Kit Protocol Documents & IFUs: Technical Guides for Cambrian Extraction Kits

A well-written protocol document should include a clear objective, list of materials, step-by-step procedural instructions, safety precautions, expected results, and troubleshooting guidance. For IVD-grade kits like those from Cambrian Bioworks, protocol documents also incorporate regulatory language, storage conditions, and performance validation data to meet ISO 13485 and CE-IVD requirements.

Protocol papers are published or documented descriptions of experimental procedures intended to guide scientists in replicating specific workflows. In molecular diagnostics, protocol papers for extraction kits—such as those for Cambrian's Whole Blood gDNA or FFPE RNA kits—describe optimized conditions, validated parameters like RIN scores and A260/280 ratios, and recommended downstream applications such as NGS or qPCR.

A protocol is a technical or procedural document classified as a standard operating procedure (SOP) or Instructions for Use (IFU) in regulated laboratory environments. It is distinct from general guides in that it provides binding, validated steps with defined parameters. Cambrian Bioworks' IFUs are regulatory-grade documents aligned with ISO 13485 quality management standards and CE-IVD requirements.

Cambrian Bioworks provides downloadable IFU documents for all their extraction kits, including the Whole Blood gDNA Isolation Kit, Blood RNA Isolation Kit, FFPE gDNA Isolation Kit, FFPE RNA Isolation Kit, and the OncoSeek cfDNA Extraction Kit. Manta Playbook guides and application notes are also available as supplementary technical resources.

Yes. All Cambrian Bioworks extraction kit protocols are designed for use with the Manta cartridge-based automated nucleic acid extraction system. Each IFU specifies the corresponding Manta protocol code (e.g., CBW-200-i4 for the Blood RNA Kit) and includes setup instructions optimized for the platform, supporting throughputs of 1 to 32 samples per run.

Cambrian Bioworks kit protocols support a broad range of downstream applications including Next-Generation Sequencing (NGS), PCR-based assays, RNA sequencing, digital PCR (ddPCR), microarray analysis, gene expression profiling, liquid biopsy, and minimal residual disease (MRD) detection. Each IFU specifies validated performance metrics—such as A260/280 ratios, RIN scores, and DV200 values—to confirm sample quality for these applications.