LIAISON Measles IgG - DiaSorin · Infectious Disease LIAISON® Measles IgG Integral on board stability 8 weeks Calibrators availability On board – positive and negative Calibration

Infectious Disease

LIAISON® Measles IgGThe fully automated solutionfor quantitative antibody detection

FOR OUTSIDE THE US AND CANADA ONLY

Infectious Disease LIAISON® Measles IgG

Integral on board stability 8 weeks

Calibrators availability On board – positive and negative

Calibration stability 4 weeks

Controls availability Positive and negative (60 tests per control kit – code 318811)

Controls stability once opened 8 weeks

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Number of tests 100

Method Indirect Quantitative

Assay range 5 – 300 AU / mL

Solid Phase Recombinant nucleoprotein expressed in baculovirus

Conjugate MoAb to human IgG conjugated to isoluminol derivative

Label ABEI

Sample 20 µL serum or plasma

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

• RepeatabilityCoefficientofVariation: 4.3-7.5 %

• ReproducibilityCoefficientofVariation: 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.

• Diagnosticspecificity: 97.4% (189/194) (95% confidence interval: 94.1-99.2%)

• Diagnosticsensitivity: 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)

DiaSorin S.p.A.Via Crescentino, snc

13040 Saluggia (VC) ItalyTel. +39 0161 487 526/947

Fax +39 0161 487 670www.diasorin.com

[email protected]

Product availability subject to required regulatory approval

AVAILABLEONSYSTEMS

Infectious Disease

LIAISON® Mumps IgGThe fully automated solutionfor quantitative antibody detection


Infectious Disease LIAISON® Mumps IgG






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Number of tests 100


Assay range 5 – 300 AU / mL

Solid Phase Recombinant nucleoprotein expressed in P. pastoris


Label ABEI


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%)


LIAISON® Mumps IgG (Code 318840) LIAISON® Control Mumps IgG (Code 318841)

LIAISON® Mumps IgM (Code 318830) LIAISON® Control Mumps IgM (Code 318831)




[email protected]


AVAILABLE ON SYSTEMS

Infectious Disease

LIAISON® Rubella IgG IIThe fully automated solutionfor sensitive antibody detection


Infectious Disease LIAISON® Rubella IgG II




[email protected]



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.

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LIAISON® Rubella IgG II

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All 100 samples of the Biomex NP-RUB- 001 panel were classified as Negative with three different lot of LIAISON® Rubella IgG II.

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Main Features Flexibility enables quick and accurate resultsNumber of test: 100 Diagnostic sensitivity in vaccinated population:

100% (95% C.I :96,34-100%)

Sample type: Serum/Plasma Diagnostic specificity in Biomex panel NP-RUB-001: 100% (95% C.I :96,95-100%)

Assay format: indirect qualitatitive/quantitative High throughput

Solid phase: Rubella viral particle (HPV 77strain) Reference to WHO Standard: 1st NIBSC International Standard RUBI-1-94 (1997)

Assay range: 0.2-350 IU/mL Calibration stable for 8 weeks

Label: isoluminol derivative High reagent stability on board: 12 weeks

Conjugate: mouse monoclonal IgG Calibrators included in the reagent cartridge

Low samples volume: 20 mL plus 150 mL dead volume

All reagents ready to use


LIAISON® Rubella IgG II (code 317260) LIAISON® Controls Rubella IgG II (code 317261)

LIAISON® Rubella IgM (code 310730) LIAISON® Controls Rubella IgM (code 310731)

A population of 99 subjects who have undergone vaccination was evaluated and 99 positive results were obtained with LIAISON® Rubella IgG II.

Fully automated solution for specific and sensitive antibody detection

Infectious Disease

LIAISON® VZV IgGThe fully automated solutionfor quantitative antibody detection


Infectious Disease LIAISON® VZV IgG






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Number of tests 100


Assay range 10 – 4000 mIU / mL

Solid Phase Partially purified extract of infected cell cultures (ROD strain)


Label ABEI


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%)


LIAISON® VZV IgG (Code 310850) LIAISON® Control VZV IgG (Code 310851)

LIAISON® VZV IgM (Code 310860) LIAISON® Control VZV IgM (Code 310861)




[email protected]



Documents

LIAISON Measles IgG - DiaSorin · Infectious Disease LIAISON® Measles IgG Integral on board stability 8 weeks Calibrators availability On board – positive and negative Calibration