Overview of a Verigene® Test Cartridge

General description:
- Single use, self-contained, test unit comprised of the following:
- Reagent pack — single use plastic carrier that creates a hybridization chamber on the surface of the array, houses all of the reagents needed for a single Test, and captures all of the waste materials generated during Test processing.
- Slide (an array) — glass slide, solid support for the capture oligonucleotides required by the Test.
Capacity:
- Each Test Cartridge is designed for single-use analysis of one sample.
- The typical sample loading volume is 25 µL.
Functionality:
- All of the wet chemistry required to run a test occur inside a Test Cartridge, including:
- Fragmentation and denaturation of genomic DNA or RNA via on-board sonication.
- Primary hybridization of genomic DNA or RNA to capture probe oligonucleotides and mediator oligonucleotides under conditions of sufficient stringency.
- Washing away of unbound sample nucleic acids and mediator oligonucleotides.
- Secondary hybridization of gold nanoparticle probes to captured target nucleic acid / mediator oligonucleotide complexes.
- Washing away of unbound gold nanoparticle probes with oligonucleotides.
- Signal amplification of gold nanoparticles oligonucleotide probes.
- Washing away of unreacted signal amplification reagents.
FDA cleared for in vitro diagnostic (IVD) with specific Verigene® Tests. Please refer to the Verigene® Nucleic Acid Tests section.