Pre-analytical Solutions

The sensitivity, resolution, and throughput of genomic and proteomic analytical instruments, such as Next-Generation DNA Sequencers and Mass Spectrometers, are leading the way to personalized medicine.  These state-of-the-art analytical systems, used in clinical diagnostics and clinical research, demand precise, accurate, and robust sample preparation.  Error, bias, and sample loss introduced into the system during sample acquisition, storage, and processing greatly decrease the accuracy and precision of these systems.

The Challenges

Why is pre-analytical sample preparation more important than the sensitivity, resolution, or throughput of your analytical system?

Precision & Accuracy

Precision is a measure of exactness – getting the same, reproducible result every time.  Accuracy is a measure of attaining the correct answer.  Precision without accuracy will provide reproducible results, however, they may not be correct.  While accurate results without precision will average close to the correct answer they will be subject to increased false-positives and false-negatives.

Many clinical assays have been developed with the focus on providing reproducible analytical results; however, if the pre-analytical steps do not properly preserve the sample the results can be reproducible but will not provide the correct answer or will be hindered by unacceptable false-positives and false-negatives.  To develop truly verifiable assays both precise and accurate pre-analytical sample preparation is required to attain precise and accurate analytical results.

Covaris systems are designed by engineers trained in developing in vitro and in vivo instrument systems.  Covaris focused-ultrasonicators are calibrated to NIST traceable standards.

Robustness

Verifiable clinical diagnostic results are only as good as the quality of the samples being analyzed.  A controlled, robust pre-analytical sample preparation method and instrument is essential for these more intricate clinical analyses.

The Solutions

Verifiable clinical diagnostics demand Precise, Accurate, and Robust pre-analytical sample preparation

Covaris pre-analytical sample preparation:

  • Preserves – the native in vivo state
  • Delivers – sensitive, unbiased, and reproducible results
  • Provides – a precise, accurate, and robust workflow

Clinical diagnostics encounter many challenges, limiting the development, implementation, and utility of new diagnostic tests.  By providing Precise, Accurate, and Robust solutions to pre-analytical sample preparation, Covaris is overcoming these challenges to deliver the next generation of diagnostics for personalized medicine.

Clinical Sequencing

Controlled acoustic energy provided by Covaris focused-ultrasonicators reproducibly generates tight DNA fragment distributions – tunable from 150 to 5,000 bp.  Isothermal processing delivers high quality DNA fragments which are not subject to heat induced damage, denaturing, or bias. Covaris DNA fragmentation with AFA is fast and highly reproducible, improving day-to-day and sample-to-sample confidence.  Covaris Focused-ultrasonicators are calibrated to NIST standards, are recommended by all the major sequencing platform providers and used in clinical labs worldwide (including CAP/CLIA certified laboratories in the US).

Nucleic Acid Extraction from Clinical FFPE samples

Covaris has developed a kit to extract DNA from Formalin-Fixed, Paraffin Embedded (FFPE) tissues, with focused-ultrasonicators.  It applies Adaptive Focused Acoustics (AFA) technology to the high efficiency extraction of nucleic acids.  When an AFA treatment is applied to a FFPE sample the paraffin is separated from the tissue sample by emulsification.  This is a mechanical process eliminating the use of hazardous organic solvents. It results in a simplified workflow, which greatly enhance DNA extraction yield, improves reproducibility, reduces hands on time, and ensures the seamless integration with Next Generation Sequencing (NGS) and other molecular analysis applications.

Cancer Biomarkers and Companion Diagnostics

The era of personalized medicine and companion diagnostics is now becoming a reality.  Many of the most promising predictive and prognostic indicators in Cancer treatment are labile molecules, such as post-translationally modified proteins, messenger and micro RNAs. The development of validated and verifiable assays for these targets demand a precise, accurate, and robust pre-analytical sample preparation capable of properly processing the samples.

The cryoPREP Extraction Systems have been purpose designed to integrate the tissue processing workflow from point-of-collection flash freezing to biochemical extraction with AFA™ Focused-ultrasonicators.  The tissueTUBE™ Systems are used to process tissue samples and extract biomolecules from a wide range of tissue samples ranging in mass from 10 mg up to 2 g.  The t-PREP™ System is designed to extract biomarkers and other biomolecules from small tissue samples (e.g., needle biopsies).

Enhanced Immunodiagnostic Assays

Adaptive Focused Acoustics (AFA), at low power, provides rapid, controlled, precise, reproducible, and isothermal enhancement of antigen binding in commercially available, off-the-shelf immunodiagnostic assays.  Assay sensitivity, specificity, reproducibility, and accuracy are improved with the AFA-enhanced assays providing superior Z’ factors.  AFA Focused-ultrasonicators can be used to achieve significant and precise enhancement of immunoreagent binding kinetics.

The significant reduction in antigen-antibody binding times achievable with AFA fits well with potential clinical diagnostic assay applications where AFA has the potential to enhance ELISAs several ways.  For example, to enhance the binding rate and to reduce non-specific binding.

Representative results on enhanced immunodiagnostics presented at the recent 2013 42nd Annual Oak Ridge Conference.