title: Evaluation of the AMPLICOR CMV, COBAS AMPLICOR CMV monitor and antigenemia assay for cytomegalovirus disease.
abstract: The AMPLICOR CMV (qualitative DNA assay by PCR), COBAS AMPLICOR CMV Monitor (quantitative DNA assay by PCR), and antigenemia assay were tested for their ability to diagnose cytomegalovirus (CMV) infection in 115 immunocompromised patients. The AMPLICOR qualitative assay and the antigenemia assay were positive for all nine patients with a clinical diagnosis of CMV disease. The AMPLICOR quantitative assay was negative for one of the nine patients. In 106 patients without CMV disease, the AMPLICOR qualitative test was positive in 22, the quantitative test was positive in 23, and the antigenemia test was positive in 55 patients. The AMPLICOR qualitative and quantitative assays had specificities of 79% and 78% in patients without CMV disease, while that of the antigenemia assay was 48%. Diagnostic efficiencies were 79% for the AMPLICOR qualitative assay, 69% for the AMPLICOR quantitative assay, and 48% for the antigenemia assay. All three tests yielded positive results before, or at the same time as, the onset of CMV disease in most cases, which suggests they can be used to predict disease before the onset of symptoms. During antiviral treatment, test results tended to decrease quantitatively and finally became negative; negative results were followed by remission of symptoms. This suggests that the AMPLICOR quantitative assay and the antigenemia assay could be useful for monitoring therapeutic efficacy. The AMPLICOR qualitative and quantitative assays, as well as the antigenemia assay were considered effective for all of the following: diagnosing CMV disease, predicting the onset of disease, and evaluating the effectiveness of antiviral chemotherapy. The antigenemia assay was at times difficult to perform in the case of severely neutropenic patients, whereas the AMPLICOR assays could be used in such cases.
authors.affiliation: Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka 537-8511, Japan. massanto@bh.mbn.or.jp
authors.forename: T
authors.initials: T
authors.lastname: Masaoka
authors.forename: A
authors.initials: A
authors.lastname: Hiraoka
authors.forename: K
authors.initials: K
authors.lastname: Ohta
authors.forename: N
authors.initials: N
authors.lastname: Tatsumi
authors.forename: S
authors.initials: S
authors.lastname: Watanabe
authors.forename: T
authors.initials: T
authors.lastname: Hotta
authors.forename: H
authors.initials: H
authors.lastname: Yabe
authors.forename: S
authors.initials: S
authors.lastname: Kato
authors.forename: A
authors.initials: A
authors.lastname: Aikawa
authors.forename: T
authors.initials: T
authors.lastname: Ohara
authors.forename: A
authors.initials: A
authors.lastname: Hasegawa
authors.forename: K
authors.initials: K
authors.lastname: Tanabe
authors.forename: H
authors.initials: H
authors.lastname: Toma
authors.forename: A
authors.initials: A
authors.lastname: Yasuoka
authors.forename: S
authors.initials: S
authors.lastname: Oka
mesh_terms: D000956:Antigens, Viral / Q000097:blood; D003587:Cytomegalovirus / Q000235:genetics / Q000276:immunology; D003586:Cytomegalovirus Infections / Q000175:diagnosis*; D004279:DNA, Viral / Q000032:analysis*; D006801:Humans; D016867:Immunocompromised Host; D009503:Neutropenia / Q000150:complications / Q000175:diagnosis; D016133:Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D016896:Treatment Outcome
chemical_list: D000956:Antigens, Viral; D004279:DNA, Viral