Eonis Q96 (IVD)

FAQs

• Does the assay detect all variants of SMA, SCID and XLA?

  The assay detects only homozygous SMN1 exon 7 deletions. The system does not detect SMA carriers or SMA that that is not due to the homozygous deletion of SMN1 exon 7.

  The assay does not detect SCID-like Syndromes, such as DiGeorge Syndrome, or Omenn Syndrome, and less acute SCID syndromes such as leaky-SCID or variant SCID.

  The system does not detect atypical XLA and XLA carriers.

• I would like to see only SMA results instead of the whole multiplex SMA-SCID-XLA panel. Can the results be filtered?

  Yes, any subset of analytes can be detected with the IVD kit. The subset of analytes is selected directly from the EASI software, and the customer cannot see or restore any results from targets that have not been selected.

• What are the space requirements? Can Eonis Q96 instrument be placed in the same room with punching and elution?

  Eonis Q system workflow is designed for laboratories with limited laboratory space. Ensure that the laboratory has at least two separate laboratory areas for the workflow. Place punching, elution, and PCR plate pipetting to one area (pre-PCR) and Eonis Q96 on the other area (PCR area) to minimize the contamination risk.

• Can other qPCR instruments than Eonis Q96 be used with the Eonis SCID-SMA dry qPCR kit?

  The qPCR reagents are pre-dried in full-skirted 96-well PCR plates. These plates will fit into qPCR instruments that take in full-skirted PCR plates, but other instruments than Eonis Q96 cannot be used for TREC or KREC quantification. The lot-specific factory-generated calibration curves are created with Eonis Q96 instrument, thus quantitative results might be affected if other qPCR instruments are used.

• Does Eonis Q PCR cycler need regular calibration or maintenance by the customer?

  The overlapping spectrums of different fluorescent dyes are handled by assay specific color compensation. Thus, regular calibrations of the instrument are not needed. Preventive maintenance with optical tests is done yearly by a Revvity service engineer.

• How are TREC, KREC and SMN1 cut-offs defined?

  Customers will need to determine the lower limits of TREC and KREC cp/µl results. Usually, these limits are derived from their own validation study and based on normal population percentiles. SMN1 and RPP30 have pre-defined Ct limits which are described in the kit insert.

• Can additional controls be used with Eonis SCID-SMA dry qPCR kit?

  The kit has been designed to contain all necessary controls, but the software allows you to analyze other controls as well. However, performance claims cannot be made about unknown control types. Any additional controls should be in DBS format and handled similarly to other samples throughout the workflow.