Evaluation of Clinical Application of Rapid Diagnostic Kit for Human Cytomegalovirus pp65 IgG-AI

Objective To evaluate the clinical application of rapid diagnostic kit for human cytomegalovirus(HCMV) pp65 IgG-avidity index(AI).Methods Determine the specific IgG in confirmed positive and negative serum specimens preserved in our laboratory with prepared HCMV pp65 IgGAI kit by indirect ELISA to analyze the sensitivity,specificity and accuracy.Determine the pp65 IgG in 89 serum specimens collected in clinic,of which 5 were from the patients with active HCMV infection,by the prepared kit,and compare the results with those by imported kit.In addition,determine the AI values of pp65 IgG positive specimens by indirect ELISA using urea as protein denaturant and compare the results with those by imported IgM kit to evaluate the significance of AI in diagnosis of HCMV infection.Results All the determination results of confirmed positive and negative serum specimens were identical to those confirmed previously,indicating that the sensitivity,specificity and accuracy of prepared kit were 100%.The determination results of IgG by prepared and imported kits showed no significant difference.By determination of AI value with prepared kit,the primary(or suspected primary) HCMV infection rate of patients from whom the clinical specimens were collected was 46.07%,which was significantly higher than that by determination of IgM with reference kit(23.59%).Of the 5 specimens diagnosed as active HCMV infection,4 were proved as IgG positive by either prepared or reference kit,indicating that the coninicidence rate of the two kits was 100%.However,3 of the 5 specimens were proved as positive by determination of AI value with the prepared kit,while only one as positive by determination of IgM with reference kit.The specimens from patients with HCMV pulmonitis diagnosed in clinic were proved as positive by determination of AI value with the prepared kit,but as negative by determination of IgM with reference kit.Conclusion The developed rapid diagnostic kit for pp65 IgG-AI may be used for preliminary diagnosis of HCMV infection.It is simple,rapid and of good reproducibility and good prospect in clinical application.