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-associated syndromes in immunocompromised patients. The many modifications proposed since the first description by our laboratory make standardisation of the HCMV-Agemia assay necessary to enable multicenter clinical trials. We report the initial work for standardization of the HCMV-Agemia assay. A standard protocol is proposed, the optimal distribution conditions are investigated and the results of the shipment of positive and negative test slides as well as of two sets of coded internal standard slides are discussed. The main conclusions are that standard slides can be distributed at room temperature 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.
Verschuuren
E A
EA
Department of Clinical Immunology, University Hospital Groningen, The Netherlands. e.a.m.verschuuren@int.azg.nl
Harmsen
M C
MC
Limburg
P C
PC
van Der Bij
W
W
van Den Berg
A P
AP
Kas-Deelen
A M
AM
Meedendorp
B
B
van Son
W J
WJ
The
T H
TH
D000911:Antibodies, Monoclonal; D003587:Cytomegalovirus / Q000276:immunology / Q000302:isolation & purification*; D003586:Cytomegalovirus Infections / Q000175:diagnosis* / Q000821:virology; D005189:False Positive Reactions; D006801:Humans; D007118:Immunoassay / Q000592:standards*; D010750:Phosphoproteins / Q000097:blood*; D012015:Reference Standards; D012680:Sensitivity and Specificity; D013048:Specimen Handling; D014763:Viral Matrix Proteins / Q000097:blood*
D000911:Antibodies, Monoclonal; D010750:Phosphoproteins; D014763:Viral Matrix Proteins; C065418:cytomegalovirus matrix protein 65kDa