CLIA CMV IgM

Description

Human cytomegalovirus (CMV, Human Herpesvirus 5, HHV 5) is a member of the Herpetoviridae family. In humans, it is mainly transmitted by the respiratory apparatus or urogenital tract. The disease is usually asymptomatic or mild, the latent infection can be reactivated in pregnancy, serious disease, stress, or immunosuppressive treatment. An individuum can be reinfected by a different CMV strain. CMV infection during pregnancy causes developmental defects. The virus is easily transmitted through the placenta during primary infection (in 30-50 % of cases); during the reactivation stage, transplacental transmission occurs in only 1% of cases. CMV infection belongs to the TORCH syndrome.

The most widely used approach in serological diagnostics of CMV infection is the detection of specific IgA, IgM, and IgG antibodies.

Antibodies of IgA class are a sign of an active infection – primary infection as well as reactivation. Production of IgM antibodies usually increases a few weeks after infection or reactivation and then decreases slowly. IgM determination alone cannot discriminate primary infection from reactivation. Specific IgG seroconversion indicates primary infection.

Detection of IgG antibodies to CMV is also used as a standard method for screening blood donors.

Technical data

• Assay stability: 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
• Sample matrix: Serum, Plasma
• Measuring range: 0.5 – 160 U/ml
• Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
• Note: The kits are CE-IVD certified and intended for professional use.

Specifications

• Catalog Number: CL-CMM100
• Size: 100 tests
• Regulatory status: CE IVD
• Clinical topic: Infectious Diseases
• Diagnostic panel: Herpes Viruses TORCH
• Producer: TestLine Clinical Diagnostics s.r.o.

References

• Blackburn NK, Besselaar TG, Schoub BD, O’Connell KF. Differentiation of primary cytomegalovirus infection from reactivation using the urea denaturation test for measuring antibody avidity. J Med Virol. 1991 Jan;33(1):6-9. doi: 10.1002/jmv.1890330103. PMID: 1849983.
• Bodéus M, Feyder S, Goubau P. Avidity of IgG antibodies distinguishes primary from non-primary cytomegalovirus infection in pregnant women. Clin Diagn Virol. 1998 Jan;9(1):9-16. doi: 10.1016/s0928-0197(97)10016-2. PMID: 9562853.
• Boeckh M, Boivin G. Quantitation of cytomegalovirus: methodologic aspects and clinical applications. Clin Microbiol Rev. 1998 Jul;11(3):533-54. doi: 10.1128/CMR.11.3.533. PMID: 9665982; PMCID: PMC88895.
• Dussaix E, Chantot S, Harzic M, Grangeot-Keros L. CMV-IGG avidity and CMV-IGM concentration in both immunocompromised and immunocompetent patients. Pathol Biol (Paris). 1996 May;44(5):405-10. PMID: 8758485.
• Grangeot-Keros L, Mayaux MJ, Lebon P, Freymuth F, Eugene G, Stricker R, Dussaix E. Value of cytomegalovirus (CMV) IgG avidity index for the diagnosis of primary CMV infection in pregnant women. J Infect Dis. 1997 Apr;175(4):944-6. doi: 10.1086/513996. PMID: 9086155.
• Joassin L, Reginster M. Elimination of nonspecific cytomegalovirus immunoglobulin M activities in the enzyme-linked immunosorbent assay by using anti-human immunoglobulin G. J Clin Microbiol. 1986 Mar;23(3):576-81. doi: 10.1128/jcm.23.3.576-581.1986. PMID: 3007570; PMCID: PMC268697.
• Lazzarotto T, Varani S, Guerra B, Nicolosi A, Lanari M, Landini MP. Prenatal indicators of congenital cytomegalovirus infection. J Pediatr. 2000 Jul;137(1):90-5. doi: 10.1067/mpd.2000.107110. PMID: 10891828.
• Pappin A, Grissom M, Mackay W, Huang Y, Yomtovian R. Stability of cytomegalovirus antibodies in plasma during prolonged storage of blood components. Clin Diagn Lab Immunol. 1995 Jan;2(1):25-9. doi: 10.1128/cdli.2.1.25-29.1995. PMID: 7719908; PMCID: PMC170095.
• Revello MG, Gerna G. Diagnosis and management of human cytomegalovirus infection in the mother, fetus, and newborn infant. Clin Microbiol Rev. 2002 Oct;15(4):680-715. doi: 10.1128/CMR.15.4.680-715.2002. PMID: 12364375; PMCID: PMC126858.

• Reagent Cartridge with specific reagents for the assay
• magnetic particles
• calibrators