BioPlex 2200 ToRC IgG and IgM Assays

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1 22 System 22 ad Ig Assays A rapid ad comprehesive testig solutio for ad Ig testig

2 Like No Other The 22 system offers IgG ad Ig assays to simultaeously detect atibodies to T. godii, rubella ad cytomegalovirus (CV). Preatal testig for Toxoplasma godii, rubella ad cytomegalovirus is used to determie exposure to ifectious agets that ca cause cogeital diseases. The 22 System offers a ovel multiplex pael to simultaeously idetify ad differetiate atibodies for these ifectious diseases. The 22 System also offers type specific HSV testig to provide a complete ToRCH pael. The 22 assay reports results for the followig Ati-T. godii IgG Quatitative Ati-Rubella IgG Quatitative Ati-CV IgG Qualitative The 22 assay reports results for the followig Ati-T. godii Ig - Qualitative Ati-Rubella Ig Qualitative Ati-CV Ig Qualitative

3 Correlatio with CDC Evaluatio Serum Paels The Ceters for Disease Cotrol (CDC) evaluatio serum paels were used to evaluate the performace of the T. godii Ig, T. godii IgG, Rubella IgG ad CV IgG assays. The 22 ad IgG assays show excellet agreemet with the CDC pael. 22 Assay Results for CDC T. godii lgg Referece Sera (N=1) CDC Samples Referece Result 7 3 Referece Result Site 2 Site 3 T. godii IgG Note: Tested at Bio-Rad Laboratories 22 Assay Results for CDC T. godii Ig Referece Sera (N=97) CDC Samples T. godii Ig Note: Tested at Bio-Rad Laboratories 22 Assay Results for CDC Rubella IgG Referece Sera (N=1) CDC Samples Referece Result Rubella IgG Site Note: Tested at 3 cliical evaluatio sites 22 Assay Results for CDC CV IgG Referece Sera (N=1) CDC Samples Referece Result CV lgg Note: Tested at Bio-Rad Laboratories

4 Precisio Reproducibility ear the cut-off is essetial for providig cosistet patiet results. Reproducibility testig was performed accordig to the priciples described i the Cliical Laboratory Stadards Istitute (CLSI) guidaces EP5-A2 ad EP5-A3. Low Positive Sample Sample (N) ea (AI) T. godii 6 Rubella Withi-Ru Betwee-Ru Total 21 IU/mL % % % 6 13 IU/mL % %.9 7.2% CV AI.9 4.7%.5 2.7% % Low Positive Sample Sample (N) ea (AI) T. godii 12 Rubella CV Withi-Ru Betwee-Ru Total 1.3 AI.5 4.%.3 2.5% % AI.6 4.8%.1 1.7% % AI.7 6.2%.3 2.5% % Guidelies for Iterpretatio of Results T. godii IgG Rubella IgG CV IgG Result 9 IU/mL 7 IU/mL.8 AI.8 AI Negative 1 11 IU/mL 8 9 IU/mL.9, 1. AI.9, 1. AI Equivocal 12 IU/mL 1 IU/mL 1.1 AI 1.1 AI Positive

5 Efficiecy ultiplex your workflow cosolidatig six traditioal assays from the ToRC pael ito two coveiet multiplexed reaget packs ultiplex your ivetory dramatically reducig reaget ad calibrator storage requiremets ultiplex your samples sigificatly reducig your sample volume requiremets ultiplex your tubes - accomodatig serum or plasma (hepariized or EDTA) Throughput arket-leadig throughput with up to 3 multiplexed test results per hour to meet heavy workload demads R adom access processig esures results are available whe you eed them T ime to first result of 45 miutes maximizes speed ad flexibility i result reportig Cofidece F ull automatio from primary tube to fial result, miimizig the chace of huma error I teral quality cotrol beads icluded with each sample to verify serum additio ad stadardize detector performace O e system with a expadig meu to meet your autoimmue ad serology testig eeds

6 Assay Priciple The 22 ad assays are multiplexed bead based immuoassays desiged to detect ad differetiate atibodies to T. godii, rubella, ad CV. Each bead reaget is a mixture of disease specific dyed microparticle beads. The beads are idividually maufactured ad combied with iteral QC beads ito a bead reaget for multiplex aalysis. ToRC lgg ultiplex Testig Rubella lgg ToRC lg ultiplex Testig Rubella lg Toxo lgg CV lgg Toxo lg CV lg Bead Reaget Bead Reaget Reaget Pack Reaget Pack Calibrator Set Calibrator Set Cotrol Set Cotrol Set ad Ig Reaget Pack The ad Ig reaget packs cotai all the ecessary reagets (sample diluet, beads ad cojugate) to process 1 samples per pack for ad 15 samples per pack for. ad Ig Calibrator Set Calibrators are ready to use ad multiplexed. For T. godii IgG ad Rubella IgG, a six poit curve is used to calculate quatitative results. For CV IgG, a four poit curve is used to calculate qualitative results. For all Ig assays, a two poit curve is used to calculate qualitative results. ad Ig Cotrol Set Quality Cotrols are ready to use ad multiplexed. The set icludes a egative cotrol as well as two differet levels of multiaalyte positive cotrols. The set icludes oe multi-aalyte positive cotrol ad multi-aalyte egative cotrol. Orderig Iformatio Catalog No. Descriptio Reaget 1 Test Pack...1 pack Calibrators...1 set Cotrols...2 sets Catalog No. Descriptio Reaget 15 Test Pack...1 pack Calibrators...1 set Cotrols...2 sets is a trademark of Bio-Rad Laboratories, Ic. i various jurisdictios. For further iformatio, please cotact the Bio-Rad office earest you or visit our website at Cliical Diagostics Group Website Australia Austria Belgium Brazil Caada Chia Czech Republic Demark Filad Frace Germay +49-() Greece Hog Kog Hugary Idia Israel Italy Japa Korea exico +52 (55) The Netherlads New Zealad Norway Polad Portugal Russia Sigapore South Africa Spai Swede Switzerlad Taiwa Thailad Uited Kigdom +44-() Prited o recycled paper with soy-based iks 217 Bio-Rad Laboratories, Ic. Prited i USA 6/17 DG T-152

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