Syphilis IgG

Overall Performance

Concordance: 433 results were obtained from pregnant women to assess positive and negative agreements
relative to a reference methodology.^† The BioPlex™ 2200 Syphilis IgG kit shows excellent correlation with the
reference method.

† Reference Assay: Combined results from commercially available RPR and TPPA assays. For discrepant results (between RPR and TPPA),
   a commercial treponemal EIA test was used for final interpretation.

 * Four (4) BioPlex 2200 Syphilis IgG reactive samples were RPR nonreactive, TPPA reactive, and treponemal EIA equivocal.
** Of eight (8) BioPlex 2200 Syphilis IgG reactive samples, 7 were RPR nonreactive, TPPA reactive, and treponemal EIA negative and
    1 sample was RPR and TPPA nonreactive.

* Three (3) BioPlex 2200 Syphilis IgG reactive samples were RPR and TPPA nonreactive.

Performance in Medically Diagnosed Patients

Comparative Reactivity: 70 characterized samples from patients medically diagnosed with syphilis infection were tested for positive agreement and reactivity vs. the reference method. The BioPlex™ 2200 Syphilis IgG kit demonstrated a higher reactivity rate than the reference method on samples from patients previously diagnosed with syphilis.

 * One (1) sample with BioPlex 2200 Syphilis IgG reactive results was RPRnonreactive, TPPA reactive and treponemal EIA equivocal.
** Three (3) samples with BioPlex 2200 Syphilis IgG reactive results were RPRand TPPA nonreactive.

Precision

Following CLSI EP5-A guidelines, the BioPlex™ 2200 Syphilis IgG Kit demonstrated %CV values of less than 8.5% for total precision near cutoff levels. The Syphilis IgG Kit exhibits market-leading performance in precision, particularly when compared to competitive automated products that have average %CV up to 21%. The low %CV of the Bioplex Kit can be attributed to a) full automation, b) the magnetic bead, heterogenous assay format and c) a minimum of 150 measurements per analyte.

Syphilis IgG Assay Procedure

Reagents, Calibrators, and Controls

	Syphilis IgG Reagent Pack Contains all the necessary reagents (sample diluent, beads and conjugate) to process 100 patients per pack and up to 100 results per patient.
	Syphilis IgG Calibrator Set Calibrators are ready-to-use and already barcoded for ease of use.
	Syphilis IgG Control Set Quality Controls are ready-to-use and already barcoded for ease of use.