Clinical Evaluation of a New Recombinant Antigen-Based Cytomegalovirus Immunoglobulin M Immunoassay in Liver Transplant Recipients

Abstract

Although this assay is a sensitive test for CMV-specific IgM, detection of CMV IgM preceded detection of virus by culture in patients only when the liver transplant recipient was CMV immune before transplantation (R+).

Clinical Utility of Cytomegalovirus (CMV) Serology Testing in High-risk CMV D+/R- Transplant Recipients

“…In a study of 42 liver and kidney transplant recipients, IgG or IgM serological responses did not differ between symptomatic and asymptomatic patients, and usually occurred only after the onset of symptoms (14). The use of a more sensitive recombinant antigen ELISA IgM assay (similar to the one used in our study), was found to have some clinical utility in predicting CMV disease in one study of 40 liver transplant recipients, although again DNAemia generally preceded detection of antibody (15). Based on these data, in the past several years, molecular detection methods have generally replaced serology and culture based tests for the diagnosis of active CMV disease (16)(17)(18).…”

“…Previous studies have assessed the utility of serology for diagnosis of CMV disease (13)(14)(15). These studies have demonstrated that serology is generally of limited clinical utility for the acute diagnosis of CMV disease, when compared with molecular assays.…”

Window period donations during primary cytomegalovirus infection and risk of transfusion‐transmitted infections

“…Nevertheless, the data of Zhang and colleagues, as well as an earlier case report by our group, support the finding of the current study that IgG antibodies are formed early in the course of primary CMV infections and precede the peak DNA concentration in plasma in immunocompetent subjects. In immunocompromised patients, CMV antibodies have rarely been detected before onset of CMV disease . It remains unclear, however, to what extent these results have been influenced by, for example, the use of far less sensitive methods for antibody detection or by antiviral prophylaxis after transplantation …”

Role of the Laboratory in Diagnosis and Management of Cytomegalovirus Infection in Hematopoietic Stem Cell and Solid-Organ Transplant Recipients

“…Humoral response to CMV infection is manifested by the production of CMV-specific antibodies. Immunoglobulin M (IgM) antibody against CMV occurs early (e.g., within 2 to 4 weeks following primary infection), and IgG antibody production occurs soon thereafter; both can be detected by a variety of methods (15,17).…”

“…Furthermore, the time lag between primary infection and IgM production, the persistence of IgM antibody in some healthy individuals, and the failure of some transplant recipients (e.g., hematopoietic stem cell recipients) to produce IgM antibody significantly decrease the clinical utility of serology in diagnosing CMV disease (15,17).…”