Qiagen, 1141-011108-96, IDNAPTEX KRAS G12C

4 x 24 reactions containing probes and primers for KRAS mutation detection that cover Exon 2 – G12C and wild-type reference. Target Process Control for 2 × 10 reactions is also included. Works with DNA extracted from plasma (cfDNA) or FFPE tissue (gDNA) and is enabled for ID-ICE detection.
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Features

- Wet-lab-validated digital PCR assays for cancer research purposes
- Ready-to-use format with Target Process Control and a universal amplification program
- Seamless compatibility with ID SOLUTIONS ID-ICE for fail-proof liquid biopsy testing
- Streamlined workflow with automated nucleic acid extraction on the EZ2 Connect
- Optimized performance on the QIAcuity Digital PCR System

QIAcuity Digital PCR System is intended for non-clinical applications. This system is not intended for the diagnosis, prevention or treatment of a disease.

Product Details

- Assay-specific reagents (primers and probe mix) for 4 × 24 reactions
- Target Process Control for 2 × 10 reactions

ID SOLUTIONS IDNAPTEX assays are multiplexed, wet-lab-validated digital PCR assays designed for simultaneous detection of multiple tumor-associated DNA variants in a single well for cancer research purposes. Each kit contains:

All IDNAPTEX assays use a universal amplification program, allowing different assays to be run in parallel. Results are available in approximately 2.5 hours.

DNA extracted from both liquid (plasma cfDNA) and tissue biopsies (FFPE gDNA) is suitable for analysis. The assays are compatible with ID SOLUTIONS ID-ICE for liquid biopsy testing, and have been validated for use with DNA extracted using the EZ2 Connect system.

Each assay is to be used in combination with the QIAcuity master mix specified (QIAcuity Probe PCR Kit or QIAcuity High Multiplex Probe PCR Kit) and the QIAcuity Nanoplate 26k 24-well on the QIAcuity Digital PCR System.

Performance

IDNAPTEX assays provide a streamlined, high-performance approach to mutation detection in cancer research. Compatible with cfDNA from plasma and gDNA from FFPE tissues, the system can detect up to 23 targets in a single reaction.

The ready-to-use format and universal amplification program ensure fast setup across all assays. Results are delivered in less than 4 hours on the QIAcuity 5Plex Digital PCR System, with the complete workflow finishing in under a day.

Principle

Absolute quantification of DNA variants

IDNAPTEX assays are designed for use on the QIAcuity Nanoplate-based Digital PCR System for absolute nucleic acid quantification without the need for standard curves. The assays use specific sets of primers and fluorescent probes to detect genomic alterations in genes involved in tumor mechanisms. Results are expressed as presence or absence of each target, with estimated fractional abundance for mutations and/or copy number variation where applicable.

Multiplex target detection

An optimized mix of primers and probes enables the simultaneous amplification of multiple targets in a single reaction well. Up to 23 genomic alterations can be identified in one assay, maintaining precision and reproducibility across targets.

Target Process Control

Each assay includes a built-in Target Process Control to validate the performance of the run. This control confirms that amplification occurred as expected and helps ensure the reliability of results.

ID-ICE control

The optional patented ID-ICE control verifies extraction efficiency and confirms that any absence of detection is not caused by DNA template loss during processing. This is especially important for liquid biopsy samples, as it supports accurate longitudinal monitoring of cfDNA levels over time, which is often critical for tracking disease progression or treatment response.

Procedure

To perform the assay, add the defined volume of the corresponding QIAcuity master mix into the assay tube containing the ready-to-use IDNAPTEX primers and probes. Distribute the resulting amplification reaction mix into the required number of reaction tubes or wells of a multiple-well plate, using one well per assay. Add one sample per well along with the necessary controls, then mix thoroughly to ensure even distribution. Transfer each prepared reaction into a QIAcuity Nanoplate 26k, with one reaction per well, and place the Nanoplate into the QIAcuity Digital PCR System. Initiate the run using the universal IDNAPTEX thermal cycling program, which supports multiple assays simultaneously. Upon completion, review the results using preset auto-thresholds or adjust them manually if needed to confirm the presence or absence of targets. Finally, calculate fractional abundance and copy number variation, if applicable, using either the multiple occupancy table or the copies/µL concentration methods.

Applications

The applications include molecular characterization of tumors from both liquid and tissue biopsy samples, enabling biomarker discovery and cancer mutation profiling. The assays are intended for non-clinical applications and not for the diagnosis, prevention or treatment of a disease.