Comparison of a new Light Diagnostics and the CMV Brite to an in-house developed human cytomegalovirus antigenemia assay.
BACKGROUND
Antigenemia, i.e. detection and quantification of human cytomegalovirus (HCMV) peripheral blood pp65-positive leukocytes, is still one of the two major assays available for diagnosis and monitoring of HCMV infections.


OBJECTIVE
To evaluate the performance of a new commercial assay under development (Light Diagnostics).


METHODS
To compare the performance of the new assay with a commercial assay (CMV Brite) already available on 300 blood samples from immunocompromised patients using as a reference the original in-house developed assay.


RESULTS
Although 30 blood samples gave discrepant results among the 3 antigenemia assays, the Light Diagnostics detected an overall number of antigenemia-positive blood samples (sensitivity 84%) identical to that detected by CMV Brite (sensitivity 88%) and in-house assay (91/300, 30.3%). Problems of non-specific cytoplasmic staining were encountered with the CMV Brite assay in 219/300 (73%) blood samples.


CONCLUSIONS
The Light Diagnostics assay provides results comparable to those of the reference assay both in terms of specificity and sensitivity (number of pp65-positive leukocytes).
Percivalle
Elena
E
Servizio di Virologia, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy.
Genini
Emilia
E
Chiesa
Antonella
A
Gerna
Giuseppe
G
D003587:Cytomegalovirus / Q000302:isolation & purification*; D003586:Cytomegalovirus Infections / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D005455:Fluorescent Antibody Technique / Q000379:methods*; D006801:Humans; D016867:Immunocompromised Host; D007962:Leukocytes / Q000821:virology; D010750:Phosphoproteins / Q000097:blood*; D012680:Sensitivity and Specificity; D014763:Viral Matrix Proteins / Q000097:blood*; D014766:Viremia / Q000175:diagnosis / Q000276:immunology
D010750:Phosphoproteins; D014763:Viral Matrix Proteins; C065418:cytomegalovirus matrix protein 65kDa