CN205749530U - A kind of classification rapid semi-quantitative test very early pregnancy colloid gold test paper and test kit - Google Patents
A kind of classification rapid semi-quantitative test very early pregnancy colloid gold test paper and test kit Download PDFInfo
- Publication number
- CN205749530U CN205749530U CN201620117763.9U CN201620117763U CN205749530U CN 205749530 U CN205749530 U CN 205749530U CN 201620117763 U CN201620117763 U CN 201620117763U CN 205749530 U CN205749530 U CN 205749530U
- Authority
- CN
- China
- Prior art keywords
- test
- gold
- line
- paper
- reagent paper
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
- G01N33/76—Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Pathology (AREA)
- General Physics & Mathematics (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Cell Biology (AREA)
- Medicinal Chemistry (AREA)
- Food Science & Technology (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- Endocrinology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Plasma & Fusion (AREA)
- Reproductive Health (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
This utility model " a kind of classification rapid semi-quantitative test very early pregnancy colloid gold test paper and test kit " belongs to medical detection consumptive material, including left side reagent paper and right side reagent paper, both sides reagent paper includes substrate supporting layer in the height direction, reaction reagent carrier absorption layer, reaction reagent carrier absorption layer is fixed on substrate supporting layer, it is sequentially provided with sample fiber pad to handheld terminal from sample-adding end, gold mark fiber mat, nitrocellulose filter, handheld terminal water-absorption material backing strap, it is stamped protecting film layer at gold mark fiber mat and handheld terminal water-absorption material backing strap overlying, nitrocellulose filter is printed with strip and the detection line vertical with reagent paper length direction and nature controlling line C line, from handheld terminal to sample-adding end, detection line on the reagent paper of left side is followed successively by T3, T1, detection line on the reagent paper of right side is followed successively by T4, T2.This utility model reagent paper for the detection of First Trimester, can interpretation First Trimester week number intuitively, and also can determine whether as normal pregnancy.
Description
Technical field
This utility model belongs to field of biological detection, relates to a kind of medical detection consumptive material, is specifically related to a kind of classification quick
Sxemiquantitative test very early pregnancy colloid gold test paper and test kit.
Background technology
The most most very early pregnancy Test paper all uses gold colloidal method to detect at present, but all can only
Inform whether examinee, either with or without pregnancy, can only contain hCG in qualitative detection urine, only when hCG concentration in urine >=
During 25mIU/ml, T line just develops the color, for the diagnosis of early gestation of the women of child-bearing age, it is impossible to the concentration of hCG in detection by quantitative urine, no
The early pregnancy of the women of child-bearing age can be made the anticipation of Gestational period and whether normal pregnancy.And for some unplanned pregnancys or the moon
The women of irregular menstrual period, did not had obvious morning sickness before 6-8 week, now needed a kind of economic simple method
Know concrete all numbers of pregnancy, in case further plan is made in work and life to oneself later stage, and to oneself later stage
Healthy etc. play suggesting effect.
Utility model content
Demand according to above-mentioned field and deficiency, this utility model aims to provide a kind of classification sxemiquantitative test very early pregnancy glue
Body gold reagent paper, this utility model reagent paper quickly detects the concentration of hCG, this practicality in human urine for early pregnancy classification sxemiquantitative
Novel method utilizes the display of variable concentrations, and one can be used for the detection of First Trimester, estimates week number of becoming pregnant in early days, and two are
Whether can be normal pregnancy according to the change auxiliary judgment of different conceived all number HCG concentration, if concentration is constantly in relatively low
Concentration, can speculate to be whether that ectopic pregnancy, tire stop improper Pregnancy such as educating.
The technical solution of the utility model is as follows:
A kind of classification sxemiquantitative test very early pregnancy colloid gold test paper, it is characterised in that include left side reagent paper and right side reagent paper,
Both sides reagent paper includes substrate supporting layer, reaction reagent carrier absorption layer in the height direction, and reaction reagent carrier absorption layer is fixed
On substrate supporting layer, and it is sequentially provided with sample fiber pad, gold mark fiber mat, celluloid medicine from sample-adding end to handheld terminal
Film, handheld terminal water-absorption material backing strap, is stamped protecting film layer, at cellulose nitrate at gold mark fiber mat and handheld terminal water-absorption material backing strap overlying
That be printed with strip on element medicine film and all vertical with reagent paper length direction detection line and nature controlling line C line, from handheld terminal to sample-adding
End, the detection line on the reagent paper of described left side is followed successively by T3, T1, and the detection line on the reagent paper of described right side is followed successively by T4, T2.
Described gold mark fiber mat is coated with the α-hCG monoclonal antibody of colloid gold label;Described T1, T2, T3, T4 line divides
Not being coated with and being coated concentration is 1.0-2.0mg/ml, and being coated concentration is 0.1-0.5mg/ml, and being coated concentration is 0.2-1.0mg/ml,
It is coated the β-hCG monoclonal antibody that concentration is 0.05-0.25mg/ml;Described nature controlling line C line is coated with sheep anti-mouse igg multi-resistance, and it is coated dense
Degree is 1-2mg/ml.
The unit are package amount ratio of the β-HCG antibody on described T1, T2, T3, T4 line is 20:2:4:1-8:2:4:1.
Described reagent paper is that test strip is two-in-one, duplex plate, or duplex pen.
A kind of classification rapid semi-quantitative test very early pregnancy gold colloidal duplex test kit, it is characterised in that: include above-mentioned glue
Body gold reagent paper.
Also include two the box obturators arranged side by side being made up of box body and lid, in described box body, be provided with installation gold colloidal examination
The locating slot of paper slip, is provided with attachment means between said two box obturator, can by attachment means between two box obturators
It is detachably connected with.Can individually use when two test kit obturators are taken apart.
Well and result observation port it is equipped with on described lid;When determining that described colloidal gold strip is positioned in box body
During the groove of position, corresponding to being sample fiber pad at lid well;Corresponding at result observation port being celluloid medicine film.
Described attachment means is two, the most detachable device 1 and detachable device 2, and is respectively arranged on two
Box obturator corresponding to well and the edge of result observation port.
Two box obturators arranged side by side are rectangle.Produce, install, transport, use, preserve extremely convenient, the most greatly
Side.
Technique effect:
This utility model realizes the detection of 4 kinds of concentration ranges by four detection lines, and reaction zone, left side is coated with C, T3, T1
Article three, line, T1 is high sensitivity, and mental retardation detects the urine (25mIU/ml≤hCG concentration < 100mIU/ml) in pregnant 3-4 week,
T3 mental retardation detects the urine (300mIU/ml≤hCG concentration < 1000mIU/ml) in pregnant 5-6 week, and reaction zone, right side is coated with
Tri-lines of C, T4, T2, T2 mental retardation detects the urine (100mIU/ml≤hCG concentration < 300mIU/ml) in pregnant 4-5 week, and T4 is minimum
Can the detection urine (hCG concentration >=1000mIU/ml) of pregnant more than 6 weeks.
This utility model one is the hCG that the capture antibodies using and being coated variable concentrations can catch variable concentrations, distinguishes
Different detection sensitivities, two is the capture antibodies using and being coated diverse location, distinguishes different detection sensitivities.If urine
Containing hCG in liquid, formation complex will be reacted with gold mark α-hCG monoclonal antibody, under chromatography effect, the β being fixed in advance on film-
HCG monoclonal antibody captures, and forms 1-4 bar aubergine band (T1/T2/T3/T4), according to the concentration of HCG in urine certainly in detection zone
Fixed which bar line of T1, T2, T3, T4 with reaction zone reacts.
In use, the sample-adding end at both sides reagent paper adds urine to this utility model product simultaneously, according to showing of detection line
Pornographic condition thus dope the hCG level of First Trimester and estimate week number of becoming pregnant in early days, and then whether auxiliary judgment is the most pregnant
It is pregnent.
This utility model can predict the hCG level of First Trimester, if in increasing trend, thus judges the morning of after fertilization
The Gestational period of phase, according to below with reference to value, becomes four detection lines by test strip designs:
Reference value: normal person: 0-3mIU/ml
This utility model can determine the concentration of HCG in urine according to the appearance of difference detection line, thus predict in early days
Conceived all numbers, the HCG concentration (mIU/ml) that conceived all numbers are corresponding is as follows:
Pregnant early stage (pregnant week is that the most secondary menstruation starts to calculate)
Pregnant 3 weeks 5.8-71.2mIU/ml
Pregnant 4 weeks 9.5-750mIU/ml
Pregnant 5 weeks 217-7138mIU/ml
Pregnant 6 weeks 158-31795mIU/m
Pregnant 7 weeks 3697-163563mIU/mL
Pregnant 8 weeks 32065-149571mIU/mL
Pregnant 9 weeks 63803-151410mIU/ml
Pregnant 10 weeks 46509-186977mIU/ml
Pregnant 11-12 week 27832-210612mIU/ml
Pregnant 13-14 week 13950-62530mIU/ml
Pregnant 15 weeks 12039-70971mIU/ml
Pregnant 16 weeks 9040-56451mIU/ml
Pregnant 17 weeks 8175-55868mIU/ml
Pregnant 18 weeks 8099-58176mIU/ml
T1 sensitivity 25mIU/ml:T1 line can develop the color, point out mental retardation detect pregnant 3-4 week urine (25mIU/ml≤
HCG concentration < 100mIU/ml).
T2 sensitivity 100mIU/ml:, T1 and T2 line can develop the color, and points out mental retardation to detect the urine (100mIU/ in pregnant 4-5 week
Ml≤hCG concentration < 300mIU/ml).
T3 sensitivity 300mIU/ml:T1, T2 and T3 line can develop the color, and point out mental retardation to detect the urine in pregnant 5-6 week
(300mIU/ml≤hCG concentration < 1000mIU/ml).
T4 sensitivity 1000mIU/ml:T1, T2, T3 and T4 line can develop the color, and point out the urine that mental retardation detects pregnant more than 6 weeks
(hCG concentration >=1000mIU/ml).
This utility model product and method are sxemiquantitative test, are appreciated that HCG concentration range value in early stage urine of becoming pregnant,
Thus utilize the display of different content for early pregnant detection, and the situation of surrounding before after becoming pregnant can be estimated, the most permissible
Whether the change auxiliary judgment according to different fertility cycle HCG concentration is normal pregnancy, if concentration is constantly in low concentration,
Can speculate to be whether that ectopic pregnancy, tire stop improper Pregnancy such as educating.
The present situation of existing methodology reagent and limitation
1, classical traditional methodology, product design and use theory before 25 years;
2, the single qualitative subjectivity interpretation denounced by people or empirical conjecture result;
3, innovation and research and development within more than 20 year such as one day, are lacked;
4, very different producer, the coarse unrest of quality of poor quality makes, OEM and personation brand, and price is barren and market mixed
Disorderly, the product seeked death.
The new method of this utility model product and reagent feature
1, new ideas lead use, the extension of methodology former dosage form life cycle and renewal;
2, science achieves from qualitative objectively to semiquantitative quick detection;
3, being still that and test by urine specimen, quantitative compared with than blood more have practicality, universality and economy;
4, classification zoning can interpretation First Trimester week number intuitively;
5, complementary accessory can also sketch out pregnancy period curve.
Accompanying drawing illustrates:
The top view of reagent paper on the left of Fig. 1 this utility model;
The top view of reagent paper on the right side of Fig. 2 this utility model;
The unilateral longitudinal sectional drawing of Fig. 3 this utility model reagent paper;
Fig. 4 this utility model duplex test kit top view;
Fig. 5 this utility model duplex test kit upward view;
Wherein: 1-handheld terminal, 2-nature controlling line C line, 3-detects line T1 line, 4-MAX markings, and 5-is loaded end, and 6-nitric acid is fine
Dimension element film layer, 7-sample fiber layer, 8-handheld terminal absorbent material layer, 9-gold mark fibrous layer, the big non-woven fabrics of 10-, the little nonwoven of 11-
Cloth, 12-handheld terminal adhesive tape, 13-arrow adhesive tape, 14-substrate supporting layer, 15-detects line T3 line, and 16-detects line T2 line, and 17-examines
Survey line T4 line, 18-lid, 19-box body, 20-well, 21-result observation port, 22-detachable connecting device 1,23-is detachable
Attachment means 2.
Detailed description of the invention:
Thering is provided following embodiment is to preferably be further appreciated by this utility model, it is not limited to described optimal enforcement
Mode, is not construed as limiting content of the present utility model and protection domain, and anyone is under enlightenment of the present utility model or incites somebody to action
As any and this utility model that the feature of this utility model and other prior aries is combined and draws is same or like
Product, within all falling within protection domain of the present utility model.
According to the principle of colloidal gold immunity chromatography detection, the sample-adding end of colloidal gold strip of the present utility model is added
Urine, urine moves to handheld terminal, when containing in urine along test strips from sample-adding end under the capillarity of fibrous sheet material
During hCG, urine along with chromatography effect first α-hCG monoclonal antibody with colloid gold label react, when creep to reaction zone again with β-HCG
Monoclonal antibody reacts, and determines which the bar line of T1, T2, T3, T4 with reaction zone reacts according to the concentration of hCG in urine.
The preparation of embodiment 1. test kit
The preparation of 1 test strips:
1.1 be coated
1.1.1 prepare: dilute β-hCG monoclonal antibody with pH7.4 10mM PBS, be configured to 2.0mg/ml, 1.0mg/ml respectively,
0.5mg/ml, 0.25mg/ml are coated for T1, T3, T2, T4 line;Dilute anti-Mus IgG multi-resistance with pH7.4 10mM PBS, join
Make 2.0mg/ml being coated for C line.Nitrocellulose filter is cut into 270mm*19mm.
1.1.2 be coated
1.1.2.1 reaction zone, left side is coated
Being coated with the BIODOT machine of being coated, a size of C line top edge that is coated of reaction zone, left side away from film top edge is
6.5mm, T1 lower limb is 6.5mm away from film lower limb, is then divided equally by tri-lines of C, T3, T1, and three line centreline spacings are about
2.6mm, CT line width is 0.8 ± 0.1mm, and the package amount of three lines is 0.8 μ l/cm, and being coated speed is 70mm/s.It is coated complete
After, it being dried 6 hours, baking temperature controls at 35-40 DEG C, humidity≤35%, adds 4-30 DEG C of desiccant after drying and seals preservation.
1.1.2.2 side reaction district, right side is coated
Being coated with the BIODOT machine of being coated, a size of C line top edge that is coated of reaction zone, right side away from film top edge is
6.5mm, T2 lower limb is 6.5mm away from film lower limb, is then divided equally by tri-lines of C, T4, T2, and three line centreline spacings are about
2.6mm, CT line width is 0.8 ± 0.1mm, and the package amount of three lines is 0.8 μ l/cm, and being coated speed is 70mm/s.It is coated complete
After, it being dried 6 hours, baking temperature controls at 35-40 DEG C, humidity≤35%, adds 4-30 DEG C of desiccant after drying and seals preservation.
1.2 labelling
1.2.1 the preparation of colloid gold particle
1.2.1.1 prepare: glass apparatus used is 2L conical flask, with the most repeatedly cleaning, standby after drying.Preparation
2% gold chloride 40ml and 2% trisodium citrate 50ml is standby.
1.2.2.2 measure the 2000ml resistance above ultra-pure water of 18M Ω in conical flask, and measure 2% chlorauric acid solution
40ml also adds in conical flask, and now solution is yellow, adds 2% citric acid three sodium solution after being heated to boiling
50ml, after boiling, solution becomes aubergine, continues to boil stopping heating in latter 5 minutes, and adds upper cover, and in room temperature, natural cooling is standby
With.
1.2.3 colloid gold label α-hCG monoclonal antibody
First taking gold colloidal 35ml, be initially charged 0.2M K2CO3 and regulate pH, addition is 10 μ l/ml, then adds
Entering α-hCG monoclonal antibody to be combined with gold colloidal, protein concentration is 10 μ g/ml, reacts 15 minutes, is subsequently adding bovine serum albumin 20 μ
L/ml closes, then after reacting 15 minutes, carries out 10000rpm, within 30 minutes, be centrifuged, abandon supernatant, and precipitation uses 10mM Tris
Buffer system (containing trisodium citrate 0.3%, 1.2%casein, 0.05%PVP40,0.7%TW20,2.5% sucrose, 1%
Glucose, 0.1%NaN3) 10% redissolution, obtain colloid gold label α-hCG monoclonal antibody stock solution 3.5ml.
1.3 the preparation of gold mark pad
Measure 10mM Tris buffer solution (containing trisodium citrate 0.3%, 1.2%casein, 0.05%PVP40,
0.7%TW20,2.5% sucrose, 1% glucose, 0.1%NaN3) 31.5ml, with colloid gold label α-hCG monoclonal antibody stock solution 3.5ml
Mix homogeneously, is layered on 30cm*30cm glass fibre, is dried 6 hours, and baking temperature controls at 35-40 DEG C, humidity≤35%,
Add 4-30 DEG C of desiccant after drying and seal preservation.
The preparation of 1.4 sample pad: first prepare the 10mM Tris buffer of pH 9.0, and be simultaneously introduced 0.5%
Casein, 1%PVP40,0.1%triton100,0.05%NaN3 mix, and measure 35ml liquid and are layered on 30*30cm glass fibre
On, it being dried 6 hours, baking temperature controls at 35-40 DEG C, humidity≤35%, adds 4-30 DEG C of desiccant after drying and seals preservation.
1.4 product pasting boards, sanction are surveyed
More than 1.1-1.3 component is attached on the plastic plate with gum respectively, is cut into the test strip that regulation bar is wide, use
HCG feminine gender urine carries out on-line checking, qualified after send QC to carry out semi-finished product detection.
1.5 packaging
QC is detected qualified test strip and is assembled into stripe shape, template or pen type, load in aluminium foil bag, fill desiccant, seal,
Mounted box, vanning, then send QC to carry out finished product detection.
2. using method:
Stripe shape:
1. sample to be tested, test strip or other detection materials etc. all take out after room temperature 10 DEG C-30 DEG C balances.
2. one end that test strip has arrow is inserted in urine specimen container, takes out and keep flat after 5 seconds, within 5 minutes, observes aobvious
Show result.
3. test strip is inserted the urine degree of depth and be may not exceed MAX markings.
Template:
1. sample to be tested, detection plate or other detection materials etc. are all cut at room temperature 10 DEG C-30 DEG C balance tailing edge aluminium foil bag
Mouth is torn, and takes out detection plate and dropper.
2. test board is kept flat, vertically add 2-3 with dropper and drip urine sample in each well.Within 5 minutes, observe in observation port
Display result.
Pen type:
1. sample to be tested, detection pen or other detection materials etc. are all cut at room temperature 10 DEG C-30 DEG C balance tailing edge aluminium foil bag
Mouth is torn, and takes out detection pen.
2. the cap for brush is unpluged, arrest inspection test pen handheld terminal, urine is directly drenched and gathers about 5 seconds left sides at hole at examination pen
Right.In observation port, display result is observed after 5 minutes.
3. sentence read result
3.1.1 it is positive
In nature controlling line position (C) and detection line position (T1-T4) colour developing, prompting may be conceived.
3.1.1.1 C line, the colour developing of T1 line, prompting: 25mIU/ml≤hCG concentration < 100mIU/ml, may conceived 3-4 week.
3.1.1.2 C line, the colour developing of T1 and T2 line, prompting: 100mIU/ml≤hCG concentration < 300mIU/ml, may be conceived
4-5 week.
3.1.1.3 C line, the colour developing of T1, T2 and T3 line, prompting: 300mIU/ml≤hCG concentration < 1000mIU/ml, may
Conceived 5-6 week.
3.1.1.4 C line, T1, T2, T3 and T4 line colour developing, prompting: hCG concentration >=1000mIU/ml, may conceived 6 weeks with
On.
3.1.2 it is negative
Only nature controlling line position (C) develop the color, point out hCG concentration < 25mIU/ml, may the most conceived or conceived concentration the lowest,
Need to survey again after 1-2 days.
3.1.3 it is invalid
Nature controlling line does not develops the color, or only in detection line position (T1-T4) colour developing, shows the failure of an experiment or product failure.
It is coated and detection case such as table 1:
Table 1 is as follows
Interpretation of result:
By result above, being coated concentration and minimal detectable concentration is inverse relationship, it is the highest to be coated concentration, can examine
The concentration surveyed is the lowest;Capture antibodies is successively and minimal detectable concentration is inverse relationship, first higher, also with the sensitivity of T line reaction
It is exactly that the concentration that can be detected by is relatively low.
The effectiveness of embodiment 2. this utility model product is able to verify that.
Table 2
Interpretation of result:
By the detection to conceived first five week urine, it can be seen that the gradually colour developing of T1-T4 detection line, can probably judge pregnant
HCG concentration and conceived all numbers in woman's urine.
The contrast test of the product of embodiment 3. this utility model product and prior art
Table 3
Interpretation of result:
Learning according to result above, prior art can only distinguish feminine gender and the positive, and this utility model product can basis
HCG concentration and conceived all numbers in the appearance general interpretation pregnant woman urine of different detection lines.
The compliance test result of embodiment 4. this utility model product
Table 4 type inspection is reported
Interpretation of result:
Learn according to result above, the physical behavior of this utility model product, lowest detectable limit, specificity, repeatability, steady
Qualitative, difference between batch is satisfied by current industry standard, and has distinguished the hCG concentration range of early pregnancy on this basis.
Claims (9)
1. a classification sxemiquantitative test very early pregnancy colloid gold test paper, it is characterised in that reagent paper and right side reagent paper on the left of including, two
Side reagent paper includes substrate supporting layer, reaction reagent carrier absorption layer in the height direction, and reaction reagent carrier absorption layer is fixed on
On substrate supporting layer, and it is sequentially provided with sample fiber pad from sample-adding end to handheld terminal, gold mark fiber mat, celluloid medicine film,
Handheld terminal water-absorption material backing strap;It is stamped protecting film layer at gold mark fiber mat and handheld terminal water-absorption material backing strap overlying;At celluloid
Be printed with on medicine film strip and all vertical with reagent paper length direction detection line and nature controlling line C line, from handheld terminal to sample-adding end,
Detection line on the reagent paper of described left side is followed successively by T3, T1, and the detection line on the reagent paper of described right side is followed successively by T4, T2.
Sxemiquantitative the most according to claim 1 test very early pregnancy colloid gold test paper, it is characterised in that at described gold mark fiber
α-hCG the monoclonal antibody of colloid gold label it is coated with on pad;Being coated with respectively on described T1, T2, T3, T4 line and being coated concentration is 1.0-
2.0mg/ml, being coated concentration is 0.1-0.5mg/ml, and being coated concentration is 0.2-1.0mg/ml, and being coated concentration is 0.05-0.25mg/
β-hCG the monoclonal antibody of ml;Described nature controlling line C line is coated with sheep anti-mouse igg multi-resistance, and it is coated concentration is 1-2mg/ml.
Sxemiquantitative the most according to claim 1 test very early pregnancy colloid gold test paper, it is characterised in that described T1, T2, T3,
The unit are package amount ratio of the β-HCG antibody on T4 line is 20:2:4:1-8:2:4:1.
Sxemiquantitative the most according to claim 1 test very early pregnancy colloid gold test paper, it is characterised in that described reagent paper is test
Bar is two-in-one, duplex plate or duplex pen.
5. a classification rapid semi-quantitative test very early pregnancy gold colloidal duplex test kit, it is characterised in that: include claim 1-4
Arbitrary described colloid gold test paper.
Sxemiquantitative the most according to claim 5 test very early pregnancy gold colloidal duplex test kit, it is characterised in that also include by
Two box obturators arranged side by side that box body and lid are constituted, are provided with the locating slot installing colloidal gold strip, institute in described box body
State and be provided with attachment means between two box obturators, by the detachable connection of attachment means between two box obturators.
Sxemiquantitative the most according to claim 6 test very early pregnancy gold colloidal duplex test kit, it is characterised in that described lid
On be equipped with well and result observation port;When described colloidal gold strip is positioned over the locating slot in box body, corresponding to box
It it is sample fiber pad at lid well;Corresponding at result observation port being celluloid medicine film.
Sxemiquantitative the most according to claim 7 test very early pregnancy gold colloidal duplex test kit, it is characterised in that described connection
Device is two, the most detachable device 1 and detachable device 2, and is respectively arranged on corresponding to of two box obturators
Well and the edge of result observation port.
Sxemiquantitative the most according to claim 8 test very early pregnancy gold colloidal duplex test kit, it is characterised in that two side by side
Box obturator be rectangle.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510520505 | 2015-08-21 | ||
CN2015105205055 | 2015-08-21 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN205749530U true CN205749530U (en) | 2016-11-30 |
Family
ID=56245055
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201620117763.9U Active CN205749530U (en) | 2015-08-21 | 2016-02-06 | A kind of classification rapid semi-quantitative test very early pregnancy colloid gold test paper and test kit |
CN201610083102.3A Pending CN105738635A (en) | 2015-08-21 | 2016-02-06 | Early pregnancy colloidal gold test paper with grading fast semiquantitative test function, kit and detection method |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201610083102.3A Pending CN105738635A (en) | 2015-08-21 | 2016-02-06 | Early pregnancy colloidal gold test paper with grading fast semiquantitative test function, kit and detection method |
Country Status (1)
Country | Link |
---|---|
CN (2) | CN205749530U (en) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN111830262A (en) * | 2020-07-27 | 2020-10-27 | 青岛汉唐生物科技有限公司 | Detection card and detection method for rapidly detecting early pregnancy and gestational week |
EP3683580A4 (en) * | 2018-03-26 | 2021-01-06 | Nantong Egens Biotechnology Co., Ltd. | Electronic detection pen and early pregnancy week number detection method |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106405121B (en) * | 2016-11-18 | 2018-07-10 | 百奥森(江苏)食品安全科技有限公司 | Two-channel detection card that is a kind of while detecting carbamazepine and sodium vedproate |
CN106932598A (en) * | 2017-03-24 | 2017-07-07 | 南通伊仕生物技术股份有限公司 | HCG cycle detection kits and preparation method thereof |
CN106896231A (en) * | 2017-04-13 | 2017-06-27 | 余凌泰 | A kind of HCG Test papers that HCG concentration is detected using two response lines |
CN107449920B (en) * | 2017-08-10 | 2020-06-05 | 深圳先进技术研究院 | Detection test strip for chemokine and derivative polypeptide thereof and preparation method thereof |
CN110850106A (en) * | 2018-08-20 | 2020-02-28 | 深圳市坪山区妇幼保健院 | Use and preparation method of human chorionic gonadotropin test strip for full-automatic analyzer |
CN110275029B (en) * | 2019-07-30 | 2024-09-10 | 南通伊仕生物技术股份有限公司 | Semi-quantitative detection test paper and reagent cup for human chorionic gonadotrophin, and preparation method and application thereof |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1998036278A1 (en) * | 1997-02-15 | 1998-08-20 | Beth Israel Deaconess Medical Center, Inc. | Multiple-site antibody capture immunoassays and kits |
CN1340707A (en) * | 2000-08-28 | 2002-03-20 | 上海华联制药有限公司 | Multi-level test method for HCG value of urine |
CN2443378Y (en) * | 2000-08-29 | 2001-08-15 | 上海华联制药有限公司 | Improved urine HCG value multi-level testing strip |
GB0607964D0 (en) * | 2006-04-21 | 2006-05-31 | British Pregnancy Advisory Ser | Pregnancy testing kit |
US7989217B2 (en) * | 2007-03-29 | 2011-08-02 | Ameritek Usa, Inc. | Method for determining hCG levels in fluid samples |
CN201229341Y (en) * | 2008-06-26 | 2009-04-29 | 崔学礼 | Test paper for detecting ectopic pregnancy and conception day by colloidal gold method |
CN102890157A (en) * | 2011-07-20 | 2013-01-23 | 天津中新科炬生物制药有限公司 | Test strip and method for fast quantitative detection of human chorionic gonadotropin (HCG) |
CN203249910U (en) * | 2013-05-21 | 2013-10-23 | 北京健乃喜生物技术有限公司 | Novel quick-drying detection test card with double slots |
CN104502586B (en) * | 2014-06-11 | 2017-08-29 | 陈岩松 | A kind of immunochromatography detection method and test paper |
CN204269657U (en) * | 2014-09-30 | 2015-04-15 | 北京金华科生物技术有限公司 | A kind of early pregnancy Test paper combination unit |
CN204330782U (en) * | 2014-12-10 | 2015-05-13 | 美利泰格诊断试剂(嘉兴)有限公司 | A kind of hCG test pen |
CN204903553U (en) * | 2015-08-10 | 2015-12-23 | 刘宗印 | Test paper stick of early pregnant result of survey |
-
2016
- 2016-02-06 CN CN201620117763.9U patent/CN205749530U/en active Active
- 2016-02-06 CN CN201610083102.3A patent/CN105738635A/en active Pending
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP3683580A4 (en) * | 2018-03-26 | 2021-01-06 | Nantong Egens Biotechnology Co., Ltd. | Electronic detection pen and early pregnancy week number detection method |
AU2018416802B2 (en) * | 2018-03-26 | 2022-03-03 | Nantong Egens Biotechnology Co., Ltd. | Electronic detection pen and early pregnancy week number detection method |
CN111830262A (en) * | 2020-07-27 | 2020-10-27 | 青岛汉唐生物科技有限公司 | Detection card and detection method for rapidly detecting early pregnancy and gestational week |
Also Published As
Publication number | Publication date |
---|---|
CN105738635A (en) | 2016-07-06 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN205749530U (en) | A kind of classification rapid semi-quantitative test very early pregnancy colloid gold test paper and test kit | |
CN205720253U (en) | A kind of classification rapid semi-quantitative test ovulation colloid gold test paper and kit | |
AU2018412729B2 (en) | HCG cycle test paper strip, kit, preparation method therefor and use thereof | |
TW459126B (en) | Analytical test device and method of use | |
BR112019026016B1 (en) | INNOVATIVE UNIVERSAL TEST SYSTEM FOR QUANTITATIVE ANALYSIS | |
US20160025752A1 (en) | Devices and methods for detecting and/or quantifying analytes in fluids | |
CA2906302C (en) | Diagnostic test device with improved structure | |
CN108139410A (en) | Improved Pregnancy Test device and method | |
CN104655835A (en) | Immune colloidal gold detect card of chlorpromazine, and preparation method thereof | |
CN102890157A (en) | Test strip and method for fast quantitative detection of human chorionic gonadotropin (HCG) | |
IE44204B1 (en) | Direct agglutination reagent for pregnancy testing | |
WO2022068641A1 (en) | Kit for detecting novel coronavirus, and preparation method therefor and detection method therefor | |
CN109459570A (en) | The colloid gold immune test paper preparation method of lead ion in a kind of quick detection blood of human body | |
CN206892112U (en) | A kind of upper forwarding light immune chromatography test paper that quantitative detection is carried out to morphine concentration in saliva | |
CN106896231A (en) | A kind of HCG Test papers that HCG concentration is detected using two response lines | |
CN105572394A (en) | Preparation method of urine HCG quantitative detection test paper strip | |
CN104237521A (en) | Three-in-one colloidal gold chromatographic test strip for detecting thiamphenicol, chloramphenicol and florfenicol and preparation method thereof | |
CN106932592B (en) | Detect the colloidal gold strip and its preparation method and application of people's surfactant protein A | |
CN208969109U (en) | The Rapid detection test strip adulterated for goat milk | |
CN207798847U (en) | A kind of clenbuterol hydrochloride detection kit | |
US20170153227A1 (en) | Devices and Formulations for Detecting, Screening and Monitoring Levels of Certain Constituents in Bodily Fluids and Method | |
CN105008922B (en) | Disposable in-vitro diagnosis (IVD) device of blood clotting international standardization ratio (INR) is checked for household self-service | |
CN112630423A (en) | Wheat immunofluorescence detection test strip and application | |
CN207636497U (en) | Calcium, magnesium quick detection kit in a kind of blood dialysis solution | |
CN204462151U (en) | A kind of immunity chromatography detection test paper |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C14 | Grant of patent or utility model | ||
GR01 | Patent grant |