Are any reagents universal for multi-batching?All AtheNA Multi-Lyte^® assays (except Borrelia) can be multi-batched and processed on the same plate. When doing so, the diluent and AtheNA Wash Buffer can be used as a universal component for all kits being used. However, the controls, bead suspension, and conjugate should still be used with their respective kits and lots when multi-batching.

• Qualitative refers to Patient Sera results that are expressed as Positive, Negative or Equivocal.
• The quantitative or numeric value is only taken into consideration to decipher whether it has met the interpretation criteria for the above three reporting options.
• Semi- Quantitative refers to the numeric value that is associated with Qualitative results.

Unless otherwise specified in the Package Insert, the Numeric Value is reported in arbitrary units. These units are Semi-Quantitative and are not calibrated to any International Standard and should not be evaluated as such.

If a QC control fails for one analyte, then the entire run is considered invalid. All QC controls must pass QC criteria in order for results to be considered valid.

Beads should be sonicated and/or vortexed as per the Package Insert requirements (30 seconds each procedure). If one wishes to go beyond this time setting, then please note that bead performance & efficiency may be affected if beads are sonicated over 8 minutes. Please note that beads can definitely be over-sonicated. Time will depend on the specific antigens on the specific bead set. Some beads will be more affected than others so it is crucial to follow the instructions listed in the package insert.

All reagents should be returned to their original vials and storage conditions immediately after use. To ensure that assay performance and reproducibility is optimal, these guidelines should be followed. Failure to do so can lead to performance variability and reagent instability over time.

Test system performance has been optimized for the incubation time frames provided in the package insert. Please note that there should be consistency between incubation times. Therefore, all subsequent incubation times should be equal or +/- 10 minutes to the original. Performance efficiency has not been established for increased or decreased incubation times from what is instructed and precision may vary.

Previously used filter plates may be reused as long as the unused wells were not exposed to moisture: i.e., AthenNA Wash Buffer, diluted samples, etc. If a plate has only been partially used, the remaining liquid should be vacuumed out of the wells after the assay has been read on the AtheNA Multi-Lyte^® instrument. The used wells should be covered with tape or parafilm to prevent reuse of wells and to ensure optimal vacuum pressure.

Every AtheNA Multi-Lyte^® Test System utilizes Intra-Well Calibration Technology™. This allows for each sample to have its own unique calibration curve applied under the same conditions as the patient serum. There are parameters set for each variable of the calibration curve and if sample interaction does not fulfill certain variable's requirements, then an invalid result will be generated. Some common causes for invalids would be: little to no sample added, abnormally high or low levels of IgG, RF positive interference, and low bead count levels. If an invalid result is produced, the sample should be re-run. If another invalid result is generated, the instrument should be calibrated and a fresh serum draw of that patient should be acquired to run again.

Specimens that exhibit equivocal results may be considered borderline. While it is up to each laboratory to establish its own guidelines for reporting equivocal results, it is suggested when an equivocal result is produced, the laboratory should either rerun the patient sample in duplicate or evaluate using another methodology.

Arbitrary Units were created during the development of the AtheNA Multi-Lyte^® Test System. As these are not International Units, and have not been calibrated to any WHO Standard, they should not be used for numeric correlation studies. Instead, the correlations should be performed based on qualitative comparisons.