Stringent Data Quality Standards

Built-in quality aimed at real-world use

The unique design, robustness and transparency of the LUNARIS™ Technology sets the stage for creating and validating assay protocols that meet top quality standards and regulatory requirements.

Reliable Multiplexing Results

High precision through measurement redundancy

beads

Each LUNARIS™ BioChip well harbors thousands of microbeads coated with different antibodies. Thus, signals from hundreds of microbeads conjugated to the same antibody are detected and used to calculate the concentration of a given analyte. This redundancy provides assurance of detection, high sensitivity down to pg/ml amounts, and a dynamic range over three to four logs.

The inter-well coefficient of variation for our validated assays is approximately 10% and accuracies are between 80% and 120%, which is compliant with EMEA and FDA guidelines.

Validated and Ready to Use

Documented and independently confirmed performance of each kit

LUNARIS™ Kits meet fundamental recommendations of international regulatory guidelines. Furthermore, reproduction and confirmation of our results through our beta-testing procedures are binding requirements for product launch. Therefore, product descriptions of our LUNARIS™ Kits include comprehensive information on validation criteria, such as assay performance, accuracy, precision, and linearity.

Feel free to contact our specialists with any additional questions about our data integrity and validation methods.

Optimized for the Toughest Samples

Antibodies selected for top performance

antibodies

A key aspect of our development work is the selection of high-quality antibody pairs that maximize assay sensitivity, while minimizing sample matrix effects and cross-reactivity among assay components and reagents.

Overall assay performance is further enhanced by the LUNARIS™ Design, which makes bead aggregation and signal quenching impossible. Finally, the high-resolution image-based readout guarantees reproducibility of results, even at sample volumes as low as 3 µL. 

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