LIAISON Measles IgG The fully automated solution for quantitative antibody detection FOR OUTSIDE THE US AND CANADA ONLY
LIAISON Measles IgG Number of tests 100 Key assay features Method Assay range Solid Phase Conjugate Label Sample Integral on board stability Calibrators availability Calibration stability Indirect Quantitative 5 300 AU / ml Recombinant nucleoprotein expressed in baculovirus MoAb to human IgG conjugated to isoluminol derivative ABEI 20 µl serum or plasma On board positive and negative 4 weeks Controls availability Positive and negative (60 tests per control kit code 318811) Controls stability once opened Performance Characteristics Reference to WHO Standard: Cut-off value equates to 175 miu/ml (WHO Third International Standard for Anti-Measles, NIBSC code: 97/648) Cross-reactions: Zero cross reactions observed with a panel consisting of antibodies to hcmv, EBV, rubella virus, parvovirus B19, mumps, Toxoplasma, HSV, VZV, HAV, ANA Repeatability Coefficient of Variation: 4.3-7.5 % Reproducibility Coefficient of Variation: Site 1: 10.0-14.5% Site 2: 5.0 11.2% Diagnostic performance was assessed by testing 529 unselected specimens collected from a European laboratory routine (300 unselected individuals, 50 children ages 0-8 years, 117 subjects with serology suggestive of susceptibility to infection, 62 patients with serology suggestive of acute infection) against a commercially available reference EIA. Diagnostic specificity: 97.4% (189/194) (95% confidence interval: 94.1-99.2%) Diagnostic sensitivity: 94.7% (306/323) (95% confidence interval: 91.7-96.9%) Ordering Information LIAISON Measles IgG (Code 318810) LIAISON Control Measles IgG (Code 318811) LIAISON Measles IgM (Code 318820) LIAISON Control Measles IgM (Code 318821) AVAILABLE ON SYSTEMS Product availability subject to required regulatory approval DiaSorin S.p.A. Via Crescentino, snc 13040 Saluggia (VC) Italy Tel. +39 0161 487 526/947 Fax +39 0161 487 670 www.diasorin.com info@diasorin.it
LIAISON Mumps IgG The fully automated solution for quantitative antibody detection FOR OUTSIDE THE US AND CANADA ONLY
LIAISON Mumps IgG Number of tests 100 Key assay features Method Assay range Solid Phase Conjugate Label Sample Integral on board stability Calibrators availability Calibration stability Indirect Quantitative 5 300 AU / ml Recombinant nucleoprotein expressed in P. pastoris MoAb to human IgG conjugated to isoluminol derivative ABEI 20 µl serum or plasma On board positive and negative 4 weeks Controls availability Positive and negative (60 tests per control kit code 318841) Controls stability once opened Performance Characteristics Cross-reactions: Zero cross reactions observed with a panel consisting of antibodies to hcmv, EBV, rubella virus, parvovirus B19, measles, Toxoplasma, HSV, VZV, HAV, Treponema, ANA Repeatability Coefficient of Variation: 3.9-7.2 % Reproducibility Coefficient of Variation (inter-site): 10.7 14.5 % Diagnostic performance was assessed by testing 519 unselected specimens collected from a European laboratory routine (300 unselected individuals, 50 children ages 0-8 years, 130 subjects with serology suggestive of susceptibility to infection, 39 patients with serology suggestive of acute infection) against a commercially available reference EIA. Diagnostic specificity: 98.2% (164/167) (95% confidence interval: 94.8-99.6%) Diagnostic sensitivity: 98.5% (330/335) (95% confidence interval: 96.5-99.5%) Ordering Information LIAISON Mumps IgG (Code 318840) LIAISON Control Mumps IgG (Code 318841) LIAISON Mumps IgM (Code 318830) LIAISON Control Mumps IgM (Code 318831) AVAILABLE ON SYSTEMS Product availability subject to required regulatory approval DiaSorin S.p.A. Via Crescentino, snc 13040 Saluggia (VC) Italy Tel. +39 0161 487 526/947 Fax +39 0161 487 670 www.diasorin.com info@diasorin.it
LIAISON Rubella IgG II The fully automated solution for sensitive antibody detection FOR OUTSIDE THE US AND CANADA ONLY
LIAISON Rubella IgG II Rubella is a contagious, generally mild viral infection that occurs most often in children and young adults. Rubella is the leading vaccine-preventable cause of birth defects. Rubella infection in pregnant women may cause fetal death or congenital defects known as congenital rubella syndrome (CRS). Today s vaccination programs have considerably reduced the incidence of acute rubella and CRS. The presence of IgG antibodies to rubella virus indicates a previous exposure either by vaccination or prior rubella infection and suggests immunity. Seroconversion of specific rubella antibodies or a significant rise of the IgG titer strongly supports the diagnosis of acute rubella infection. LIAISON Rubella IgG II is a sensitive assay able to detect low IgG antibody titers present in vaccinated population reducing the number of samples to be confirmed. Fully automated solution for specific and sensitive antibody detection 60 100 N of samples 50 40 30 20 Closed System A LIAISON Rubella IgG II 40 49 29 42 18 N of samples 90 80 70 60 50 40 30 88 85 81 Lot A Lot B Lot C 10 7 7 20 0 2 3 1 0 0 0 0 0 0 0 0 0 0 10 0 4 7 6 5 5 1 1 0 0 1 1 1 1 0 0 0 0 0 0 0 0 0 0-0.2 02.3.0 3.0-5.0 5.0-7.0 7.0-10 10-15 15-20 20-25 20-30 30 0-0.2 02-0.7 0.7-2.0 2.0-3.0 3.0-4.0 4.0-5.0 5.0-7.0 7.0-10 10 IU/mL IU/mL A population of 99 subjects who have undergone vaccination was evaluated and 99 positive results were obtained with LIAISON Rubella IgG II. All 100 samples of the Biomex NP-RUB- 001 panel were classified as Negative with three different lot of LIAISON Rubella IgG II. Main Features Number of test: 100 Sample type: Serum/Plasma Assay format: indirect qualitatitive/quantitative Solid phase: Rubella viral particle (HPV 77strain) Assay range: 0.2-350 IU/mL Label: isoluminol derivative Conjugate: mouse monoclonal IgG Low samples volume: 20 ml plus 150 ml dead volume Flexibility enables quick and accurate results Diagnostic sensitivity in vaccinated population: 100% (95% C.I :96,34-100%) Diagnostic specificity in Biomex panel NP-RUB-001: 100% (95% C.I :96,95-100%) High throughput Reference to WHO Standard: 1 st NIBSC International Standard RUBI-1-94 (1997) Calibration stable for High reagent stability on board: 12 weeks Calibrators included in the reagent cartridge All reagents ready to use Ordering Information LIAISON Rubella IgG II (code 317260) LIAISON Controls Rubella IgG II (code 317261) LIAISON Rubella IgM (code 310730) LIAISON Controls Rubella IgM (code 310731) AVAILABLE ON SYSTEMS Product availability subject to required regulatory approval DiaSorin S.p.A. Via Crescentino, snc 13040 Saluggia (VC) Italy Tel. +39 0161 487 526/947 Fax +39 0161 487 670 www.diasorin.com info@diasorin.it
LIAISON VZV IgG The fully automated solution for quantitative antibody detection FOR OUTSIDE THE US AND CANADA ONLY
LIAISON VZV IgG Number of tests 100 KEY ASSAY FEATURES Method Assay range Solid Phase Conjugate Label Sample Integral on board stability Calibrators availability Calibration stability Indirect Quantitative 10 4000 miu / ml Partially purified extract of infected cell cultures (ROD strain) MoAb to human IgG conjugated to isoluminol derivative ABEI 20 µl serum or plasma On board positive and negative Controls availability Positive and negative (40 tests per control kit code 310851) Controls stability once opened 4 weeks Performance Characteristics Reference to WHO Standard: Calibrated against WHO International Preparation W1044 Cross-reactions: Zero cross reactions observed with a panel consisting of antibodies to EBV EBNA, EBV VCA, hcmv, rubella, HSV 1/2, Toxoplasma, Borrelia, ANA Repeatability Coefficient of Variation: 5.4-14.1% Reproducibility Coefficient of Variation (inter-site): 6.0 8.6% Diagnostic performance was assessed by testing 393 unselected specimens (pregnant women, blood donors, transplant recipients) against three CE-marked reference methods. Diagnostic specificity: 97.1% (68/70) (95% confidence interval: 90.1-99.7%) Diagnostic sensitivity: 100.0% (319/319) (95% confidence interval: 98.9-100.0%) Ordering Information LIAISON VZV IgG (Code 310850) LIAISON Control VZV IgG (Code 310851) LIAISON VZV IgM (Code 310860) LIAISON Control VZV IgM (Code 310861) AVAILABLE ON SYSTEMS Product availability subject to required regulatory approval DiaSorin S.p.A. Via Crescentino, snc 13040 Saluggia (VC) Italy Tel. +39 0161 487 526/947 Fax +39 0161 487 670 www.diasorin.com info@diasorin.it