US6335166B1
Expired / Lapsed
US
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Automated process for isolating and amplifying a target nucleic acid sequence
Assignee: Gen Probe Inc
•
Filing: 1999-04-30
•
Granted: 2002-01-01
•
Expires: 2019-04-30
Abstract
Abstract An automated analyzer for performing multiple diagnostic assays simultaneously includes multiple stations, or modules, in which discrete aspects of the assay are performed on fluid samples contained in reaction receptacles. The analyzer includes stations for automatically preparing a specimen sample, incubating the sample at prescribed temperatures for prescribed periods, preforming an analyte isolation procedure, and ascertaining the presence of a target analyte. An automated receptacle transporting system moves the reaction receptacles from one station to the next. The analyzer further includes devices for carrying a plurality of specimen tubes and disposable pipette tips in a machine-accessible manner, a device for agitating containers of target capture reagents comprising suspensions of solid support material and for presenting the containers for machine access thereto, and a device for holding containers of reagents in a temperature controlled environment and presenting the containers for machine access thereto. A method for performing an automated diagnostic assay includes an automated process for isolating and amplifying a target analyte. The process is performed by automatically moving each of a plurality of reaction receptacles containing a solid support material and a fluid sample between stations for incubating the contents of the reaction receptacle and for separating the target analyte bound to the solid support from the fluid sample. An amplification reagent is added to the separated analyte after the analyte separation step and before a final incubation step.
Inventors
- 👤 Kelly G. Ammann
- 👤 Ralph E. Burns
- 👤 Ernest V. Hansberry
- 👤 Glenn A. Horner
- 👤 Cheryl A. Jakub
- 👤 John E. Kling
- 👤 Donald J. Nieglos
- 👤 Robert E. Schneider
- 👤 Robert J. Smith
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-04 23:36
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; C; C12; C12Q; C12Q1/00; C12Q1/68; C12Q1/6813; C12Q1/6834; B; B01; B01F; B01F29/00; B01F29/10; B01F29/30; B01F29/32; B01F29/322; B01L; B01L7/00; B01L7/52; B01L7/525; B01L7/5255; B03; B03C; B03C1/00; B03C1/02; B03C1/28; B03C1/282; B03C1/288; B03C1/30; C12Q1/6832; G01N35/00; G01N35/02; G01N35/025; B01F29/40; B01F29/403; B01F29/4035; B01F29/40354; B01L2200/00; B01L2200/14; B01L2200/143; B01L2200/147; B01L2300/00; B01L2300/18; B01L2300/1805; B01L2300/1822; B01L2300/1827; B01L9/00; B01L9/06; B03C2201/00; B03C2201/26; C12Q2537/00; C12Q2537/10; G01N2035/00346; G01N2035/00356; G01N2035/00465; G01N2035/00524; G01N35/04; G01N2035/0401; G01N2035/0437; G01N2035/0439; G01N2035/0453; G01N2035/0455; G01N35/10; G01N2035/1027; G01N2035/103; G01N35/0098; G01N35/0099; G01N35/1065; Y; Y10; Y10T; Y10T156/00; Y10T156/11; Y10T156/1105; Y10T156/19; Y10T156/1906; Y10T29/00; Y10T29/53; Y10T29/53657; Y10T29/53683; Y10T29/53796; Y10T29/53839; Y10T29/53843; Y10T436/00; Y10T436/11; Y10T436/111666; Y10T436/113332; Y10T436/114998; Y10T436/119163; Y10T436/25; Y10T436/2575
Claims Analysis
Total Claims: 49
Claim 1
Independent Claim
139 words
An automated process for isolating and amplifying a target nucleic acid sequence that may be present in a fluid sample contained in a reaction receptacle, said process comprising: a) separating the target sequence from non-target nucleic acid that may be present in the fluid sample in a separation station; b) transporting the reaction receptacle containing the separated target sequence, if present in the fluid sample, from the separation station to an amplifying incubation station comprising one or more incubators, each said incubator of said amplifying incubation station defining a temperature-controlled chamber; and c) incubating the contents of the reaction receptacle, to which one or more amplification reagents have been provided, in said amplifying incubation station for a period of time and under conditions sufficient to permit the target sequence to be amplified, wherein each of steps a)-c) is automated.
Claim 2
Dependent Claim
139 words
An automated process for isolating and amplifying a target nucleic acid sequence that may be present in a fluid sample contained in a reaction receptacle, said process comprising: a) separating the target sequence from non-target nucleic acid that may be present in the fluid sample in a separation station; b) transporting the reaction receptacle containing the separated target sequence, if present in the fluid sample, from the separation station to an amplifying incubation station comprising one or more incubators, each said incubator of said amplifying incubation station defining a temperature-controlled chamber; and c) incubating the contents of the reaction receptacle, to which one or more amplification reagents have been provided, in said amplifying incubation station for a period of time and under conditions sufficient to permit the target sequence to be amplified, wherein each of steps a)-c) is automated.
Claim 3
Dependent Claim
131 words
The automated process of claim 1 , further comprising: transporting the reaction receptacle to an immobilizing incubation station comprising one or more incubators, each said incubator of said immobilizing incubation station defining a temperature-controlled chamber; incubating the contents of the reaction receptacle, to which a solid support material has been provided, for a period of time and under conditions sufficient to permit the target sequence to be immobilized by the solid support material; transporting the reaction receptacle to said separation station, wherein the separating step includes separating the target sequence from the non-target nucleic acid that may be present in the fluid sample within said separation station by a separation procedure that includes isolating the solid support material within the reaction receptacle; and removing the fluid sample from the reaction receptacle.
Claim 4
Dependent Claim
27 words
The automated process of claim 2 , wherein said immobilizing and amplifying incubation stations are independent of one another or share at least one incubator in common.
Claim 5
Dependent Claim
19 words
The automated process of claim 2 , wherein said immobilizing and amplifying incubation stations are independent of one another.
Claim 6
Dependent Claim
29 words
The automated process of claim 2 , wherein the reaction receptacle is transported to said immobilizing incubation station from a holding station for holding a plurality of reaction receptacles.
Claim 7
Dependent Claim
22 words
The automated process of claim 5 , wherein the step of transporting the reaction receptacle to said immobilizing incubation station is automated.
Claim 8
Dependent Claim
22 words
The automated process of claim 2 , wherein the solid support material comprises a magnetically responsive particle having a polynucleotide bound thereto.
Claim 9
Dependent Claim
31 words
The automated process of claim 7 , wherein a target nucleic acid containing the target sequence is hybridized to a capture probe prior to being immobilized by the solid support material.
Claim 10
Dependent Claim
24 words
The automated process of claim 7 , wherein the contents of the reaction receptacle are subjected to a magnetic field during said separation procedure.
Claim 11
Dependent Claim
23 words
The automated process of claim 2 , wherein the fluid sample is aspirated from the reaction receptacle after isolating the solid support material.
Claim 12
Dependent Claim
55 words
The automated process of claim 10 , further comprising: providing a wash buffer to the reaction receptacle after removing the fluid sample from the reaction receptacle, and thereafter: agitating the reaction receptacle to resuspend the solid support material; isolating the solid support within the reaction receptacle; and removing the wash buffer from the reaction receptacle.
Claim 13
Dependent Claim
37 words
The automated process of claim 2 , wherein the incubators of said amplifying incubation station are maintained at a temperature or temperatures different than the temperature or temperatures maintained by the incubators of said immobilizing incubation station.
Claim 14
Dependent Claim
37 words
The automated process of claim 2 , further comprising raising or lowering the temperature of the contents of the receptacle prior to transporting the reaction receptacle to at least one of said immobilizing and hybridizing incubation stations.
Claim 15
Dependent Claim
28 words
The automated process of claim 2 , wherein the solid support material is provided to the reaction prior to transporting the reaction receptacle to said immobilizing incubation station.
Claim 16
Dependent Claim
81 words
The automated process of claim 2 , further comprising: transporting the reaction receptacle to a hybridizing incubation station comprising one or more incubators, each said incubator of said hybridizing incubation station defining a temperature-controlled chamber; and incubating, within said hybridizing incubation station, the contents of the reaction receptacle, to which one or more probe reagents have been provided, for a period of time and under conditions sufficient to permit the probe to hybridize to the target sequence or an amplicon thereof.
Claim 17
Dependent Claim
55 words
The automated process of claim 15 , further comprising detecting the presence or absence of the probe hybridized to the target sequence, or an amplicon thereof, as an indication of the presence or absence of an organism or virus or one or more members of a group of organisms or viruses in the fluid sample.
Claim 18
Dependent Claim
30 words
The automated process of claim 16 , further comprising transporting the reaction receptacle to a detection station for detecting the presence or amount of the label in the reaction receptacle.
Claim 19
Dependent Claim
21 words
The automated process of claim 17 , wherein the step of transporting the reaction receptacle to said detection station is automated.
Claim 20
Dependent Claim
22 words
The automated process of claim 15 , wherein the step of transporting the reaction receptacle to said hybridizing incubation station is automated.
Claim 21
Dependent Claim
21 words
The automated process of claim 2 , wherein the step of transporting the reaction receptacle to said separation station is automated.
Claim 22
Dependent Claim
21 words
The automated process of claim 20 , wherein the step of transporting the reaction to said immobilizing incubation station is automated.
Claim 23
Dependent Claim
81 words
The automated process of claim 1 , further comprising: transporting the reaction receptacle to a hybridizing incubation station comprising one or more incubators, each said incubator of said hybridizing incubation station defining a temperature-controlled chamber; and incubating, within said hybridizing incubation station, the contents of the reaction receptacle, to which one or more probe reagents have been provided, for a period of time and under conditions sufficient to permit the probe to hybridize to the target sequence or an amplicon thereof.
Claim 24
Dependent Claim
27 words
The automated process of claim 22 , wherein said amplifying and hybridizing incubation stations are independent of one another or share at least one incubator in common.
Claim 25
Dependent Claim
19 words
The automated process of claim 22 , wherein said amplifying and hybridizing incubation stations are independent of one another.
Claim 26
Dependent Claim
18 words
The automated process of claim 22 , wherein the probe reagents include a probe having a detectable label.
Claim 27
Dependent Claim
17 words
The automated process of claim 25 , wherein the label is a fluorescent dye or chemiluminescent compound.
Claim 28
Dependent Claim
70 words
The automated process of claim 25 , further comprising detecting the presence or absence of the probe hybridized to the target sequence, or an amplicon thereof, by detecting the amount of light emitted by the contents of the reaction receptacle, Thereby providing an indication of the presence or absence of an organism or virus or one or more members of a group of organisms or viruses in the fluid sample.
Claim 29
Dependent Claim
26 words
The automated process of claim 27 , further comprising determining the amount of the organism or virus or the organisms or viruses in the fluid sample.
Claim 30
Dependent Claim
31 words
The automated process of claim 27 , further comprising transporting each reaction receptacle to a luminometer station for detecting the amount of light emitted by the contents of the reaction receptacle.
Claim 31
Dependent Claim
20 words
The automated process of claim 29 , wherein the step of transporting the receptacle to said luminometer station is automated.
Claim 32
Dependent Claim
30 words
The automated process of claim 25 , further comprising transporting the reaction receptacle to a detection station for detecting the presence or amount of the label in the reaction receptacle.
Claim 33
Dependent Claim
28 words
The automated process of claim 31 , wherein said detection station comprises a luminometer for detecting the amount of light emitted by the contents of the reaction receptacle.
Claim 34
Dependent Claim
20 words
The automated process of claim 31 , wherein the step of transporting the receptacle to said detection station is automated.
Claim 35
Dependent Claim
55 words
The automated process of claim 22 , further comprising detecting the presence or absence of the probe hybridized to the target sequence, or an amplicon thereof, as an indication of the presence or absence of an organism or virus or one or more members of a group of organisms or viruses in the fluid sample.
Claim 36
Dependent Claim
26 words
The automated process of claim 34 , further comprising determining the amount of the organism or virus or the organisms or viruses in the fluid sample.
Claim 37
Dependent Claim
34 words
The automated process of claim 34 , further comprising transporting the reaction receptacle to a deactivation station and providing to the reaction receptacle a deactivating reagent after permitting the target sequence to be amplified.
Claim 38
Dependent Claim
30 words
The automated process of claim 22 , wherein the one or more probe reagents are provided to the reaction receptacle after transporting the reaction receptacle to said hybridizing incubation station.
Claim 39
Dependent Claim
22 words
The automated process of claim 22 , wherein the step of transporting the reaction receptacle to said hybridizing incubation station is automated.
Claim 40
Dependent Claim
32 words
The automated process of claim 1 , further comprising raising or lowering the temperature of the contents of the reaction receptacle prior to transporting the reaction receptacle to said amplifying incubation station.
Claim 41
Dependent Claim
19 words
The automated process of claim 1 , wherein the target sequence is amplified by a polymerase chain reaction procedure.
Claim 42
Dependent Claim
18 words
The automated process of claim 1 , wherein the target sequence is amplified by a transcription-mediated amplification procedure.
Claim 43
Dependent Claim
31 words
The automated process of claim 1 , wherein the one or more amplification reagents are provided to the reaction receptacle prior to transporting the reaction receptacle to said amplifying incubation station.
Claim 44
Dependent Claim
17 words
The automated process of claim 1 , further comprising dispensing a fluid sample into the reaction receptacle.
Claim 45
Dependent Claim
25 words
The automated process of claim 1 , further comprising transporting the reaction receptacle to said amplifying incubation station by means of a receptacle transport mechanism.
Claim 46
Dependent Claim
53 words
The automated process of claim 1 , wherein the reaction receptacle comprises an integrally-formed array of a plurality of test tubes so that a target nucleic acid sequence that may be present in a fluid sample contained in each test tube of the reaction receptacle is isolated and amplified during said automated process.
Claim 47
Dependent Claim
34 words
The automated process of claim 1 , further comprising transporting the reaction receptacle to a deactivation station and providing to the reaction receptacle a deactivating reagent after permitting the target sequence to be amplified.
Claim 48
Dependent Claim
35 words
The automated process of claim 46 , wherein the deactivating reagent comprises a chemical agent selected from the group consisting of solutions of potassium permanganate, formic acid, solutions of sodium hypochlorite, hydrazine, and dimethyl sulfate.
Claim 49
Dependent Claim
21 words
The automated process of claim 46 , wherein the step of transporting the reaction receptacle to said deactivation station is automated.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2004-12-31 | 2005-07-02 | 2006-01-01 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-12-31 | 2009-07-02 | 2010-01-01 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-12-31 | 2013-07-02 | 2014-01-01 | $7700.00 | Window Closed / Lapsed |