Now there's an even better way to catch West Nile virus tests for more people better tests better for more people Next generation West Nile virus ELISAs 1 West Nile Virus IgM Capture ELISA performance Agreement with CDC MAC EIA WNV (presumptive by CDC MAC EIA) Agreement 95% Confidence Interval Positive agreement 11/11 (100%) 71.5 - 100% Negative agreement 61/62 (98.4%) 91.3 - 100% Clinical sensitivity Specimen characterization No. Pos/Total Pos Sensitivity 95% Confidence Interval 51/51 100.0% 93.0 -100.0% Encephalitis/meningitis patients (confirmed WNV infection by PRNT) Cross-reactivity data Disease state (IgM antibodies) Panbio WNV IgM Capture ELISA Positive Equivocal Total Reactive Epstein-Barr virus Varicella-zoster virus Cytomegalovirus Ross River virus Enterovirus Dengue virus St. Louis encephalitis La Crosse encephalitis Hepatitis A Anti-nuclear antibody Rheumatoid factor 0 0 0 0 0 2 0 0 0 0 3 0 0 0 0 0 0 0 0 0 0 1 0/15 0/15 0/15 0/26 0/7 2/16 0/6 0/19 0/11 0/15 4/15 0.0% 0.0% 0.0% 0.0% 0.0% 12.5% 0.0% 0.0% 0.0% 0.0% 26.7% Total 5 1 6/160 3.8% Panbio ELISA methodology The Panbio West Nile Virus ELISAs are designed to assist in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis/meningitis.2 West Nile Virus IgM Capture ELISA Superior specificity and is even simpler to use 3. Results in 2.5 hours. West Nile Virus IgG Indirect ELISA Use with the Panbio WNV IgM Capture ELISA. Results in 1.5 hours. WNV IgM ELISA WNV IgG ELISA Prepare 1/100 serum dilution Add 100 µL sample to wells incubate 60 min (37°C) WASH x 6 Prepare 1/100 serum dilution Add equal volume of MAb Tracer and Antigen. Incubate 60 min (RT). Add 100 µL sample to wells. Incubate 30 min (37°C). WASH x 6 Add 100 µL Antigen/MAb to wells. Incubate 60 min (37°C). Add 100 µL of Conjugate to wells. Incubate 30 min (37°C). WASH x 6 WASH x 6 Add 100 µL TMB to wells. Incubate 10 min (RT). Add 100 µL TMB to wells. Incubate 10 min (RT). Add 100 µL Stop Solution to wells. Add 100 µL Stop Solution to wells. READ 450 nm reference filter 600-650 nm READ 450 nm reference filter 600-650 nm The most efficient diagnostic method is detection of IgM antibody to West Nile virus in serum... Petersen LR et al., 2002 4 1 West Nile Virus IgG Indirect ELISA performance Negative presumptive agreement5 Specimen characterization Agreement 95% Confidence Interval Endemic normal specimens 181/200 (90.5%) 85.6 - 94.2% Endemic normal specimens 180/195 (92.3%) 87.6 - 95.6% Positive presumptive agreement compared with IFA5 Specimen characterization Agreement 95% Confidence Interval IgG IFA positive 26/32 (81.3%) 63.6 - 92.8% IgG IFA positive 29/38 (76.3%) 59.8 - 88.6% IgG IFA positive 286/325 (88.0%) 84.5 - 91.5% Serological sensitivity Specimen characterization WNV positive specimens (PRNT positive) No. Pos/Total Pos Sensitivity 79/100 79.0% 95% Confidence Interval 69.7 - 86.5% Specimen characterization Encephalitis/meningitis patients (WNV confirmed infection by PRNT) No. pos/total pos 41/51 Sensitivity 80.4% 95% Confidence Interval 66.9 - 90.2% better tests for more people Clinical sensitivity Ordering information Product Description ELISA E-WNV02M E-WNV01G West Nile Virus IgM Capture ELISA West Nile Virus IgG Indirect ELISA No. of tests 96 96 Also available Also available through Panbio is a range of IFA kits and slides Product Description IFA kits# I-WNV01G I-WNV01M West Nile virus IgG West Nile virus IgM IFA components I-WNV01X* CC093* O-GAH02G* O-GAH02M* O-GAH02A* West Nile Virus Slides West Nile Virus Positive Control Serum Goat Anti-human IgG (H+L) FITC Goat Anti-human IgM FITC Goat Anti-human IgA FITC Other reagents O-AVR02G* Buffered Avidity Reagent No. of tests 120 120 10 x 12 well 250 mL 5 mL (200T) 5 mL (200T) 5 mL (200T) 50 mL *Analyte Specific Reagent. Analytic and performance characteristics are not established. #Product not available for sale or distribution in the USA. 1 The data presented is extracted from the West Nile Virus IgM and IgG instructions for use and is representative of the performance of the kit. Please refer to the instructions for use for further performance data and details on the study sites. Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms of meningioencephalitis or automated instruments. The user is responsible for establishing these assay performance characteristics. 2 Positive results must be confirmed by plaque reduction neutralization test (PRNT), or by using the current Centers for Disease Control and Prevention (CDC) guidelines for diagnosis of this disease. 3 When compared to the previous generation of this product (E-WNV01M). 4 Petersen LR, et al. (2002). NEJM 347; 1225-26. 5 Data from varous study sites is presented in this table. Please refer to the instructions for use for further details. For further information please visit www.panbio.com or contact either Panbio or your Panbio distributor. Panbio Limited. 532 Seventeen Mile Rocks Rd, Sinnamon Park, Queensland, 4073 Australia. tel: +61 7 3357 1177 fax: +61 7 3357 1222 free-call: 1800 622 642 Panbio Inc. 9075 Guilford Rd, Columbia, 21046 MD USA. tel: +1 410 381 8550 fax: +1 410 381 8984 toll free: 800 962 6790 web: www.panbio.com email: panbio@panbio.com PB0057 Rev 2005/04