CN105628939A - Grade rapid semi-quantitative ovulation colloidal gold test paper, kit and detection method - Google Patents

Grade rapid semi-quantitative ovulation colloidal gold test paper, kit and detection method Download PDF

Info

Publication number
CN105628939A
CN105628939A CN201610083099.5A CN201610083099A CN105628939A CN 105628939 A CN105628939 A CN 105628939A CN 201610083099 A CN201610083099 A CN 201610083099A CN 105628939 A CN105628939 A CN 105628939A
Authority
CN
China
Prior art keywords
test
ovulation
gold
coated
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.)
Pending
Application number
CN201610083099.5A
Other languages
Chinese (zh)
Inventor
聂丽芳
祝明
张学敏
刘晓翠
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BLUE CROSS BIO-MEDICAL (BEIJING) Co Ltd
Original Assignee
BLUE CROSS BIO-MEDICAL (BEIJING) Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by BLUE CROSS BIO-MEDICAL (BEIJING) Co Ltd filed Critical BLUE CROSS BIO-MEDICAL (BEIJING) Co Ltd
Priority to CN201610083099.5A priority Critical patent/CN105628939A/en
Publication of CN105628939A publication Critical patent/CN105628939A/en
Pending legal-status Critical Current

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical 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
    • G01N33/76Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575Hormones
    • G01N2333/59Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]

Abstract

The invention belongs to medical test consumables and relates to 'grade rapid semi-quantitative ovulation colloidal gold test paper, kit and detection method', comprising left test paper and right test paper. The test paper on two sides comprises base board supporting layers and reagent carrier adsorbing layers in the height direction, the reagent carrier adsorbing layers are fixed to the base board supporting layers, a sample fiber pad, a gold-labeled fiber pad, a nitrocellulose drug film and a handheld end absorbent material pad are disposed in succession from a sample feeding end to the handheld end, a protective film layer covers the gold-labeled fiber pad and the handheld end absorbent material pad, a cellulose drug film is printed with stripy detection lines T1, T2, T3 and T4 and a quality control line C that are perpendicular to the length direction of the test paper, and from the handheld end to the sample feeding end, a left reaction zone is coated sequentially with C, T3 and T1 and a right reaction zone is coated sequentially with C, T4 and T2. The test paper of the invention predicts ovulation with displaying under different concentrations, and can predict different luteinizing hormone concentrations in different menstrual cycles for predicting ovulation time, and judge whether LH level is normal or not and whether normal ovulation is available or not according to the height of LH.

Description

A kind of classification rapid semi-quantitative test ovulation colloid gold test paper, test kit and detection method
Technical field
The invention belongs to field of biological detection, relate to a kind of medical detection consumptive material, be specifically related to a kind of classification rapid semi-quantitative test ovulation colloid gold test paper, test kit and detection method.
Background technology
Most ovulation test paper all adopts gold colloidal method to detect on the market at present, but all can only inform whether examinee ovulated in 24-48 hour, whether qualitative detection urine can only contain LH, only T line >=C line as LH concentration >=25mIU/ml in urine, for predicting the ovulation period of the women of child-bearing age, can not the concentration of LH in detection by quantitative urine, it is impossible to the LH concentration of the women of child-bearing age with whether can normally ovulate and make anticipation.
Summary of the invention
Demand according to above-mentioned field and deficiency, it is desirable to provide a kind of classification sxemiquantitative test ovulation colloid gold test paper, reagent paper of the present invention quickly detects the concentration of the LH in human urine for classification sxemiquantitative, the inventive method utilizes the display of variable concentrations, one is to draw time-concentration curve, and the more accurate predicting ovulation time, two is the variable concentrations that can detect LH, anticipation is made, it will be appreciated that female organism hormonal readiness to whether can normally ovulate.
Technical scheme is as follows:
A kind of sxemiquantitative test ovulation colloid gold test paper, it is characterized in that, 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, and from application of sample end to handheld terminal, it is sequentially provided with sample fiber pad, gold mark fiber mat, celluloid medicine film, handheld terminal water-absorption material backing strap, it is stamped protection rete at gold mark fiber mat and handle end water-absorption material backing strap overlying, that be printed with strip on celluloid medicine film and all vertical with reagent paper length direction detection line T1, T2, T3, T4 line and nature controlling line C line, from handheld terminal to application of sample end, reagent paper reaction zone, left side is followed successively by C, T3, T1, reagent paper reaction zone, right side is followed successively by C, T4, T2.
Described gold mark fiber mat is coated with the ��-LH monoclonal antibody of colloid gold label; Being coated with respectively on described T1, T2, T3, T4 line and being coated concentration is 0.5-1mg/ml, and being coated concentration is 0.1-0.2, and being coated concentration is 0.1-0.2mg/ml, is coated the ��-LH antibody that concentration is 0.01-0.02mg/ml; Described nature controlling line C is coated with sheep anti-mouse igg multi-resistance, and it is coated concentration is 0.2-1mg/ml.
The unit are package amount ratio of the ��-LH antibody on described T1, T2, T3, T4 line is 50:10:10:1.
Described reagent paper is that test strip is two-in-one, duplex plate, or duplex pen.
A kind of classification rapid semi-quantitative test ovulation gold colloidal duplex test kit, it is characterised in that: include above-mentioned colloid gold test paper.
Also including two the box obturators arranged side by side being made up of box body and lid, be provided with the locating slot installing colloidal gold strip in described box body, described box body is provided with connecting device, by the detachable connection of connecting device between two box bodys. Can individually use when two test kits are taken apart.
Described lid is equipped with well and result observation port; When described colloidal gold strip is positioned over the locating slot in box body, it is sample fiber pad corresponding to lid well place; It is celluloid medicine film corresponding to result observation port place.
Described connecting device is two, respectively detachable device 1 and detachable device 2, and is respectively arranged on the edge corresponding to well and result observation port of two box obturators.
Two test kits arranged side by side are rectangle. Produce, install, transport, use, preserve extremely convenient, simply generous.
Use the method that above-mentioned sxemiquantitative test ovulation colloid gold test paper or duplex test kit carry out the test ovulation of classification rapid semi-quantitative.
Technique effect:
The present invention detects line by four and realizes the detection of 4 kinds of concentration, reaction zone, left side is coated with tri-lines of C, T3, T1, T1 is high sensitivity, most mental retardation detection LH concentration is 1mIU/ml, the most mental retardation detection LH concentration of T3 is 25mIU/ml, reaction zone, right side is coated with tri-lines of C, T4, T2, and the most mental retardation detection hLH concentration of T2 is 5mIU/ml, and the most mental retardation detection hLH concentration of T4 is 65mIU/ml.
This method one is the LH that the capture antibodies adopting and being coated variable concentrations can catch variable concentrations, distinguishes different detection sensitivities, and two is the capture antibodies adopting and being coated diverse location, distinguishes different detection sensitivities. If containing LH in urine, ��-LH monoclonal antibody will be marked with gold and react formation complex, under chromatography effect, ��-LH the monoclonal antibody being fixed in advance on film is caught, in detection zone, form 1-4 bar aubergine band (T1/T2/T3/T4), determine which the bar line of T1, T2, T3, T4 with reaction zone reacts according to the concentration of HCG in urine.
Product of the present invention in use, simultaneously adds urine at the application of sample end of both sides reagent paper, according to the colour developing situation of detection line thus the predicting ovulation time, it is possible to the variable concentrations of detection LH, makes anticipation to whether can normally ovulate, thus understanding female organism hormonal readiness.
The present invention can according to the LH situation detected, it was predicted that ovulation period and determining female physiological periodicity hLH level, according to below with reference to value, test strip designs becoming four detection lines:
LH value term of reference (unit: IU/L)
Man: 1.5-9.3
Female: follicular phase 1.9-12.5
The onset of ovulation 8.7-76.3
Luteal phase 0.5-16.9
Menopause 15.9-54
Trimester of pregnancy 0-1.5
The concentration of blood LH,
Preovulatory phase be 2��15mIU/ml
The onset of ovulation is 30��100mIU/ml,
The ovum later stage is 4��10mIU/ml.
The normal value being typically in the non-onset of ovulation is 2��25mIU/ml.
Design the meaning of four detection lines:
T1 sensitivity 1mIU/ml:T1 line can develop the color, and prompting is not likely in the onset of ovulation.
T2 sensitivity 5mIU/ml:T1 and T2 line can develop the color, and prompting is not likely in the onset of ovulation.
T3 sensitivity 25mIU/ml:T1, T2 and T3 line can develop the color, and prompting is likely in the onset of ovulation.
T4 sensitivity 65mIU/ml:T1, T2, T3 and T4 line can develop the color, and prompting is likely in the onset of ovulation.
Consideration abnormal conditions that if test result only has T1 to develop the color in the physiological period of women always or four lines all develop the color.
Product of the present invention and method are sxemiquantitative test, it is possible to learn LH concentration range value in determining female physiological periodicity urine, thus utilizing the display prediction for ovulating of different content, and whether determining female physiological periodicity LH level is normal. Reagent paper of the present invention utilizes the display of the variable concentrations prediction for ovulating, different interstitialcellstimulating hormone (ICSH)s (hereinafter referred to as the LH) concentration of women difference physiological period can be estimated, in order to estimate the time of ovulation, can decide whether into normal LH level, can normally ovulate according to the height of LH.
At the release peak of menstrual cycle LH and ovary ovulation close relation, LH peak is once appearance, indicate ovary ovulation in 24-36 hour, therefore can monitor serum Lh peak value (onset of ovulation is 30��100mIU/ml) in menstrual cycle, to determine best Time to pregnancy. LH can promote female ovulation and form corpus luteum secretion progestogen, is the condition become pregnant, but if this balance is broken arises that obstacle of becoming pregnant, then, LH has a standard value, and LH is secreted by adenohypophysis basophil. If LH is abnormal when checking, occurring higher or on the low side, will affect estrogen function, eventually resulting in women can not normally ovulate. LH is higher relevant with organism endocrine disorder, occurs that LH is higher and makes ovarian dysfunction, making estrogen and progestogen level secretion unbalance, thus affecting the growth of follicle, causing ovulation failure, it is possible to cause infertility.
The present situation of existing methodology reagent and limitation
1, methodology, product design and the use theory that before 25 years, classics are traditional;
2, the single qualitative subjectivity interpretation denounced by people or empirical conjecture result;
3, within more than 20 year, such as shortage innovation on the one and research and develop;
4, very different producer, the coarse unrest of quality of poor quality is made, OEM and personation brand, and price is barren and the confusion in market, the product seeked death.
New method of the present invention and reagent feature
1, new ideas lead use, the extension of the former dosage form life cycle of methodology and renewal;
2, science achieves from qualitative to semiquantitative quick detection objectively;
3, being still that and test by urine specimen, relatively quantitative than blood more have practicality, universality and economy;
4, classification zoning can relative analysis predicting ovulation phase natural law, even within 12 hours;
5, complementary accessory can also sketch out the curve onset of ovulation.
Accompanying drawing illustrates:
The top view of reagent paper on the left of Fig. 1 present invention;
The top view of reagent paper on the right side of Fig. 2 present invention;
The longitudinal sectional drawing of Fig. 3 reagent paper of the present invention;
Fig. 4 duplex test kit top view of the present invention;
Fig. 5 duplex test kit upward view of the present invention;
Wherein: 1-handheld terminal, 2-nature controlling line C line, 3-detects line T1 line, 4-MAX markings, 5-application of sample end, 6-celluloid medicine 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 non-woven fabrics of 11-, 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-detects line T4 line, 18-lid, 19-box body, 20-well, 21-result observation port, 22-detachable connecting device 1,23-detachable connecting device 2.
Detailed description of the invention:
Thering is provided following embodiment is to be further appreciated by the present invention better; it is not limited to described preferred forms; present disclosure and protection domain are not construed as limiting; anyone under the enlightenment of the present invention or any and present invention feature of the present invention Yu other prior aries being combined and drawing same or like like product, all fall within protection scope of the present invention.
Principle according to gold colloidal detection, the application of sample end of the colloidal gold strip of the present invention is immersed in urine, or the sample fiber layer at application of sample end drips urine, material in urine moves to handheld terminal along test strips from application of sample end under the capillarity of fibrous sheet material, when in urine containing LH, urine is along with the first ��-LH antibody response with colloid gold label of chromatography effect, when creep to reaction zone again with ��-LH antibody response, determine with T1, T2, T3, T4 any bar line of reaction zone to react according to the content of LH in urine.
The preparation of embodiment 1. test kit
The preparation of 1 test strips:
1.1 are coated
1.1.1 prepare: dilute ��-LH monoclonal antibody with pH7.410mMPBS, be configured to 0.5mg/ml (for T1), 0.1mg/ml (for T2, T3), 0.01mg/ml (for T4) respectively; Dilute against murine IgG multi-resistance with pH7.410mMPBS, be configured to 0.2mg/ml being coated for C line. Nitrocellulose filter is cut into 270mm*19mm.
1.1.2 it is coated
1.1.2.1 reaction zone, left side is coated
It is coated with the BIODOT machine of being coated, reaction zone, left side be coated that to be of a size of C line top edge from film top edge be 6.5mm, T1 lower limb is 6.5mm from film lower limb, then tri-lines of C, T3, T1 are divided equally, article three, line centreline spacing is about 2.6mm, CT line width is 0.8 �� 0.1mm, and the package amount of three lines is 0.8 �� l/cm, and being coated speed is 70mm/s. After being coated, dry 6 hours, baking temperature controlled 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
It is coated with the BIODOT machine of being coated, reaction zone, right side be coated that to be of a size of C line top edge from film top edge be 6.5mm, T2 lower limb is 6.5mm from film lower limb, then tri-lines of C, T4, T2 are divided equally, article three, line centreline spacing is about 2.6mm, CT line width is 0.8 �� 0.1mm, and the package amount of three lines is 0.8 �� l/cm, and being coated speed is 70mm/s. After being coated, dry 6 hours, baking temperature controlled at 35-40 DEG C, humidity��35%, adds 4-30 DEG C of desiccant after drying and seals preservation.
1.2 labellings
1.2.1 the preparation of colloid gold particle
1.2.1.1 prepare: glass apparatus used is 2L conical flask, with repeatedly cleaning before, standby after drying. Prepare 2% gold chloride 40ml and 2% trisodium citrate 50ml standby.
1.2.2.2 the 2000ml resistance above ultra-pure water of 18M �� is measured in conical flask, and measure 2% chlorauric acid solution 40ml and also add in conical flask, now solution is yellow, 2% citric acid three sodium solution 50ml is added after being heated to boiling, after boiling, solution becomes aubergine, continuing to boil latter 5 minutes and stop heating, and add upper cover, in room temperature, natural cooling is standby.
1.2.3 colloid gold label ��-LH monoclonal antibody
1.2.3.1 gold colloidal 35ml is first taken, it is initially charged 0.2MK2CO3 and regulates pH, addition is 8 �� l/ml, it is subsequently adding ��-LH monoclonal antibody to be combined with gold colloidal, protein concentration is 20 �� g/ml, react 15 minutes, it is subsequently adding bovine serum albumin 20 �� l/ml to close, after reacting 15 minutes again, carry out 10000rpm, within 30 minutes, it is centrifuged, abandon supernatant, precipitation uses 10mMTris 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% redissolves, obtain colloid gold label ��-LH monoclonal antibody stock solution 3.5ml.
The preparation of 1.3 gold medal mark pads
Measure 10mMTris 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, mix homogeneously with colloid gold label ��-LH monoclonal antibody stock solution 3.5ml, being layered on 30cm*30cm glass fibre, dry 6 hours, baking temperature controlled at 35-40 DEG C, humidity��35%, adds 4-30 DEG C of desiccant after drying and seals preservation.
The preparation of 1.4 sample pad: first prepare the 10mMTris buffer of pH9.0, and it is 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, dry 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, carry out on-line checking with PBS, after qualified, send QC to carry out semi-finished product detection.
1.5 packagings
QC is detected qualified test strip and is assembled into stripe shape, template or pen type, load in aluminium foil bag, fill desiccant, sealing, mounted box, vanning, then send QC to carry out finished product detection.
2. using method:
Stripe shape:
1. testing sample, Test paper or other detection materials etc. are all in 10 DEG C-30 DEG C balances of room temperature, are then torn along otch by aluminium foil bag, take out reagent paper.
2. one end that test paper has arrow is inserted in urine specimen container, takes out and keep flat after 5 seconds, within 5 minutes, observes display result.
3. test paper inserts the urine degree of depth and may not exceed MAX markings.
Template:
1. testing sample, detection test plate (panel) or other detection materials etc. all in 10 DEG C-30 DEG C balances of room temperature, then aluminium foil bag is torn along otch, taking-up test board and dropper.
2. test board is kept flat, vertically add 2-3 with dropper and drip urine sample in each well. Within 5 minutes, in observation port, observe display result.
Pen type:
1. testing sample, test pen or other detection materials etc. are all in 10 DEG C-30 DEG C balances of room temperature, are then torn along otch by aluminium foil bag, take out test pen.
2. the cap for brush is unpluged, arrest test pen handheld terminal and urine is directly drenched test pen collection terminal about 5 seconds. Within 5 minutes, in observation port, observe display result.
3. sentence read result
3.1.1 positive
There is following two situation:
3.1.1.1C line, T1, T2 and T3 line develop the color, prompting: 25mIU/ml��LH concentration < 65mIU/ml, it is possible in the onset of ovulation.
3.1.1.2C line, T1, T2, T3 and T4 line develop the color, prompting: LH concentration >=65mIU/ml, it is possible in the onset of ovulation.
3.1.2 negative
There are following three kinds of situations:
3.1.2.1 only develop the color at nature controlling line position (C), point out LH concentration < 1mIU/ml, it is possible to not in the onset of ovulation.
3.1.1.2C line, T1 line develop the color, prompting: 1mIU/ml��LH concentration < 5mIU/ml, it is possible to not in the onset of ovulation.
3.1.1.3C line, T1 and T2 line develop the color, prompting: 5mIU/ml��LH concentration < 25mIU/ml, it is possible to not in the onset of ovulation.
3.1.3 invalid
Nature controlling line does not develop the color, or only in detection line position (T1-T4) colour developing, it was shown that the failure of an experiment or product failure.
According to the date that individual physiological computation of Period is likely ovulated, test 5-7 days, draw curve according to test concentrations, it is determined that LH peak value.
It is coated and detection case such as table 1:
Table 1 is as follows
Interpretation of result: by result above it can be seen that be coated concentration and minimal detectable concentration is inverse relationship, it is more high to be coated concentration, and the concentration that can be detected by is more low; Capture antibodies priority and minimal detectable concentration are inverse relationship, and first higher with the sensitivity of T line reaction, the concentration that namely can be detected by is relatively low.
The effectiveness of embodiment 2. product of the present invention is able to verify that.
Table 2
Interpretation of result:
By the detection to women of child-bearing age's around ovulation urine, it can be seen that T1-T4 detects the colour developing gradually of line, it is possible to find LH peak value, for the predicting ovulation time.
The contrast test of the product of embodiment 3. product of the present invention and prior art.
Table 3
Interpretation of result:
Learning according to result above, prior art can only distinguish feminine gender and the positive, and product of the present invention can detect the appearance of line according to difference judges LH concentration in women of child-bearing age's urine, it is possible to finds out LH peak value more accurately, calculates ovulation period more accurately.
The compliance test result of embodiment 4. product of the present invention
Table 4 type inspection is reported
Interpretation of result:
Learning according to result above, the physical behavior of product of the present invention, lowest detectable limit, specificity, repeatability, stability, difference between batch are satisfied by current national standard, and have distinguished the LH concentration of women difference physiological period on this basis.

Claims (10)

1. a sxemiquantitative test ovulation colloid gold test paper, it is characterized in that, 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, and from application of sample end to handheld terminal, it is sequentially provided with sample fiber pad, gold mark fiber mat, celluloid medicine film, handheld terminal water-absorption material backing strap, it is stamped protection rete at gold mark fiber mat and handle end water-absorption material backing strap overlying, that be printed with strip on celluloid medicine film and all vertical with reagent paper length direction detection line T1, T2, T3, T4 line and nature controlling line C line, from handheld terminal to application of sample end, reagent paper reaction zone, left side is followed successively by C, T3, T1, reagent paper reaction zone, right side is followed successively by C, T4, T2.
2. sxemiquantitative according to claim 1 test ovulation colloid gold test paper, it is characterised in that be coated with the ��-LH monoclonal antibody of colloid gold label on described gold mark fiber mat; Being coated with respectively on described T1, T2, T3, T4 line and being coated concentration is 0.5-1.0mg/ml, and being coated concentration is 0.1-0.2mg/ml, and being coated concentration is 0.1-0.2mg/ml, is coated the ��-LH antibody that concentration is 0.01-0.02mg/ml; Described nature controlling line C is coated with sheep anti-mouse igg multi-resistance, and it is coated concentration is 0.2-1mg/ml.
3. sxemiquantitative according to claim 1 test ovulation colloid gold test paper, it is characterised in that the unit are package amount ratio of the ��-LH antibody on described T1, T2, T3, T4 line is 50:10:10:1.
4. sxemiquantitative according to claim 1 test ovulation colloid gold test paper, it is characterised in that described reagent paper is that test strip is two-in-one, duplex plate, or duplex pen.
5. a classification rapid semi-quantitative test ovulation gold colloidal duplex test kit, it is characterised in that: include the arbitrary described colloid gold test paper of claim 1-4.
6. sxemiquantitative according to claim 5 test ovulation gold colloidal duplex test kit, it is characterized in that, also include two the box obturators arranged side by side being made up of box body and lid, the locating slot installing colloidal gold strip it is provided with in described box body, described box body is provided with connecting device, by the detachable connection of connecting device between two box bodys.
7. sxemiquantitative according to claim 6 test ovulation gold colloidal duplex test kit, it is characterised in that be equipped with well and result observation port on described lid; When described colloidal gold strip is positioned over the locating slot in box body, it is sample fiber pad corresponding to lid well place; It is celluloid medicine film corresponding to result observation port place.
8. sxemiquantitative according to claim 7 test ovulation gold colloidal duplex test kit, it is characterized in that, described connecting device is two, respectively detachable device 1 and detachable device 2, and is respectively arranged on the edge corresponding to well and result observation port of two box obturators.
9. sxemiquantitative according to claim 8 test ovulation gold colloidal duplex test kit, it is characterised in that two test kits arranged side by side are rectangle.
10. use the method that the arbitrary described sxemiquantitative test ovulation colloid gold test paper of claim 5-9 or duplex test kit carry out the test ovulation of classification rapid semi-quantitative.
CN201610083099.5A 2015-08-21 2016-02-06 Grade rapid semi-quantitative ovulation colloidal gold test paper, kit and detection method Pending CN105628939A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201610083099.5A CN105628939A (en) 2015-08-21 2016-02-06 Grade rapid semi-quantitative ovulation colloidal gold test paper, kit and detection method

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201510518936 2015-08-21
CN2015105189368 2015-08-21
CN201610083099.5A CN105628939A (en) 2015-08-21 2016-02-06 Grade rapid semi-quantitative ovulation colloidal gold test paper, kit and detection method

Publications (1)

Publication Number Publication Date
CN105628939A true CN105628939A (en) 2016-06-01

Family

ID=56044069

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201620118770.0U Active CN205720253U (en) 2015-08-21 2016-02-06 A kind of classification rapid semi-quantitative test ovulation colloid gold test paper and kit
CN201610083099.5A Pending CN105628939A (en) 2015-08-21 2016-02-06 Grade rapid semi-quantitative ovulation colloidal gold test paper, kit and detection method

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CN201620118770.0U Active CN205720253U (en) 2015-08-21 2016-02-06 A kind of classification rapid semi-quantitative test ovulation colloid gold test paper and kit

Country Status (1)

Country Link
CN (2) CN205720253U (en)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106443022A (en) * 2016-07-12 2017-02-22 昆明云大生物技术有限公司 Luteinizing hormone semi-quantitative ovulation determination test paper and making method thereof
CN107192827A (en) * 2017-07-13 2017-09-22 济南齐鲁医学检验有限公司 A kind of anti-Miao Le pipes hormone(AMH)Detection means and method
CN107340398A (en) * 2017-06-06 2017-11-10 北京热景生物技术股份有限公司 Turn the anti-Miao Le Shi pipes hormone quantitative determination reagent and method of luminescence method based on
CN110095614A (en) * 2019-05-27 2019-08-06 武汉上成生物科技有限公司 A kind of method of quick detection genetically modified plants transgenic protein B t-Cry1AbAc
CN110531091A (en) * 2019-09-04 2019-12-03 南通伊仕生物技术股份有限公司 A kind of interstitialcellstimulating hormone (ICSH) Test paper, test card and its preparation method and application
CN111579768A (en) * 2019-06-25 2020-08-25 山西康健恩生物科技有限公司 Anti-mullerian hormone detection kit and preparation method thereof
CN114252631A (en) * 2021-12-20 2022-03-29 金华科生物技术河北有限公司 Preparation method of ovulation interval quantitative detection test paper

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114252632B (en) * 2021-12-20 2023-09-05 金华科生物技术河北有限公司 Preparation method of triple semi-quantitative ovulation reagent

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102565426A (en) * 2011-12-22 2012-07-11 正元盛邦(天津)生物科技有限公司 Method for diagnosing luteinizing hormone (LH) in semi-quantitative mode by employing double-indicatrix immunochromatography
CN102707067A (en) * 2012-05-24 2012-10-03 蓝十字生物药业(北京)有限公司 Test strip for semi-quantitative detection of microalbuminuria
CN202735344U (en) * 2012-07-23 2013-02-13 天津中新科炬生物制药有限公司 Immunochromatographic detection device
CN103439487A (en) * 2013-09-18 2013-12-11 南京农业大学 Simple pesticide three-channel semi-quantitative detection gold-labeled test strip sensor
WO2014196803A1 (en) * 2013-06-04 2014-12-11 Proteometech Inc. A strip for rapid testing having a variable control line and a diagnosis kit using the same
CN204142736U (en) * 2014-09-30 2015-02-04 北京金华科生物技术有限公司 A kind of interstitialcellstimulating hormone (ICSH) Test paper combination unit

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102565426A (en) * 2011-12-22 2012-07-11 正元盛邦(天津)生物科技有限公司 Method for diagnosing luteinizing hormone (LH) in semi-quantitative mode by employing double-indicatrix immunochromatography
CN102707067A (en) * 2012-05-24 2012-10-03 蓝十字生物药业(北京)有限公司 Test strip for semi-quantitative detection of microalbuminuria
CN202735344U (en) * 2012-07-23 2013-02-13 天津中新科炬生物制药有限公司 Immunochromatographic detection device
WO2014196803A1 (en) * 2013-06-04 2014-12-11 Proteometech Inc. A strip for rapid testing having a variable control line and a diagnosis kit using the same
CN103439487A (en) * 2013-09-18 2013-12-11 南京农业大学 Simple pesticide three-channel semi-quantitative detection gold-labeled test strip sensor
CN204142736U (en) * 2014-09-30 2015-02-04 北京金华科生物技术有限公司 A kind of interstitialcellstimulating hormone (ICSH) Test paper combination unit

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
张冰: "阴道B超联合半定量尿促黄体生成素试纸在不孕症监测排卵中的应用", 《临床医药实践》 *

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106443022A (en) * 2016-07-12 2017-02-22 昆明云大生物技术有限公司 Luteinizing hormone semi-quantitative ovulation determination test paper and making method thereof
CN107340398A (en) * 2017-06-06 2017-11-10 北京热景生物技术股份有限公司 Turn the anti-Miao Le Shi pipes hormone quantitative determination reagent and method of luminescence method based on
CN107340398B (en) * 2017-06-06 2019-07-26 北京热景生物技术股份有限公司 Turn the anti-Miao Le Shi pipe hormone quantitative determination reagent and method of luminescence method based on
CN107192827A (en) * 2017-07-13 2017-09-22 济南齐鲁医学检验有限公司 A kind of anti-Miao Le pipes hormone(AMH)Detection means and method
CN110095614A (en) * 2019-05-27 2019-08-06 武汉上成生物科技有限公司 A kind of method of quick detection genetically modified plants transgenic protein B t-Cry1AbAc
CN111579768A (en) * 2019-06-25 2020-08-25 山西康健恩生物科技有限公司 Anti-mullerian hormone detection kit and preparation method thereof
CN110531091A (en) * 2019-09-04 2019-12-03 南通伊仕生物技术股份有限公司 A kind of interstitialcellstimulating hormone (ICSH) Test paper, test card and its preparation method and application
CN110531091B (en) * 2019-09-04 2024-04-05 南通伊仕生物技术股份有限公司 Luteinizing hormone detection test paper, test paper card, and preparation methods and applications thereof
CN114252631A (en) * 2021-12-20 2022-03-29 金华科生物技术河北有限公司 Preparation method of ovulation interval quantitative detection test paper

Also Published As

Publication number Publication date
CN205720253U (en) 2016-11-23

Similar Documents

Publication Publication Date Title
CN105628939A (en) Grade rapid semi-quantitative ovulation colloidal gold test paper, kit and detection method
CN105738635A (en) Early pregnancy colloidal gold test paper with grading fast semiquantitative test function, kit and detection method
AU2018412729B2 (en) HCG cycle test paper strip, kit, preparation method therefor and use thereof
CN105116153B (en) The half-quantitative detection system and its detection method of interstitialcellstimulating hormone (ICSH)
Hyun et al. Reference values for serum levels of insulin-like growth factor-I and insulin-like growth factor binding protein-3 in Korean children and adolescents
CN103777002B (en) Preparation method of multifunctional test paper for early pregnancy
CA3089441C (en) Test paper for semi-quantitative detection of human chorionic gonadotropin, reagent cup, preparation method therefor and use thereof
CN110531091B (en) Luteinizing hormone detection test paper, test paper card, and preparation methods and applications thereof
JP2009512871A5 (en)
CN108139410A (en) Improved Pregnancy Test device and method
CN102890157A (en) Test strip and method for fast quantitative detection of human chorionic gonadotropin (HCG)
CN102207507A (en) Semi-quantitative detecting test paper of cardiac troponin and preparation method thereof
CN104655835A (en) Immune colloidal gold detect card of chlorpromazine, and preparation method thereof
AU2002229970A1 (en) Urine assay for ovarian reserve
CN208420950U (en) A kind of detection device judging early pregnancy time and early pregnancy exception
CN106896231A (en) A kind of HCG Test papers that HCG concentration is detected using two response lines
US20180306815A1 (en) Lateral flow assay ratio test
CN106841605A (en) A kind of thyrotropic hormone Test paper and preparation method thereof
CN208172022U (en) It is a kind of for β-HCG in human urine, the kit of PDG quantitative detection
CN211697830U (en) Luteinizing hormone detection test paper and test paper card
CN202512121U (en) Micro-albuminuria (MAU) colloidal gold quantitative detection kit
CN205941566U (en) A side flow detects and blocks for detecting short thyroid gland hormones
CN105807071A (en) E3G and LH colloidal gold detection kit
Toldy et al. Comparative analytical evaluation of thyroid hormone levels in pregnancy and in women taking oral contraceptives: a study from an iodine deficient area
US9651545B1 (en) Devices and formulations for detecting, screening and monitoring levels of certain constituents in bodily fluids and method

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication

Application publication date: 20160601

RJ01 Rejection of invention patent application after publication