. 2 is the disposable structural representation for quantifying whole blood sampling device of the present utility model；

Fig. 3 is the structural representation of color chart of the present utility model；

Fig. 4 is the structural representation of Test paper of the present utility model；

Fig. 5 is the flow chart of the processing technology of the new two-in-one CRP Test papers of saliva blood of the present utility model

Fig. 6 is the structural representation of Test paper card of the present utility model.

Embodiment

Below in conjunction with the accompanying drawing in the utility model embodiment, the technical scheme in the utility model embodiment is carried out Clearly and completely describe, it is clear that described embodiment is only a part of embodiment of the utility model, rather than whole Embodiment.

The utility model embodiment is used as detection sample using saliva, whole blood or serum；

When using saliva as detection sample, collecting sample is made using spittle collector；When being used as sample using whole blood or serum This when, using disposably quantifying whole blood sampling device collecting sample, including it is Test paper, spittle collector, disposable quantitative complete Blood sampling apparatus and detection means.

Embodiment one

The two-in-one CRP Test papers of saliva blood of the present embodiment include Test paper, spittle collector, disposably quantified Whole blood sampling device, wherein, described spittle collector is wound packages spittle collector.Refer to shown in Fig. 1, described wound packages saliva Liquid collector includes collection handle frame 11, container cartridge 12, collection head 13 and cylinder cap 14, and described collection handle frame 11, which is arranged on, to be adopted The top of market-head 13, both are connected as a single entity；Collection handle frame 11 and collection head 13 are arranged on inside container cartridge 12.

Refer to shown in Fig. 4, the Test paper of the present embodiment includes sample pad 1, gold conjugation pad 2, NC cellulose nitrates Plain film 3, water sucting plate 4, hemofiltration film 8 and PVC board 5, described sample pad 1, the gold conjugation pad 2 of hemofiltration film 8, NC nitrocellulose Film 3, water sucting plate 4 are pasted on the described surface of PVC board 5, and its width is identical；Hemofiltration film 8 is provided with described sample pad, Hemofiltration film is cut into 0.5*30cm bar shapeds.

Described sample pad 1 and the hemofiltration film 8 of its underpart, the gold conjugation pad 2 of described its underpart of hemofiltration film 8, institute The gold conjugation pad 2 stated and the nitrocellulose filter 3 of its underpart, described nitrocellulose filter 3 and the water sucting plate on its top 4, partly overlap handing-over respectively, and overlapping widths are respectively 1-4mm.

Described gold conjugation pad 2 is sprayed with the CRP- alpha monoclonal antibodies of colloid gold label；

Two parallel antibody capture lines are drawn on described NC nitrocellulose membranes 3 respectively, close to gold conjugation pad 2 One contains CRP- β monoclonal antibodies, as detection line 6, i.e. T lines, and another contains the sheep anti-mouse igg through concentration is determined and resist Body, is used as normal concentration colour developing nature controlling line 7, i.e. C lines.

It is described disposably to quantify whole blood sampling device, including be arranged on the block 31 of upper end, 10uL quantitative sample-sucking devices 32, The bottom of suction nozzle 33 and bottom cylinder 34,10uL quantitative sample-sucking devices sets suction nozzle, and 10uL quantitative sample-sucking devices, suction nozzle are arranged in the cylinder of bottom.

Reaction principle is：

The wound packages collector cylinder cap for being collected saliva is backed out, the middle part of collection cylinder is pinched, saliva sample is squeezed into test card Saliva well 21, saliva sample is the sample end for being added to test strips, and sample is to start lateral chromatography motion, is detected, When containing a certain amount of CRP antigens in sample, display window shows two parallel lines（C and T), when there is no CRP antigens in sample When or less than detection range of linearity lower concentration values below, display window only shows a C line.

Embodiment two

The two-in-one CRP Test papers of saliva blood of the present embodiment include Test paper, spittle collector and disposably determined Whole blood sampling device and supporting color chart are measured, wherein, described spittle collector is the wound packages spittle collector of embodiment one；Inspection Test paper is the Test paper of embodiment one；Disposably quantify whole blood sampling device identical with embodiment one.

The wound packages collector cylinder cap for being collected saliva is backed out, the middle part of collection cylinder is pinched, saliva sample is squeezed into test card Saliva well, saliva sample is the sample pad for being added to test strips, and sample is to start lateral chromatography motion, is detected, when When containing a certain amount of CRP antigens in sample, display window shows two parallel lines（C and T), when there is no CRP antigens in sample When or less than detection range of linearity lower concentration values below, display window only shows a C line.

Refer to and be provided with T line colors and corresponding concentration value on the supporting color chart described in Fig. 3, CRP concentration can be carried out Half-quantitative detection.

Embodiment three

The present embodiment is using the two-in-one CRP Test papers of quantitative saliva blood, including Test paper, spittle collector dress Put, disposably quantify whole blood sampling device and equipped with supporting APP software smart mobile phones；

Wherein, described Test paper is identical with the Test paper of embodiment one, using the CRP Test papers of embodiment one Card；

Wherein, described APP software memorys contain corresponding detectable concentration value.Carry out CRP concentration quantitatives or sxemiquantitative Detection.

Reaction mechanism of the present utility model is：

Fig. 6 examples are referred to, described Test paper card plastics jam includes saliva well 21, the and of blood well 24 Display window 22.

When gathering saliva sample, the spittle collector carried by this product gathers saliva, during collection blood sample, passes through What this product was carried disposably quantifies whole blood sampling device collection finger tip blood.There are two wells on product test card, use saliva sample Need to be added drop-wise in saliva well 21 during this detection, use whole blood（Or serum）Need to be added drop-wise to blood sample-adding during pattern detection In hole 24, a test card only allows a kind of sample is added dropwise.The principle of product development is by CRP- β monoclonal antibodies and sheep anti mouse IgG is coated on cellulose nitrate film respectively, is that the specific extremely strong CRP- alpha monoclonals of colloid gold label resist on polyester film Body.In detection, there is no c reactive protein presence, the specific antibody Zhi Yumo areas sheep anti-mouse igg of colloid gold label in such as sample With reference in one red line (nature controlling line C) of formation of display window 22, it is feminine gender to show testing result；As there is C reaction eggs in sample When the concentration of white and c reactive protein reaches test limit concentration value, the c reactive protein of c reactive protein antigen just with colloid gold label Monoclonal antibody is combined, and when sample is sprung up forward, the c reactive protein monoclonal antibody that can be coated on nitrocellulose filter is caught Obtain, formed macroscopic（It is purple）Red detection line, the coated sheep anti-mouse igg of nature controlling line can also capture the C of colloid gold label Reactive protein monoclonal antibody, so as to form one（It is purple）Red nature controlling line, in two red line (detection line T of the formation of display window 22 With nature controlling line C), it is the positive to show testing result.In certain concentration range, the deeper explanation concentration of colour developing color of detection line It is higher, on the contrary concentration is lower.In addition, half-quantitative detection 1 can be carried out）Supporting gradient colour developing card is with detection various concentrations The gradient colour atla that the detection line reaction color that standard quality-control product is respectively obtained is made, in use, by the detection line in testing result Contrasted with colour atla, you can know the substantially concentration of CRP in sample.It can be also used in combination with mobile phone A PP and quantitatively be detected 2）Such as Fruit scans the detection line and nature controlling line of test paper with matching used smart mobile phone APP, and mobile phone can detect sample with direct quantitative Concentration.

Refer to shown in Fig. 5, a kind of new two-in-one CRP Test papers of saliva blood that the utility model is provided, it is wrapped Include

A kind of preparation method for new two-in-one CRP Test papers of saliva blood that the utility model is provided is as follows：

1）The preparation of sample pad：The plain film of glass fibre is cut into 25*30cm, soaked with sample pad treatment fluid on 30 minutes, Drying is taken out, the 2.5*30cm sample filler strips for being cut into respective width are standby；

2）The preparation of hemofiltration film：Hemofiltration film is cut into 0.5*30cm stripe shapes standby；

3）The preparation of gold conjugation pad：The cooling of collaurum liquid is prepared with gold chloride-trisodium citrate reduction method standby, adjusted Whole pH value adds the CRP- alpha monoclonal antibodies of required amount to appropriate value, stirs 30 minutes, adds appropriate BSA, stirs 10 points Supernatant is removed in clock, centrifugation, is added appropriate redissolution liquid and is redissolved to appropriate volume, shaken well, is sprayed on polyester film, 37 DEG C of dryings More than 4 hours, the direction of liquid is redissolved along metal spraying, ensure every it is golden it is complete in the case of, be cut into 1*30cm collaurum knots Close pad standby；

4）The preparation of coated film：Dilute CRP- β monoclonal antibodies respectively with antibody diluent, and resist sheep anti mouse to certain more Concentration, rule respectively on NC films, form the position of T and C lines, such as above-mentioned product figure respectively, 37 DEG C of dryings more than 4 hours, Then it is cut into 30cm length standby；

5）The preparation of absorbent material：Water sucting plate is cut into 3.3*30cm bar shapeds standby；

6）Golden film is combined：By coated film, hemofiltration film, absorbent material, gold conjugation pad, sample pad according to upper figure order It is bonded at stacking in PVC board, forms profiled sheeting；

7）Cutting：Above-mentioned profiled sheeting is cut into 3mm or the bar of width is required；

8）Stripe shape product：Pack and sealing：By above-mentioned bar, it is respectively charged into one by one in aluminum foil bag, sealing；It is standby；

9）Board products：Pack and sealing：By 6）The bar of step production is respectively charged into corresponding card, is respectively charged into aluminium Moor in bag, sealing；It is standby.

Wherein, the production technology of above-mentioned wound packages collector is：

1）Collection handle frame, collection head, container cartridge, cylinder cap are cleaned three times with purified water, scatter be laid in clothes hanger respectively；

2）Above-mentioned clothes hanger is pushed into drying room and is dried, is respectively charged into stand-by in the bag of cleaning；

3）Collection head is soaked in specific solution, is placed in after 30 minutes on clothes hanger, scatters and be laid on clothes hanger, then Send into drying room and dry；

4）The collection handle frame that drying is crossed, and the dried collection head of immersion treatment are taken, by collection head in ultrasonic wave The connection end of collection handle frame is welded on bonding machine；Quality inspection；

5）The qualified collector welded of quality inspection is loaded into each container cartridge one by one, a cap is taken；

Above process is produced in 100,000 grades of clean rooms；

7）Above-mentioned assembling is finished after collector sterilized, and the qualified storage of quality inspection is stand-by.

Wherein, above-mentioned color chart production technology is：

1）CRP quality-control product concentration is respectively configured（mg/L)：0.5、1、5、10、20、50、80、100、120、150；

2）Detect the quality-control product of above-mentioned concentration respectively with qualified CRP Test papers, detection line is drawn respectively（T lines）It is aobvious Colour band；

3）Developed band is taken pictures with camera, passed on computer, concentration and developed band are corresponded, color chart is done Template original；

4）Color chart original is printed factory is printed；

5）Quality inspection it is qualified enter it is stand-by.

Above embodiment is only unrestricted to illustrate the technical solution of the utility model, although with reference to preferable reality Example is applied the utility model is described in detail, it will be understood by those within the art that, can be to the utility model Technical scheme modify or equivalent, without departing from the spirit and scope of technical solutions of the utility model, it all should Cover among right of the present utility model.

Claims (7)

1. a kind of two-in-one CRP Test papers of new saliva blood, it is characterised in that inspection is used as using saliva, whole blood or serum Test sample sheet, including Test paper, detection means and sample collecting apparatus；

Wherein, described Test paper include sample pad, hemofiltration film, gold conjugation pad, nitrocellulose filter, water sucting plate and PVC board, described sample pad, hemofiltration film, gold conjugation pad, nitrocellulose filter, water sucting plate are pasted on described PVC board table Face；

Described sample pad and its underpart hemofiltration film, described hemofiltration film and the gold conjugation pad of its underpart, described colloid Golden pad and the nitrocellulose filter of its underpart, described nitrocellulose filter and the water sucting plate on its top, part is heavy respectively Overlap and connect；

Described gold conjugation pad is sprayed with the CRP- alpha monoclonal antibodies of colloid gold label；

Two parallel antibody capture lines are drawn on described nitrocellulose membrane respectively, one close to gold conjugation pad is contained CRP- β monoclonal antibodies, as detection line, another contains the sheep anti-mouse igg polyclonal antibody through concentration is determined, and is used as mark Quasi- concentration colour developing nature controlling line.

2. the two-in-one CRP Test papers of new saliva blood according to claim 1, it is characterised in that saliva is detection Sample, described sample collection cartridge is set to spittle collector.

3. the two-in-one CRP Test papers of new saliva blood according to claim 2, it is characterised in that described saliva Collector is wound packages spittle collector, and it includes collection handle frame, container cartridge, collection head and cylinder cap, described collection handle frame The top of collection head is arranged on, both are connected as a single entity；Collection handle frame and collection head are arranged on inside container cartridge.

4. the two-in-one CRP Test papers of new saliva blood according to claim 1, it is characterised in that whole blood or blood It is sample clearly, described sample collection cartridge, which is set to, disposably quantifies whole blood sampling device.

5. the two-in-one CRP Test papers of new saliva blood according to claim 4, it is characterised in that it is described once Property quantitative whole blood sampling device, including be arranged on the block of upper end, 10uL quantitative sample-sucking devices, suction nozzle and bottom cylinder, 10uL quantitatively inhales The bottom of sample device sets suction nozzle, and the suction nozzle of 10uL quantitative sample-sucking devices is arranged in the cylinder of bottom.

6. the two-in-one CRP Test papers of new saliva blood according to claim 1, it is characterised in that described detection Device is supporting color chart, and it is provided with T line colors and corresponding concentration value.

7. the two-in-one CRP Test papers of new saliva blood according to claim 1, it is characterised in that described detection Device is APP softwares, is stored with corresponding detectable concentration value.