JP2002131324A - Coagulation time measuring instrument - Google Patents
Coagulation time measuring instrumentInfo
- Publication number
- JP2002131324A JP2002131324A JP2000324059A JP2000324059A JP2002131324A JP 2002131324 A JP2002131324 A JP 2002131324A JP 2000324059 A JP2000324059 A JP 2000324059A JP 2000324059 A JP2000324059 A JP 2000324059A JP 2002131324 A JP2002131324 A JP 2002131324A
- Authority
- JP
- Japan
- Prior art keywords
- inr
- value
- referential
- seconds
- inr value
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は、臨床検査診断薬の
分野でとりわけ血液凝固機能検査機器に利用される。[0001] The present invention is used in the field of diagnostic reagents for clinical tests, especially for blood coagulation function test equipment.
【０００２】[0002]
【従来の技術】血液凝固検査は先天的または後天的な血
液凝固異常を検査するため、広く行なわれている。中で
もプロトンビン時間（ＰＴ）の測定は経口抗凝固療法の
経口抗凝固剤の投与量を決めるために、重要な検査であ
る。しかしながら、ＰＴの測定に用いる測定用試薬の感
度が試薬により異なるため、被検検体のＰＴ或いは正常
検体のＰＴとの比（ＰＴ比）のみで一義的に経口抗凝固
剤の投与量を決めることは、重大な出血事故や抗凝固効
果の低下等種々の問題が起きる。そのため、国際的にＰ
Ｔ測定試薬の感度を指標化して標準化を図る方法（ＩＳ
Ｉ−ＩＮＲ法）が提案されている。すなわち被検検体の
ＰＴ比に試薬のＩＳＩ値を累乗した値をＩＮＲ値とし
て、その値でもって被検検体のＰＴを評価する方法であ
る。自動血液凝固能測定機器では、このような演算機能
を設定しておき、被検検体のＰＴ測定により、自動的に
ＩＮＲ値も合わせて出力される機能を有している。この
方法は、ＰＴそのものには絶対的な評価価値を認めず
に、ＩＮＲ値のみで評価する方法である。2. Description of the Related Art Blood coagulation tests are widely performed to check for congenital or acquired blood coagulation abnormalities. Above all, measurement of proton bin time (PT) is an important test for determining the dose of oral anticoagulant in oral anticoagulation therapy. However, since the sensitivity of the measurement reagent used for the measurement of PT differs depending on the reagent, the dose of the oral anticoagulant must be uniquely determined only by the ratio of the PT of the test sample or the PT of the normal sample (PT ratio). Various problems occur such as serious bleeding accidents and a decrease in anticoagulant effect. Therefore, internationally P
Method of standardizing by indexing the sensitivity of T measurement reagent (IS
I-INR method) has been proposed. That is, a method is used in which a value obtained by raising the ISI value of the reagent to the power of the PT ratio of the test sample as an INR value is used to evaluate the PT of the test sample using the value. The automatic blood coagulation ability measuring device has a function of setting such a calculation function and automatically outputting the INR value together with the PT measurement of the test sample. This method is a method of evaluating only the INR value without recognizing the absolute evaluation value of the PT itself.
【０００３】[0003]
【発明が解決しようとする課題】本発明の課題は、被検
検体のＰＴを、ＩＮＲ値を基に補正することによりＰＴ
そのものも評価できる計算方法、凝固検査結果の表示方
法、報告方法の機能を有した凝固時間測定装置を提供す
ることである。An object of the present invention is to correct the PT of a test sample by correcting the PT based on the INR value.
An object of the present invention is to provide a coagulation time measuring device having a function of a calculation method capable of evaluating itself, a method of displaying a coagulation test result, and a method of reporting.
【０００４】[0004]
【課題を解決するための手段】発明者らは鋭意研究を重
ねた結果、設定した基準ＩＮＲ値、当該基準ＩＮＲ値に
対応する基準ＰＴで補正した被検検体のＰＴを算出する
方法よび／または凝固検査結果の表示方法および／また
は報告方法をおよび当該機能を組み入れた装置を発明
し、本発明を完成させた。すなわち （１）基準の国際標準比（基準ＩＮＲ値）および当該基
準ＩＮＲ値に対応する基準ＰＴを予め任意に設定する工
程（工程１）、被検検体のプロトロンビン時間（ＰＴ）
測定とＩＮＲ値を求める工程（工程２）、工程２で求め
たＩＮＲ値を予め工程１で設定した基準のＩＮＲ値と対
比させ、基準ＰＴを基準のＩＮＲ値に対応する被検検体
のＰＴと対比させて算出する工程を行なう含むＰＴの算
出方法および／または凝固検査結果の表示方法および／
または報告方法。 （２）基準のＩＮＲ値を１に設定する前記（１）記載の
ＰＴの算出方法および／または凝固検査結果の表示方法
および／または報告方法。 （３）基準ＰＴを１０秒〜１３秒に設定する前記（１）
に記載のＰＴの算出方法および／または凝固検査結果の
表示方法および／または報告方法。 （４）基準のＩＮＲ値が１のときの基準ＰＴを１０秒〜
１３秒に設定することを特徴とする前記（１）〜（３）
にいずれか１に記載のＰＴの算出方法および／または凝
固検査結果の表示方法および／または報告方法。 （５）前記（１）〜（４）にいずれか１に記載の方法を
組み入れた装置。Means for Solving the Problems As a result of intensive studies, the inventors have calculated a reference INR value, a method of calculating a PT of a test sample corrected by a reference PT corresponding to the reference INR value, and / or The present invention was completed by inventing a method of displaying and / or reporting a coagulation test result and an apparatus incorporating the function. That is, (1) a step of arbitrarily setting in advance a reference international standard ratio (reference INR value) and a reference PT corresponding to the reference INR value (step 1), the prothrombin time (PT) of the test sample
A step of measuring and obtaining an INR value (step 2); comparing the INR value obtained in the step 2 with a reference INR value set in advance in the step 1; and comparing the reference PT with the PT of the test sample corresponding to the reference INR value. A method of calculating PT including performing a step of comparing and / or displaying a coagulation test result and / or
Or how to report. (2) The method for calculating a PT and / or the method for displaying and / or reporting a coagulation test result according to the above (1), wherein the reference INR value is set to 1. (3) The reference PT is set to 10 to 13 seconds (1).
And / or a method for displaying and / or reporting a coagulation test result. (4) The reference PT when the reference INR value is 1 is 10 seconds or more.
(1) to (3), wherein the time is set to 13 seconds.
2. The method for calculating PT and / or the method for displaying and / or reporting coagulation test results according to any one of (1) to (4). (5) An apparatus in which the method according to any one of (1) to (4) is incorporated.
【０００５】[0005]
【発明の実施の態様】本発明の具体的な実施態様により
さらに詳細に説明する。DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described in more detail with reference to specific embodiments.
【０００６】ＩＮＲ値はＰＴ比にＰＴ測定試薬のＩＳＩ
値を累乗することにより求めることが出来き、下式（数
１）により表すことが可能である。[0006] The INR value is calculated based on the PT ratio of the ISI
It can be obtained by raising the value to the power, and can be expressed by the following equation (Equation 1).
【数１】 既知のＩＮＲ値を付したキャリブレーターを用い、ＰＴ
試薬で当該キャリブレーターのＰＴを測定し（測定値を
ａ秒とする）、横軸にＬｏｇ（ａ）、縦軸にＬｏｇ（Ｉ
ＮＲ）をプロットし、その傾きからＩＳＩ値を求めるこ
とが出来る（ＩＳＩ値をｓとする）。このＩＳＩ値はＰ
Ｔ測定試薬に固有の値である。さらに、当該キャリブレ
ーターのＩＮＲ値、ＰＴ測定値（ａ秒）およびＰＴ測定
試薬のＩＳＩ値（ｓ）より、正常検体ＰＴが算出される
（ｘ秒）。(Equation 1) Using a calibrator with a known INR value, PT
The PT of the calibrator was measured with the reagent (measured value is a second), Log (a) was plotted on the horizontal axis, and Log (I) was plotted on the vertical axis.
NR) is plotted, and the ISI value can be obtained from the slope (the ISI value is s). This ISI value is P
This is a value specific to the T measurement reagent. Further, the normal sample PT is calculated (x seconds) from the INR value of the calibrator, the PT measurement value (a seconds) and the ISI value (s) of the PT measurement reagent.
【０００７】次に式１に示すＩＮＲ値、当該ＩＮＲ値に
対応するＰＴを任意に設定する（それぞれ基準ＩＮＲ
値、基準ＰＴという）。基準ＩＮＲ値を１．０それに対
応する基準ＰＴを１０〜１３秒に設定するのが好ましい
（設定した基準ＰＴをｔ秒とする）。基準ＩＮＲ値は下
式（数２）により表される。Next, the INR value shown in Expression 1 and the PT corresponding to the INR value are arbitrarily set (each of the reference INRs).
Value, reference PT). It is preferable that the reference INR value is set to 1.0 and the reference PT corresponding thereto is set to 10 to 13 seconds (the set reference PT is set to t seconds). The reference INR value is represented by the following equation (Equation 2).
【数２】 ｚは基準ＩＮＲ値に対応する基準ＰＴで補正した被検検
体のＰＴである。(Equation 2) z is the PT of the test sample corrected by the reference PT corresponding to the reference INR value.
【０００８】さらに、被検検体をＰＴ測定試薬で測定し
たときのＰＴをｙ秒とする。式1より被検検体のＩＮＲ
値は下式（数３）により算出することができる。Further, let PT be y seconds when a test sample is measured with a PT measuring reagent. From Equation 1, the INR of the test sample
The value can be calculated by the following equation (Equation 3).
【数３】 (Equation 3)
【０００９】数２および数３より、実測ＰＴ（ｙ秒）を
基準ＩＮＲ値およびそれに対応する基準ＰＴで補正値し
た値ｚは下式（数４）により算出できる。From Equations 2 and 3, a value z obtained by correcting the actually measured PT (y seconds) with the reference INR value and the corresponding reference PT can be calculated by the following equation (Equation 4).
【数４】 従ってｚは（ｔ／ｘ）×ｙにより算出される。(Equation 4) Therefore, z is calculated by (t / x) × y.
【００１０】上述の計算機能を演算プログラムとして凝
固時間測定装置に組み込む。演算プログラムを組み込ん
だ凝固時間測定装置は、予め入力されたＰＴ試薬のＩＳ
Ｉ値、設定した基準のＩＮＲ値とその基準ＰＴにより、
各測定検体の実測ＰＴからＩＮＲ値を算出後、補正ＰＴ
を算出および／または表示、および／または報告形式、
および／または報告値として出力する。出力は、プリン
ト、電子ファイル等の形で行われるのが一般的である。
さらに、出力項目は少なくとも補正ＰＴを含んでいれば
よく予め入力されたＰＴ試薬のＩＳＩ値、設定した基準
のＩＮＲ値とその基準ＰＴ、各測定検体の実測ＰＴとそ
のＩＮＲ値を適宜含むことも可能である。The above-mentioned calculation function is incorporated in a coagulation time measuring device as a calculation program. The coagulation time measuring device incorporating the calculation program is based on the PT reagent
By the I value, the set reference INR value and the reference PT,
After calculating the INR value from the measured PT of each measurement sample, the corrected PT
Calculating and / or displaying, and / or reporting format,
And / or output as a reported value. Output is generally performed in the form of a print, an electronic file, or the like.
Further, the output items only need to include at least the corrected PT, and may appropriately include the ISI value of the PT reagent previously input, the set reference INR value and its reference PT, the actually measured PT of each measurement sample, and its INR value. It is possible.
【００１１】本発明の実施態様のフローを図１に示し
た。それを参考にして本発明を説明する。先ず予め、基
準のＩＮＲ（通常ＩＮＲ値＝１．０）を設定し、そのＰ
Ｔを任意に設定する（例えば１１．０秒）。被検検体の
ＰＴを測定しＩＮＲ値を算出し、そのＩＮＲ値を基にＰ
Ｔを算出する。算出したＰＴ値を報告値として出力す
る。FIG. 1 shows the flow of an embodiment of the present invention. The present invention will be described with reference to it. First, a reference INR (normal INR value = 1.0) is set in advance, and its P
T is set arbitrarily (for example, 11.0 seconds). The PT of the test sample is measured to calculate the INR value, and the P value is calculated based on the INR value.
Calculate T. The calculated PT value is output as a report value.
【００１２】[0012]
【実施例】以下に実施例をあげて本発明を更に説明する
が、本発明は実施例に限定されるものではない。EXAMPLES The present invention will be further described below with reference to examples, but the present invention is not limited to the examples.
【００１３】[0013]
【実施例１】既知ＩＮＲのキャリブレター（ＡＫキャリ
ブラント：国際試薬株式会社製）をＰＴ測定試薬で測定
した結果を表１に示した。Example 1 Table 1 shows the results of measurement of a calibrated letter of a known INR (AK Calibrant: manufactured by Kokusai Reagent Co., Ltd.) using a PT measuring reagent.
【表１】 この結果よりＰＴ試薬のＩＳＩ値を求めると１．０３と
なった。このＩＳＩ値、表１に示す結果及び数１を用い
ることにより正常検体のＰＴを算出した。その結果、１
２．６２秒と算出されこの値を正常検体のＰＴとした。[Table 1] From this result, the ISI value of the PT reagent was determined to be 1.03. The PT of the normal sample was calculated by using the ISI value, the results shown in Table 1, and Expression 1. As a result, 1
The calculated value was 2.62 seconds, and this value was used as the PT of the normal sample.
【００１４】ＩＮＲ＝１．０のＰＴ（基準ＰＴ）を１
１．０秒と設定し、各検体のＰＴを測定し、その測定値
を上記正常検体のＰＴ＝１２．６２で除してＩＮＲ値を
求め、本発明の方法により補正した補正ＰＴを算出し
た。その結果を表２に示した。The PT of INR = 1.0 (reference PT) is set to 1
At 1.0 second, the PT of each sample was measured, the measured value was divided by the PT of the normal sample = 12.62 to obtain an INR value, and a corrected PT corrected by the method of the present invention was calculated. . The results are shown in Table 2.
【表２】 以上の結果、正常検体のＰＴが約１３秒近いＰＴ試薬で
の測定値も常に１１秒前後に補正され、ＰＴの絶対値の
比較評価が可能となることが判った。[Table 2] From the above results, it was found that the measured value of the PT of the normal sample with the PT reagent having a PT of about 13 seconds was always corrected to about 11 seconds, and the comparative evaluation of the absolute value of the PT became possible.
【００１５】[0015]
【発明の効果】ＩＮＲ値を基準にして実測ＰＴを補正す
ることにより、測定試薬のロット間差等によるＰＴ値の
変動を補正することが可能となり、ＰＴ値そのものを評
価することが可能となる。By correcting the actually measured PT based on the INR value, it is possible to correct the fluctuation of the PT value due to the difference between the lots of the measurement reagents, and to evaluate the PT value itself. .
【図１】本発明の実施態様のフローを示す図である。FIG. 1 is a diagram showing a flow of an embodiment of the present invention.
Claims (5)
び当該基準ＩＮＲ値に対応する基準プロトロンビン時間
（基準ＰＴ）を予め任意に設定する工程（工程１）、被
検検体のＰＴ測定とＩＮＲ値を求める工程（工程２）、
工程２で求めたＩＮＲ値を予め工程１で設定した基準の
ＩＮＲ値と対比させ、基準ＰＴを基準のＩＮＲ値に対応
する被検検体のＰＴと対比させて算出する工程を含むＰ
Ｔの算出方法および／または凝固検査結果の表示方法お
よび／または報告方法。A step of arbitrarily setting in advance a reference international standard ratio (reference INR value) and a reference prothrombin time (reference PT) corresponding to the reference INR value (step 1); A step of obtaining a value (step 2),
P includes a step of comparing the INR value obtained in step 2 with a reference INR value set in advance in step 1 and comparing the reference PT with a PT of a test sample corresponding to the reference INR value.
A method for calculating T and / or a method for displaying and / or reporting a coagulation test result.
記載のＰＴの算出方法および／または凝固検査結果の表
示方法および／または報告方法。2. The method according to claim 1, wherein the reference INR value is set to 1.
A method for calculating the PT described and / or a method for displaying and / or reporting a coagulation test result.
求項１に記載のＰＴの算出方法および／または凝固検査
結果の表示方法および／または報告方法。3. The method for calculating a PT and / or displaying and / or reporting a coagulation test result according to claim 1, wherein the reference PT is set to 10 seconds to 13 seconds.
１０秒〜１３秒に設定することを特徴とする請求項１〜
３にいずれか１に記載のＰＴの算出方法および／または
凝固検査結果の表示方法および／または報告方法。4. The reference PT when the reference INR value is 1 is set to 10 seconds to 13 seconds.
3. The method for calculating a PT and / or the method for displaying and / or reporting a coagulation test result according to any one of 3).
を組み入れた装置。5. An apparatus incorporating the method according to claim 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2000324059A JP2002131324A (en) | 2000-10-24 | 2000-10-24 | Coagulation time measuring instrument |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2000324059A JP2002131324A (en) | 2000-10-24 | 2000-10-24 | Coagulation time measuring instrument |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2002131324A true JP2002131324A (en) | 2002-05-09 |
Family
ID=18801647
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2000324059A Pending JP2002131324A (en) | 2000-10-24 | 2000-10-24 | Coagulation time measuring instrument |
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| Country | Link |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2008533496A (en) * | 2005-03-21 | 2008-08-21 | ホルスティ，ユハ | How to determine prothrombin time |
| JP2012505910A (en) * | 2008-10-20 | 2012-03-08 | エピトム ファーマシューティカルズ リミテッド | Method and system for improved pharmaceutical intervention in coagulation control |
-
2000
- 2000-10-24 JP JP2000324059A patent/JP2002131324A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2008533496A (en) * | 2005-03-21 | 2008-08-21 | ホルスティ，ユハ | How to determine prothrombin time |
| JP2012505910A (en) * | 2008-10-20 | 2012-03-08 | エピトム ファーマシューティカルズ リミテッド | Method and system for improved pharmaceutical intervention in coagulation control |
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