JP2005255884A - Wash liquid for probe for clinical test automatic analyzer and method for washing - Google Patents

Wash liquid for probe for clinical test automatic analyzer and method for washing Download PDF

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JP2005255884A
JP2005255884A JP2004070682A JP2004070682A JP2005255884A JP 2005255884 A JP2005255884 A JP 2005255884A JP 2004070682 A JP2004070682 A JP 2004070682A JP 2004070682 A JP2004070682 A JP 2004070682A JP 2005255884 A JP2005255884 A JP 2005255884A
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probe
automatic analyzer
washing
sample
clinical test
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Shino Odawara
紫野 小田原
Hisahiko Iwamoto
久彦 岩本
Michiyasu Kawano
充康 川野
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A&T Corp
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Abstract

<P>PROBLEM TO BE SOLVED: To make washing of a probe for collecting a specimen complete, to prevent contamination among specimens and to improve reliability of measured values when the specimens are continuously analyzed with a clinical test automatic analyzer. <P>SOLUTION: A wash liquid for the clinical test automatic analyzer containing a chaotropic ion, e.g. SCN<SP>-</SP>is used. The concentration of the chaotropic ion used as the wash liquid is at least ≥0.1 mol/L and the pH is ≥10. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

本発明は臨床検査自動分析装置用プローブの洗滌液および洗滌法に関する。さらに詳しくは、検体間汚染を防止するのに有効な、上記プローブの洗滌液および洗滌法に関する。   The present invention relates to a cleaning solution and a cleaning method for a probe for an automatic clinical analyzer. More specifically, the present invention relates to a cleaning solution and a cleaning method for the probe, which are effective for preventing contamination between samples.

臨床検査自動分析装置による分析では、数多くの検体を短時間で集中的に分析することを要求されることが多く、そのため特定の臨床検査マーカーについて検体間汚染の発生が危惧される。   In the analysis by the clinical laboratory automatic analyzer, it is often required to intensively analyze a large number of specimens in a short time, and there is a concern about the occurrence of contamination between specimens for a specific clinical laboratory marker.

すなわち、臨床検査自動分析装置では、1の検体を採取したプローブは、分析後洗滌され、次の検体の採取に用いられるので、洗滌が十分でないときには、特定の検査マーカーについて先の検体が後の検体を汚染する危険があり、特に先の検体が特定の検査マーカーを高濃度で含んでいたような場合には、洗滌が十分でないと後の検体を激しく汚染することが起るようになる。   That is, in the clinical laboratory automatic analyzer, the probe from which one sample is collected is washed after analysis and is used for collecting the next sample. There is a risk of contaminating the specimen, and particularly when the previous specimen contains a specific test marker at a high concentration, the subsequent specimen may be severely contaminated if the washing is not sufficient.

従来、このような検体間汚染を防止すべく、プローブの洗滌を単に水洗するのではなく、次亜塩素酸ナトリウム水溶液で行うことが実際になされてきた。   Conventionally, in order to prevent such contamination between specimens, it has been actually practiced to wash the probe with an aqueous sodium hypochlorite solution instead of simply washing with water.

しかしながら、臨床検査マーカーの種類が多岐に亘り、検査感度が非常に上昇しているような状況において、短時間で多数の検体を分析するようなときには、上記の如き、従来知られていたプローブの洗滌法では検体間汚染を完全に防止することは実際に不可能であった。   However, when analyzing a large number of specimens in a short time in a situation where there are a wide variety of clinical test markers and the test sensitivity is very high, In the cleaning method, it was actually impossible to completely prevent contamination between samples.

それ故、本発明の目的は、プローブの洗滌を簡単に且つ確実になすことができ、それによって検体間汚染を防止する、臨床検査自動検査装置用プローブの洗滌液および洗滌法を提供することにある。   SUMMARY OF THE INVENTION Therefore, an object of the present invention is to provide a cleaning solution and a cleaning method for a probe for an automatic clinical testing apparatus, which can easily and reliably clean the probe and thereby prevent contamination between specimens. is there.

本発明のさらに他の目的および利点は、以下の説明から明らかになろう。   Still other objects and advantages of the present invention will become apparent from the following description.

本発明によれば、本発明の上記目的および利点は、第1に、カオトロピックイオンを含有することを特徴とする、臨床検査自動分析装置用プローブの洗滌液によって達成される。   According to the present invention, the above objects and advantages of the present invention are achieved firstly by a washing solution for a probe for an automatic analyzer for clinical testing, characterized in that it contains chaotropic ions.

本発明の上記目的および利点は、本発明によれば、第2に、臨床検査自動分析装置で特定の臨床検査マーカーを、プローブに検体を採取して測定する方法において、第1の検体について測定したのち、第2の検体について測定する前に、第1の検体を採取したプローブをカオトロピックイオンを含有する洗滌液で洗滌することを特徴とする、臨床自動分析装置による臨床検査マーカーの測定法によって達成される。   According to the present invention, the above-mentioned objects and advantages of the present invention are as follows. Secondly, in the method of collecting and measuring a specific clinical test marker with a clinical test automatic analyzer, the first sample is measured. Then, before measuring the second specimen, the probe from which the first specimen is collected is washed with a washing solution containing chaotropic ions. By the clinical laboratory marker measurement method using a clinical automatic analyzer, Achieved.

本発明の洗滌剤によれば、プローブの洗滌が確実に行われるため、検体間汚染が防止できるので、継続して次々と各検体について分析した臨床検査マーカーの測定値の信頼性を確保することができる。   According to the cleaning agent of the present invention, since the probe is reliably cleaned, contamination between samples can be prevented, so that the reliability of the measured values of the clinical laboratory markers analyzed for each sample continuously can be ensured. Can do.

本発明の洗滌液はカオトロピックイオン(chaotropic ion)を含有する。カオトロピックイオンとしては、陰イオンと陽イオンが知られているが、本発明ではカオトロピック陰イオンが好ましく用いられる。カオトロピック陰イオンとしては、例えばSCN-、I-、ClO4 -、NO3 -およびBr-を好ましいものとして挙げることができる。かかるカオトロピック陰イオンを水中で生成する化合物としては、例えば上記陰イオンのナトリウム塩、カリウム塩、アンモニウム塩等を好ましいものとして挙げることができる。 The washing liquid of the present invention contains chaotropic ions. Anions and cations are known as chaotropic ions, but chaotropic anions are preferably used in the present invention. Preferred examples of the chaotropic anion include SCN , I , ClO 4 , NO 3 and Br . As a compound which produces | generates this chaotropic anion in water, the sodium salt of the said anion, potassium salt, ammonium salt etc. can be mentioned as a preferable thing, for example.

カオトロピックイオンの濃度は、少なくとも0.1モル/lであることが好ましく、さらに好ましくは0.5〜4.0モル/l、より好ましくは0.8〜1.5モル/lである。0.1モル/lより低い濃度ではプローブの洗滌が必ずしも十分でないことがある。   The concentration of chaotropic ions is preferably at least 0.1 mol / l, more preferably 0.5 to 4.0 mol / l, more preferably 0.8 to 1.5 mol / l. At concentrations lower than 0.1 mol / l, probe cleaning may not always be sufficient.

本発明の洗滌液は、好ましくは10以上、より好ましくは12以上、特に好ましくは13以上のpHを有する。かかるpHの調整はアルカリ性化合物例えば苛性ソーダ、苛性カリの如き無機塩基あるいは水酸化テトラメチルアンモニウムの如き有機塩基を挙げることができる。   The washing liquid of the present invention preferably has a pH of 10 or more, more preferably 12 or more, and particularly preferably 13 or more. Such pH adjustment can include alkaline compounds such as inorganic bases such as caustic soda and caustic potash or organic bases such as tetramethylammonium hydroxide.

臨床検査自動分析装置では、検体をプローブに採取してその検体について特定の臨床検査マーカーの測定を行う。臨床検査マーカーとしては、例えばBNP、ANP、AFP、CEA、PSA、PLAII、HBs抗原などを挙げることができる。臨床検査自動分析装置では、例えば次のようにして分析が行われる。同装置に備え付けの第1反応カップ内に、プローブで採取した所定量のヒト血漿(検体)、測定しようとする臨床検査マーカー例えば心疾患マーカー(抗原)に対する抗体として例えばビオチン標識抗体および該臨床検査マーカーに対する別の抗体として例えばALP標識抗体を入れ、臨床検査マーカーをビオチン標識抗体とALP標識抗体でサンドイッチにした抗原抗体複合体を生成せしめる。次いで、同装置に備え付けの第2反応カップ内で、固定された抗ビオチン抗体と、第1反応カップ内の反応液とを接触せしめて、固定された抗ビオチン抗体と、第1反応カップ内に生成した上記抗原抗体複合体を反応せしめる。次に、固定された上記反応生成物を洗滌したのち、発光基質を加えてALP標識に由来する発光量を測定する。測定された発光量から、測定しようとした臨床検査マーカーの濃度を検量線を用いて求める。   In an automatic clinical test analyzer, a sample is collected on a probe and a specific clinical test marker is measured for the sample. Examples of clinical laboratory markers include BNP, ANP, AFP, CEA, PSA, PLAII, and HBs antigen. In an automatic clinical test analyzer, analysis is performed as follows, for example. In a first reaction cup provided in the apparatus, a predetermined amount of human plasma (specimen) collected with a probe, a clinical test marker to be measured, for example, an antibody against a heart disease marker (antigen), for example, a biotin-labeled antibody and the clinical test For example, an ALP-labeled antibody is inserted as another antibody against the marker, and an antigen-antibody complex is produced in which a clinical test marker is sandwiched between a biotin-labeled antibody and an ALP-labeled antibody. Next, the immobilized anti-biotin antibody and the reaction solution in the first reaction cup are brought into contact with each other in the second reaction cup provided in the apparatus, and the immobilized anti-biotin antibody and the first reaction cup are brought into contact with each other. The produced antigen-antibody complex is reacted. Next, after washing the immobilized reaction product, a luminescent substrate is added and the amount of luminescence derived from the ALP label is measured. From the measured luminescence amount, the concentration of the clinical test marker to be measured is obtained using a calibration curve.

上記の如き手順で1つの検体について測定が終了するが、検体の採取に用いられたプローブは、その後次の検体を採取するため洗滌される。本発明の洗滌剤はその際に用いられる。洗滌剤で洗滌されたプローブは次いでイオン交換水で洗滌されたのち、次の検体の採取に用いられる。このような手順により、臨床検査分析装置により次々と検体の分析が継続して行われる。実際の洗滌は、プローブ中に洗滌液を吸引し、直ちに排出するだけで十分である。   The measurement for one sample is completed by the procedure as described above, but the probe used for collecting the sample is then washed to collect the next sample. The cleaning agent of this invention is used in that case. The probe washed with the washing agent is then washed with ion-exchanged water and then used for collecting the next specimen. According to such a procedure, analysis of samples is continuously performed one after another by the clinical laboratory analyzer. In actual cleaning, it is sufficient to suck the cleaning liquid into the probe and immediately drain it.

本発明を更に詳細に説明するために、以下実施例および比較例を挙げて説明するが、本発明はこれらの実施例に限定されるものではない。   In order to describe the present invention in more detail, examples and comparative examples will be described below, but the present invention is not limited to these examples.

実施例1
キャリーオーバー(検体間汚染)を確認するため、測定項目としてBNPを選択し、汚染を与える検体として高BNP濃度検体(検体A、BNP濃度:3833.9pg/mL)、汚染を確認する検体として低BNP濃度検体(検体B、BNP濃度:2.7pg/mL)を選択した。臨床検査自動分析装置として全自動化学発光免疫測定装置MI02(エイアンドティー(株)製)を用い、プローブの洗滌効果を本発明の洗滌液について行った。本発明の洗滌液として、1mol/Lのチオシアン酸ナトリウム(和光純薬(株)製)と1Nの水酸化ナトリウム(和光純薬(株)製)から成る水溶液を用いた。また、実際の洗滌操作は、上記臨床検査自動分析装置内にこの洗滌液の入ったボトルをセットすることにより、自動的にプローブに供給して行った。
Example 1
In order to confirm carryover (contamination between samples), BNP is selected as a measurement item, a high BNP concentration sample (specimen A, BNP concentration: 3833.9 pg / mL) as a sample that gives contamination, and low as a sample that checks contamination. A BNP concentration sample (Sample B, BNP concentration: 2.7 pg / mL) was selected. Using a fully automatic chemiluminescence immunoassay device MI02 (manufactured by A & T Co., Ltd.) as an automatic analyzer for clinical examination, the cleaning effect of the probe was performed on the cleaning solution of the present invention. As the washing liquid of the present invention, an aqueous solution composed of 1 mol / L sodium thiocyanate (manufactured by Wako Pure Chemical Industries, Ltd.) and 1N sodium hydroxide (manufactured by Wako Pure Chemical Industries, Ltd.) was used. Moreover, the actual washing operation was performed by automatically supplying the probe to the probe by setting the bottle containing the washing liquid in the clinical analyzer automatic analyzer.

その結果を表1に示した。表1から明らかなように、検体Aを測定した直後に検体Bを測定した場合でも、検体Aによる汚染は認められなかった。   The results are shown in Table 1. As is clear from Table 1, even when the sample B was measured immediately after the sample A was measured, no contamination by the sample A was observed.

Figure 2005255884
Figure 2005255884

実施例2〜5および比較例1〜12
洗滌液として、下記表2に記載の洗滌液を準備した。
Examples 2-5 and Comparative Examples 1-12
As the washing liquid, the washing liquid described in Table 2 below was prepared.

Figure 2005255884
Figure 2005255884

洗滌液を上記各洗滌液に変え、実施例1と同じ手順で各検体のBNP濃度を測定した。その結果を表3に示した。   The washing solution was changed to each washing solution, and the BNP concentration of each specimen was measured in the same procedure as in Example 1. The results are shown in Table 3.

Figure 2005255884
Figure 2005255884

Claims (8)

カオトロピックイオンを含有することを特徴とする、臨床検査自動分析装置用プローブの洗滌液。 A cleaning solution for a probe for an automatic analyzer for clinical examination, characterized by containing chaotropic ions. カオトロピックイオンがSCN-、I-、ClO4 -、NO3 -またはBr-である請求項1に記載の洗滌液。 Chaotropic ions SCN -, I -, ClO 4 -, NO 3 - or Br - cleaning solution according to claim 1 is. カオトロピックイオンの濃度が少なくとも0.1モル/lである請求項1または2に記載の洗滌液。 The washing solution according to claim 1 or 2, wherein the concentration of chaotropic ions is at least 0.1 mol / l. pHが10以上である請求項1〜3のいずれかに記載の洗滌液。 The washing liquid according to any one of claims 1 to 3, wherein the pH is 10 or more. 臨床検査自動分析装置で特定の臨床検査マーカーを、プローブに検体を採取して測定する方法において、第1の検体について測定したのち、第2の検体について測定する前に、第1の検体を採取したプローブをカオトロピックイオンを含有する洗滌液で洗滌することを特徴とする、臨床自動分析装置による臨床検査マーカーの測定法。 In a method of collecting a specific clinical test marker by using a clinical test automatic analyzer and collecting a sample on a probe, the first sample is collected after measuring the first sample and before measuring the second sample. A method for measuring a clinical laboratory marker using a clinical automatic analyzer, wherein the probe is washed with a washing solution containing chaotropic ions. カオトロピックイオンがSCN-、I-、ClO4 -、NO3 -またはBr-である請求項5に記載の方法。 The method according to claim 5, wherein the chaotropic ion is SCN , I , ClO 4 , NO 3 or Br . 洗滌液のカオトロピックイオンの濃度が少なくとも0.1モル/lである請求項5または6に記載の方法。 The method according to claim 5 or 6, wherein the concentration of chaotropic ions in the washing liquid is at least 0.1 mol / l. 洗滌液のpHが10以上である請求項5〜7のいずれかに記載の方法。
The method according to any one of claims 5 to 7, wherein the pH of the washing liquid is 10 or more.
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007108209A (en) * 2005-10-11 2007-04-26 Tokuyama Corp Cleaning agent

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007108209A (en) * 2005-10-11 2007-04-26 Tokuyama Corp Cleaning agent

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