RUBELLA

Rubella virus causes a very common infectious disease in humans, accompanied by a typical diffused rash. The course of the illness is generally short and without complications. However, it is harmful for the fetus if contracted during pregnancy, because the virus is teratogenic and may cause very serious malformations especially during the first month of pregnancy. It is therefore essential to determine the patient's state of immunity before the start of pregnancy, if possible, in order to perform vaccination or, if this is impossible, to monitor the course of the pregnancy to observe whether seroconversion occurs. Several methods are employed for the assay of specific immunoglobulins. Of these methods, the ELISA technique offers the advantage of being completely automated.

Method:

Immunoenzymatic method for the quantitative determination of IgG-class antibodies, qualitative determination of IgM-antibodies and the qualitative determination of the avidity of IgG class antibodies to Rubella in human serum. The test is based on the ELISA principle (Enzyme Linked ImmunoSorbent Assay) which uses the reaction between the antibodies present in the tested sample and the immobilized antigen bound to solid phases. The immunoglobulins bind to the antigen through incubation with diluted human serum. The result is expressed as an INDEX (ratio between the OD value of the sample and that of the Cut-off) for qualitative tests and in International Units (IU/mL) for quantitative tests.

RUBELLA IgG

coated with Rubella Virus

Kit for the determination of anti-Rubella IgG antibodies in human serum. Contains liquid ready for use calibrators for the preparation of the calibration curve in International Units (IU/mL).
Code 91030
Quantity 96 tests
METHOD Indirect ELISA
TYPE Quantitative Test
DIAGNOSTIC SENSITIVITY 100%
DIAGNOSTIC SPECIFITY 97%
INCUBATION TIME 105 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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IFU

SDS

CoA

EC Declaration of Conformity

RUBELLA IgG AVIDITY

coated with Rubella Virus

Kit for the determination of anti-Rubella IgG antibodies avidity in human serum.
Code 91095
Quantity 24 tests
METHOD Indirect ELISA
TYPE Qualitative Test
INCUBATION TIME 130 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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IFU

SDS

CoA

EC Declaration of Conformity

RUBELLA IgM

coated with anti-human IgM monoclonal antibodies

Kit for the determination of anti-Rubella IgM antibodies in human serum. Capture method.
Code 91031
Quantity 96 tests
METHOD CAPTURE ASSAY
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 97.3%
DIAGNOSTIC SPECIFITY 99.6%
INCUBATION TIME 105 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

Download

IFU

SDS

CoA

EC Declaration of Conformity

Bibliography

PRELIMINARY EVALUATION OF THE CHORUS SYSTEM FOR THE ANALYSIS OF ANTI-RUBELLA IgG and IgM