尿中代謝物の再現性ある定量

尿の分析は極めて複雑な反面、尿中の広範な栄養素や薬物、環境汚染物質の代謝経路を同定できるため、代謝分析には特に価値があり、そこから得られる情報も豊富です。臨床研究での大規模なサンプルコホートには、非常に優れた情報コンテンツと再現性で測定・分析が可能な自動化されたソリューションが必要です。

ブルカーのAvance® IVDr(In Vitro Diagnostics research)プラットフォームの新しいB.I.QUANT-UR™モジュールを使用することで、高精度、高感度で十分に再現性のある結果が得られるようになりました。このモジュールは、非臨床動物実験や臨床研究・トランスレーショナルリサーチ分野で高い実用可能性が示されてきました。

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B.I.QUANT-URには3種類のバージョンがあります

  • B.I.QUANT-UR b: 基本のバージョン。ほとんどの人尿に含まれる50種類の化合物と濃度範囲
  • B.I.QUANT-UR e: 拡張バージョン。生後6カ月以降用の150種類の化合物と濃度範囲。IEMその他の疾患マーカーを含む
  • B.I.QUANT-UR ne: 新生児用拡張バージョン。150種類の化合物と濃度範囲。疾患マーカーおよび健康な新生児モデルでのノンターゲットクラス分類を含む。

拡張バージョンは以下の目的にも使用できます。

  • 小児学
  • IEM患者の薬効と治療のモニタリング
  • 機能性食品の有効性と用量・組成
  • 選択的スクリーニング
  • 新生児の健康

Benefits of B.I.QUANT-PS 2.0

  • Ease of use, simple and rapid sample preparationƒƒ
  • Fully automated quantification of 41 metabolitesƒƒ
  • Different analytes classes can be quantified simultaneously in a single runƒƒ
  • Absolute concentration for each metabolite is given due to the calibration with one Quantification Reference sample(B.I.Methods™)ƒƒ
  • Validation of all LODs has been done following ISO 17025 guidelines for wet spiking
  • ƒƒRaw concentration and additionalƒƒ quantification result assessment information (correlation and residue) for each metabolite is given even below LOD
  • ƒƒInteractive PDF report allowing visual fit ambiguity assessmentƒƒ
  • Rapid analysis: daily 120 samples can be prepared, measured and analyzedƒƒ
  • Retrospective analysis possible if the sample was prepared and measured using B.I.Methods moduleƒƒ
  • Works on plasma or serum sample

Further Information

Deliverables B.I.QUANT-PS 2.0

  • ƒƒIncludes 41 metabolites (free metabolites, no protein denaturing done) with concentration ranges, occurring inmost human plasma/serum samples
  • ƒƒIncludes matrix identity test, differentiation between EDTA plasma and heparin plasma or serumƒƒ
  • In the analysis report, the metabolites are grouped according to their chemical class

    • Alcohols and derivatives
    • Amines and derivatives
    • Amino acids and derivatives
    • Carboxylic acids
    • Essential nutrient
    • Keto acids and derivatives
    • Sugars and derivatives
    • Sulfones
    • Technical additives

Figure 1

In table 1 an extract of the report automatically generatedby B.I.QUANT-PS 2.0 is shown. Metabolites are sorted intochemical classes. Absolute quantification values are given,LODs are listed as well as a 95% concentration range derivedfrom the validation spectra set. The actual sample is shownas a black bar in the concentration range, if the correspondingmetabolite is detected.

Table 1

Extract of B.I.QUANT-PS 2.0 of a serum

Figure 1 shows the interactive graphics of Alanine on aB.I.QUANT-PS 2.0 PDF report. It is an ideal situation, wherethe fit corresponds fully to the metabolite signal well aboveLOD, the raw concentration (r) is close to the result concentrationand the correlation (ρ) is > 95% and the residue (Δ) isclose to zero mmol/L.

Figure 2

Validation of Plasma/Serum Quantification Method

To test the validity of the results, the following measureswere taken and continuously followed:„„

  • Test reproducibility of measurement and analysis
  • „„Test transferability of measurement and analysis(participation of multi-laboratory trial)
  • „„Recovery rate (wet spiking)„„
  • Comparison to conventional methods
  • „„Traceability tests on some metabolites

For detailed metabolite lists and more technical information,please contact manfred.spraul@bruker.com and for sales information your local sales representative.B.I.QUANT-PS 2.0 module is offered as flat rate for 1 year,3 years with remote result generation and as pay per use transferring data sets to be analyzed by email or other means.

Figure 2 shows the interactive graphics of phenylalanine,where the raw concentration is below LOD. Using the graphical figure displayed, the fit signal can be clearly discriminated from the rest of the spectrum and the correlation is > 95%. The raw concentration can be used as approximative concentration estimate.

The results are provided twice, in PDF format as well as in XML format, which allows easier transfer into other programs for statistical analysis.

Disclaimer

The B.I.QUANT-PS 2.0 module is for research use only and is
not released for clinical diagnostics.

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