Immunoassay with cytomegalovirus early antigens from gene products p52 and CM2 (UL44 and UL57) detects active infection in patients with chronic fatigue syndrome
- 1Pathgroup Labs, Nashville, TN, USA
- 2Departments of Medicine, William Beaumont Hospital and Wayne State University School of Medicine, Royal Oak, Michigan, USA
- 3Department of Medical Education, University of Michigan School of Medicine, Ann Arbor, Michigan, USA
- Dr A Martin Lerner, 32804 Pierce St, Beverly Hills, MI 48025, USA;
- Accepted 22 October 2007
- Published Online First 23 November 2007
Aims: To investigate whether the use of recombinant early antigens for detection of antibodies to human cytomegalovirus (HCMV) gene products CM2 (UL44, UL57) and p52 (UL44) is specific in the diagnosis and differentiation of active HCMV infection in a subset of patients with chronic fatigue syndrome (CFS), a diagnosis which is often missed by the current ELISA assay that uses crude viral lysate antigen.
Methods: At a single clinic from 1999 to 2001, a total of 4774 serological tests were performed in 1135 patients with patients using two immunoassays, Copalis and ELISA. The Copalis immunoassay utilised HCMV early gene products of UL44 and UL57 recombinant antigens for detection of HCMV IgM antibody, and viral capsid antigen for detection of HCMV IgG antibody. The ELISA immunoassay utilised viral crude lysate as antigen for detection of both HCMV IgG and IgM.
Results: 517 patients (45.6%) were positive for HCMV IgG by both assays. Of these, 12 (2.2%) were positive for HCMV(V) IgM serum antibody by HCMV ELISA assay, and 61 (11.8%) were positive for IgM HCMV serum antibody by Copalis assay. The Copalis assay that uses HCMV early recombinant gene products CM2 (UL44, UL57) and p52 (UL44) in comparison with ELISA was 98% specific.
Conclusions: Immunoassays that use early antigen recombinant HCMV CM2 and p52 are five times more sensitive than HCMV ELISA assay using viral lysate, and are specific in the detection and differentiation of active HCMV infection in a subset of patients with CFS.
Competing interests: All authors hold US patents on diagnosis and treatment of chronic fatigue syndrome.
Funding: The p52 and CM2 antigens were a gift from Diasorin Inc., Stillwater, MN, USA.