JP4026804B2 - Quality control method - Google Patents
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【０００１】
【発明が属する技術分野】
この発明は、臨床検査における検査結果の精度管理方法であって、測定値の信頼度の客観性を担保した精度管理方法に関する。
【０００２】
【従来の技術】
医学的診断の中で、最も客観的な情報提供が臨床検査である。正しい診断には、その検査情報が信頼できなければならない。高い客観性と信頼性には検査結果の正確さと精密さが長期に亘り維持・管理される必要がある。その精度管理を基盤に検査情報に適切な精度保証(Quality Assurance,QA)を与えるための工夫が種々検討されている。
検査データを評価するものに日内精密度（日内再現性）、日間精密度（日差再現性）、日内の精密度と日間精密度を合わせた総合精密度がある。しかし、日内精密度は検討された日のみの評価であり、日を変えてもより同じ再現性が得られる保証がなく、そのため１回の検討では日常の検査精度を把握しているとはいえない（図１）。また、日間精密度は、管理試料を１日１回測定し、１から数週間測定しその再現性を検討されているが、日内変動による影響は無視できないので、本来の日差変動を観察しているのではなく、見かけ上の日差を見ているにすぎず、本来の日差変動を見落としている可能性がある（図２）。
そこで、日内精密度と日間変動が合成された総合精密度を用いた精密度の評価方法が日本臨床衛生検査技師会の定量検査の精密さ正確さ評価法標準化ワーキンググループより「定量検査の精密さ正確さ評価法」が、1997年に提唱され、日本臨床検査標準協議会から指針（GC-JAMT1-1999）として公表された。
【０００３】
【発明が解決しようとする課題】
本発明の課題は、臨床検査における検査結果の精度管理方法であって、測定値の信頼度の客観性を担保した精度管理方法の提供をすることにある。
【０００４】
【課題を解決するための手段】
本発明は、各施設で精度管理試料を測定して得られた測定データを、広域情報伝達ツールを用いて収集し、収集した測定データの集計を行って、ＳＤ／（ intra −ＳＤ）〔但し、ＳＤは施設の標準偏差を示し、（ intra −ＳＤ）は下記式で示される施設内変動を示す。〕およびＳＤｓ／（Ｓｗ／２）〔但し、ＳＤｓは総合精密度（標準偏差）を表し、（Ｓｗ／２）は参考許容誤差（標準偏差）を示す。〕を評価し、その評価結果を各施設に送信する精度管理方法に関する。
【数４】
また、本発明は、各施設で精度管理試料を測定して得られた測定データを、広域情報伝達ツールを用いて収集し、収集した測定データの集計を行って、ＳＤ／（ intra −ＳＤ）〔但し、ＳＤは施設の標準偏差を示し、（ intra −ＳＤ）は下記式で示される施設内変動を示す。〕およびＣＶｓ／Ｃｗ〔但し、ＣＶｓは総合精密度（変動係数）を表し、Ｃｗは参考許容誤差（変動係数）を示す。〕を評価し、その評価結果を各施設に送信する精度管理方法に関する。
【数５】
また、本発明は、各施設で精度管理試料を測定して得られた測定データを、広域情報伝達ツールを用いて収集し、収集した測定データの集計を行って、ＳＤ／（ intra −ＳＤ）〔但し、ＳＤは施設の標準偏差を示し、（ intra −ＳＤ）は下記式で示される施設内変動を示す。〕、ＳＤｓ／（Ｓｗ／２）〔但し、ＳＤｓは総合精密度（標準偏差）を表し、（Ｓｗ／２）は参考許容誤差（標準偏差）を示す。〕およびＣＶｓ／Ｃｗ〔但し、ＣＶｓは総合精密度（変動係数）を表し、Ｃｗは参考許容誤差（変動係数）を示す。〕を評価し、その評価結果を各施設に送信する精度管理方法に関する。
【数６】
【０００６】
【発明の実施の形態】
本発明におけるデータの収集法は以下である。
▲１▼管理試料と精密管理ソフトにて日常の精度管理を実施する。
▲２▼管理試料を１日２回以上測定し、１６日以上（好ましくは２０日以上）の測定データを確保する。精度管理データを週単位もしくは、月単位でＱＡＰセンター（データ解析部門又はデータ解析機関）にインターネット等の情報伝達媒体を利用（ｆｔｐもしくはｈｔｔｐ）し、送信する。
▲３▼収集された全国データには、各施設の各日の平均値と標準偏差、日数より一元配置分散分析を利用して施設内変動と施設間変動を計算する。
▲４▼用意された許容誤差テーブルと全国集計からの全国の施設内変動を用いて参加各施設の総合精密度を評価する。
▲５▼評価結果は、月毎にレポート（ＱＡＰ-216図７、７-2）にまとめてｅＭａｉｌ等の広域情報伝達媒体にて各施設に送信する。
【０００７】
臨床データが、臨床上許容できるかを判断するため、３種類の臨床的許容誤差が考えられているが、それらは、▲１▼技術的水準（実際の測定精度）：現在の技術水準に基づいて定める方法で優れた検査室における分析法の実際の測定誤差の大きさに目標を定めるものである。▲２▼臨床的な有用性から経験的に定められた精度
：有用性にもとづき医学的意思決定濃度における基準であるが、治療方針決定の立場や疾患の種類により基準が異なる点等に解決すべき問題がある。▲３▼測定誤差を生体の生理的変動と比較する考え方：個人の生理的変動値（ＳＤｗ）の１／２（ＳＤｗ/2）を基準値で割った値を誤差の限界とする考え方である。この▲３▼の方法が、個人の時系列データの観察という目的からも最も優れたものと考えられる。かくして、日内精密度と日間精密度を考慮した総合精密度が、臨床的に許容できれば、信頼性あるデータが提供できるといえる。
【０００８】
本発明の客観性を担保した評価方法は以下である。
上記で収集したデータを集計し、施設の標準偏差、各施設の総合精密度（ＳＤ、ＣＶ）を点数化することにより客観的な評価を可能にした。つまり施設の標準偏差（ＳＤ）を下記式で示される施設内変動（ｉｎｔｒａ−ＳＤ）で割った値（ＳＤ／ｉｎｔｒａ−ＳＤ）が１より小さい場合は５点、２より小さい場合は３点、３より小さい場合は１点、３より大きい場合は０点と点数をつける。
【数７】
【０００９】
同様に、総合精密度（標準偏差）（ＳＤｓ）を許容誤差（標準偏差）（Ｓｗ／２ ＪＡＭＴ参考テーブル）で割った値（ＳＤｓ／（Ｓｗ／２））が１より小さい場合は５点、２より小さい場合は３点、３より小さい場合は１点、３より大きい場合は０点と点数をつける。
【００１０】
さらに、総合精密度（変動係数）（ＣＶｓ）を許容誤差（変動係数）（Ｃｗ ＪＡＭＴ参考テーブル）で割った値（ＳＤｓ／（Ｃｗ／２））が１より小さい場合は５点、２より小さい場合は３点、３より小さい場合は１点、３より大きい場合は０点と点数をつける。
【００１１】
上記点数は一例であり、適宜点数は設定可能である。
【００１２】
具体的にｉｎｔｒａ−ＳＤ（施設内変動）、ＳＤｓ（総合精密度：標準偏差）、ＣＶｓ（総合精密度：変動係数）の計算方法は、図６、図８に開示した。
【００１３】
評価結果の送信先は、測定データを送信した施設に送信する場合の他、測定データを送信した施設とは異なる施設（例えば、測定データを送信した施設を管理する施設）に送信する場合等がある。
【００１４】
【実施例】
【実施例１】
日内変動と日間変動を検討するために，同一の試料を用いて日内を複数回測定し経時的に測定する必要がある。日本臨床検査標準協議会の指針（GC-JAMT1-1999)によると管理試料を１日に2回以上測定し１６日以上できれば２０日以上の測定値が必要である。図３の図-3は、10月1日から同一試料を複数回測定し6日間の測定したデータをプロットしたものである。各日の平均値を塗りつぶして、日内の変動を四角の大きさに表した。図３の図-3・2のように平均値を観察することで日間変動が観察できる。図４の図-4・2は日内変動を日間変動の影響を受けずに観察するために図４の図-4から日間の平均値を全平均値にスライド移動させたものであり、こうすると日内変動の大きさを観察することができる。このように変動を分解・合成して各変動の大きさを観察する手法が分散分析といい、このケースのように日内と日間と日という１要因を特定するので一元配置分散分析とよばれる。この日常の測定値には、上記の日内変動である日内精密度と日間変動である日間精密度が合成された総合変動である総合精密度が臨床的に許容できるかが評価の対象になる。
【００１５】
【実施例２】
日常の精度管理データから定期的な精密度の評価を行えるよう、評価基準に外部精度管理「ｅＱＡＰ：国際試薬精度管理システム」での全国集計による施設内精度と許容誤差を併用した総合精密さ評価システムを提供した。その流れの概要報告書は図５と図５-２、及び図７と図７-2に記載した。
１）システムの概要
▲１▼ｅＱＡＰへの参加により提供される管理試料と精度管理ソフトにて日常の精度管理を実施する。
▲２▼測定条件は、１日２回以上で月単位１６日以上の精度管理データを週単位もしくは、月単位でＱＡＰセンターにインターネット利用（ｆｔｐもしくはｈｔｔｐ）し、送信する。各検査室より送付されたデータは、図６及び図８のようにまとめられ、データ処理される。
▲３▼収集された全国データには、各施設の各日の平均値と標準偏差、日数より一元配置分散分析を利用して、施設内変動(intra SD:intra lavoratory SD)と施設間変動(SDP=各施設のSD/intra SD）を計算する。SDは、標準偏差を意味する。例えば毎日ｎ本の管理試料をｋ日間測定したデータから分散分析表を計算し、各精密度が求められる（図6）。
図中の各記号の意味は以下である。
【００１６】
Ｘｉｊ ： ｉ日目のｊ本目測定値（ｉ=1,2,・・・・,k ； j=1,2,・・・・,n）
日内精密度 ：ＳＤｅ＝［ＳＥ／｛ｋ（ｎ−１）｝］１／２
総合精密度 ：ＳＤｓ＝（ ＳＤａ ２ ＋ ＳＤｅ ２ ） １／２
日内変動に対する日間変動の有意性を自由度ｆ１＝ｆＡ，ｆ２＝ｆＥにより検定する。
Ｆ０＝ＶＡ／ＶＥ
Ｆ０＞Ｆ０．０５（ｆＡ，ｆＥ）であれば有意水準５％で有意な日間変動があると判断する。
【００１８】
▲４▼用意された許容誤差テーブル（Sw/2とCwの設定テーブル）と全国集計からの全国の施設内変動を用いて参加各施設の総合精密度を評価する（図７-２のJUDGE)。
図中の各記号の意味は以下である。
【００１９】
SDP:SD/intra-SD
SD:施設の標準偏差
intra-SD:施設内変動
SDIs:SDs/(Sw/2）
SDs:総合精密度（標準偏差）
Sw/2:参考許容誤差（標準偏差）
CVIs:CVs/Cw
CVs:総合精密度（変動係数）
Cw:参考許容誤差（変動係数）
5.評価結果は、月毎にＱＡＰ-216レポート（図７、７-２）、にまとめて「ｅＭａｉｌ」にて各施設に返送する。
【００２０】
【発明の効果】
本発明によれば、臨床検査における精度管理方法であって、測定値の信頼度の客観性を担保した精度管理方法を提供することができる。
【００２１】
【参考資料・文献】
参考資料・文献
１)「臨床化学における定量検査の精密さ・正確さ評価法指針（改訂版）（GC-JAMT1-1999）」：日本臨床検査標準協議会会誌、51、3‐26 (1999)
２）R.N.Barnett 著,臼井敏明 訳：「臨床検査統計学 正常値、精度管理」，医学書院，1980
３）丹後俊郎 著：「臨床検査への統計学」，朝倉書店，1986
４）臼井敏明：パーソナルコンピューターを用いた臨床検査プログラムＴＱＡSystemの解説．QAP News 22，2-18，国際試薬，1984
５）桑克彦：自動分析の精度管理―誤差の要因分析の手法―．QAP News 15，21-30，国際試薬，1982
【図面の簡単な説明】
【図１】日内再現性試験を示す図。
【図２】日差再現性試験を示す図。
【図３】日間変動を示す図。
【図４】日内変動を示す図。
【図５】精度管理システムの流れ図。
【図５−２】精度管理システムの流れ図の説明。
【図６】分散分析表を利用した各精密度の計算。
【図７】QAP216レポート。
【図７−２】QAP216レポートの続き。
【図８】データ処理の方法図。
【符号の説明】
Sw/2：参考許容誤差（標準偏差）
Cw：参考許容誤差（変動係数）
table：Sw/2、Cwの設定テーブル
SDP ：各施設のＳＤ／ｉｎｔｒａＳＤ
Ｘｉｊ ： ｉ日目のｊ本目測定値（ｉ=1,2,・・・・,k ； j=1,2,・・・・,n）
SD：施設の標準偏差
DAYS：測定日数
SDｅ：施設の日内精密度： SDe＝［ＳＥ／｛ｋ（ｎ−１）｝］１／２
SDａ：施設の日間精密度： SDa＝｛（ＶＡ−ＶＥ）／ｎ｝１／２
SDｓ：施設の総合精密度（標準偏差）： SDs＝（ SDa ２ ＋ SDe ２ ）１／２
CVｓ：施設の総合精密度（変動係数）
intra-SD：施設内変動
SD ｗ /2：許容誤差（JAMT参考テーブル値）
CVｗ：許容誤差（JAMT参考テーブル値）
LABO ： 施設番号
ME :方法
MACHIN :機種
CA :較正
TM : 温度
MKR :試薬
TAN :単位
Ｆ＝Vａ/Vｅ（分散比の検定）[0001]
[Technical field to which the invention belongs]
The present invention relates to an accuracy management method for test results in clinical examinations, and relates to an accuracy management method that guarantees the objectivity of the reliability of measurement values.
[0002]
[Prior art]
Among medical diagnoses, the most objective information provision is clinical examination. For correct diagnosis, the test information must be reliable. For high objectivity and reliability, the accuracy and precision of inspection results must be maintained and managed over a long period of time. Based on the accuracy management, various devices for giving appropriate quality assurance (Quality Assurance, QA) to inspection information have been studied.
Evaluation of inspection data includes daily precision (day reproducibility), daily precision (day difference reproducibility), and total precision that combines daily precision and daily precision. However, the intraday precision is an evaluation only for the day examined, and there is no guarantee that the same reproducibility can be obtained even if the day is changed. Therefore, it can be said that daily examination accuracy is grasped by one examination. No (Figure 1). In addition, the daily precision is measured once a day for a control sample, measured for 1 to several weeks, and its reproducibility has been studied. However, since the effects of daily fluctuations cannot be ignored, observe the original daily fluctuations. Instead, they are merely looking at the apparent day difference and may overlook the original day difference (Figure 2).
Therefore, the precision evaluation method using the total precision that is the combination of the daily precision and the daily fluctuation is the “Qualitative examination precision” The “Accuracy Evaluation Method” was proposed in 1997 and published as a guideline (GC-JAMT1-1999) by the Japan Clinical Laboratory Standards Council.
[0003]
[Problems to be solved by the invention]
An object of the present invention is to provide an accuracy management method for a test result in a clinical test, which guarantees the objectivity of the reliability of a measurement value.
[0004]
[Means for Solving the Problems]
The present invention collects measurement data obtained by measuring quality control samples at each facility using a wide-area information transmission tool, and aggregates the collected measurement data to obtain SD / ( intra- SD) [however, , SD represents the standard deviation of the facility, and ( intra- SD) represents the intra- facility variation represented by the following formula. ] And SDs / (Sw / 2) [where SDs represents the total precision (standard deviation), and (Sw / 2) represents the reference allowable error (standard deviation). ] , And an accuracy management method for transmitting the evaluation result to each facility.
[Expression 4]
In addition, the present invention collects measurement data obtained by measuring quality control samples at each facility using a wide area information transmission tool, and aggregates the collected measurement data to obtain SD / ( intra- SD) [However, SD indicates the standard deviation of the facility, and ( intra- SD) indicates the intra- facility variation represented by the following formula. ] And CVs / Cw (where CVs represents the total precision (variation coefficient), and Cw represents a reference tolerance (variation coefficient)). ] , And an accuracy management method for transmitting the evaluation result to each facility.
[Equation 5]
In addition, the present invention collects measurement data obtained by measuring quality control samples at each facility using a wide area information transmission tool, and aggregates the collected measurement data to obtain SD / ( intra- SD) [However, SD indicates the standard deviation of the facility, and ( intra- SD) indicates the intra- facility variation represented by the following formula. ], SDs / (Sw / 2) [where SDs represents the total precision (standard deviation), and (Sw / 2) represents the reference tolerance (standard deviation). ] And CVs / Cw (where CVs represents the total precision (variation coefficient), and Cw represents a reference tolerance (variation coefficient)). ] , And an accuracy management method for transmitting the evaluation result to each facility.
[Formula 6]
[0006]
DETAILED DESCRIPTION OF THE INVENTION
The data collection method in the present invention is as follows.
(1) Perform daily quality control with control samples and precision control software.
(2) Measure the control sample twice or more a day and secure measurement data for 16 days or more (preferably 20 days or more). The quality control data is transmitted by using an information transmission medium such as the Internet (ftp or http) to the QAP center (data analysis department or data analysis organization) on a weekly or monthly basis.
(3) For the collected nationwide data, intra-facility fluctuations and inter-facility fluctuations are calculated using a one-way analysis of variance based on the average value, standard deviation, and number of days for each facility.
(4) Evaluate the total accuracy of each participating facility using the prepared tolerance table and the nationwide variation from the nationwide summary.
(5) The evaluation results are collected in a monthly report (QAP-216, FIGS. 7 and 7-2) and transmitted to each facility using a wide-area information transmission medium such as eMail.
[0007]
In order to judge whether clinical data is clinically acceptable, three types of clinical tolerances are considered. (1) Technical level (actual measurement accuracy): Based on current technical level The target is determined by the magnitude of the actual measurement error of the analytical method in an excellent laboratory. (2) Accuracy determined empirically from clinical usefulness: Although it is a standard in medical decision-making concentration based on usefulness, it resolves to different points depending on the position of treatment policy decision and the type of disease There is a problem. (3) The idea of comparing measurement errors with physiological changes in the living body: The idea is to use a value obtained by dividing 1/2 (SDw / 2) of an individual's physiological change value (SDw) by a reference value as the limit of error. . This method (3) is considered to be the most excellent for the purpose of observing individual time-series data. Thus, it can be said that reliable data can be provided if the overall precision considering the daily precision and the daily precision is clinically acceptable.
[0008]
The evaluation method ensuring the objectivity of the present invention is as follows.
The data collected above was aggregated, and the standard deviation of the facilities and the overall precision (SD, CV) of each facility were scored to enable objective evaluation. That is, if the value (SD / intra-SD) obtained by dividing the standard deviation (SD) of the facility by the intra- facility variation (intra-SD) represented by the following formula is less than 1, 5 points, If it is smaller than 3, 1 point is given, and if it is larger than 3, 0 point is given.
[Expression 7]
[0009]
Similarly, when the total precision (standard deviation) (SDs) divided by the allowable error (standard deviation) (Sw / 2 JAMT reference table) (SDs / (Sw / 2)) is smaller than 1, 5 points. If it is less than 2, the score is 3 points.
[0010]
Further, when the value (SDs / (Cw / 2)) obtained by dividing the total precision (variation coefficient) (CVs) by the allowable error (variation coefficient) (Cw JAMT reference table) is smaller than 1, 5 points is smaller than 2. In the case, the score is 3 points, 1 if it is less than 3, and 0 if it is greater than 3.
[0011]
The above score is an example, and the score can be set as appropriate.
[0012]
Specifically i ntra-SD (site fluctuations), SDs (Overall accuracy: standard deviation), CVs: Calculation method (Comprehensive precision coefficient of variation) is 6, disclosed in FIG. 8.
[0013]
The transmission destination of the evaluation result may be transmitted to a facility different from the facility that transmitted the measurement data (for example, a facility that manages the facility that transmitted the measurement data), in addition to the case where the measurement data is transmitted to the facility. is there.
[0014]
【Example】
[Example 1]
In order to examine daily fluctuations and daily fluctuations, it is necessary to measure the daily multiple times using the same sample and measure it over time. According to the guidelines of the Japan Clinical Laboratory Standards Association (GC-JAMT1-1999), a control sample is measured at least twice a day, and if it can be done for 16 days or more, a measurement value of 20 days or more is required. Fig. 3 in Fig. 3 is a plot of data measured for 6 days after the same sample was measured multiple times from October 1st. The average value for each day was filled in, and the fluctuations within the day were expressed as squares. Daily fluctuations can be observed by observing the average values as shown in Fig. 3 ・ 2 in Fig. 3. Fig. 4 ・ 2 in Fig. 4 is a slide of the daily average from Fig. 4 in Fig. 4 to the total average in order to observe daily fluctuations without being affected by daily fluctuations. The magnitude of daily fluctuation can be observed. The method of decomposing and synthesizing fluctuations and observing the magnitude of each fluctuation is called analysis of variance, and as in this case, one factor of day, day and day is specified, so it is called one-way analysis of variance. This daily measurement value is subject to evaluation as to whether or not the overall accuracy, which is the total variation obtained by synthesizing the above-mentioned daily accuracy and the daily accuracy, is clinically acceptable.
[0015]
[Example 2]
Comprehensive precision evaluation that uses both internal accuracy and tolerances based on nation-wide tabulation based on external quality control "eQAP: International Reagent Quality Management System" as an evaluation standard so that periodic accuracy can be evaluated from daily quality control data Provided the system. The summary report of the flow is shown in Fig. 5 and Fig. 5-2, and Fig. 7 and Fig. 7-2.
1) Outline of the system (1) Daily quality control is carried out with the control sample and quality control software provided by participating in eQAP.
(2) The measurement condition is that the quality control data of 16 days or more per month is used twice a day or more, and is transmitted to the QAP Center using the Internet (ftp or http) on a weekly or monthly basis. The data sent from each laboratory is collected and processed as shown in FIGS.
(3) For the collected national data, intra-facility variability (intra SD: intra SD) and inter-facility variability (intra SD: intra lavoratory SD) using the one-way analysis of variance based on the average value, standard deviation, and number of days SDP = SD / intra SD of each facility) is calculated. SD means standard deviation. For example, an analysis of variance table is calculated from data obtained by measuring n control samples every day for k days, and each precision is obtained (FIG. 6).
The meaning of each symbol in the figure is as follows.
[0016]
Xij: j-th measurement value on day i (i = 1, 2,..., K; j = 1, 2,..., N)
Intraday precision: SDe = [SE / {k (n-1)}] 1/2
Total precision: SDs = ( SDa 2 + SDe 2 ) 1/2
The significance of the daily fluctuation with respect to the daily fluctuation is tested by the degrees of freedom f 1 = f A and f 2 = f E.
F 0 = V A / V E
If F 0 > F 0.05 (f A , f E ), it is determined that there is a significant daily fluctuation at a significance level of 5%.
[0018]
(4) Evaluate the total accuracy of each participating facility using the prepared tolerance table (Sw / 2 and Cw setting table) and the nationwide fluctuations from the nationwide summary (JUDGE in Fig. 7-2) .
The meaning of each symbol in the figure is as follows.
[0019]
SDP: SD / intra-SD
SD: Facility standard deviation
intra-SD: the facility fluctuations
SDIs: SDs / (Sw / 2)
SDs: Overall precision (standard deviation)
Sw / 2: Reference tolerance (standard deviation)
CVIs: CVs / Cw
CVs: Total precision (coefficient of variation)
Cw: Reference tolerance (variation coefficient)
5. Evaluation results are sent back to each facility by “eMail” in a QAP-216 report (Figures 7 and 7-2) every month.
[0020]
【The invention's effect】
ADVANTAGE OF THE INVENTION According to this invention, it is an accuracy management method in a clinical test, Comprising: The accuracy management method which ensured the objectivity of the reliability of a measured value can be provided.
[0021]
[Reference materials and literature]
Reference Materials / Reference 1) “Guidelines for Evaluation of Accuracy and Accuracy of Quantitative Tests in Clinical Chemistry (Revised) (GC-JAMT1-1999)”: Journal of Japan Clinical Laboratory Standards Association, 51, 3-26 (1999)
2) RNBarnett, Toshiaki Usui Translated by: “Clinical laboratory statistics normal values, accuracy control”, Medical School, 1980
3) Toshiro Tango: “Statistics for Clinical Testing”, Asakura Shoten, 1986
4) Toshiaki Usui: Explanation of the clinical testing program TQASystem using a personal computer. QAP News 22, 2-18, International Reagents, 1984
5) Kuwahiko Kuwa: Accuracy management of automatic analysis-Method of error factor analysis-. QAP News 15, 21-30, International Reagents, 1982
[Brief description of the drawings]
FIG. 1 is a diagram showing a daily reproducibility test.
FIG. 2 is a diagram showing a daily difference reproducibility test.
FIG. 3 is a diagram showing daily fluctuations.
FIG. 4 is a diagram showing daily fluctuations.
FIG. 5 is a flowchart of a quality control system.
FIG. 5-2 is a flowchart of a quality control system.
FIG. 6 Calculation of each precision using an analysis of variance table.
FIG. 7: QAP216 report.
Fig. 7-2 Continuation of the QAP216 report.
FIG. 8 is a data processing method diagram.
[Explanation of symbols]
Sw / 2: Reference tolerance (standard deviation)
Cw: Reference tolerance (variation coefficient)
table: Sw / 2, Cw setting table
SDP : SD / intraSD of each facility
Xij: j-th measurement value on day i (i = 1, 2,..., K; j = 1, 2,..., N)
SD: Facility standard deviation
DAYS: Measurement days
SDe: Daily accuracy of facility: SDe = [SE / {k (n-1)}] 1/2
SDa: Facility daily precision: SDa = {(V A −V E ) / n} 1/2
SDs: overall precision (standard deviation) of the facility: SDs = (SDa 2 + SDe 2) 1/2
CVs: Overall accuracy of the facility (coefficient of variation)
intra-SD: Intra - facility variation
SD w / 2 : Tolerance (JAMT reference table value)
CVw: Tolerance (JAMT reference table value)
LABO: Facility number
ME: Method
MACHIN: Model
CA: Calibration
TM: Temperature
MKR: Reagent
TAN: Unit F = Va / Ve (dispersion ratio test)
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