Comparison of monoclonal antibodies for immunostaining in the cytomegalovirus shell vial assay on 4,388 specimens.

The shell vial assay is a sensitive, rapid test for the detection of cytomegalovirus (CMV) in a variety of specimens. The sensitivity of this assay is dependent on a number of factors including the antibodies used for immunostaining. Monoclonal antibodies to the CMV major immediate-early antigen (p72) from Chemicon (MAB810) and Dupont (NEA-9221) were assessed side by side in duplicate vials on 4,388 specimens from a patient population consisting of > 90% organ transplant recipients. A total of 240 specimens (5.5%) were CMV positive in either one or both vials. Positivity rates were variable across different specimen types but highest (12.9%) in urine specimens. Of the positive specimens, 175 (72.9%) tested positive in both vials, 43 (17.9%) tested positive in the Chemicon-stained vial only, and 22 (9.2%) tested positive in the Dupont-stained vial only (P < 0.01, McNemar's chi-square test). This gave an overall positivity rate of 5.0% for Chemicon antibodies and 4.5% for Dupont. There was no difference in the fluorescent focus counts produced by the two antibody sets. It is concluded that use of the Chemicon antibodies provides increased sensitivity of detection of CMV in the shell vial assay above that afforded by the Dupont antibody.