Ella Automated Immunoassay System

FAQs for Ella Automated Immunoassay System

• Where can Certificates of Analysis (CoAs) be found for Simple Plex cartridges and controls?

  Proceed to the Certificate of Analysis Finder Tool on the Bio-Techne.com website here: https://www.bio-techne.com/support/cofa-finder-tool.htmlFrom here, please enter the full catalog number and the lot number in the appropriate fields. 

• Can expired cartridges be run on the Ella?

  The Ella instrument is not programmed to reject expired cartridges, however Bio-Techne can only support the performance of cartridges within the expiration date.

• What is the minimum sample volume required for Simple Plex assays?

  A minimum final volume of 50 µL of diluted sample is required per sample inlet. See analyte specific specification sheet for Minimum Required Dilution (MRD). 

• What is the expiration date of a Simple Plex cartridge?

  Simple Plex cartridges expire one year from the date of manufacture.

• What is the expiration date of Simple Plex controls?

  Lyophilized controls are stable for up to 12 months from the date of receipt when stored at 2-8 °C. Reconstituted controls are stable for up to 6 months from date of preparation when stored at ≤ -70 °C. Storage at -20 °C is not recommended.

• Why do Simple Plex controls need to be frozen before use?

  The controls need to be frozen to ensure consistent readings between control aliquots.  Control aliquots used fresh may give different readings in the Simple Plex assays than aliquots that have been exposed to a freeze/thaw cycle.

• Are controls included when ordering Simple Plex cartridges?

  Simple Plex controls are sold separately. Instructions for use can be found on the control insert and lot-specific CoA. 

• Are custom Simple Plex assays available for analytes not currently on the menu?

  Custom panels with existing targets can be built using our Simple Plex Panel Builder Tool. Not finding a target you are interested in? Custom options are available for the Ella platform. Please fill out the custom services form and our team will contact you soon. Click Here

• Does Ella interface with a Laboratory Information Management System (LIMS)? 

  The Ella platform supports integration with Watson LIMS and also includes a Generic LIMS option for use with other LIMS interfaces. Please reference the Ella User Guide for more information regarding specific settings and export instructions.

• Can users be tracked and use separate log in accounts using the Simple Plex Software?

  After purchase and activation of the 21 CFR Part 11 capabilities, the software can be used to track users and each user will have their own separate log in. Please see the Ella User Guide for more information about the 21 CFR Part 11 capabilities.

• Are Simple Plex assays correlated to R&D Systems ELISA Assays?  

  Many Simple Plex assays have been correlated to R&D Systems Quantikine ELISAs. Simple Plex assays are not correlated to R&D Systems Luminex or DuoSet assays.

• Can Simple Plex assays be fully automated with a Liquid Handler? 

  Each of the cartridge inlets are spaced the same as a 96-well ELISA plate, but the dimensions are different for each cartridge format (48-Digoxigenin, 16x4, 32x4, 32x8, or 72x1). If you need more detailed dimensions of the plate to generate your liquid handler settings, please contact Technical Service. It may require some experimentation from the end user to determine optimal settings.

• Is assay performance comparable in a Single Plex and in a Multianalyte Simple Plex cartridge?

  Yes. The multianalyte cartridges have separate microfluidic chambers for each analyte. These multianalyte assays are not true multiplex assays, but rather 4 single plex assays run in parallel. The antibodies do not interact, so antibody compatibility and cross-reactivity are not a factor in considering whether any two analytes are compatible. In the Multiplex cartridges, up to two analytes share a single channel. Analytes available in the Multiplex cartridge have been fully validated as a panel to ensure that there is not any cross-reactivity or interference, and assay performance is comparable to the same assay run in a Single Plex or Multianalyte cartridge.

• Can high molecular weight proteins be run in a Simple Plex assay? 

  Simple Plex cartridges do not have any size limitations. The Glass Nano Reactors (GNRs) have an approximate inner diameter of 72 microns, which can accommodate very high molecular weight proteins.

• Can the assay range change from lot-to-lot in Simple Plex assays?

  The Limits of Quantification for each assay are established during development and do not change lot-to-lot.

• What is a self-test and how often should it be run? What is a verification cartridge? 

  The Ella includes a verification cartridge that enables the system to perform a self-test that ensures the instrument is running properly. The verification cartridge features a level indicator, a surface to seal Ella’s pneumatic interface, and an auto-fluorescing glass covered surface as an RFU reference. It is recommended that the self-test is run once a week to create a running history of system performance. Whenever handling the verification cartridge, wear gloves to avoid getting it dirty.