BioPlex 2200 Syphilis Total & RPR Assay

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Magdalene Louisa Hoover
5 years ago
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1 BioPlex 2200 System BioPlex 2200 & Assay Simultaneous detection and differentiation of Treponemal and non-treponemal antibodies

2 Redefine your workflow. The BioPlex 2200 & Assay is the only automated dual treponemal/nontreponemal immunoassay test that offers laboratories a global one-step testing solution for Syphilis. The BioPlex 2200 & Assay is intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma. The BioPlex 2200 & Assay offers a one-step universal testing method Reportable results include: (IgG/IgM) Qualitative (Rapid Plasma Reagin) Onboard titer determination (1:4, 1:8, 1:16, 1:32, 1:64) Productivity Reduced hands-on time and labor savings and higher total throughput, up to 200 results per hour. Consolidation Dual non-treponemal/treponemal assay to streamline your syphilis testing algorithm. Detect, diagnose and monitor. Performance Improved sensitivity and specificity including differentiation of current and/or past infection. Accuracy Excellent precision, objective result reporting.

3 Performance Test Ordered Samples A total of 210 syphilis test ordered prospective samples and 278 retrospective /VDRL positive samples were evaluated by the BioPlex 2200 & Assay. The BioPlex 2200 & Assay shows excellent agreement with the reference methods.* BioPlex Population egative Test Ordered % (27/28) 82.3% 99.4% 98.9% (180/182) 95.9%-99.5% Retrospective /VDRL positive % (260/260) 98.5%-100% - - * Result: Combined results from commercially available, and TPPA assays. BioPlex Population egative Test Ordered % (18/19) 75.4% 99.1% 99.5% (190/191) 97.1%-99.9% Retrospective /VDRL positive % (253/268) 91.0%-96.6% - - * Result: Commercially available assay. Performance in Medically Diagnosed Patients 118 characterized samples from patients medically diagnosed with syphilis infection were tested for positive agreement versus the reference result. Both the and the show excellent correlation with clinical samples with a positive agreement of 99.1% and 100% respectively. BioPlex BioPlex Population Samples from patients medically diagnosed with syphilis infection % (110/111) 95.1%-100.0% 100% (92/92) 96.1%-100%

4 Precision Following EP5-A3 the BioPlex 2200 & Assay demonstrated %CV s for total precision near the cutoff of 4.8% and 9.3% respectively for the and. Panel Members Sample Mean (AI) Within run Between run Between day Total SD %CV SD %CV SD %CV SD %CV Low egative A 0.00.A 0.03.A 0.04.A High egative % % % % ear Cutoff % % % % Low % % % % Mid % % % % High % % % % Control % % % % Panel Members Sample Mean (AI) Within run Between run Between day Total SD %CV SD %CV SD %CV SD %CV Low egative A 0.02.A 0.04.A 0.05.A High egative % % % % ear Cutoff % % % % ear Cutoff/Low % % % % Mid % % % % High % % % % Control % % % % Seroconversion Panel - Sera Care PSS901 The BioPlex assay detects infection up to 2 weeks earlier (PSS901-5) than all the treponemal reference methods. Panel Bleed Day BioPlex Syphilis IgM Syphilis IgG TPPA BioPlex Manual PSS eg eg 0.9 eg PSS eg eg 0.3 eg PSS eg eg 0.6 eg PSS eg eg 0.5 eg PSS eg eg 1.8 PSS >10.0 PSS > >10.0 PSS > >10.0 PSS > >10.0 BioPlex is a trademark of Bio-Rad Laboratories, Inc. in various jurisdictions.

5 Simplify your testing with the BioPlex 2200 & Assay. Traditional and Reverse Syphilis Algorithms Load and walk away with the BioPlex 2200 & Assay Traditional Reverse BioPlex & SCREE CIA SCREE SCREE TOTAL & COFIRM TOTAL TOTAL TOTAL TOTAL TPHA COFIRM COFIRM RECOFIRM RECOFIRM Features Dual non-treponemal/treponemal assay Automated Onboard titer/dilutions (1:4, 1:8, 1:16, 1:32, 1:64) TPHA Up to 200 results per hour Excellent precision Ready to use reagents 30 day calibration curve stability Challenges Longer turn-around time for final result eed to maintain at least 2 different methods/assays Benefits Accurate, consistent and objective result reporting Full traceability Better patient management Manual testing and result reporting

Assay Principle The BioPlex 2200 & Assay is dual treponemal/nontreponemal assay.

(Treponemal Fusion Protein) Analyte beads are manufactured individually (Cardiolipin Antigen) ITERAL QC BEADS Internal Standard Bead (ISB) Serum Verification Bead (SVB) Beads are combined into a

Bead Reagent & Reagent Pack Contains all the necessary reagents (sample diluent, beads and conjugate) to process 100 samples per pack and up to 200 results & Calibrator Set Calibrators are

6 Assay Principle The BioPlex 2200 & Assay is dual treponemal/nontreponemal assay. The bead reagent is a mixture of 2 distinct populations of dyed microparticle beads in addition to two internal quality beads. (Treponemal Fusion Protein) Analyte beads are manufactured individually (Cardiolipin Antigen) ITERAL QC BEADS Internal Standard Bead (ISB) Serum Verification Bead (SVB) Beads are combined into a single Bead Reagent for multiplex analysis. Bead Reagent & Reagent Pack Contains all the necessary reagents (sample diluent, beads and conjugate) to process 100 samples per pack and up to 200 results & Calibrator Set Calibrators are ready-to-use and pre bar-coded for ease of use. & Control Set Quality controls are ready-to-use and pre bar-coded for ease of use. Ordering Information Catalog # Description BioPlex 2200 & Reagent Pack... 1 pack BioPlex 2200 & Calibrator Set... 1 set BioPlex 2200 & Control Set... 2 sets Bio-Rad Laboratories, Inc. For further information, please contact the Bio-Rad office nearest you or visit our website at Clinical Diagnostics Group Web site USA Australia Austria Belgium Brazil Canada China Czech Republic Denmark Finland France Germany Greece Hong Kong Hungary India Israel Italy Japan Korea Mexico The etherlands ew Zealand orway Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland Taiwan Thailand United Kingdom Bio-Rad Laboratories, Inc. Printed in USA DG T /2016 Printed on recycled paper with soy-based inks

Bio-Rad Laboratories BIOPLEX 2200 SYSTEM. BioPlex 2200 ANA Screen with MDSS. The first and only fully-automated, multiplexed ANA Screen

Bio-Rad Laboratories BIOPLEX 2200 SYSTEM BioPlex 2200 ANA Screen with MDSS The first and only fully-automated, multiplexed ANA Screen Bio-Rad Laboratories BIOPLEX 2200 SYSTEM Like no other The BioPlex