Towards standardization of the human cytomegalovirus antigenemia assay

The Human Cytomegalovirus antigenemia (HCMV-Agemia) test has been accepted worldwide as a clinical tool in the diagnosis and management of HCMV-associ ated syndromes in immunocompromised patients. The many modifications propos ed since the first description by our laboratory make standardisation of th e HCMV-Agemia assay necessary to enable multicenter clinical trials. We rep ort the initial work for standardization of the HCMV-Agemia ia assay. A sta nda rd protocol is proposed, the optimal distribution conditions are inves tigated and the results of the shipment of positive and negative test slide s as well as of two sets of coded internal standard slides are discussed. T he main conclusions are that standard slides can be distributed at room tem perature and that the results of participating laboratories with the coded internal standard slides were strikingly similar in spite of differences in HCMV-Agemia protocols used by participating laboratories. Copyright (C) 20 00 S. Karger AG, Basel.