Rapid diagnostic device, assay and multifunctional buffer
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
G01N-033/00
G01N-033/53
G01N-033/543
출원번호
US-0064486
(2013-10-28)
등록번호
US-9164087
(2015-10-20)
발명자
/ 주소
Chan, Hermes K. W.
출원인 / 주소
MedMira Inc.
대리인 / 주소
Sundby, Esq., Suzannah K.
인용정보
피인용 횟수 :
1인용 특허 :
26
초록▼
An improved 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 capable of receiv
An improved 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 capable of receiving the fluid sample and multifunctional buffer, respectively. The test unit comprises a reaction zone containing immobilized capture reagent that can specifically 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 dried indicator reagent delivery unit comprises a label zone permeated with a dried indicator reagent which is capable of being 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▼
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, whereby the downward or vertical flow of the fluid test sample through the reaction zone terminates in the absorbent zone; anda post-filter cap which is affixed to a test unit so as to operably move into 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, wherein the inner space defined by the sidewalls is dimensioned to control the flow rate of the buffer through the post-filter unit. 14. 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. 15. The device according to claim 14, 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. 16. The device according to claim 15, wherein the material is a glass fiber matrix. 17. The device according to claim 15, 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. 18. 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, whereby the downward or vertical flow of the fluid test sample through the reaction zone terminates in the absorbent zone;a post-filter cap which is affixed to a test unit so as to operably move into 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. 19. The diagnostic test kit according to claim 18, further comprising one or more pipettes for use in the assay. 20. The diagnostic test kit according to claim 18, further comprising instructions for conducting the assay. 21. The diagnostic test kit according to claim 18, 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. 22. The kit according to claim 18, 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. 23. The device of claim 1, wherein the fluid test sample is drawn through the reaction zone into the absorbent zone. 24. The kit of claim 18, wherein the fluid test sample is drawn through the reaction zone into the absorbent zone.
연구과제 타임라인
LOADING...
LOADING...
LOADING...
LOADING...
LOADING...
이 특허에 인용된 특허 (26)
Sullivan ; Kevin J., Anticoagulant coating method.
Gordon Julian (Lake Bluff IL) McMahon Michael E. (Libertyville IL) Ching Shanfun (Vernon Hills IL), Chromatographic test strip for determining ligands or receptors.
Jou Yi-Her (Libertyville IL) Stroupe Stephen D. (Libertyville IL) Markese James J. (Libertyville IL), Devices for performing ion-capture binding assays.
Kalra Krishan L. (Moraga CA) Pawlak Katarzyna (Oakland CA) Moon Patricia A. (San Ramon CA) French Larry D. (Oakland CA), Immunoassay test device and method.
Eisinger Robert W. (San Diego CA) Khalil Mohammed H. (San Diego CA) Katz David H. (La Jolla CA) Sargeant Robert B. (Ramona CA), Lateral flow, non-bibulous membrane assay protocols.
Kline Steven (Grayslake IL) Jou Yi-Her (Libertyville IL) Stroupe Stephen D. (Libertyville IL) Adamczyk Janina (Gurnee IL) Berry Daniel S. (Libertyville IL) Fico Rosario M. (Zion IL) Markese James J. , Methods and reagents for performing ion-capture digoxin assays.
Brown William E. (Grayslake IL) Clemens John M. (Gurnee IL) Devereaux Sharon M. (Gurnee IL) Hofler John G. (Ingleside IL) Knigge Kevin M. (Wheeling IL) Safford Sarah E. (Libertyville IL), Solid phase analytical device and method for using same.
Brown ; III William E. (Grayslake IL) Safford Sarah E. (Libertyville IL) Clemens John M. (Gurnee IL), Solid-phase analytical device and method for using same.
Brown ; III William E. (Grayslake IL) Safford Sarah E. (Libertyville IL) Clemens John M. (Gurnee IL), Solid-phase analytical device and method for using same.
Brown ; III William E. (Grayslake IL) Safford Sarah E. (Libertyville IL) Clemens John M. (Gurnee IL), Solid-phase analytical device and method for using same.
※ AI-Helper는 부적절한 답변을 할 수 있습니다.