CN103185799A - Uterine neck-vagina rapid detector for early warning of premature delivery - Google Patents
Uterine neck-vagina rapid detector for early warning of premature delivery Download PDFInfo
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- CN103185799A CN103185799A CN2011104481026A CN201110448102A CN103185799A CN 103185799 A CN103185799 A CN 103185799A CN 2011104481026 A CN2011104481026 A CN 2011104481026A CN 201110448102 A CN201110448102 A CN 201110448102A CN 103185799 A CN103185799 A CN 103185799A
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Abstract
The invention provides a uterine neck-vagina rapid detector for early warning of premature delivery. The rapid detector comprises a plastic protective housing, an fFN or FGP immunochromatographic reagent strip arranged in the plastic protective housing and a sample collector, wherein the fFN or FGP immunochromatographic reagent strip comprises a sample injection zone, a reaction zone and a water absorption zone which are successively arranged, the sample collector has a capillary micro-porous substrate structure, comprises a handle part, a plate part and a joint part connecting the handle part with the plate part and is used for collecting uterine neck-vagina secretion and automatically separating and conveying fFN or FGP in the uterine neck-vagina secretion, the plastic protective housing comprises a base plate and a face plate arranged to be cooperated with the base plate, the face plate is provided with an observation window used for interpretation of detection results, the observation window is arranged to be corresponding to the fFN or FGP immunochromatographic reagent strip, the handle part of the sample collector is partially overlapped above the sample injection zone of the fFN or FGP immunochromatographic reagent strip, and the plate part extends out of the plastic protective housing. The uterine neck-vagina rapid detector provided by the invention is used for predicting probability of premature delivery of a pregnant woman in two weeks after detection.
Description
Technical field
The present invention is about a kind of fast detecting instrument, relates in particular to a kind ofly can effectively detect " premature labor early warning " uterine neck-vagina fast detecting instrument that whether contains fFN or FGP in uterine neck-vaginal secretion fluid samples.
Background technology
Premature labor refers to produce in 23~37 pregnant weeks.Premature labor is not only the main cause of enclosing living youngster's case fatality rate, also have influence on the baby and the childhood existence and health and long-dated survival quality.China premature birth rate from 1999 4.5% rise to 2006 8.2%, that is to say 1,500,000 premature's births are arranged every year approximately, its mortality ratio is 12.7%~20.8%, account for 60%~70% of infant deaths, disease incidents such as premature's brain paralysis of survival, dysnoesia are also than higher.In western countries, premature's birth rate is 6%~10%, and premature's mortality ratio also accounts for 2/3rds of perinatal mortality.In addition, factor affecting such as sexual life first becomes younger, a plurality of sexual, sexually transmitted disease infect, frequent miscarriage, low age or lying-in woman advanced in years, cause incidence of preterm birth to increase day by day, bring for family, society and hygiene and health department and have a strong impact on, public health problem becomes international.
Fetal fibronectin (Fetal Fibronectin, fFN) or tire glue protein (Fetus Glue Protein, FGP) be the different glycoprotein that fetal membrane is secreted, play the effect of sticking in decidua and intervillous space, before conceived 16~18 weeks, be present in normal uterine neck-vaginal secretion, after this disappear, until occur conceived latter stage again.But between conceived 23~35 weeks, as the premature labor tendency occurs, namely fine hair discharges fetal fibronectin (fFN) or tire glue protein (FGP) with decidua when lower uterine segment separates, and is shown in advance in following 2 weeks premature labor may take place.Wherein tire glue protein (FGP) is fetal fibronectin (fFN) precursor, compare the latter, possesses better sensitivity, therefore, detect in this pregnant week whether have fetal fibronectin (fFN) or tire glue protein (FGP) in pregnant woman's uterine neck-vaginal secretion, significant to reducing the premature labor probability.
Summary of the invention
The object of the present invention is to provide a kind of " premature labor early warning " uterine neck-vagina fast detecting instrument, can effectively detect in pregnant week of 21-35 and whether have fetal fibronectin (fFN) or tire glue protein (FGP) in pregnant woman's uterine neck-vaginal secretion, be used for the prediction pregnant woman and detecting the probability that premature labor took place or do not take place in 2 weeks in the enforcement back, instruct the woman to produce the doctor and carry out the treatment of preventing miscarriage pointedly, reduce premature labor probability and inborn defect premature's birth rate.
For achieving the above object, the invention provides a kind of " premature labor early warning " uterine neck-vagina fast detecting instrument, comprise: the plastics containment vessel, place fFN in the plastics containment vessel or FGP immunochromatography reagent bar, and sample collecting device, this fFN or FGP immunochromatography reagent bar comprise sample application zone, reaction zone and the suction zones that sets gradually; Sample collecting device has capillary micropore matrix structure, comprises shank, board and connects the joint portion of shank and board, and this sample collecting device is used for collection uterine neck-vaginal secretion, and separates voluntarily and carry fFN or FGP in uterine neck-vaginal secretion; The panel that the plastics containment vessel comprises base plate and is equipped with base plate, panel is provided with the watch window for the interpretation testing result, the corresponding setting of reaction zone of watch window and fFN or FGP immunochromatography reagent bar; The sample application zone top that the shank of sample collecting device is overlapped and is positioned over fFN or FGP immunochromatography reagent bar, board stretches out outside the plastics containment vessel.
Also comprise developping agent, be used with this " premature labor early warning " uterine neck-vagina fast detecting instrument, make an addition on the sample collecting device, with the pH value of regulating uterine neck-vaginal secretion fluid samples and directivity and the flow velocity that guarantees uterine neck-vaginal secretion fluid samples transportation, make fFN or FGP immunochromatography reagent bar obtain enough uterine neck-vaginal secretion fluid samples, and promote fFN in uterine neck-vaginal secretion fluid samples or FGP to separate voluntarily and carry; This developping agent splendid attire is in the transparent rigid plastic bottle of sealing.
Described developping agent is that a kind of pH value is the compound damping fluid of 6.5-8.5, and is formulated in proportion by potassium dihydrogen phosphate, trishydroxymethylaminomethane, sodium hydrogen phosphate, sodium chloride, potassium chloride, Tween-20, thimerosal, lauryl sodium sulfate, ethylenediamine tetraacetic acid, deionized water.
Described plastics containment vessel one end is made as the holding area, and the base plate of plastics containment vessel arranges several air holes in an end of holding area, and its inboard is made as the sample collecting device assembly section away from an end of holding area, and the sample collecting device stationary installation is set on it; The middle part is made as fFN or FGP immunochromatography reagent bar assembly section, and it is provided with for the stationary installation of placing fFN or FGP immunochromatography reagent bar.
Described watch window top is bonded with an eyeglass, is marked with " T " on the eyeglass, " C " indicates line, respectively with detection line and the corresponding setting of nature controlling line of fFN or FGP immunochromatography reagent bar; Eyeglass is made by transparent rigid plastic.
The base plate of described plastics containment vessel and panel inboard arrange coupling arrangement, are used for base plate is fixedlyed connected with panel, and fixed connection method adopts the method for withholding or adopts the ultrasonic plastic welder welding fixedly connected.
Described fFN or FGP immunochromatography reagent strip adoption colloid gold label, electroselenium mark, color latex particle mark or the preparation of fluorescent-substance markers technology, this fFN or FGP immunochromatography reagent bar comprise fFN immunochromatography reagent bar and FGP immunochromatography reagent bar.
Described sample collecting device is made by hydrophilic fibre and hydrophobic material, and this hydrophilic fibre and hydrophobic material form capillary micropore matrix structure; It is 8%~80% that hydrophilic fibre accounts for sample collecting device general assembly (TW) ratio range, and hydrophilic fibre is cotton fiber, filter paper, sponge or cloth; Hydrophobic material is tygon, polypropylene, multi-styrene, high density polyethylene, ultra high molecular polyethylene, Polyvinylidene fluoride, teflon, nylon and polyethersulfone and other plastics, glass or resin; The weight ratio scope of hydrophilic fibre and hydrophobic material is 1: 9 to 4: 1; The profile of sample collecting device is table tennis plate or slurry shape, and its total surface area is not less than 700 square millimeters, and cumulative volume is not less than 650 cubic millimeters, and the surface area of sample collecting device board is not less than sample collecting device total surface area 50%; 20~500 microns of the average pore sizes of capillary micropore matrix, total void volume are no more than 500 cubic millimeters, total void rate and are no more than 80%, and the corresponding density of sample collecting device is 0.21~0.86 gram/cubic centimetre.
Described sample collecting device is made by one or more hydrophobic materials, and this hydrophobic material forms capillary micropore matrix structure; Hydrophobic material is tygon, polypropylene, multi-styrene, high density polyethylene, ultra high molecular polyethylene, Polyvinylidene fluoride, teflon, polyester, nylon, polyethersulfone or other plastics, glass or resin; The sample collecting device profile is bar-shaped or tabular, and its total surface area is not less than 700 square millimeters, and cumulative volume is not less than 650 cubic millimeters, and the surface area of sample collecting device board is not less than 50% of sample collecting device total surface area; 20~500 microns of the average pore sizes of capillary micropore matrix structure, total void volume are no more than 500 cubic millimeters, total void rate and are no more than 80%, and the corresponding density of sample collecting device is 0.49~0.92 gram/cubic centimetre.
Beneficial effect of the present invention: " premature labor early warning " of the present invention uterine neck-vagina fast detecting instrument, can effectively detect in pregnant week of 21-35 and whether have fetal fibronectin or tire glue protein in pregnant woman's uterine neck-vaginal secretion, be used for the prediction pregnant woman and detecting the probability that premature labor took place or do not take place in 2 weeks in the enforcement back, instruct the woman to produce the doctor and carry out the treatment of preventing miscarriage pointedly, reduce premature labor probability and inborn defect premature's birth rate.This detector is not only applicable to medical institutions pregnant woman in 21~35 pregnant weeks is carried out fetal fibronectin or tire glue protein clinical detection, is applicable to that individuality or family detect voluntarily yet, is the standing health detection product of family.
Description of drawings
Below in conjunction with accompanying drawing, by the specific embodiment of the present invention is described in detail, will make technical scheme of the present invention and other beneficial effects apparent.
In the accompanying drawing,
Fig. 1 is the combination synoptic diagram of " premature labor early warning " of the present invention uterine neck-vagina fast detecting instrument;
Fig. 2 is the decomposing schematic representation of Fig. 1;
Fig. 3 is fFN among Fig. 2 or the synoptic diagram of FGP immunochromatography reagent bar;
Fig. 4 is the synoptic diagram of the sample collecting device among Fig. 2;
Fig. 5 is the assembling synoptic diagram of each several part.
Embodiment
Shown in Fig. 1-5, " premature labor early warning " of the present invention uterine neck-vagina fast detecting instrument comprises: plastics containment vessel 2, place fFN in the plastics containment vessel 2 or FGP immunochromatography reagent bar 4, and sample collecting device 6.
Wherein, fFN or FGP immunochromatography reagent bar 4 comprise sample application zone 42, reaction zone 44 and the suction zones 46 that sets gradually, and reaction zone 44 is connected between sample application zone 42 and the suction zones 46, and reaction zone 44 is provided with detection line 45 and nature controlling line 47; Plastics containment vessel 2 comprises base plate 22; the panel 24 that is equipped with base plate 22; base plate 22 is fixedlyed connected by its inboard coupling arrangement 29 that arranges with panel 24, and fixing means can adopt the method for withholding, and also can adopt the ultrasonic plastic welder welding fixedly connected.Plastics containment vessel 2 one ends are made as holding area 23, base plate 22 arranges several air holes 21 in holding area 23, base plate 22 inboards are made as sample collecting device assembly section 25 away from an end of holding area 23, and sample collecting device 6 stationary installations 252 are set on it, are used for settling sample collecting device 6; The middle part is made as fFN or FGP immunochromatography reagent bar 4 assembly sections 26, fFN or FGP immunochromatography reagent bar 4 stationary installations 262 is set, in order to place fFN or FGP immunochromatography reagent bar 4 on it respectively.Panel 24 is provided with the watch window 27 for the interpretation testing result, watch window 27 and reaction zone 25 corresponding settings; Above watch window 27, be bonded with an eyeglass 28, be marked with " T " on the eyeglass 28, " C " indicates line, respectively with detection line 45 and the nature controlling line 47 corresponding settings of fFN or FGP immunochromatography reagent bar 4; Described eyeglass 28 is made by transparent rigid plastic.
Described sample collecting device 6 has capillary micropore matrix structure, and this sample collecting device 6 comprises shank 62, board 64 and connects the joint portion 66 of shank 62 and board 64; The shank 62 of sample collecting device 6 is overlapped and is positioned over sample application zone 42 tops of fFN or FGP immunochromatography reagent bar 4, and board 64 stretches out outside the plastics containment vessel 2.Uterine neck-vaginal secretion fluid samples and in fFN or the FGP sample application zone 42 that absorbed, separate, be delivered to fFN or FGP immunochromatography reagent bar 4 by sample collecting device 6, utilize chromatographic theory to be delivered to reaction zone 44 again, and a series of immunological responses take place at reaction zone 44, demonstrate the directly result of interpretation (as red stripes) of the watch window 27 of naked eyes by panel.
Described fFN or FGP immunochromatography reagent bar 4 adopt colloid gold label, electroselenium mark, color latex particle mark or the preparation of fluorescent-substance markers technology, so are not limited thereto.This fFN or FGP immunochromatography reagent bar 4 comprise fFN immunochromatography reagent bar and FGP immunochromatography reagent bar.
Described sample collecting device 6 is made by hydrophilic fibre and hydrophobic material, and this hydrophilic fibre and hydrophobic material form capillary micropore matrix structure, have the effect that separates voluntarily and carry the target detection thing in the liquid sample.It is 8%~80% that hydrophilic fibre accounts for sample collecting device general assembly (TW) ratio range, and hydrophilic fibre can be cotton fiber, filter paper, sponge, cloth; Hydrophobic material can be tygon, polypropylene, multi-styrene, high density polyethylene, ultra high molecular polyethylene, Polyvinylidene fluoride, teflon, polyester, nylon, polyethersulfone or other plastics, also can be glass, resin; The weight ratio scope of hydrophilic fibre and hydrophobic material is 1: 9 to 4: 1.These sample collecting device 6 profiles can be soldier's pang plate or oar shape, its parameter: total surface area is not less than 700 square millimeters, cumulative volume and is not less than 650 cubic millimeters, the surface area of sample collecting device board and is not less than 50% of sample collecting device total surface area; 20~500 microns of the average pore sizes of capillary micropore matrix structure, total void volume are no more than 500 cubic millimeters, total void rate and are no more than 80%, and the corresponding density of this sample collecting device is 0.21~0.86 gram/cubic centimetre.In this sample collecting device, preferred parameter be hydrophilic fibre to account for sample collecting device general assembly (TW) ratio range be 10%~58%, hydrophilic fibre is preferably cotton fiber, hydrophobic material is preferably polyester; Cotton fiber is preferably 1: 9 to 3: 2 with weight polyester than scope; The average pore size of capillary micropore matrix structure is preferably 20~200 microns, and the total void rate is preferably 40~45%, and the density of sample collecting device 6 is preferably 0.48~0.52 gram/cubic centimetre.
As another kind of selectivity embodiment, described sample collecting device 6 is made by hydrophobic material, can be made by one or more hydrophobic materials, this hydrophobic material forms capillary micropore matrix structure, has the effect that separates voluntarily and carry the target detection thing in the liquid sample.Hydrophobic material can be tygon, polypropylene, multi-styrene, high density polyethylene, ultra high molecular polyethylene, Polyvinylidene fluoride, teflon, polyester, nylon, polyethersulfone or other plastics, glass, resin etc.; This sample collecting device profile can be bar-shaped or tabular, its parameter: total surface area is not less than 700 square millimeters, cumulative volume and is not less than 650 cubic millimeters, the surface area of sample collecting device board and is not less than 50% of sample collecting device total surface area; 20~500 microns of the average pore sizes of capillary micropore matrix structure, total void volume are no more than 500 cubic millimeters, total void rate and are no more than 80%, and the corresponding density of sample collecting device is 0.49~0.92 gram/cubic centimetre.In this sample collecting device, preferred parameter is the hydrophobic material preferred polyester; The average pore size of capillary micropore matrix structure is preferably 20~200 microns, total void rate and is preferably 35~55%, and the density of sample collecting device is preferably 0.58~0.72 gram/cubic centimetre.This hydrophobic material also can be through making sample collecting device after the hydrophilic treatment again, or the sample collecting device that will be made by hydrophobic material is through hydrophilic treatment, with the ability that improves the sample collecting device collection and carry uterine neck-vaginal secretion fluid samples.
Above-mentioned sample collecting device 6 is controlled below 500 cubic millimeters by the amount of its capillary micropore matrix structure saturated absorption liquid sample, time with immersion way saturated absorption liquid sample was controlled in 5 minutes, in preferred 1 minute, behind the sample collecting device saturated absorption liquid, its inner structure requires not take place significant change, especially after super-dry was handled, tangible change did not take place in its rate of water absorption.Under the prerequisite that does not have extraneous mechanical compress or filtration, the liquid sample that is adsorbed in the capillary micropore matrix structure runs to the time control at shank 62 edges in 10 minutes, preferably in 2 minutes from board 64 edges.
Also comprise developping agent (not shown), be used with this " premature labor early warning " uterine neck-vagina fast detecting instrument that can make an addition on the sample collecting device 6, this developping agent is placed in the transparent rigid plastic bottle of sealing.Described developping agent is different from damping fluids such as laboratory PBS commonly used or Tris, it is the composite buffer system of a kind of pH value between 6.5~8.5, it act as the pH value of adjusting uterine neck-vaginal secretion fluid samples, make it to meet the potential of hydrogen needs of fFN or FGP immunochromatography reagent bar 4 detection fFN or FGP, guarantee directivity and flow velocity that uterine neck-vaginal secretion fluid samples is carried, filling up because of uterine neck-vaginal secretion fluid samples carries the back in space that sample collecting device 6 stays to fFN or FGP immunochromatography reagent bar 4 directions, the fFN or the FGP that can also wash-out adhere to sample collecting device 6 capillary micropore matrix structure surfaces, and it is flowed to fFN or FGP immunochromatography reagent bar 4 directions with developping agent, thereby make fFN or FGP immunochromatography reagent bar 4 obtain enough uterine neck-vaginal secretion fluid samples, and the fFN in promotion uterine neck-vaginal secretion fluid samples or FGP separate voluntarily and carry, improve fFN or the FGP front end concentration in solvent (comprising uterine neck-vaginal secretion and developping agent) effectively, guarantee to detect the needs of fFN or FGP.The component of every 1L developping agent is: potassium dihydrogen phosphate 0.2g, trishydroxymethylaminomethane 6.06g, sodium hydrogen phosphate 1.15g, sodium chloride 8.0g, potassium chloride 0.2g, Tween-20 0.5ml, thimerosal 0.1g, lauryl sodium sulfate 1.25g, ethylenediamine tetraacetic acid 1ml, add deionized water dissolving to 1L solution, rigid plastic bottle splendid attire with transparent sealing, every bottle of 0.8~3.0ml, room temperature preservation.
In the present embodiment, the base plate 22 of plastics containment vessel 2 is connecting line with the panel 24 inboard coupling arrangements 29 that arrange, and adopts the ultrasonic plastic welder welding fixedly connected.During installation; in the ultrasonic plastic welder mould, lay the base plate 22 of plastics containment vessel 2; assemble fFN or FGP immunochromatography reagent bar 4 and sample collecting device 6 successively in base plate 22 inboards; make the shank 62 of sample collecting device 6 and the sample application zone 42 overlapping 1-3 millimeters of fFN or FGP immunochromatography reagent bar 4; the panel 24 of plastics containment vessel 2 is installed then; eyeglass 28 is installed in testing result watch window 27 positions at panel 24 middle parts; with the base plate 22 and panel 24 of ultrasonic plastic welder with plastics containment vessel 2; and sealing wire fusion and the fixing welding of the panel 24 of plastics containment vessel 2 and eyeglass 28, thereby form " premature labor early warning " uterine neck-vagina fast detecting instrument of an integral body.
During detection, utilize the board 64 of sample collecting device 6 to absorb uterine neck-vaginal secretion fluid samples, and be transported to the sample application zone 42 of fFN or FGP immunochromatography reagent bar 4 by the shank 62 of sample collecting device 6, immunochromatography principle by this reagent strip makes uterine neck-vaginal secretion fluid samples fFN or FGP be transported to the reaction zone 44 of this reagent strip, fFN in uterine neck-vaginal secretion fluid samples or FGP are carried out fast detecting, a series of biology, chemical reaction take place in this reaction zone 44, and demonstrate colored band at reaction zone, can read testing result accordingly.
In sum, " premature labor early warning " of the present invention uterine neck-vagina fast detecting instrument is in conjunction with sample collecting device and fFN or FGP immunochromatography reagent bar, can effectively detect in pregnant week of 21-35 and whether have fetal fibronectin or tire glue protein in pregnant woman's uterine neck-vaginal secretion, be used for the prediction pregnant woman and detecting the probability that premature labor took place or do not take place in 2 weeks in the enforcement back, instruct the woman to produce the doctor and carry out the treatment of preventing miscarriage pointedly, reduce premature labor probability and inborn defect premature's birth rate.This detector is not only applicable to medical institutions pregnant woman in 21~35 pregnant weeks is carried out fetal fibronectin or tire glue protein clinical detection, is applicable to that individuality or family detect voluntarily yet, is the standing health detection product of family.
The above for the person of ordinary skill of the art, can make other various corresponding changes and distortion according to technical scheme of the present invention and technical conceive, and all these changes and distortion all should belong to the scope that the present invention protects.
Claims (9)
1. one kind " premature labor early warning " uterine neck-vagina fast detecting instrument, it is characterized in that, comprise: the plastics containment vessel, place fFN in the plastics containment vessel or FGP immunochromatography reagent bar, and sample collecting device, this fFN or FGP immunochromatography reagent bar comprise sample application zone, reaction zone and the suction zones that sets gradually; Sample collecting device has capillary micropore matrix structure, comprises shank, board and connects the joint portion of shank and board, and this sample collecting device is used for collection uterine neck-vaginal secretion, and separates voluntarily and carry fFN or FGP in uterine neck-vaginal secretion; The panel that the plastics containment vessel comprises base plate and is equipped with base plate, panel is provided with the watch window for the interpretation testing result, the corresponding setting of reaction zone of watch window and fFN or FGP immunochromatography reagent bar; The sample application zone top that the shank of sample collecting device is overlapped and is positioned over fFN or FGP immunochromatography reagent bar, board stretches out outside the plastics containment vessel.
2. " premature labor early warning " as claimed in claim 1 uterine neck-vagina fast detecting instrument, it is characterized in that, also comprise developping agent, be used with this " premature labor early warning " uterine neck-vagina fast detecting instrument, make an addition on the sample collecting device, with the pH value of regulating uterine neck-vaginal secretion fluid samples and directivity and the flow velocity that guarantees uterine neck-vaginal secretion fluid samples transportation, make fFN or FGP immunochromatography reagent bar obtain enough uterine neck-vaginal secretion fluid samples, and promote fFN in uterine neck-vaginal secretion or FGP to separate voluntarily and carry; This developping agent splendid attire is in the transparent rigid plastic bottle of sealing.
3. " premature labor early warning " as claimed in claim 2 uterine neck-vagina fast detecting instrument, it is characterized in that, described developping agent is that a kind of pH value is the compound damping fluid of 6.5-8.5, and is formulated in proportion by potassium dihydrogen phosphate, trishydroxymethylaminomethane, sodium hydrogen phosphate, sodium chloride, potassium chloride, Tween-20, thimerosal, lauryl sodium sulfate, ethylenediamine tetraacetic acid, deionized water.
4. " premature labor early warning " as claimed in claim 1 uterine neck-vagina fast detecting instrument, it is characterized in that, described plastics containment vessel one end is made as the holding area, the base plate of plastics containment vessel arranges several air holes in an end of holding area, its inboard is made as the sample collecting device assembly section away from an end of holding area, and the sample collecting device stationary installation is set on it; The middle part is made as fFN or FGP immunochromatography reagent bar assembly section, and it is provided with for the stationary installation of placing fFN or FGP immunochromatography reagent bar.
5. " premature labor early warning " as claimed in claim 1 uterine neck-vagina fast detecting instrument, it is characterized in that, described watch window top is bonded with an eyeglass, is marked with " T " on the eyeglass, " C " indicates line, respectively with detection line and the corresponding setting of nature controlling line of fFN or FGP immunochromatography reagent bar; Eyeglass is made by transparent rigid plastic.
6. " premature labor early warning " as claimed in claim 1 uterine neck-vagina fast detecting instrument; it is characterized in that; the base plate of described plastics containment vessel and panel inboard arrange coupling arrangement; be used for base plate is fixedlyed connected with panel, fixed connection method adopts the method for withholding or adopts the ultrasonic plastic welder welding fixedly connected.
7. " premature labor early warning " as claimed in claim 1 uterine neck-vagina fast detecting instrument, it is characterized in that, described fFN or FGP immunochromatography reagent strip adoption colloid gold label, electroselenium mark, color latex particle mark or the preparation of fluorescent-substance markers technology, this fFN or FGP immunochromatography reagent bar comprise fFN immunochromatography reagent bar and FGP immunochromatography reagent bar.
8. " premature labor early warning " as claimed in claim 1 uterine neck-vagina fast detecting instrument is characterized in that described sample collecting device is made by hydrophilic fibre and hydrophobic material, and this hydrophilic fibre and hydrophobic material form capillary micropore matrix structure; It is 8%~80% that hydrophilic fibre accounts for sample collecting device general assembly (TW) ratio range, and hydrophilic fibre is cotton fiber, filter paper, sponge or cloth; Hydrophobic material is tygon, polypropylene, multi-styrene, high density polyethylene, ultra high molecular polyethylene, Polyvinylidene fluoride, teflon, nylon and polyethersulfone and other plastics, glass or resin; The weight ratio scope of hydrophilic fibre and hydrophobic material is 1: 9 to 4: 1; The profile of sample collecting device is table tennis plate or slurry shape, and its total surface area is not less than 700 square millimeters, and cumulative volume is not less than 650 cubic millimeters, and the surface area of sample collecting device board is not less than sample collecting device total surface area 50%; 20~500 microns of the average pore sizes of capillary micropore matrix, total void volume are no more than 500 cubic millimeters, total void rate and are no more than 80%, and the corresponding density of sample collecting device is 0.21~0.86 gram/cubic centimetre.
9. " premature labor early warning " as claimed in claim 1 uterine neck-vagina fast detecting instrument is characterized in that described sample collecting device is made by one or more hydrophobic materials, and this hydrophobic material forms capillary micropore matrix structure; Hydrophobic material is tygon, polypropylene, multi-styrene, high density polyethylene, ultra high molecular polyethylene, Polyvinylidene fluoride, teflon, polyester, nylon, polyethersulfone or other plastics, glass or resin; The sample collecting device profile is bar-shaped or tabular, and its total surface area is not less than 700 square millimeters, and cumulative volume is not less than 650 cubic millimeters, and the surface area of sample collecting device board is not less than 50% of sample collecting device total surface area; 20~500 microns of the average pore sizes of capillary micropore matrix structure, total void volume are no more than 500 cubic millimeters, total void rate and are no more than 80%, and the corresponding density of sample collecting device is 0.49~0.92 gram/cubic centimetre.
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