IPC분류정보
국가/구분 |
United States(US) Patent
등록
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국제특허분류(IPC7판) |
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출원번호 |
US-0243293
(2011-09-23)
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등록번호 |
US-8287817
(2012-10-16)
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발명자
/ 주소 |
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출원인 / 주소 |
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대리인 / 주소 |
Sundby, Esq., Suzannah K.
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인용정보 |
피인용 횟수 :
1 인용 특허 :
25 |
초록
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A rapid diagnostic device, assay and multifunctional buffer reagent are provided for the detection of a target analyte in a fluid test sample. The 2-step assay utilizes a dual component flow-through device comprising a test unit and a dried indicator reagent delivery unit for receiving the fluid sam
A rapid diagnostic device, assay and multifunctional buffer reagent are provided for the detection of a target analyte in a fluid test sample. The 2-step assay utilizes a dual component flow-through device comprising a test unit and a dried indicator reagent delivery unit for receiving the fluid sample and multifunctional buffer, respectively. The test unit comprises a reaction zone containing immobilized capture reagent that can bind to the target analyte, an absorbent zone supporting the reaction zone, and optionally, a blood separation zone in lateral fluid communication with the reaction zone. The delivery unit comprises a label zone permeated with a dried indicator reagent which can be placed in transient fluid communication with the reaction zone of the test unit during the assay procedure. The rapid diagnostic assay system reduces the number of assay reagents, method steps and time required for performance compared to other conventional assays.
대표청구항
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1. A downward or vertical flow through test device for determining the presence or absence of a target analyte in a fluid test sample, the test device comprising: a test unit comprising: a reaction zone containing an immobilized capture reagent that binds a target analyte in the fluid test sample to
1. A downward or vertical flow through test device for determining the presence or absence of a target analyte in a fluid test sample, the test device comprising: a test unit comprising: a reaction zone containing an immobilized capture reagent that binds a target analyte in the fluid test sample to form a two-membered complex of a specific binding interaction, andan absorbent zone in vertical communication with the reaction zone, the absorbent zone comprising an absorbent material positioned underneath the reaction zone for facilitating the downward or vertical flow of the fluid test sample through the reaction zone and into the absorbent zone; anda post-filter cap which is operably affixable to a test unit so as to be in vertical communication with a reaction zone after a fluid test sample has been applied to the reaction zone, the post-filter cap comprising: an outer sleeve comprising an outwardly extending flange, sidewalls depending from the outwardly extending flange and terminating at an open-ended base, the base further comprising a collar projecting inwardly from the sidewalls;an inner sleeve dimensioned to frictionally engage the inner surface of the outer sleeve, the inner sleeve comprising an outwardly extending flange, sidewalls depending from the outwardly extending flange and terminating at an open-ended base; anda removable post-filter unit supported by the collar of the outer sleeve and held in place by the open-ended base of the inner sleeve, the post-filter unit comprising a porous material having a direct label conjugated general marker protein complex embedded thereon, whereby application of a buffer to the porous material mobilizes the direct label conjugated general marker protein complex and liberates the complex from the porous material to flow-through the base of the outer sleeve. 2. The device according to claim 1, wherein the direct label conjugated general marker protein is capable of binding to the target analyte at a site which does not interfere with the specific binding interaction between the target analyte and the capture reagent. 3. The device according to claim 1, wherein the direct label conjugated general marker protein complex binds to the capture reagent at a site which interferes with the specific binding interaction between the target analyte and the capture reagent. 4. The device according to claim 1, wherein the porous material has a pore size that allows the direct label conjugated general marker protein complex to be effectively resolubilized by the buffer and transferred to the reaction zone by laminar fluid flow. 5. The device according to claim 4, wherein the porous material is a glass fiber material. 6. The device according to claim 3, wherein the direct label is colloidal gold. 7. The device according to claim 1, wherein the general marker protein is selected from the group consisting of protein A, protein G and anti-IgG. 8. The device according to claim 1, wherein the general marker protein is an antibody that binds to the target analyte in the two-membered complex. 9. The device according to claim 1, wherein the general marker protein is an antigen that binds to the target analyte in the two-membered complex. 10. The device according to claim 1, wherein the specific binding interaction is an antibody-antigen interaction. 11. The device according to claim 1, wherein the target analyte is an antigen and the general protein marker is a monoclonal antibody or an affinity purified polyclonal antibody for the antigen. 12. The device according to claim 1, wherein the reaction zone is comprised of a material which has a pore size permitting separation and filtration of unbound components from the fluid test sample and a thickness which permits an adequate amount of capture reagent to be immobilized thereto. 13. The device according to claim 1, further comprising a handle attached to the outwardly extending flange of the outer sleeve for facilitating the attachment and removal of the post-filter cap to the test unit. 14. The device according to claim 13, wherein the inner space defined by the sidewalls is dimensioned to control the flow rate of the buffer through the post-filter unit. 15. The device according to claim 1, further comprising a blood separation zone in lateral communication with the reaction zone, wherein the blood separation zone has a first end defining a region for receiving a whole blood test sample, and a second end in communication with the reaction zone. 16. The device according to claim 15, wherein the blood separation zone comprises a material capable of selectively retaining cellular components of the whole blood test sample to generate a substantially cellular component-free fluid portion which can flow from the first end of the blood separation zone to the reaction zone. 17. The device according to claim 16, wherein the material is a glass fiber matrix. 18. The device according to claim 16, wherein the material comprises a hydrophobic carrier capable of reducing seepage of the whole blood test sample and the cellular component-free fluid portion as it migrates along the blood separation zone. 19. A diagnostic test kit for conducting an assay to determine the presence or absence of a target analyte in a fluid test sample, the diagnostic test kit comprising: a test unit comprising: a reaction zone containing an immobilized capture reagent that binds a target analyte in the fluid test sample to form a two-membered complex of a specific binding interaction, andan absorbent zone in vertical communication with the reaction zone, the absorbent zone comprising an absorbent material positioned underneath the reaction zone for facilitating the downward or vertical flow of the fluid test sample through the reaction zone and into the absorbent zone;a post-filter cap which is operably affixable to a test unit so as to be in vertical communication with a reaction zone after a fluid test sample has been applied to the reaction zone, the post-filter cap comprising: an outer sleeve comprising an outwardly extending flange, sidewalls depending from the outwardly extending flange and terminating at an open-ended base, the base further comprising a collar projecting inwardly from the sidewalls;an inner sleeve dimensioned to frictionally engage the inner surface of the outer sleeve, the inner sleeve comprising an outwardly extending flange, sidewalls depending from the outwardly extending flange and terminating at an open-ended base; anda removable post-filter unit supported by the collar of the outer sleeve and held in place by the open-ended base of the inner sleeve, the post-filter unit comprising a porous material having a direct label conjugated general marker protein complex embedded thereon; anda buffer reagent for use in the assay. 20. The diagnostic test kit according to claim 19, further comprising one or more pipettes for use in the assay. 21. The diagnostic test kit according to claim 19, further comprising instructions for conducting the assay. 22. The diagnostic test kit according to claim 19, wherein the buffer reagent is a multifunctional buffer comprising: a biological buffer to maintain the pH between 7.0 to 10.0;at least one surfactant to reduce non-specific binding of assay reagents while simultaneously avoiding inhibition of a specific binding interaction;a high molecular weight polymer as a dispersing and suspending reagent having a molecular weight in a range of from about 2×102 to about 2×106 D;a pH stabilizer to maintain the pH of the multifunctional buffer within a range of about pH 7.0 to 10.0;an ionic salt to reduce non-specific binding of antibodies;at least one preservative to reduce bacterial and microbial growth; anda calcium chelator to prevent a whole blood test sample from clotting;wherein the biological buffer, the surfactant, the high molecular weight polymer, the pH stabilizer, the ionic salt, the preservative and the calcium chelator are all in effective concentrations. 23. The kit according to claim 19, wherein the test unit further comprises a blood separation zone in lateral communication with the reaction zone, wherein the blood separation zone has a first end defining a region for receiving a whole blood test sample, and a second end in communication with the reaction zone.
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