Diagnostic value of enzyme linked immuno-sorbent assay for cytomegalovirus disease.

BACKGROUND

Since interpretation of results of enzyme linked immuno-sorbent assay (ELISA) for diagnosis of Cytomegalovirus (CMV) infection in India is difficult, its diagnostic value required evaluation.

AIMS

To evaluate the diagnostic value of ELISA against polymerase chain reaction (PCR) in CMV disease.

SETTINGS AND DESIGN

Results of ELISA test for CMV antibodies in CMV-DNA PCR positive and negative patients and normal healthy blood donors were analysed.

METHODS AND MATERIAL

Anti-CMV antibodies were assayed by ELISA on the sera of 26 CMV PCR positive and 21 PCR negative patients and 35 normal healthy blood donors.

STATISTICAL ANALYSIS

Chi square and Fischer exact test were used for statistical analysis.

RESULTS

Anti-CMV antibodies (IgG or IgG and IgM) were present in 20 (76.9%) of 26 PCR positive and 13 (61.9%) of 21 PCR negative patients. ELISA was negative in six (23.1%) of 26 PCR positive patients. Of the 28 paediatric patients, ELISA was positive in 14 (73.7%) of 19 PCR positive and three (33.3%) of nine PCR negative patients showing a statistically significant difference (Chi square test, P value 0.038). Among the 19 patients having complications after organ transplant, ELISA showed anti-CMV antibodies in six (85.7%) of seven PCR positive and 11 (91.7%) of 12 PCR negative patients showing no significant difference. CMV-DNA was not detected in the buffy coat of 35 sero-positive blood donors.

CONCLUSION

ELISA has no diagnostic value in the detection of CMV activation although it may help in the differential diagnosis of CMV infection in the paediatric age group.