As oncology testing expands, laboratories are challenged with finding highly characterized, standardized and reproducible quality control materials to support validation or verification of new assays. Prior to reporting patient results, validation or verification is required to establish or verify the performance characteristics of a new assay. Furthermore, for each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytical process.
Thermo Fisher Scientific, through the AcroMetrix control products, provides innovative standards for validation and verification processes that offer an effective solution to some of the challenges presented during the adoption of new assays. The AcroMetrix product portfolio provides molecular quality control products that aid laboratories in meeting quality and regulatory requirements, while supporting the goal of standardization in molecular testing by establishing traceability of results for consistent, accurate, and meaningful test results.
The AcroMetrix™ Oncology Hotspot Control is intended for use with next generation sequencing (NGS) assays that are designed to identify somatic mutations in DNA from human samples. As a multiplexed, proprietary DNA quality control, the AcroMetrix Oncology Hotspot Control is designed to enable labs to control the hundreds of amplicons targeted by NGS panels. It contains over 500 mutations from the Catalogue of Somatic Mutations in Cancer (COSMIC) database, and has five variant types of different nucleotide lengths. This product is for in vitro diagnostic use.
The Acrometrix FFPE full process controls provide flexibility to process the controls based on your workflow protocols, from sample extraction to analysis. AcroMetrix synthetic formalin-fixed and paraffin-embedded (FFPE) controls use a proprietary process that optimizes reproducibility of the sections within a single production lot. By embedding synthetic tissue in a homogeneous block, the tumor content in each section can be controlled and quantified.
FFPE controls make ideal full process controls for the testing of tumor samples because they can be used in all steps of processing a solid tumor sample, from nucleic acid extraction through testing and data analysis.
The Acrometrix FFPE full process controls are for Research Use Only and are not intended for clinical use.
The AcroMetrix Oncology Hotspot Control is a highly multiplexed quality control used to assess the performance of next-generation sequencing (NGS) assays that detect somatic mutations. Against a highly characterized genomic background, over 500 SNPs, insertions, and deletions of varying lengths and complexities were added. The different mutation types allow a lab to use the Hotspot Control with various next-generation sequencing platforms, including custom library preparation panels. For more information on the genes and variants included in the AcroMetrix Oncology Hotspot Control, please click on the gene box below.
|Variant frequency near LOD||Can be used for analytical test method development and validation|
|Multiple variant types: SNVs, MNVs, and InDels||Captures the diversity of different types of somatic cancer hotspot mutations|
|500 + clinically relevant variants||·Highly multiplexed controls allows for detection of multiple targets using NGS platforms in a single reaction|
·Every mutation is Sanger Sequenced to confirm the identity of the mutation
|IVD labeled||Can be potentially used as an external quality control for clinical diagnostics on NGS platforms|
Not all AcroMetrix products are available in all countries. Please contact your sales representative for more information.