CN105403709A - Whole-blood one-step alpha fetoprotein collaurum detection kit and detection method thereof - Google Patents

Whole-blood one-step alpha fetoprotein collaurum detection kit and detection method thereof Download PDF

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Publication number
CN105403709A
CN105403709A CN201510708316.0A CN201510708316A CN105403709A CN 105403709 A CN105403709 A CN 105403709A CN 201510708316 A CN201510708316 A CN 201510708316A CN 105403709 A CN105403709 A CN 105403709A
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CN
China
Prior art keywords
line
collaurum
fetoprotein
alpha
blood
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
CN201510708316.0A
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Chinese (zh)
Inventor
金杰
郜恒骏
张小燕
吴舒歌
张淼
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SHANGHAI OUTDO BIOTECH CO Ltd
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SHANGHAI OUTDO BIOTECH 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 SHANGHAI OUTDO BIOTECH CO Ltd filed Critical SHANGHAI OUTDO BIOTECH CO Ltd
Priority to CN201510708316.0A priority Critical patent/CN105403709A/en
Priority to PCT/CN2015/099833 priority patent/WO2017071092A1/en
Publication of CN105403709A publication Critical patent/CN105403709A/en
Pending legal-status Critical Current

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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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701—Details
    • G01N2333/471—Pregnancy proteins, e.g. placenta proteins, alpha-feto-protein, pregnancy specific beta glycoprotein

Abstract

The invention provides a whole-blood one-step alpha fetoprotein collaurum detection kit which comprises a box base, a box cover and a reagent strip, wherein the reagent strip is fixed between the box base and the box cover; an observation port is formed on the box cover; a sampling hole is formed on the side between the box cover and the box base; the sampling hole can be directly applied to the fingertip blood-sampling or the sampling detection; the reagent strip is divided into an upper layer and a bottom layer; a plastic film is arranged on the bottom layer; a glass fiber film, a first nitrocellulose film, a plastic protecting film and a second nitrocellulose film are successively arrayed end-to-end on the upper layer; a rabbit IgG collaurum is arranged on the glass fiber film; the first nitrocellulose film serves as a bridging film with alpha fetoprotein collaurum; an anti-alpha fetoprotein collaurum monoclonal antibody and a goat-anti-rabbit IgG are arranged on the second nitrocellulose film. Compared with the prior art, the whole-blood one-step alpha fetoprotein collaurum detection kit has the beneficial effects that the alpha fetoprotein (AFP) content and concentration in a human body can be quickly and accurately detected and the diseases can be timely diagnosed.

Description

A kind of whole blood single stage method alpha-fetoprotein gold-immunochromatographyreagent reagent for assay box and detection method thereof
Technical field
The present invention relates to invention immune colloid gold detection kit, particularly relate to whole blood single stage method alpha-fetoprotein gold-immunochromatographyreagent reagent for assay box and detection method.
Background technology
Alpha-fetoprotein (AFP) is a kind of single chain glycoprotein, and be a kind of Embryo associated protein, molecular weight is about 69kDa, is made up of the carbohydrates of 96% protein and 4%.AFP mainly synthesizes in fetus liver, accounts for 1/3 of plasma proteins total amount at fetus 13 weeks AFP.Reached top at pregnant 30 weeks, decline gradually later, during birth, Plasma is about 1% of peak period, about 40mg/L.After fetal birth about two weeks, alpha-fetoprotein disappears from blood, therefore in normal human serum the content of alpha-fetoprotein still less than 20ng/mL.
As everyone knows, alpha-fetoprotein (AFP) has the value of diagnosing primary liver cancer.But a large amount of clinical manifestation proves, part patient with liver cirrhosis there will be AFP rise phenomenon, but does not all occur cancer sign for many years.And in oxyhepatitis, chronic active hepatitis crowd, the AFP level of some patients also occurs obviously increasing phenomenon.It may be because virus copies propagation in liver cell that hepatopath AFP increases, make the process that liver cell is in damage, repairs and regenerate, and AFP gene is activated in the liver cell of hyperplasia, thus AFP can raise, but concentration is general not too high, how lower than 400ng/mL, and along with the improvement of hepatitis, AFP also declines thereupon, and then recovers normal gradually.At the pregnancy duration of pregnant woman, the change of AFP is also by as an important indicator, under the situation occurring AFP abnormal expression, there will be spina bifida, anencephalus, neural-tube defect (deformity), 21-patau syndrome, even the phenomenon such as dead occurs in fetus uterine cavity.In the patient of teratoma, embryoma, AFP expression also can obviously rise.
Summary of the invention
The object of the invention is to be difficult to solve human body alpha-fetoprotein (AFP) content in prior art the defect determined, providing a kind of whole blood single stage method alpha-fetoprotein gold-immunochromatographyreagent reagent for assay box and detection method thereof to solve the problems referred to above.
To achieve these goals, technical scheme of the present invention is as follows:
A kind of whole blood single stage method alpha-fetoprotein gold-immunochromatographyreagent reagent for assay box, comprise cassette holder, lid and reagent strip, described reagent strip is fixed between described cassette holder and described lid, described lid is provided with viewport, avris between lid and cassette holder is provided with well, can be used for direct finger tip and gets blood or application of sample detection.Described reagent strip is divided into upper strata and bottom, and bottom is plastic sheeting, and upper strata successively headtotail is arranged with glass fibre membrane, nitrocellulose filter one, plastic protective film for plastics, nitrocellulose filter two.Described glass fibre membrane is provided with rabbit igg collaurum, and described nitrocellulose filter one is for being provided with the bridge joint film of AFP collaurum, and described nitrocellulose filter two is provided with AFP monoclonal antibody, goat anti-rabbit igg.
Preferably, use procedure is A, the reagent card of original packing and the blood sample that need detect is equilibrated to room temperature; Take out reagent card from original packing aluminium foil bag before B, use, horizontal positioned, adds sample from adding mouth, and to sample arrival stops ledger line, general application of sample amount is between 35 ~ 40 μ L; Observations in 15 minutes to 30 minutes after C, application of sample;
There is a red stripes as each on the detection line and nature controlling line position of reagent card, illustrate that alpha-fetoprotein colloid is abnormal; As a red stripes appears in the nature controlling line position of only reagent card, illustrate that alpha-fetoprotein colloid is normal; As all there is not red stripes on the detection line and nature controlling line position of reagent card, or only having that a red stripes appears in detection line and band does not appear in nature controlling line, illustrating that testing result is invalid, need resurvey.
Preferably, described detection line and nature controlling line all on nitrocellulose membrane two, between distance be 5.3mm, and the line of alpha-fetoprotein colloid detection line is near application of sample end.
Preferably, described alpha-fetoprotein collaurum line is on nitrocellulose membrane one, and distance alpha-fetoprotein colloid detection line distance is 5mm.Described rabbit igg collaurum line is on glass fibre membrane, and distance alpha-fetoprotein colloid gold thread is 3.5mm.Preferably, the observation panel on described lid runs through lid, is square aperture, and has diaphragm to be affixed on top.
Preferably, the blood capillary pipe seam well between lid and cassette holder both can get blood for finger tip, also may be used for pipettor application of sample.Lid and cassette holder are provided with corresponding engaging or the parts that are fastened and connected, and fasten through described link or fasten.
Compared with prior art, beneficial effect of the present invention is: can human body alpha-fetoprotein (AFP) content and concentration fast and accurately, makes diagnosis in time to disease.
Accompanying drawing explanation
Fig. 1 is the structural front view detecting reagent card
Fig. 2 is the reagent strip structural front view included in reagent card
Fig. 3 is loading methods schematic diagram
Fig. 4 is that result judges schematic diagram
Wherein: 1, outer box, 2, test strips, 3, glass fibre membrane, 4, nitrocellulose filter one, 5, detection line, 6, nature controlling line, 7, nitrocellulose filter two, 8, adding mouth, 9, stop ledger line, 10, result display window.
Embodiment
For making to have a better understanding and awareness architectural feature of the present invention and effect of reaching, coordinating detailed description in order to preferred embodiment and accompanying drawing, being described as follows:
Detect human serum or whole blood sample, method of operating following (see accompanying drawing 3):
(1) reagent card of original packing and the blood sample that need detect are equilibrated to room temperature.
(2) reagent card is taken out from original packing aluminium foil bag before using, horizontal positioned.Added from adding mouth by sample, to sample arrival stops ledger line, general application of sample amount is between 35 ~ 40 μ L.
(3) observations in 15 minutes to 30 minutes after application of sample.
Result explains (see accompanying drawing 4):
There is a red stripes as each on the detection line (T line) and nature controlling line (C line) position of reagent card, AFP abnormal (concentration is not less than 20ng/mL) is described; As a red stripes appears in nature controlling line (C line) position of only reagent card, illustrates that AFP normally (concentration is lower than 20ng/mL); As all there is not red stripes on the detection line (T line) and nature controlling line (C line) position of reagent card, or only have that a red stripes appears in detection line (T line) and band does not appear in nature controlling line (C line), explanation testing result is invalid, need resurvey.
More than show and describe ultimate principle of the present invention, principal character and advantage of the present invention.The technician of the industry should understand; the present invention is not restricted to the described embodiments; the just principle of the present invention described in above-described embodiment and instructions; the present invention also has various changes and modifications without departing from the spirit and scope of the present invention, and these changes and improvements all fall in claimed scope of the present invention.The protection domain of application claims is defined by appending claims and equivalent thereof.

Claims (6)

1. a whole blood single stage method alpha-fetoprotein gold-immunochromatographyreagent reagent for assay box, it is characterized in that: comprise cassette holder, lid and reagent strip, described reagent strip is fixed between described cassette holder and described lid, described lid is provided with viewport, avris between lid and cassette holder is provided with well, can be used for direct finger tip and gets blood or application of sample detection.Described reagent strip is divided into upper strata and bottom, and bottom is plastic sheeting, and upper strata successively headtotail is arranged with glass fibre membrane, nitrocellulose filter one, plastic protective film for plastics, nitrocellulose filter two.Described glass fibre membrane is provided with rabbit igg collaurum, and described nitrocellulose filter one is for being provided with the bridge joint film of AFP collaurum, and described nitrocellulose filter two is provided with AFP monoclonal antibody, goat anti-rabbit igg.
2. the detection method of kit according to claim 1, is characterized in that: described detection method comprises the following steps:
A, the reagent card of original packing and the blood sample that need detect are equilibrated to room temperature;
Take out reagent card from original packing aluminium foil bag before B, use, horizontal positioned, adds sample from adding mouth, and to sample arrival stops ledger line, general application of sample amount is between 35 ~ 40 μ L;
Observations in 15 minutes to 30 minutes after C, application of sample;
There is a red stripes as each on the detection line and nature controlling line position of reagent card, illustrate that alpha-fetoprotein colloid is abnormal; As a red stripes appears in the nature controlling line position of only reagent card, illustrate that alpha-fetoprotein colloid is normal; As all there is not red stripes on the detection line and nature controlling line position of reagent card, or only having that a red stripes appears in detection line and band does not appear in nature controlling line, illustrating that testing result is invalid, need resurvey.
3. the detection method of kit according to claim 2, is characterized in that: described detection line and nature controlling line all on nitrocellulose membrane two, between distance be 5.3mm, and the line of alpha-fetoprotein colloid detection line is near application of sample end.
4. the detection method of kit according to claim 2, is characterized in that: described alpha-fetoprotein collaurum line is on nitrocellulose membrane one, and distance alpha-fetoprotein colloid detection line distance is 5mm.Described rabbit igg collaurum line is on glass fibre membrane, and distance alpha-fetoprotein colloid gold thread is 3.5mm.
5. the detection method of kit according to claim 1, is characterized in that: the observation panel on described lid runs through lid, is square aperture, and has diaphragm to be affixed on top.
6. the detection method of kit according to claim 1, is characterized in that: the blood capillary pipe seam well between lid and cassette holder both can get blood for finger tip, also may be used for pipettor application of sample.Lid and cassette holder are provided with corresponding engaging or the parts that are fastened and connected, and fasten through described link or fasten.
CN201510708316.0A 2015-10-27 2015-10-27 Whole-blood one-step alpha fetoprotein collaurum detection kit and detection method thereof Pending CN105403709A (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201510708316.0A CN105403709A (en) 2015-10-27 2015-10-27 Whole-blood one-step alpha fetoprotein collaurum detection kit and detection method thereof
PCT/CN2015/099833 WO2017071092A1 (en) 2015-10-27 2015-12-30 Whole blood one-step alpha-fetoprotein colloidal gold detection kit and detection method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201510708316.0A CN105403709A (en) 2015-10-27 2015-10-27 Whole-blood one-step alpha fetoprotein collaurum detection kit and detection method thereof

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CN111650384A (en) * 2020-06-22 2020-09-11 江苏奥雅生物科技有限公司 Soluble growth stimulation expression gene 2 protein determination kit
CN114560936B (en) * 2022-04-08 2022-06-28 北京科跃中楷生物技术有限公司 Fluorescent microsphere labeling method and detection kit

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Application publication date: 20160316