LIAISON Measles IgG The fully automated solution for quantitative antibody detection

Transcription

1 LIAISON Measles IgG The fully automated solution for quantitative antibody detection FOR OUTSIDE THE US AND CANADA ONLY

2 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 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 ) 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: % Reproducibility Coefficient of Variation: Site 1: % Site 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: %) Diagnostic sensitivity: 94.7% (306/323) (95% confidence interval: %) Ordering Information LIAISON Measles IgG (Code ) LIAISON Control Measles IgG (Code ) LIAISON Measles IgM (Code ) LIAISON Control Measles IgM (Code ) AVAILABLE ON SYSTEMS Product availability subject to required regulatory approval DiaSorin S.p.A. Via Crescentino, snc Saluggia (VC) Italy Tel /947 Fax info@diasorin.it

3 LIAISON Mumps IgG The fully automated solution for quantitative antibody detection FOR OUTSIDE THE US AND CANADA ONLY

4 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 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 ) 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: % Reproducibility Coefficient of Variation (inter-site): % 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: %) Diagnostic sensitivity: 98.5% (330/335) (95% confidence interval: %) Ordering Information LIAISON Mumps IgG (Code ) LIAISON Control Mumps IgG (Code ) LIAISON Mumps IgM (Code ) LIAISON Control Mumps IgM (Code ) AVAILABLE ON SYSTEMS Product availability subject to required regulatory approval DiaSorin S.p.A. Via Crescentino, snc Saluggia (VC) Italy Tel /947 Fax info@diasorin.it

5 LIAISON Rubella IgG II The fully automated solution for sensitive antibody detection FOR OUTSIDE THE US AND CANADA ONLY

6 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 N of samples Closed System A LIAISON Rubella IgG II N of samples Lot A Lot B Lot C 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: 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 ) LIAISON Controls Rubella IgG II (code ) LIAISON Rubella IgM (code ) LIAISON Controls Rubella IgM (code ) AVAILABLE ON SYSTEMS Product availability subject to required regulatory approval DiaSorin S.p.A. Via Crescentino, snc Saluggia (VC) Italy Tel /947 Fax info@diasorin.it

7 LIAISON VZV IgG The fully automated solution for quantitative antibody detection FOR OUTSIDE THE US AND CANADA ONLY

8 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 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 ) 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: % Reproducibility Coefficient of Variation (inter-site): % 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: %) Diagnostic sensitivity: 100.0% (319/319) (95% confidence interval: %) Ordering Information LIAISON VZV IgG (Code ) LIAISON Control VZV IgG (Code ) LIAISON VZV IgM (Code ) LIAISON Control VZV IgM (Code ) AVAILABLE ON SYSTEMS Product availability subject to required regulatory approval DiaSorin S.p.A. Via Crescentino, snc Saluggia (VC) Italy Tel /947 Fax info@diasorin.it