JP2015225032A5 - - Google Patents
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- JP2015225032A5 JP2015225032A5 JP2014111439A JP2014111439A JP2015225032A5 JP 2015225032 A5 JP2015225032 A5 JP 2015225032A5 JP 2014111439 A JP2014111439 A JP 2014111439A JP 2014111439 A JP2014111439 A JP 2014111439A JP 2015225032 A5 JP2015225032 A5 JP 2015225032A5
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- Prior art keywords
- nucleic acid
- acid amplification
- reaction curve
- amplification reaction
- normal
- Prior art date
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- 230000003321 amplification Effects 0.000 claims 69
- 238000003199 nucleic acid amplification method Methods 0.000 claims 69
- 150000007523 nucleic acids Chemical class 0.000 claims 67
- 108020004707 nucleic acids Proteins 0.000 claims 67
- 238000005259 measurement Methods 0.000 claims 5
- 238000000034 method Methods 0.000 claims 4
- 230000002159 abnormal effect Effects 0.000 claims 2
- 239000012295 chemical reaction liquid Substances 0.000 claims 1
- 239000003153 chemical reaction reagent Substances 0.000 claims 1
Claims (20)
正常な核酸増幅反応曲線と測定した核酸増幅反応曲線を比較する比較部と、
比較結果に基づいて、測定した前記核酸増幅反応曲線が正常か否か判定する判定部と
を有する核酸増幅分析装置。 For a sample to be measured, a measurement unit that acquires a nucleic acid amplification reaction curve having a first axis of a two-dimensional graph as a measurement value for a nucleic acid amplification product and a second axis as a value indicating the progress of the nucleic acid amplification reaction;
A comparison unit for comparing a normal nucleic acid amplification reaction curve with a measured nucleic acid amplification reaction curve;
A nucleic acid amplification analyzer comprising: a determination unit that determines whether the measured nucleic acid amplification reaction curve is normal based on a comparison result.
前記比較部は、正常な核酸増幅反応曲線の変曲点における傾き又はプラトー値と、測定した核酸増幅反応曲線の変曲点での傾き又はプラトー値を比較する
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 1,
The comparison unit compares the slope or plateau value at the inflection point of a normal nucleic acid amplification reaction curve with the slope or plateau value at the inflection point of the measured nucleic acid amplification reaction curve. .
前記核酸増幅反応曲線の不連続な測定値に対してシグモイド関数を適用する第１の処理、シグモイド関数へ準ニュートン法を用いた近似処理を繰り返し適用する第２の処理、シグモイド関数のパラメータを決定する第３の処理を実行して、前記核酸増幅反応曲線の近似式を算出する演算機能部
を更に有する核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 2,
A first process for applying a sigmoid function to discontinuous measurement values of the nucleic acid amplification reaction curve, a second process for repeatedly applying an approximate process using a quasi-Newton method to the sigmoid function, and determining parameters of the sigmoid function A nucleic acid amplification analyzer further comprising an arithmetic function unit that executes the third process to calculate an approximate expression of the nucleic acid amplification reaction curve.
前記演算機能部は、
算出された前記近似式に従い算出された増幅産物に基づく測定値に対し、閾値に達する核酸増幅反応の進捗を示す値を算出する
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 3,
The arithmetic function unit is
A nucleic acid amplification analyzer, wherein a value indicating the progress of a nucleic acid amplification reaction reaching a threshold value is calculated for a measurement value based on an amplification product calculated according to the calculated approximate expression.
前記演算機能部は、
算出された前記近似式を前記核酸増幅反応曲線にフィッティング可能な場合、前記近似式を１階微分した関数に、前記近似式を２階微分して算出した変曲点の値を代入して、前記変曲点における前記近似式の傾きを算出する
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 3,
The arithmetic function unit is
When the calculated approximate expression can be fitted to the nucleic acid amplification reaction curve, the function of the first derivative of the approximate expression is substituted with the value of the inflection point calculated by second derivative of the approximate expression, A nucleic acid amplification analyzer that calculates the slope of the approximate expression at the inflection point.
前記演算機能部は、
前記核酸増幅反応曲線が算出された前記近似式にフィッティング不可の場合、前記核酸増幅反応曲線のプラトー値を算出する
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 3,
The arithmetic function unit is
A nucleic acid amplification analyzer that calculates a plateau value of the nucleic acid amplification reaction curve when fitting to the approximate expression in which the nucleic acid amplification reaction curve is calculated is impossible.
前記正常な核酸増幅反応曲線の前記変曲点と当該変曲点における前記傾き、又は、前記プラトー値を試薬容器の情報記憶手段から読み取る読み取り部
を更に有することを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 2 ,
A nucleic acid amplification analyzer further comprising a reading unit that reads the inflection point of the normal nucleic acid amplification reaction curve and the slope at the inflection point or the plateau value from information storage means of a reagent container.
前記正常な核酸増幅反応曲線の変曲点における傾きと、前記測定した核酸増幅反応曲線の変曲点における傾きを表示画面上に対比的に表示する
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 1,
A nucleic acid amplification analyzer characterized in that the inclination at the inflection point of the normal nucleic acid amplification reaction curve and the inclination at the inflection point of the measured nucleic acid amplification reaction curve are displayed on a display screen in contrast.
前記正常な核酸増幅反応曲線のプラトー値と、前記測定した核酸増幅反応曲線のプラトー値を表示画面上に対比的に表示する
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 1,
A nucleic acid amplification analyzer, wherein the plateau value of the normal nucleic acid amplification reaction curve and the plateau value of the measured nucleic acid amplification reaction curve are displayed on a display screen in contrast.
前記判定部は、測定した前記核酸増幅反応曲線が正常でないと判定された場合、想定される不具合内容及び／又は増幅不良を報知する
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 1,
The determination unit, when it is determined that the measured nucleic acid amplification reaction curve is not normal, informs of an assumed defect content and / or amplification failure.
前記判定部は、測定した前記核酸増幅反応曲線が正常でないと判定された場合、再キャリブレーション条件設定画面を通じて事前に設定された条件に従い、再キャリブレーションを実行させる
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 1,
The determination unit, when it is determined that the measured nucleic acid amplification reaction curve is not normal, recalibration is executed according to conditions set in advance through a recalibration condition setting screen. apparatus.
前記判定部は、測定した前記核酸増幅反応曲線が正常でないと判定された場合、再キャリブレーション条件設定画面を通じて事前に設定された条件に従い、再キャリブレーションを実行させ、
前記再キャリブレーション条件が、正常な核酸増幅反応曲線の変曲点における傾きと測定した核酸増幅反応曲線の変曲点での傾きとの比である
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 1,
When it is determined that the measured nucleic acid amplification reaction curve is not normal, the determination unit performs recalibration according to conditions set in advance through a recalibration condition setting screen ,
The recalibration condition is a ratio of a slope at an inflection point of a normal nucleic acid amplification reaction curve to a slope at an inflection point of a measured nucleic acid amplification reaction curve.
前記判定部は、測定した前記核酸増幅反応曲線が正常でないと判定された場合、再キャリブレーション条件設定画面を通じて事前に設定された条件に従い、再キャリブレーションを実行させ、
前記再キャリブレーション条件が、正常な核酸増幅反応曲線のプラトー値と測定した核酸増幅反応曲線のプラトー値との比である
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 1,
When it is determined that the measured nucleic acid amplification reaction curve is not normal, the determination unit performs recalibration according to conditions set in advance through a recalibration condition setting screen ,
The nucleic acid amplification analyzer is characterized in that the recalibration condition is a ratio of a plateau value of a normal nucleic acid amplification reaction curve and a plateau value of a measured nucleic acid amplification reaction curve.
前記判定部は、測定した前記核酸増幅反応曲線が正常でないと判定された場合、再検査条件設定画面を通じて事前に設定された再検査条件に従い、再検査を実行させる
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 1,
The determination unit, when it is determined that the measured nucleic acid amplification reaction curve is not normal, performs a retest according to a retest condition set in advance through a retest condition setting screen. apparatus.
前記再検査条件が、正常な核酸増幅反応曲線の変曲点における傾きと測定した核酸増幅反応曲線の変曲点での傾きとの比である
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 14,
The nucleic acid amplification analyzer is characterized in that the reexamination condition is a ratio of a slope at an inflection point of a normal nucleic acid amplification reaction curve to a slope at an inflection point of a measured nucleic acid amplification reaction curve.
前記再検査条件が、正常な核酸増幅反応曲線のプラトー値と測定した核酸増幅反応曲線のプラトー値との比である
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 14,
The nucleic acid amplification analyzer is characterized in that the reexamination condition is a ratio between a plateau value of a normal nucleic acid amplification reaction curve and a plateau value of a measured nucleic acid amplification reaction curve.
前記測定部は、
それぞれ独立に温度制御可能な複数の温調ブロックと、
反応液を収容する複数の反応容器がそれぞれの前記温調ブロックで温度制御される保持具と
を更に有することを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 1,
The measuring unit is
Multiple temperature control blocks that can be controlled independently,
A nucleic acid amplification analyzer comprising: a plurality of reaction containers that contain reaction liquids; and a holder whose temperature is controlled by each of the temperature control blocks.
前記測定部は、測定した前記核酸増幅反応曲線が正常でないと判定された場合の不具合内容に前記温調ブロックの異常が含まれたとき、異常が疑われる温調ブロックで温度制御される前記保持具の使用を禁止する
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 17,
The measurement unit is configured to control the temperature of the temperature control block in which the abnormality is suspected when the abnormality of the temperature control block is included in the failure content when it is determined that the measured nucleic acid amplification reaction curve is not normal. Nucleic acid amplification analyzer characterized in that the use of tools is prohibited.
再キャリブレーション条件設定画面を通じ、ユーザは、異常が疑われる温調ブロックの使用を禁止するか否かを事前に選択できる
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 18,
Through the recalibration condition setting screen, the user can select in advance whether or not to prohibit the use of a temperature control block suspected of being abnormal. The nucleic acid amplification analyzer.
再検査条件設定画面を通じ、ユーザは、異常が疑われる温調ブロックの使用を禁止するか否かを事前に選択できる
ことを特徴とする核酸増幅分析装置。 The nucleic acid amplification analyzer according to claim 18,
Through the retest condition setting screen, the user can select in advance whether or not to prohibit the use of a temperature control block suspected of being abnormal. The nucleic acid amplification analyzer.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2014111439A JP2015225032A (en) | 2014-05-29 | 2014-05-29 | Nucleic acid amplification analyzer |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2014111439A JP2015225032A (en) | 2014-05-29 | 2014-05-29 | Nucleic acid amplification analyzer |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2015225032A JP2015225032A (en) | 2015-12-14 |
| JP2015225032A5 true JP2015225032A5 (en) | 2017-04-20 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014111439A Pending JP2015225032A (en) | 2014-05-29 | 2014-05-29 | Nucleic acid amplification analyzer |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2015225032A (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2966769T3 (en) | 2017-09-26 | 2024-04-24 | Hoffmann La Roche | Calibration procedure |
| JP2021153516A (en) * | 2020-03-27 | 2021-10-07 | シスメックス株式会社 | Method for determining success or failure of nucleic acid amplification, apparatus for determining success or failure of nucleic acid amplification, and system for determining success or failure of nucleic acid amplification |
| JP2022109744A (en) * | 2021-01-15 | 2022-07-28 | シスメックス株式会社 | Nucleic acid analysis method and nucleic acid analyzer |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2107482B1 (en) * | 2003-12-06 | 2014-06-25 | Abbott Laboratories | Method and system for analyzing reactions using an information system |
| US8095322B2 (en) * | 2007-06-29 | 2012-01-10 | Roche Molecular Systems, Inc. | Systems and methods for determining cross-talk coefficients in PCR and other data sets |
| US9932628B2 (en) * | 2012-07-27 | 2018-04-03 | Gen-Probe Incorporated | Dual reference calibration method and system for quantifying polynucleotides |
| EP2719770B1 (en) * | 2012-10-15 | 2015-12-30 | F. Hoffmann-La Roche AG | A method of detecting a presence and/or measuring a quantity of an analyte in a sample by a nucleic acid amplification reaction |
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