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Sample Matrix Validation

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Sample Matrix Validation

R Absolute Quantitation

R Rigorous Quality Control

R End-to-end Service

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Small Molecule Biochemistry In Your Chosen Matrix

Researchers often need to analyze new sample matrices not currently validated on available targeted panels, but require or desire a fully validated data pipeline to meet their needs. Metabolon previously included the validation of a new sample matrix as part of our Custom Targeted Panel offering, but recognized researchers’ need for a more stream-lined stand-alone product.  

Metabolon is proud to offer Sample Matrix Validation as a new solution to help you achieve your research goals within your chosen sample matrix. Any validation or development request will be tailored to your specific needs and ensure the highest possible accuracy, quality, and reproducibility for your current and future cohorts.

Not only is Sample Matrix Validation a more flexible solution, but it also gives customers access to Metabolon’s expertise in handling a wide variety of sample matrices and rigorous method validation, including GCP/GCLP (Good Clinical Practice / Good Clinical Laboratory Practice) level validation if needed.

Explore Functional Phenotype In Any Biological Sample

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Plant Matrices
Alfalfa Algae Alligator Wood Allium
Apple Arabidopsis Blueberry Brassica
Cacao Camelina Corn Cotton
Cranberry Cucumber Euphoria Ginseng
Hibiscus Hydrangea Iceplant Kalanchoe
Maize Millet Moss Oat
Opuntia (Cactus) Orange Oryza Sativa (Rice) Palm
Pea Peanut Peony Pepper
Petunia Pine Pomegranate Poplar
Potato Pumpkin Selaginella Sorphum
Soybean Sporobolus Sugar Beet Sugarcane
Summergrass Switchgrass Teff Tobacco
Tomato Walnut Watermelon Wheat
Human Matrices
Adrenal Gland Amniotic Fluid Aqueous Humor Ascites
BALF Bile Bone Marrow Breast Milk
Breath Condensate Cartilage Colon Dried Blood Spots
Endometrium Fallopian Tube Feces Hair Follicles
Heart Illeum Kidney Liver
Muscle Ovary Plasma Prostate
Retina Saliva Sebum Serum
Skin Spleen Sweat Synovial Fluid
Tears Tumor Urine Urine Sediment
Vitreous Fluid Whole Blood
Animal Matrices
Cat Chicken Cow Dog
Dolphin Ferret Fish (various) Fox
Frog Goat Guinea Pig Hamster
Horse Insect (various) Lobster Mollusk (various)
Monkey Mouse Nematode Pig
Rabbit Rat Reptile (various) Sea Urchin
Sheep Squirrel
Other Matrices
Cell Media Fungus (Yeast) Hydrolysates Mammalian Cells (CHO, HELA, Lymphocytes, RBC, etc.)
Non-Mammalian Cells (Bacteria, etc.) Organoids Phytoplankton

Delivering Absolute Quantification for Research and Biomarker Analysis

Our readily available or custom developed quantitative assays help you achieve your research and biomarker validation objectives with precise and fully validated methods. Our targeted assays and panels cover >1,000 metabolites and lipids across a wide range of biochemical classes, metabolic pathways, and physiological processes, and they can be customized to best fit any application.

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Sample Matrix Validation Details

Our Quality—ISO 9001:2015 Certified Laboratory

Metabolon offers three levels of sample validation: Exploratory (research-oriented, limited validation), RUO (Routine Use Only), and GCP/GCLP (Good Clinical Practice / Good Clinical Laboratory Practice).

All methods at Metabolon are validated to adhere to Metabolon’s ISO 9001:2015 certified quality system. Validation experiments are based on the FDA, EMA, and ICH M10 Bioanalytical Guidance documents. All data are peer-reviewed, and a summary report containing the results of the validation experiment is provided.

For GCP/GCLP validation, all experiments and acceptance criteria strictly adhere to the FDA, EMA, and ICH M10 Bioanalytical Guidances. All GCP/GCLP studies are peer-reviewed and audited by the Metabolon Quality Assurance Department. A validation report containing all of the elements listed in the M10 Bioanalytical Guidance is provided.

The table below outlines all evaluated analytical performance parameters for Exploratory, RUO, and GCP/GCLP standards.

ISO 9001

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Method Validation Offerings
Evaluated Parameters Exploratory RUO GCP/GCLP
Linearity, Accuracy, and Precision of Calibration Standards ✓ (1 run) ✓ (3 runs) ✓ (3 runs)
QC Precision Accuracy ✓ (1 level, precision only) ✓ (3 levels) ✓ (3 levels)
Lower Limit of Quantitation ✓ (1 run) ✓ (3 runs) ✓ (3 runs)
Selectivity ✓ (1 run) ✓ (3 runs) ✓ (3 runs)
Carryover ✓ (1 run) ✓ (3 runs) ✓ (3 runs)
Dilution Accuracy ✕ ✓ ✓
Extraction Recovery (also used to show accuracy) ✕ ✓ ✓
Sample Stability Testing – Benchtop Stability ✕ ✓ ✓
Sample Stability Testing – Freeze/Thaw Stability ✕ ✓ ✓
Secondary Instrument ✕ ✕ ✓
Parallelism ✕ ✕ ✓
Matrix Effect Testing ✕ ✕ ✓
Specificity ✕ ✕ ✓
Sample Stability Testing – Long-Term Stability ✕ ✕ ✓
Extract Stability Testing ✕ ✕ ✓
Run Injection Stability Testing ✕ ✕ ✓
Solution Stability Testing ✕ ✕ ✓
QA Review ✕ ✕ ✓
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Save Time, Reduce Costs

By leveraging Metabolon’s Sample Matrix Validation services, you can save time and reduce costs by validating your sample matrix for an established targeted panel. This new stream-lined Matrix Validation service bypasses the time and costs of developing a full custom panel and moves directly into sample matrix testing and validation. Metabolon is pleased to offer a turnaround time of 8 to 12 weeks for sample matrix validation once we receive your samples.

Why Metabolon?

Achieving absolute quantification for a panel of analytes in a reproducible, cost-effective, and timely manner can be challenging to achieve on your own. With Metabolon’s decades of experience, a library of over 5,400 known metabolites, and clinical know-how, we’re fully equipped to help you meet your research goals. Only Metabolon can follow an investigator through the scientific paradigm of target discovery, using our Global Discovery Panel to interrogate thousands of metabolites, through to target validation, using our suite of customizable targeted panels and validation levels—all at the cost-effective scale necessary to support your needs.

Big Insights with Metabolon

Cited in over 3,000 publications, we help scientists and manufacturers gain greater insight into their studies through metabolomics. See how our approach can become a successful part of your workflow.

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Request a quote for our services, get more information on sample types and handling procedures, request a letter of support, or submit a question about how metabolomics can advance your research.

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Morrisville, NC 27560

Mailing Address:
P.O. Box 110407
Research Triangle Park, NC 27709

+1 (919) 572-1711

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References

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