CYTOMEGALOVIRUS

Cytomegalovirus is a herpes virus transmitted by close human contact. No symptoms of infection are apparent in the majority of cases. However, the virus is very dangerous and may be fatal in immunodepressed patients. Serum-negative female patients who become infected during pregnancy may transmit the disease to the fetus. In 95% of cases this occurs without symptoms, but some neonates may present jaundice, hepato-splenomegaly and retarded psycho-motorial development. For this reason it is of great importance to determine the immunitary state of the patient and check for serum conversion. A significant increase in the anti-Cytomegalovirus IgG titer is indicative of a recent infection or reactivation of a latent infection.Sometimes it is not sufficient to test for IgM antibodies, as the presence of this class may be due to the persistence of IgM or asymptomatic reinfection by Cytomegalovirus, without risk for the fetus. For this reason it is useful to assay the avidity of the IgG antibodies, in as far as it has been demonstrated that avidity is low in the acute phase of infection and increases over a period of time. The presence of low avidity antibodies is therefore an indication of a recent or current infection.

Methods:

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 Cytomegalovirus in human serum, using a disposable device applied on the Chorus and Chorus TRIO instruments.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 disposable devices contain all the reagents to perform the test when applied on the Chorus instruments. 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.

Chorus CYTOMEGALOVIRUS IgG

coated with Cytomegalovirus antigens

For the determination of anti-Cytomegalovirus IgG antibodies in human serum. Contains calibrator and positive control.
Code 81010
Quantity 36 tests
METHOD Indirect ELISA
TYPE Quantitative Test
DIAGNOSTIC SENSITIVITY 98% (CI 95%: 93–99)
DIAGNOSTIC SPECIFITY 100% (CI 95%: 83–100)
CALIBRATION RANGE 0,5 - 20 UI/ml
INCUBATION TIME < 30 min
SHELF LIFE 12 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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Chorus CYTOMEGALOVIRUS IgG AVIDITY

coated with Cytomegalovirus

For the determination of anti-Cytomegalovirus IgG antibodies avidity in human serum. Contains avidity controls.
Code 81092
Quantity 12 tests
METHOD Indirect ELISA
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 100% CI95%: 67.5.-99.6
DIAGNOSTIC SPECIFITY 96.9.% CI95%: 84.2.-99.3
INCUBATION TIME 60 min
SHELF LIFE 12 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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CoA

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Chorus CYTOMEGALOVIRUS IgM

coated with Cytomegalovirus antigen obtained from the culture of human fibroblasts infected with partially purified and inactivated Cytomegalovirus

For the determination of anti-Cytomegalovirus IgM antibodies in human serum. Contains calibrator and positive control.
Code 81011
Quantity 36 tests
METHOD Indirect ELISA
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 100% CI95%: 83.9-99.8
DIAGNOSTIC SPECIFITY 98.3% CI95%: 94.0-99.5
INCUBATION TIME < 30 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

Bibliography

Analisi della concordanza analitica e clinica tra due sistemi analitici nella determinazione di anticorpi anti toxoplasma, rosoliavirus e cytomegalovirus

PRELIMINARY EVALUATION OF CHORUS SYSTEM IN COMPARISON WITH MINI-VIDAS SYSTEM FOR DETECTION OF CYTOMEGALOVIRUS-IgM ANTIBODIES