Mobile rapid test system for nucleic acid analysis
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
C12Q-001/68
B01L-003/00
B01L-007/00
출원번호
US-0723315
(2012-12-21)
등록번호
US-9260750
(2016-02-16)
우선권정보
DE-10 2007 062 441 (2007-12-20)
발명자
/ 주소
Hillebrand, Timo
Knippschild, Claus
Jaschinsky, Benjamin
Graser, Elmara
출원인 / 주소
AJ INNUSCREEN, GmbH
대리인 / 주소
Oblon, McClelland, Maier & Neustadt, L.L.P.
인용정보
피인용 횟수 :
0인용 특허 :
4
초록▼
A mobile rapid test system for nucleic acid analysis. A method comprising the steps of amplification of the nucleic acids by means of rapid-PCR technology, conversion of a double-stranded amplification product into a single-stranded DNA fragment, hybridization with a labeled probe and detection of t
A mobile rapid test system for nucleic acid analysis. A method comprising the steps of amplification of the nucleic acids by means of rapid-PCR technology, conversion of a double-stranded amplification product into a single-stranded DNA fragment, hybridization with a labeled probe and detection of the nucleic acids on a lateral-flow test strip. A device comprising a reaction cavity which preferably consists of a thin film, inlet and outlet openings for the reaction cavity, one or more heatable sample blocks which are connected to miniaturized cooling bodies and a window for reading off the result. The lateral-flow test strip is a component of the mobile rapid test system. Operation of the instrument system requires no external power source, but only batteries or a rechargeable battery.
대표청구항▼
1. A mobile rapid test system for analysis of a nucleic acid to be determined, comprising: a device for amplification and hybridization of nucleic acids,amplification primers optionally comprising at least one marker,at least one hybridization probe comprising at least one marker,and a test kit for
1. A mobile rapid test system for analysis of a nucleic acid to be determined, comprising: a device for amplification and hybridization of nucleic acids,amplification primers optionally comprising at least one marker,at least one hybridization probe comprising at least one marker,and a test kit for detection of an amplification event that comprises at least one lateral-flow test strip having a zone for coupling markers;wherein the mobile rapid test system is a hand-held device that can be operated in mobile manner, which does not require any external voltage source during operation, but rather is operated by a battery or a rechargeable battery, and which integrates said device and said test kit;and wherein the hand-held device comprises a reaction cavity for carrying out an amplification of nucleic acids by PCR, one or more inlet and/or outlet openings for the reaction cavity, one or more heatable sample blocks that are connected with miniaturized cooling bodies, and a means for reading the result, wherein the reaction cavity contains a plastic film having a film thickness that is less than 300 μm, and wherein the plastic film consists of polypropylene and is welded in a desired geometry, in shape-stable manner, and is pressed against each of the one or more sample blocks by slight contact pressure from above. 2. The mobile rapid test system according to claim 1, further comprising a nucleic acid to be determined. 3. The mobile rapid test system according to claim 1, further comprising a nucleic acid to be determined that is marked. 4. The mobile rapid test system according to claim 1, wherein the amplification primers comprise a marker. 5. The mobile rapid test system according to claim 1, further comprising a marked nucleic acid produced from the nucleic acid to be determined. 6. The mobile rapid test system according to claim 1, wherein said plastic film as a film thickness of less than 100 μm. 7. The mobile rapid test system according to claim 1, wherein the reaction cavity and the test strip are disposed in a reaction cartridge and the plastic film produces connection channels with the reaction cartridge. 8. The mobile rapid test system according to claim 1, further comprising a reservoir and an outlet opening for running buffer. 9. The mobile rapid test system according to claim 8, which contains connection channels between the reaction cavity, the test strip, and the running buffer reservoir which can be closed off. 10. The mobile rapid test system according to claim 1, wherein the reaction cavity contains two surfaces that can be connected with one another at channel or chamber edges, with force fit and/or shape fit, whereby at least one of these surfaces consists of a plastically or elastically deformable material. 11. The mobile rapid test system according to claim 1, wherein the reaction cavity contains a depression and the one or more sample blocks are configured in convex manner and the opening of the reaction cavity is circular. 12. The mobile rapid test system according to claim 1, wherein the reaction cavity contains movable pistons and related hollow cylinders for storage of reactants. 13. The mobile rapid test system according to claim 1, wherein the one or more heatable sample blocks are each connected with a miniaturized cooling body that contains a battery-operated Peltier element having a heating rate of up to 15° C./s. 14. The mobile rapid test system according to claim 1, wherein an amplification primer and a hybridization probe are marked at the 5′-end. 15. The mobile rapid test system according to claim 14, wherein the amplification primer is marked by biotin and the hybridization probe is marked by FITC, and protected against polymerization at the 3′-end. 16. The mobile rapid test system according to claim 1, wherein the lateral-flow test strip carries two separate binding locations, a streptavidin location for coupling of the marked amplification products, and a binding location for monitoring the function of the test strip, as well as a zone with conjugated detection particles. 17. The mobile rapid test system according to claim 16, wherein the conjugated detection particles are anti-FITC gold particles. 18. A method for detection of nucleic acids comprising: amplifying of the nucleic acids with the system according to claim 1 wherein at least one of the amplification primers contains a marker or wherein the amplified nucleic acids contain a marker, denaturing the amplification products,hybridizing of the denatured amplification product with at least one marked hybridization probe, detecting of the amplification products on the lateral-flow test strip. 19. The method according to claim 18, wherein the PCR reaction is carried out with a marked primer and an unmarked primer for each DNA fragment to be detected, in each instance, and the test strip contains a binding location for the marker of the primer, in each instance, whereby the detection of the nucleic acids takes place in that the denatured amplification product is hybridized with a marked probe that is complementary to the DNA strand marked with the primers, the PCR batch is mixed with a running buffer and applied to the test strip. 20. The method according to claim 18, wherein the marked amplification primers contain a biotin marker that produces a biotin marked amplification product and wherein after denaturing and cooling of the PCR reaction batch, the hybridization probe specifically binds to the complementary DNA strand of the amplification product that is biotin marked.
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이 특허에 인용된 특허 (4)
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