JP3125576U - Automatic analyzer - Google Patents

Abstract

【課題】臨床検査における測定不確かさを表示，補正する機能を備えた自動分析装置を提供すること。
【解決手段】臨床検査における既知濃度試料の濃度値決定時に定義される不確かさを、操作者による入力や、ネットワークを通じた配信により自動分析装置のデータベースに格納する。この値と、既知濃度試料を複数回測定した際に得られる装置の測定のばらつきの大きさから、当該測定系における測定不確かさの大きさを算出し、表示，出力する機能を備えた自動分析装置。
【選択図】図１To provide an automatic analyzer having a function of displaying and correcting measurement uncertainty in a clinical examination.
Uncertainty defined when determining a concentration value of a known concentration sample in a clinical test is stored in a database of an automatic analyzer by input by an operator or distribution through a network. Automatic analysis with a function to calculate, display, and output the measurement uncertainty in the measurement system from this value and the measurement variation of the device obtained when measuring a sample of known concentration multiple times. apparatus.
[Selection] Figure 1

Description

本考案は、生体試料中の成分を分析する臨床用自動分析装置に関するものである。   The present invention relates to an automatic clinical analyzer for analyzing components in a biological sample.

臨床検査における自動分析装置では、値付けされた既知濃度試料である標準液を測定し、得られた信号量と前記既知濃度より測定信号量と濃度の相関式を作成し、未知濃度試料である患者試料測定時の信号量を前記相関式を用いて濃度に変換する。装置の管理手法としては、前記相関式を用いて濃度算出された市販の管理試料を患者検体の測定間に定期的に測定し、一定の範囲内であることを確認する手法が一般的である。   In an automated analyzer in a clinical test, a standard solution, which is a known concentration sample with a price, is measured, and a correlation equation between the obtained signal amount and the known concentration is used to create a correlation equation between the measured signal amount and the concentration. The signal amount at the time of patient sample measurement is converted into a concentration using the correlation equation. As a device management method, a method is generally used in which a commercially available control sample whose concentration is calculated using the above-mentioned correlation formula is periodically measured during measurement of a patient sample and confirmed to be within a certain range. .

近年、臨床検査における測定結果の信頼性に対し、科学的な解析とルール化が国際的に進んでおり、国際標準で決められた値に対するトレーサビリティが保証されていることが、国内における臨床検査にも求められるようになった。   In recent years, scientific analysis and rule-making have progressed internationally for the reliability of measurement results in clinical tests, and traceability to the values determined by international standards is guaranteed in clinical tests in Japan. Also came to be required.

ＩＳＯ １５１８９：２００３，臨床検査室−質と適合能力に対する特定要求事項ISO 15189: 2003, Clinical laboratories-Specific requirements for quality and compatibility ＩＳＯ １７５１１：２００３，体外診断用医薬品・医療機器−生物試料の定量測定−校正物質と管理用物質の表示値の計量学的トレーサビリティISO 17511: 2003, In-vitro diagnostic pharmaceuticals and medical devices-Quantitative measurement of biological samples-Quantitative traceability of displayed values of calibration and control substances

上記国際的流れの中では、国際標準で定められる値を元に、最終的な未知濃度試料の測定結果に対し値とともにその値の不確かさを含めて伝達されることが求められているが、臨床検査における既知濃度試料は値のみのが伝達され、不確かさが含まれないことが通常であり、不確かさを伝達する場合においても、その手段は既知濃度試料の包装に含まれる紙であることが一般的であった。また、最終的な未知濃度試料の測定結果に含まれる値の不確かさには、その測定系（個々の装置）における測定のばらつきを考慮する必要があるが、一部の検査室においてのみ実験の上、ばらつきを含めた不確かさを算出しているのが現状であった。   In the above international flow, based on the value determined by the international standard, it is required that the measurement result of the final unknown concentration sample is transmitted together with the value including the uncertainty of the value. Samples of known concentration in clinical tests are usually transmitted only in value and do not include uncertainty, and even when transmitting uncertainty, the means should be paper included in the packaging of samples of known concentration Was common. In addition, the uncertainty of the value included in the measurement result of the final sample of unknown concentration needs to take into account the measurement variation in the measurement system (individual device). In the current situation, uncertainty including variation is calculated.

本考案は、臨床検査における既知濃度試料の濃度値決定時に定義される測定不確かさの大きさを、操作者による入力や、ネットワークを通じた配信により自動分析装置のデータベースに格納する。この値と、既知濃度試料を複数回測定した際に得られる装置の測定のばらつきの大きさから、当該測定系における測定不確かさの大きさを算出する。   In the present invention, the magnitude of measurement uncertainty defined when determining the concentration value of a known concentration sample in a clinical test is stored in a database of an automatic analyzer by input by an operator or distribution through a network. The magnitude of measurement uncertainty in the measurement system is calculated from this value and the magnitude of the measurement variation of the apparatus obtained when measuring a known concentration sample a plurality of times.

本考案によれば、個々の自動分析装置のもつばらつきの大きさの違いに由来する不確かさの大きさの違いを考慮した、精度の高い測定不確かさを測定結果に付加することが出来、測定結果の信頼性を向上させることができる。   According to the present invention, it is possible to add measurement uncertainty with high accuracy to the measurement result in consideration of the difference in uncertainty due to the difference in variation of each automatic analyzer. The reliability of the result can be improved.

以下図面を用いて本発明の実施例を説明する。   Embodiments of the present invention will be described below with reference to the drawings.

自動分析装置の動作は下記のように試料分注，試薬分注，撹拌，測光，反応容器の洗浄，濃度換算等のデータ処理の順番に実施される。   The operation of the automatic analyzer is performed in the order of data processing such as sample dispensing, reagent dispensing, stirring, photometry, reaction vessel cleaning, concentration conversion, and the like as follows.

患者試料を入れた試料容器は、検体ディスク１上に複数個設置されている。検体ディスク１は、コンピュータ２によりインターフェイス３を介して回転制御される。   A plurality of sample containers containing patient samples are installed on the specimen disk 1. The sample disk 1 is rotationally controlled by the computer 2 via the interface 3.

検体ディスク１は、分析される試料の順番に従って試料容器を試料分注機構４の下まで移動させ、所定の試料容器の検体は、試料分注機構４に連結された試料用ポンプ５により反応ディスク６の円周上に配置された反応容器７の中に所定量分注される。   The sample disk 1 moves the sample container to below the sample dispensing mechanism 4 according to the order of the samples to be analyzed, and the sample in the predetermined sample container is reacted by a sample pump 5 connected to the sample dispensing mechanism 4. A predetermined amount is dispensed into the reaction vessel 7 arranged on the circumference of 6.

前記試料を分注された前記反応容器７は、反応ディスク６が回転することにより第１試薬添加位置まで移動する。移動した前記反応容器７には、試薬分注機構８に連結された試薬用ポンプ９により試薬容器から吸引された試薬が所定量加えられる。   The reaction container 7 into which the sample has been dispensed moves to the first reagent addition position as the reaction disk 6 rotates. A predetermined amount of the reagent sucked from the reagent container by the reagent pump 9 connected to the reagent dispensing mechanism 8 is added to the moved reaction container 7.

試薬容器は試薬ディスク１０上に複数個設置されている。試薬ディスク１０は、コンピュータ２によりインターフェイス３を介して回転制御される。   A plurality of reagent containers are installed on the reagent disk 10. The reagent disk 10 is rotationally controlled by the computer 2 via the interface 3.

第１試薬添加後の反応容器７は、撹拌機構１１の位置まで移動し、試料と試薬の撹拌が行われる。このような試薬の添加−撹拌が、第１〜第４試薬について行われる。   The reaction container 7 after the addition of the first reagent moves to the position of the stirring mechanism 11, and the sample and the reagent are stirred. Such reagent addition-stirring is performed for the first to fourth reagents.

内容物が撹拌された前記反応容器７は光源から発した光束中を通過し、通過ごとに吸光度が測定される。この時の吸光度は多波長光度計１２により検知される。検知された前記吸光度信号は増幅器１３，Ａ／Ｄ変換器１４を経由して、インターフェイス３を介してコンピュータ２に入り、検体の濃度に変換される。   The reaction vessel 7 in which the contents are stirred passes through the light beam emitted from the light source, and the absorbance is measured for each passage. The absorbance at this time is detected by the multiwavelength photometer 12. The detected absorbance signal enters the computer 2 via the interface 13 via the amplifier 13 and the A / D converter 14 and is converted into the concentration of the sample.

濃度変換されたデータは、前記インターフェイス３を介してプリンタ１５から印字出力され、画面１６に表示される。   The density-converted data is printed out from the printer 15 via the interface 3 and displayed on the screen 16.

測光の終了した前記反応容器７は、洗浄機構１７の位置まで移動し、容器洗浄ポンプ
１８により内部を排出後、水で洗浄され、次の分析に供される。 After completion of photometry, the reaction container 7 moves to the position of the cleaning mechanism 17, and after the inside is discharged by the container cleaning pump 18, it is cleaned with water and used for the next analysis.

本考案を適応した自動分析装置では、既知濃度試料の濃度情報とその不確かさの大きさ情報が入力部１９から操作者によりインターフェース３を介してコンピュータ２に格納される。既知濃度試料は操作者によって試料容器に分注され、検体ディスク１上の標準液用ポジションに架設され、患者試料と同様に試料分注機構４まで移動し、精度確保のため１濃度につき複数回ずつ反応容器７に分注される。複数回の吸光度測定結果の平均値とコンピュータ２内で格納された濃度情報を元に、濃度と吸光度の相関式が作成される。また、複数回の吸光度測定結果を濃度に変換し、そのばらつきとあらかじめコンピュータ２に入力されている試料濃度の不確かさの大きさを合成し、測定系での不確かさの大きさが算出される。前記相関式を用いて、未知濃度試料の吸光度測定結果を濃度に換算され、前記不確かさの大きさが、未知濃度試料の測定結果の不確かさとしてプリンタ１５や画面１６に出力される結果に付加される。   In the automatic analyzer to which the present invention is applied, the concentration information of the known concentration sample and the magnitude information of the uncertainty are stored in the computer 2 from the input unit 19 via the interface 3 by the operator. The sample of known concentration is dispensed into the sample container by the operator, installed at the position for the standard solution on the specimen disc 1, and moved to the sample dispensing mechanism 4 in the same manner as the patient sample, and multiple times per concentration to ensure accuracy. One by one is dispensed into the reaction vessel 7. Based on the average value of a plurality of absorbance measurement results and the concentration information stored in the computer 2, a correlation equation between the concentration and the absorbance is created. Further, the result of the absorbance measurement of a plurality of times is converted into a concentration, the variation and the magnitude of the uncertainty of the sample concentration input in advance to the computer 2 are synthesized, and the magnitude of the uncertainty in the measurement system is calculated. . Using the correlation equation, the absorbance measurement result of the unknown concentration sample is converted into a concentration, and the magnitude of the uncertainty is added to the result output to the printer 15 or the screen 16 as the uncertainty of the measurement result of the unknown concentration sample. Is done.

本考案を適応した別の自動分析装置では、既知濃度試料の濃度情報とその不確かさの大きさ情報がネットワーク２０を介してインターフェース３からコンピュータ２に格納される。既知濃度試料は操作者によって試料容器に分注され検体ディスク１上の標準液用ポジションに架設され、患者試料と同様に試料分注機構４まで移動し、精度確保のため１濃度につき複数回ずつ反応容器７に分注される。複数回の吸光度測定結果の平均値とコンピュータ２内で格納された濃度情報を元に、濃度と吸光度の相関式が作成される。また、複数回の吸光度測定結果を濃度に変換し、吸光度情報と変換濃度結果がネットワーク２０を介し、データベース２１に送信される。データベース２１上ではこれらの情報の値をあらかじめ想定した値や、全施設における値の分布と比較し、偏りが見られる場合、偏りを補正する補正値を算出する。本補正値をネットワーク２０を介してインターフェース３に送信され、コンピュータ２に格納される。これらと、あらかじめコンピュータ２に入力されている試料濃度の不確かさの大きさを合成し、測定系での不確かさの大きさが算出される。ここで用いる既知濃度試料は、精度管理に用いられる精度管理試料でも良い。この場合、日内および複数日に渡って得られた測定結果が使用できる。前記相関式を用いて、未知濃度試料の吸光度測定結果を濃度に換算され、前記不確かさの大きさが、未知濃度試料の測定結果の不確かさとしてプリンタ１５や画面１６に出力される結果に付加される。   In another automatic analyzer to which the present invention is applied, the concentration information of the known concentration sample and the magnitude information of the uncertainty are stored from the interface 3 to the computer 2 via the network 20. The sample of known concentration is dispensed into the sample container by the operator, installed at the standard solution position on the specimen disc 1, and moved to the sample dispensing mechanism 4 in the same manner as the patient sample, and multiple times per concentration to ensure accuracy. It is dispensed into the reaction vessel 7. Based on the average value of a plurality of absorbance measurement results and the concentration information stored in the computer 2, a correlation equation between the concentration and the absorbance is created. In addition, a plurality of absorbance measurement results are converted into concentrations, and the absorbance information and the converted concentration results are transmitted to the database 21 via the network 20. On the database 21, the values of these information are compared with values assumed in advance or distributions of values in all facilities, and when a bias is found, a correction value for correcting the bias is calculated. This correction value is transmitted to the interface 3 via the network 20 and stored in the computer 2. These and the magnitude of the uncertainty of the sample concentration inputted in advance to the computer 2 are synthesized, and the magnitude of the uncertainty in the measurement system is calculated. The known concentration sample used here may be an accuracy control sample used for accuracy control. In this case, measurement results obtained within a day and over a plurality of days can be used. Using the correlation equation, the absorbance measurement result of the unknown concentration sample is converted into a concentration, and the magnitude of the uncertainty is added to the result output to the printer 15 or the screen 16 as the uncertainty of the measurement result of the unknown concentration sample. Is done.

本考案を用いた自動分析装置の構成例である。It is an example of composition of an automatic analyzer using the present invention.

符号の説明Explanation of symbols

１…検体ディスク、２…コンピュータ、３…インターフェース、４…試料分注機構、５…試料用ポンプ、６…反応ディスク、７…反応容器、８…試薬分注機構、９…試薬用ポンプ、１０…試薬ディスク、１１…攪拌機構、１２…多波長光度計、１３…増幅器、１４…Ａ／Ｄ変換器、１５…プリンタ、１６…画面、１７…洗浄機構、１８…洗浄用ポンプ、
１９…入力部、２０…ネットワーク、２１…データベース。

DESCRIPTION OF SYMBOLS 1 ... Sample disk, 2 ... Computer, 3 ... Interface, 4 ... Sample dispensing mechanism, 5 ... Sample pump, 6 ... Reaction disk, 7 ... Reaction container, 8 ... Reagent dispensing mechanism, 9 ... Reagent pump, 10 DESCRIPTION OF SYMBOLS ... Reagent disk, 11 ... Agitation mechanism, 12 ... Multi-wavelength photometer, 13 ... Amplifier, 14 ... A / D converter, 15 ... Printer, 16 ... Screen, 17 ... Cleaning mechanism, 18 ... Cleaning pump,
19 ... input unit, 20 ... network, 21 ... database.

Claims (8)

既知濃度の試料を測定し、得られた信号量と前記既知濃度より測定信号量と濃度の相関式を作成し、未知濃度試料測定時の信号量を前記相関式を用いて濃度に変換する臨床用の自動分析装置において、
項目ごとにあらかじめ測定値の不確かさの大きさを入力しておき、試料の測定結果に当該不確かさを付加して出力することを特徴とする自動分析装置。 A clinical method in which a sample of a known concentration is measured, a correlation equation is created between the obtained signal amount and the known concentration, and a signal amount and concentration are measured, and the signal amount at the time of unknown concentration sample measurement is converted into a concentration using the correlation equation Automatic analyzer for
An automatic analyzer characterized in that the magnitude of uncertainty of a measured value is input in advance for each item, and the uncertainty is added to the measurement result of the sample and output. 既知濃度の試料を測定し、得られた信号量と前記既知濃度より測定信号量と濃度の相関式を作成し、未知濃度試料測定時の信号量を前記相関式を用いて濃度に変換する臨床用の自動分析装置において、
項目ごとにあらかじめ入力された測定値の不確かさの大きさを、同一試料の複数回の測定結果により補正し、試料の測定結果に補正された不確かさを付加して出力することを特徴とする自動分析装置。 A clinical method in which a sample of a known concentration is measured, a correlation equation is created between the obtained signal amount and the known concentration, and a signal amount and concentration are measured, and the signal amount at the time of unknown concentration sample measurement is converted into a concentration using the correlation equation Automatic analyzer for
It is characterized in that the uncertainty of the measurement value input in advance for each item is corrected by multiple measurement results of the same sample, and the corrected uncertainty is added to the measurement result of the sample and output. Automatic analyzer. 既知濃度の試料を測定し、得られた信号量と前記既知濃度より測定信号量と濃度の相関式を作成し、未知濃度試料測定時の信号量を前記相関式を用いて濃度に変換する臨床用の自動分析装置において、
既知濃度試料にあらかじめ与えられた測定値の不確かさの大きさと、既知濃度試料の複数回における測定結果のばらつきの大きさより、未知濃度試料の測定結果の持つ不確かさの大きさを算出することを特徴とする自動分析装置。 A clinical method in which a sample of a known concentration is measured, a correlation equation is created between the obtained signal amount and the known concentration, and a signal amount and concentration are measured, and the signal amount at the time of unknown concentration sample measurement is converted into a concentration using the correlation equation Automatic analyzer for
It is possible to calculate the degree of uncertainty of the measurement result of the unknown concentration sample from the magnitude of the uncertainty of the measurement value given in advance to the sample of known concentration and the size of the variation of the measurement result of the known concentration sample multiple times. A featured automatic analyzer. 既知濃度の試料を測定し、得られた信号量と前記既知濃度より測定信号量と濃度の相関式を作成し、未知濃度試料測定時の信号量を前記相関式を用いて濃度に変換する臨床用の自動分析装置において、
既知濃度試料にあらかじめ与えられた測定値の不確かさの大きさと、既知濃度試料の複数回における測定結果のばらつきの大きさより、未知濃度試料の測定結果の持つ不確かさの大きさを算出し、測定結果に不確かさの大きさを付加することを特徴とする自動分析装置。 A clinical method in which a sample of a known concentration is measured, a correlation equation is created between the obtained signal amount and the known concentration, and a signal amount and concentration are measured, and the signal amount at the time of unknown concentration sample measurement is converted into a concentration using the correlation equation Automatic analyzer for
Calculate the uncertainty of the measurement result of the unknown concentration sample from the uncertainty of the measurement value given to the sample of the known concentration in advance and the variation of the measurement result of the known concentration sample multiple times. An automatic analyzer characterized by adding uncertainty to the result. 既知濃度の試料を測定し、得られた信号量と前記既知濃度より測定信号量と濃度の相関式を作成し、未知濃度試料測定時の信号量を前記相関式を用いて濃度に変換する臨床用の自動分析装置に接続される臨床用ネットワークシステムにおいて、
ネットワーク回線を通じ複数施設における同一既知濃度試料の測定結果を受信し、施設間での測定結果を集計し、既知濃度試料にあらかじめ与えられた測定値の不確かさの大きさと、同一施設内での既知濃度試料の複数回における測定結果のばらつきの大きさにより算出された未知濃度試料の測定結果の持つ不確かさの大きさを、施設間の集計結果を用いて補正することを特徴とする臨床用ネットワークシステム。 A clinical method in which a sample of a known concentration is measured, a correlation equation is created between the obtained signal amount and the known concentration, and a signal amount and concentration are measured, and the signal amount at the time of unknown concentration sample measurement is converted into a concentration using the correlation equation In a clinical network system connected to an automatic analyzer for medical use,
Receives the measurement results of the same known concentration sample at multiple facilities through the network line, aggregates the measurement results between the facilities, and the magnitude of the uncertainty of the measurement value given to the known concentration sample in advance and the known in the same facility A clinical network characterized by correcting the magnitude of uncertainty of measurement results of unknown concentration samples calculated based on the magnitude of variation in measurement results of multiple concentration samples using the aggregated results between facilities system. 請求項３のネットワークシステムより出力される補正結果を受信し、未知濃度試料の測定結果の持つ不確かさの大きさを補正することを特徴とする自動分析装置。   An automatic analyzer that receives the correction result output from the network system of claim 3 and corrects the magnitude of the uncertainty of the measurement result of the unknown concentration sample. 既知濃度の試料を測定し、得られた信号量と前記既知濃度より測定信号量と濃度の相関式を作成し、未知濃度試料測定時の信号量を前記相関式を用いて濃度に変換する臨床用の自動分析装置において、
既知試料濃度情報に不確かさの大きさを測定項目ごとに入力することを特徴とする自動分析装置。 A clinical method in which a sample of a known concentration is measured, a correlation equation is created between the obtained signal amount and the known concentration, and a signal amount and concentration are measured, and the signal amount at the time of unknown concentration sample measurement is converted into a concentration using the correlation equation Automatic analyzer for
An automatic analyzer that inputs the magnitude of uncertainty for each measurement item in known sample concentration information. 既知濃度の試料を測定し、得られた信号量と前記既知濃度より測定信号量と濃度の相関式を作成し、未知濃度試料測定時の信号量を前記相関式を用いて濃度に変換する臨床用の自動分析装置において、
項目ごとにあらかじめ測定値の不確かさの大きさを入力しておき、試料の測定結果に当該不確かさを付加して出力することを特徴とする自動分析装置。
A clinical method in which a sample of a known concentration is measured, a correlation equation is created between the obtained signal amount and the known concentration, and a signal amount and concentration are measured, and the signal amount at the time of unknown concentration sample measurement is converted into a concentration using the correlation equation Automatic analyzer for
An automatic analyzer characterized in that the magnitude of uncertainty of a measured value is input in advance for each item, and the uncertainty is added to the measurement result of the sample and output.

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