Format

Each kit is presented as a 96-well plate with one SmartBead (formulated with ~7,500 UltraCodes of ten types) in each well. All buffers and detection reagents are provided. Each kit is suitable for determination of 80 samples in singlicate, together with a standard curve for the dsDNA assay and kit positive and negative control sera.

Antigens

The kit uses closed circular plasmid DNA (~3.4kbp) from E. Coli for the dsDNA assay. The Sm, SmRNP and SSA are purified (>90% pure) from natural sources. RNP70 is a recombinant protein from a bacterial expression system. The remaining antigens are recombinant proteins purified from an eukaryotic expression system. Full details of the antigens are provided in the kit insert. Qmax zero control particles are also included.

Summary of Procedure

Diluted serum, from primary tubes, is added to the 96-well plate by the SmartStation robot. All washes and addition of detection reagent is performed automatically. The plate is then transferred to the SmartReader and results are exported to the LIMS system for reporting.

Clinical Data

The UltraPlex ANA assay has been tested side-by-side with various market-leading assay products, including Hep2 and Hep2000 cells in indirect immunofluoresence assays, and conventional single-analyte ELISAs. More than 1,000 samples in various cohorts have been compared in several independent laboratories, and in each case UltraPlex ANA equals or exceeds the performance of competitor products.

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