Why choose GenomEra^®?

GenomEra^® CDX is a molecular diagnostics system intended to aid in the diagnosis of infections in humans. It is designed to be used with GenomEra in vitro diagnostic (IVD) nucleic acid assay kits for the qualitative detection of specific DNA or RNA in different direct clinical or cultured sample matrices. The platform includes the GenomEra CDX instrument, GenomEra CDX Software and GenomEra Assay Kits with GenomEra Test Chips and offers an easy-to-use and cost-effective solution for routine molecular testing with high performance, reliability, and top-quality results. Its innovative technology enables a high detection sensitivity with minimal signal interference from clinical samples.

GenomEra CDX System can be used in a clinical laboratory or healthcare unit not necessarily having a specialist in molecular biology but rather personnel who routinely perform assays and analyses in the field of infectious diseases diagnostics. The system presents simplicity at its extreme, as it requires no dedicated laboratory premises or prior expertise in PCR diagnostics. GenomEra CDX System is highly scalable as up to eight instruments can be linked to a single workstation. The instrument is of robust design and will provide reliable day-to-day operation over many years, with no need for regular calibration. The integrated and intuitive GenomEra CDX Software interface provides a powerful tool for automated, simple, and reliable result interpretation.

Key facts

• Automated PCR assay platform for rapid GenomEra Assay Kits with ready-to-use GenomEra Test Chips,
• Superior simplicity and sensitivity—intuitive GenomEra CDX Software, and high detection sensitivity with minimal signal interference
• Automated, traceable, and cost-efficient with results for four samples in just 50 or 70 minutes, depending on the Assay Kit
• Safe and easy disposal of sealed test chips with zero risk of contamination

GenomEra® CDX instrument and Software

GenomEra® CDX is a molecular diagnostics analyzer consisting of an integrated thermal cycler and a time-resolved fluorometer.¹ The GenomEra CDX system utilizes a unique combination of highly fluorescent, proprietary lanthanide labels and robust time-resolved detection technology (Figure 1). In addition, promt labels are used in some of the assay kits in combination with proprietary lanthanide labels. The innovative technology enables high detection sensitivity with minimal signal interference from clinical samples. For full traceability, every GenomEra® Test Chip has a unique barcode, and all actions are recorded in an audit log. The GenomEra CDX system is connectable to Laboratory Information Systems (LIS).

Figure 1. Lanthanide chelate labels allow highly sensitive measurement using time-resolved fluorometry. The sensitivity stems from the labels’ long decay time as well as their large Stokes shift.

The patented multi-block thermal cycling technology of GenomEra CDX enables rapid real-time PCR (qPCR), reverse transcription qPCR (RT-qPCR), and homogenous end-point PCR amplification with 45 thermal cycles. Sample preparation of four specimens takes less than 5 min or no more than 10 minutes depending on the Assay Kit, and the amplification run is complete in 50 or 70 minutes depending on the Assay Kit. One GenomEra CDX instrument allows the processing of 1-4 samples in about an hour, translating to a workflow of up to 32 samples per 8h working shift. For higher test volumes, for example, during epidemics, up to 8 instruments can be connected to a single workstation, allowing up to 256 samples to be analyzed in an 8-hour working shift.

The instrument is operated via the intuitive GenomEra® CDX Software with robust and automated result reporting.

GenomEra® Test Chips

The GenomEra CDX instrument is used to run analyte specific, ready-to-use GenomEra® Test Chips that come with the Assay Kit, and that have been developed for the detection of specific DNA or RNA sequences in different direct clinical or cultured sample matrices. The sample preparation is simple with minimal hands-on time. The GenomEra Test Chips are very robust and will tolerate an exceptionally high presence of PCR inhibitors. No separate DNA/RNA extraction is needed, even with direct stool specimens. This significantly reduces the workload of laboratory personnel.

All reagents required for performing the amplification and detection are readily dried and preloaded in the patented, ready-to-use disposable Test Chips. All Assay Kits utilize an amplification control to monitor for assay inhibition. The preloaded Test Chip design eliminates the need for reagent handling, and the automated, permanent sealing of the Test Chips enables easy disposal with a low volume of waste and with zero risk of contamination.

Test procedure

An example of sample preparation for C.difficile.

1. Sample preparation Simple sample preparation for every sample type The average hands on time is only  a few minutes per sample
2. Add sample to the Test Chip 1-4 samples can be analysed in the same run Mixed runs are enabled for assays that utilize the same PCR protocol
3. Start the assay Load the Test Chips into the instrument Type or scan the sample ID  and start the run
4. Read results Results are automatically calculated and reported in the GenomEra® software

Dimensions of the GenomEra instrument

39.3cm (width) x 32.5 cm (height) x 54 cm (depth)

Ordering information

To place an order, please contact your local distributor.

Product name	Product code
GenomEra CDX System	CDX-10-020

The GenomEra CDX System is CE marked according to the regulation (EU) 2017/746 (IVDR).

Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

GenomEra® is a registered trademark of Uniogen.

References

1. Hagren V., Von Lode P., Syrjälä A., Soukka T., Lövgren T., Kojola H., Nurmi J. An automated PCR platform with homogeneous time-resolved fluorescence detection and dry chemistry assay kits. Anal Biochem 2008;374:411.