WO2012105176A1 - 核酸検査装置 - Google Patents
核酸検査装置 Download PDFInfo
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- WO2012105176A1 WO2012105176A1 PCT/JP2012/000361 JP2012000361W WO2012105176A1 WO 2012105176 A1 WO2012105176 A1 WO 2012105176A1 JP 2012000361 W JP2012000361 W JP 2012000361W WO 2012105176 A1 WO2012105176 A1 WO 2012105176A1
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- nucleic acid
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- test apparatus
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6844—Nucleic acid amplification reactions
- C12Q1/686—Polymerase chain reaction [PCR]
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/0092—Scheduling
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L7/00—Heating or cooling apparatus; Heat insulating devices
- B01L7/52—Heating or cooling apparatus; Heat insulating devices with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6844—Nucleic acid amplification reactions
- C12Q1/6846—Common amplification features
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2527/00—Reactions demanding special reaction conditions
- C12Q2527/107—Temperature of melting, i.e. Tm
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2561/00—Nucleic acid detection characterised by assay method
- C12Q2561/113—Real time assay
Definitions
- the present invention relates to a nucleic acid test apparatus for amplifying and detecting a target nucleic acid.
- Nucleic acid amplification technology that amplifies and detects nucleic acids is used as a method for infectious diseases and genetic testing.
- the amplification technique there is a PCR (Polymerase Chain Reaction) method.
- the PCR method is a method for selectively amplifying a specific base sequence by repeating a temperature change (temperature cycle) for a reaction solution containing a target nucleic acid.
- a conventional real-time PCR apparatus simultaneously starts the same temperature cycle for a plurality of reaction solutions and performs an amplification reaction.
- the ratio of the process of repeating the real-time PCR and fluorescence measurement and measuring the amplification reaction of the nucleic acid in real time to the analysis time is larger than that of the sample preparation process, which greatly affects the analysis processing speed.
- amplification detection determination is performed before a predetermined amplification completion time, and the reaction solution in which the amplification reaction is completed (amplification is detected) is discharged from the region where the amplification reaction is performed, and a new reaction is performed.
- a real-time PCR apparatus configured to supply a liquid to a region where an amplification reaction is performed.
- amplification detection determination is performed by plateau detection.
- a method for detecting amplification there is a means that can determine amplification earlier than plateau detection, such as Ct value detection. For this reason, even if there are a plurality of conditions for determining amplification, if the amplification detection determination is uniformly defined, there is a problem that the user cannot select the optimal amplification termination condition according to the measurement sample. .
- processing after amplification reaction such as HRM analysis has also been diversified.
- the Melting analysis or the HRM analysis is uniformly performed after a predetermined measurement completion time.
- Melting analysis or HRM analysis is not necessary for a reaction solution in which amplification could not be detected, and analysis was wasted.
- the present invention has been made in view of the above, and an object of the present invention is to provide a nucleic acid test apparatus capable of selecting an optimal analysis method according to a user and improving throughput.
- the nucleic acid analyzer of the present invention measures and analyzes a nucleic acid amplification reaction in real time, performs amplification detection determination before a predetermined measurement completion time, and detects amplification when amplification is detected.
- the reaction end condition can be selected by the user.
- the user can select the amplification reaction end condition after amplification detection, so that the throughput can be improved according to the measurement data required by the user.
- the present invention is also characterized in that the user can select the next treatment selection condition after the amplification reaction is completed.
- the user can select the next processing after the amplification reaction is completed, and the throughput can be improved by performing only the necessary next processing according to the measurement sample and analysis conditions.
- the present invention also measures and analyzes a nucleic acid amplification reaction in real time, performs amplification detection determination before a predetermined measurement completion time, and when amplification is detected, for each amplification reaction end condition, The next process selection condition can be selected by the user.
- the user can select the amplification reaction termination condition after amplification detection, it is possible to improve the throughput according to the measurement data required by the user, and the user can perform the next processing according to the amplification result. By being selectable, it is possible to improve the throughput by performing only necessary next processing according to the measurement sample, analysis conditions, and required results.
- the present invention also includes a holder provided with a plurality of temperature control blocks each holding at least one reaction vessel containing a reaction solution, and each of the plurality of temperature control blocks provided with the reaction.
- amplification detection mechanism equipped with a temperature adjustment device that adjusts the temperature of the liquid
- each of the temperature control blocks is independent of the aforementioned amplification reaction end operation process or the next process after the end of the amplification reaction. It is characterized by giving.
- the nucleic acid analyzer of the present invention can execute the amplification reaction termination operation optimal for the user and improve the throughput by making it possible to select the amplification reaction termination conditions.
- the apparatus can automatically execute an optimal analysis operation and improve the throughput.
- FIG. 1 is an overall schematic configuration diagram of a nucleic acid analyzer.
- the block diagram which shows the function of the control part of this nucleic acid analyzer.
- the figure which shows the example of an amplification curve.
- the figure which shows the relationship between an initial nucleic acid copy number and an amplification curve.
- FIG. 3 is a diagram illustrating a flowchart in processing of Embodiment 1; The figure explaining the amplification reaction termination condition screen of Example 1.
- FIG. 3 is a diagram for explaining an amplification detection condition selection screen according to the first embodiment.
- FIG. 10 is a diagram illustrating a next process selection screen according to the second embodiment.
- FIG. The figure explaining the analysis condition setting screen for every reaction container of Example 3.
- FIG. FIG. 6 is a diagram illustrating a nucleic acid amplification device of Example 4.
- FIG. 1 shows the overall configuration of a nucleic acid test apparatus 100 according to the present invention.
- the nucleic acid test apparatus 100 includes a plurality of sample containers 101 containing a sample containing nucleic acids to be amplified, a sample container rack 102 containing a plurality of sample containers 101, and various kinds of samples to be added to the sample.
- a plurality of reagent containers 103 storing reagents
- a reagent container rack 104 storing a plurality of reagent containers 103
- a reaction container 105 for mixing a sample and a reagent and a plurality of unused reaction containers 105 are stored.
- Reaction container rack 106 unused reaction container 105, reaction liquid adjustment position 107 for dispensing the specimen and reagent from each of the sample container 101 and the reagent container 103 to the reaction container 105, and the specimen
- a capping unit 108 for sealing a reaction vessel 105 containing a reaction solution, which is a mixed solution of a reagent and a reagent, with a lid member (not shown);
- a stirring unit 109 for stirring the contained reaction solution in the reaction vessel 105 is provided with.
- the nucleic acid test apparatus 100 includes a robot arm X-axis 110 provided on the nucleic acid test apparatus 100 so as to extend in the X-axis direction (left-right direction in FIG. 1), and the Y-axis direction (up-down direction in FIG. 1). And a robot arm device 112 having a robot arm Y axis 111 provided on the robot arm X axis 110 to be movable in the X axis direction, and movable to the robot arm Y axis 111 in the Y axis direction.
- a gripper unit 113 that holds the reaction container 105 and conveys it to each part in the nucleic acid test apparatus 100, and a robot arm Y axis 111 that is movable in the Y axis direction.
- a dispensing unit 114 that aspirates 103 reagents and discharges (dispenses) them into the reaction container 105 placed in the reaction liquid adjustment position 107;
- a control unit 121 that includes the display unit 120 and controls the overall operation of the nucleic acid test device 100 including the nu
- Each sample container 101 is managed by identification information such as a barcode for each sample contained, and is managed by position information such as coordinates assigned to each position of the sample container rack 102.
- each reagent container 103 is managed by identification information such as a barcode for each stored reagent, and is managed by positional information such as coordinates assigned to each position of the reagent container rack 104. These identification information and position information are registered and managed in the control unit 121 in advance. Further, each reaction vessel 105 is similarly managed by identification information and position information.
- the control unit 121 includes at least an analysis planning unit that performs an analysis operation plan according to an analysis condition specified through the display unit 120 and a predetermined analysis unit of the nucleic acid test device, an analysis execution unit that controls each mechanism according to the analysis plan, and each reaction container It comprises a data processing unit that manages the fluorescence detection data and the like.
- Fig. 2 shows a block diagram of the data processing unit.
- the data processing unit includes at least a fluorescence intensity calculation unit 200 that calculates the intensity of measured fluorescence data, a temperature cycle management unit 201 that manages a temperature cycle for each temperature control mechanism, and a measurement time management unit that manages the elapsed time of analysis.
- a fluorescence intensity calculation unit 200 a temperature cycle management unit 201
- a measurement data management unit 203 that manages data of the measurement time management unit 202 for each measurement sample
- an amplification curve analysis unit 204 an amplification detection determination unit 205
- an amplification end A determination unit 206 is included.
- the amplification curve analysis unit 204 acquires an amplification curve from the measurement data management unit 203 and calculates a Ct value and a plateau.
- the amplification detection determination unit 205 determines nucleic acid amplification detection for each amplification curve according to the analysis conditions from the Ct value and plateau calculation information calculated by the amplification curve analysis unit 204.
- the amplification end determination unit 206 is based on the Ct value, plateau calculation information, temperature cycle information, amplification detection time information calculated by the amplification curve analysis unit 204, and the determination result of nucleic acid amplification detection by the amplification detection determination unit 205. Determine the end of the amplification reaction.
- the amplification detection determination information of the amplification detection determination unit 205 and the amplification reaction end determination information of the amplification detection determination unit 205 are transmitted to an analysis planning unit (not shown), and replanning of analysis is performed as necessary.
- Fig. 3 shows an example of the measurement data of the nucleic acid amplification reaction.
- the horizontal axis indicates the passage of time (or the number of temperature cycles), and the vertical axis indicates the fluorescence intensity.
- the amplification curve 300 includes a lag phase 301, an exponent phase 302, and a stationary phase 303.
- the lag phase 301 is sometimes called a baseline or a baseline region.
- the stationary phase 303 is sometimes called a plateau or a plateau region.
- the nucleic acid amplification reaction does not occur until the measurement completion time 308, only the lag phase 301 may be observed, or the measurement completion time 308 elapses during the exponent phase 302 and the steady phase. In some cases, 303 is not observed.
- the measurement completion time is synonymous with the temperature cycle completion timing in which the temperature change (temperature cycle) is repeated a predetermined number of times.
- the amplification curve 300 includes a transition region 304 between the lag phase 301 and the exponent phase 302.
- the transition region 304 is called a cycle threshold (Ct value) or an elbow value.
- the amplification curve 300 includes a transition region 306 between the exponent phase 302 and the steady phase 303.
- a transition region 306 is a plateau detection point. Nucleic acid amplification can be determined based on the Ct value detection time 305 and the plateau detection time 307.
- nucleic acid amplification curve the larger the initial nucleic acid copy number at the start of amplification, the faster the exponent phase and steady phase are reached. For this reason, when nucleic acid amplification curves are obtained using serially diluted standard samples, amplification curves 401 to 403 are obtained in descending order of the initial nucleic acid copy number as shown in FIG.
- the initial nucleic acid contained in the unknown sample is compared. It becomes possible to identify the copy number.
- the plateau detection time can be used to identify the initial copy number of the nucleic acid.
- the Ct value or the plateau detection time is very important in analyzing the nucleic acid amplification curve.
- the Ct value or the measurement data of the stationary phase after detecting the plateau may not be necessary depending on the user. In such a case, continuing the amplification reaction until the measurement completion time becomes a factor of reducing the throughput of the entire nucleic acid test apparatus.
- the presence or absence of amplification is determined before a predetermined measurement completion time, and when amplification is detected, the amplification reaction end condition is displayed on the screen, and the user can select the amplification reaction end condition.
- FIG. 5 shows a processing flow of the present embodiment in the control unit 121.
- this flow it is preferable to perform processing on all reaction vessels in the amplification reaction every measurement period of fluorescence detection. Note that. It is also possible to perform a process such that the process is performed at regular intervals or a part of the reaction vessel during the amplification reaction is processed at each period.
- step 500 an amplification curve is acquired.
- the amplification curve used here may use all the fluorescence data from the start of the amplification reaction to the present processing, or only a part of it may be used.
- step 501 it is determined whether or not the amplification reaction end condition has been selected. If not selected, the process proceeds to step 502, and if selected, the process proceeds to step 505.
- step 502 an amplification curve is analyzed and amplification detection determination is performed.
- step 503 according to the determination result in step 502, if amplification is detected, the process proceeds to step 504, and an amplification reaction end condition selection screen is presented to the user.
- the amplification reaction end condition is selected on this screen, the amplification reaction end condition is selected in step 501. Depending on the selection conditions, the amplification detection determination may be changed while the amplification reaction end condition is not selected. The selected amplification reaction end condition is used in the amplification end determination in step 505.
- step 505 the amplification curve is analyzed, and amplification completion determination is performed.
- step 506 according to the determination result in step 505, when amplification is completed, the process proceeds to step 507, and the amplification reaction in this reaction container is completed.
- FIG. 6 (A) shows an example of display of the amplification reaction end condition selection screen.
- the display screen displays the amplification reaction termination conditions such as immediately terminating the amplification reaction, continuing the amplification reaction until the measurement time is completed, or continuing the amplification reaction for the desired time.
- the user can select a desired end condition.
- the screen has an input area 600 for inputting a desired time for continuing the amplification reaction.
- the desired unit of time is displayed in seconds.
- a desired unit such as the number of temperature cycles and the number of measurements may be used under the condition.
- amplification reaction termination conditions include displaying the selection screen again after a desired time has elapsed.
- the amplification reaction termination condition at the time of detecting the Ct value may include options such as terminating the amplification reaction after plateau detection or displaying the amplification reaction termination condition selection screen again after plateau detection.
- an amplification detection condition 601 and a sample ID 602 may be displayed.
- the specimen information, reagent information, and the like may be displayed or referred to.
- an amplification reaction curve 603 may be displayed. Furthermore, it is preferable that the amplification reaction curve 603 can be enlarged and reduced. It is preferable that the maximum value on the horizontal axis of the amplification reaction curve 603 is the measurement completion time, and the user can know the amplification curve and the remaining time until the measurement is completed. Alternatively, the remaining time until the completion of measurement may be directly displayed. These pieces of information serve as a reference when the user selects an amplification reaction end condition.
- amplification detection is determined by Ct value detection or plateau detection in the amplification detection determination.
- the user may be able to select amplification detection conditions from Ct value detection or plateau detection before starting analysis.
- the Ct value detection method may be selectable from Crossing Point method and 2nd Derivative Maximum method, and in the case of Crossing Point method, a threshold value may be input.
- the user may be able to register the amplification reaction end condition before starting the analysis. That is, the nucleic acid analyzer performs amplification presence / absence determination before a predetermined measurement completion time, and when amplification is detected, the amplification reaction may be automatically ended according to the amplification reaction end condition registered before the analysis is started. it can. As a result, the user can select the optimal amplification reaction termination condition, and the unnecessary amplification detection time can be shortened, thereby improving the throughput.
- amplification reaction termination conditions may be set in a batch for a sample container, a reagent container, a reaction container, or a group of reaction containers. Thereby, the user can select the optimum amplification completion condition according to the measurement sample.
- the next process selection condition is displayed on the screen, and the user can select the next process selection condition.
- Fig. 8 (A) shows an example of the display of the next process selection screen.
- the display screen displays the next processing selection conditions such as performing Melting analysis or HRM analysis processing, performing heat denaturation processing to inactivate the enzyme, or discarding the reaction vessel.
- the next process to be performed can be selected.
- Examples of other conditions for selecting the next treatment may include combined conditions such as moving the reaction vessel to the storage area, or performing a discarding by performing a heat denature treatment after the melting analysis or the HRM analysis. .
- an amplification detection condition 800 or a sample ID 801 may be displayed.
- the specimen information, reagent information, and the like may be displayed or referred to.
- an amplification reaction curve 802 may be displayed. These pieces of information are helpful when the user selects the next process selection condition.
- the user may be able to register the next process selection condition before starting the analysis. That is, when the amplification reaction is completed, the present nucleic acid analyzer can automatically shift to the next process in accordance with the next process selection condition registered before the start of analysis. As a result, only the next processing selection condition required by the user can be selected, unnecessary processing can be eliminated, and throughput can be improved.
- the next process selection condition may be set collectively for the sample container, the reagent container, the reaction container, or the group of reaction containers. Thereby, the user can select the optimum next process according to the measurement sample.
- the next process selection condition is held for each amplification reaction result, and after the amplification reaction is completed, the next process is automatically executed according to the amplification reaction result.
- the amplification reaction result preferably includes at least Ct value detection, plateau detection, and non-amplification detection.
- information obtained by analyzing an amplification curve may be displayed. It is preferable that the items shown in the second embodiment can be selected as the next process selection condition.
- the user can register the next processing selection condition for each amplification reaction result before starting amplification.
- amplification reaction termination conditions may be retained, amplification detection determination may be performed before a predetermined measurement completion time, and amplification may be terminated according to amplification detection termination conditions when amplification is detected.
- amplification reaction termination conditions are preferably registered by the user before starting amplification.
- the next treatment selection conditions for each amplification detection condition, amplification reaction end condition, and amplification detection result are set for a sample container, a reagent container, a reaction container, or a group of reaction containers. It does not matter if it is possible.
- the analysis condition setting target 1000 displays an ID for identifying the reaction container.
- the analysis condition setting target 1000 may be configured such that a reaction vessel can be selected from a selection box in a list format, and the analysis condition setting target may be sequentially changed.
- the analysis condition setting target 1000 when the analysis condition setting target 1000 is changed, the amplification process condition, the amplification reaction condition, and the next process selection condition for each amplification detection result are updated to the conditions of the held analysis condition setting target 1000.
- the analysis condition setting target 1000 a sample container, a reagent container, or a group of reaction containers may be designated.
- the user can select the optimal amplification reaction end condition according to the measurement sample, and can select only the necessary next processing selection condition. Therefore, unnecessary amplification detection time can be shortened, analysis without unnecessary processing can be performed, and throughput can be improved according to the needs of the user.
- the nucleic acid amplification device shown in FIG. 11 has a holder 1102 provided with a plurality of temperature control blocks 1101 having a configuration for holding a reaction container on a holder base 1100, and fluorescence detection of a reaction solution stored in the reaction container.
- a fluorescence detector 1103 to be performed, a holder 1102, and a cover 1104 that covers the fluorescence detector 1103 are provided.
- the temperature control block 1101 includes a temperature adjusting device including a Peltier element, a heat radiating fin, and a temperature sensor, and has a function of adjusting the reaction vessel held by the holder 1102 to a predetermined temperature.
- the temperature set in each temperature control block 1101 and the timing of temperature change are controlled independently of the temperature of other temperature control blocks 1101.
- the holder base 1100 has a rotatable structure (not shown). When the holder base 1100 rotates and the holder 1102 passes through each fluorescence detector 1103, fluorescence detection of the reaction liquid stored in the reaction container is performed.
- the relative speed between the reaction container and the fluorescence detector 1103 at the time of fluorescence measurement can be controlled by controlling the rotation speed (relative rotation speed) of the holder base 1100 with respect to the fluorescence detector 1103.
- the relative speed may be a constant speed, or fluorescence detection may be performed by temporarily stopping the reaction container or holder 1102 and the fluorescence detector 1103 at opposite positions.
- each nucleic acid test apparatus having a nucleic acid amplification apparatus equipped with a temperature control apparatus for each reaction container, the amplification reaction completion process and amplification reaction completion described in Examples 1 to 3 are performed for each reaction container. The following processing is performed.
- reaction vessel that has completed the amplification reaction is carried out of the nucleic acid amplification device by the robot arm device 112 and the gripper unit 113, and a new reaction vessel is carried into the nucleic acid amplification device.
- a new temperature change (temperature cycle) is newly given to the new reaction vessel.
- the temperature control block 1101 can be provided with a plurality of holders 1102.
- throughput can be improved by performing Melting analysis, HRM analysis, or heat treatment continuously after the amplification reaction of all reaction vessels is completed. It is.
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Abstract
Description
101 サンプル容器
102 サンプル容器ラック
103 試薬容器
104 試薬容器ラック
105 反応容器
106 反応容器ラック
107 反応液調整ポジション
108 閉栓ユニット
109 攪拌ユニット
110 ロボットアームX軸
111 ロボットアームY軸
112 ロボットアーム装置
113 グリッパユニット
114 分注ユニット
115 ノズルチップ
116 ノズルチップラック
117 核酸増幅装置
118 廃棄ボックス
119 入力部
120 表示部
121 制御部
200 蛍光強度算出部
201 温度サイクル管理部
202 測定時間管理部
203 測定データ管理部
204 増幅曲線解析部
205 増幅検出判定部
206 増幅終了判定部
300,401~403,407 増幅曲線
301 ラグフェーズ
302 指数フェーズ
303 定常フェーズ
304 ラグフェーズと指数フェーズの遷移領域(Ct値検出点)
305,404~406,408 Ct値検出時間
306 指数フェーズと定常フェーズの遷移領域(プラトー検出点)
307 プラトー検出時間
308 測定完了時間
409 Ct値
500~507 フローチャート中のステップ
600 入力エリア
601,800 増幅検出条件
602,801 サンプルID
603,802 増幅反応曲線
1000 分析条件設定対象
1100 保持具ベース
1101 温調ブロック
1102 保持具
1103 蛍光検出器
1104 カバー
Claims (30)
- 核酸の増幅反応をリアルタイムに測定、及び解析する核酸検査装置において、
所定の測定完了時間前に増幅検出判定を行い、増幅を検出した場合に、
ただちに増幅反応を終了,測定完了時間まで測定を継続して終了、及び、所望する時間の増幅反応を継続して終了、の増幅反応終了条件を画面に表示し、ユーザがいずれかの前記増幅反応終了条件を選択可能であることを特徴とする核酸検査装置。 - 核酸の増幅反応をリアルタイムに測定、及び解析する核酸検査装置において、
(a)所定の測定完了時間前に増幅検出判定を行い、増幅を検出した場合に、ただちに増幅反応を終了、
(b)所定の測定完了時間前に増幅検出判定を行い、増幅を検出した場合に、測定完了時間まで測定を継続して終了、または、
(c)所定の測定完了時間前に増幅検出判定を行い、増幅を検出した場合に、所望する時間の増幅反応を継続して終了、のいずれかの増幅反応終了条件をユーザが事前に選択可能であり、
自動でユーザが事前に選択した増幅反応終了条件に従い、増幅反応終了処理を行うことを特徴とする核酸検査装置。 - 請求項1に記載の核酸検査装置において、前記増幅検出判定の増幅検出条件がCt値検出であることを特徴とする核酸検査装置。
- 請求項1に記載の核酸検査装置において、前記増幅検出判定の増幅検出条件がプラトー検出であることを特徴とする核酸検査装置。
- 請求項1に記載の核酸検査装置において、前記増幅検出条件をCt値検出、あるいは、プラトー検出とすることを、事前にユーザが選択可能であることを特徴とする核酸検査装置。
- 請求項1に記載の核酸検査装置において、前記増幅反応終了条件の画面に、増幅検出条件を含むことを特徴とする核酸検査装置。
- 請求項1に記載の核酸検査装置において、前記増幅反応終了条件の画面に、増幅反応曲線表示を含むことを特徴とする核酸検査装置。
- 請求項2に記載の核酸検査装置において、前記増幅反応終了条件を反応容器ごとに設定可能とすることを特徴とする核酸検査装置。
- 核酸の増幅反応をリアルタイムに測定、及び解析する核酸検査装置において、
増幅反応を終了した場合に、次処理選択条件を画面に表示し、ユーザが前記次処理選択条件を選択可能であることを特徴とする核酸検査装置。 - 請求項9に記載の核酸検査装置において、前記次処理選択条件を検査前に予めユーザが設定可能であり、増幅反応を終了した場合に、自動で前記次処理選択条件に従い、次処理を行うことを特徴とする核酸検査装置。
- 請求項9に記載の核酸検査装置において、前記次処理選択条件画面に、増幅反応検出結果を含むことを特徴とする核酸検査装置。
- 請求項9に記載の核酸検査装置において、前記次処理選択条件画面に、増幅反応曲線表示を含むことを特徴とする核酸検査装置。
- 請求項9に記載の核酸検査装置において、前記次処理選択条件に、Melting解析あるいは、HRM解析処理を含むことを特徴とする核酸検査装置。
- 請求項9に記載の核酸検査装置において、前記次処理選択条件に、酵素を失活させる加熱処理を含むことを特徴とする核酸検査装置。
- 請求項10に記載の核酸検査装置において、前記次処理選択条件を反応容器ごとに設定可能とすることを特徴とする核酸検査装置。
- 核酸の増幅反応をリアルタイムに測定、及び解析する核酸検査装置において、
増幅反応結果ごとに、前記次処理選択条件を保持し、増幅反応を終了した場合に、自動で前記増幅反応結果ごとの、前記次処理選択条件に従い、次処理を行うことを特徴とする核酸検査装置。 - 請求項16に記載の核酸検査装置において、前記増幅反応結果ごとに、前記次処理選択条件を、検査前に予めユーザが設定可能であることを特徴とする核酸検査装置。
- 請求項16に記載の核酸検査装置において、前記増幅検出条件と、前記増幅反応終了条件とを保持し、所定の測定完了時間前に増幅検出判定を行い、増幅を検出した場合に、自動で前記増幅反応終了条件に従い、増幅反応終了処理を行うことを特徴とする核酸検査装置。
- 請求項18に記載の核酸検査装置において、前記増幅検出条件、および、前記増幅反応終了条件を検査前に予めユーザが設定可能であることを特徴とする核酸検査装置。
- 請求項16に記載の核酸検査装置において、前記増幅反応結果に、Ct値検出を含むことを特徴とする核酸検査装置。
- 請求項16に記載の核酸検査装置において、前記増幅反応結果に、プラトー検出を含むことを特徴とする核酸検査装置。
- 請求項16に記載の核酸検査装置において、前記増幅反応結果に、増幅未検出を含むことを特徴とする核酸検査装置。
- 請求項16に記載の核酸検査装置において、前記次処理選択条件に、Melting解析あるいは、HRM解析処理を含むことを特徴とする核酸検査装置。
- 請求項16に記載の核酸検査装置において、前記次処理選択条件に、酵素を失活させる加熱処理を含むことを特徴とする核酸検査装置。
- 請求項16に記載の核酸検査装置において、前記増幅反応結果ごとの、前記次処理選択条件を、反応容器ごとに設定可能とすることを特徴とする核酸検査装置。
- 請求項18に記載の核酸検査装置において、前記増幅検出条件と、前記増幅反応終了条件と、前記増幅反応結果ごとの前記次処理選択条件とを、反応容器ごとに設定可能とすることを特徴とする核酸検査装置。
- 請求項1から26に記載の核酸検査装置において、反応液を収容した少なくとも1つの反応容器をそれぞれ保持する複数の温調ブロックを設けた保持具と、
前記複数の温調ブロックのそれぞれに設けられ、前記反応液の温度を調整する温度調整装置とを備えた増幅検出機構を有することを特徴とする核酸検査装置。 - 請求項27に記載の核酸検査装置において、前記保持具に、反応容器を順次搬入する機構を有することを特徴とする核酸検査装置。
- 請求項27に記載の核酸検査装置において、前記保持具に、反応容器を順次搬出する機構を有することを特徴とする核酸検査装置。
- 請求項27に記載の核酸検査装置において、核酸の増幅反応と、Melting解析処理、あるいは、HRM解析、あるいは、酵素を失活させる加熱処置とを、反応容器の移動なしに、連続して処理することを特徴とする核酸検査装置。
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