Jpn. J. Infect. Dis., 54 (1), 12-16, 2001

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Original Article

Evaluation of the AMPLICOR CMV, COBAS AMPLICOR CMV Monitor and Antigenemia Assay for Cytomegalovirus Disease

Tohru Masaoka*, Akira Hiraoka, Kensuke Ohta¹, Noriyuki Tatsumi², Shigeki Watanabe³, Tomomitsu Hotta³, Hiromasa Yabe⁴, Shunichi Kato⁴, Atsushi Aikawa⁵, Takehiro Ohara⁵, Akira Hasegawa⁵, Kazunari Tanabe⁶, Hiroshi Toma⁶, Akira Yasuoka⁷ and Shinichi Oka⁷

Osaka Medical Center for Cancer and Cardiovascular Diseaseｓ, Nakamichi 1-3-3, Higashinari-ku, Osaka 537-8511, ¹Department of Clinical Hematology and ²Department of Clinical and Laboratory Medicine, Osaka City University Medical School, Asahimachi 1-4-3, Abeno-ku, Osaka 545-8585, ³Department of Internal Medicine, Division of Hematology and Rheumatology and ⁴Department of Pediatrics, School of Medicine, Tokai University, Shimokatsuya 143, Isehara, Kanagawa 259-1193, ⁵Tokyo Women's Medical College Kidney Center, Kawadacho 8-1, Shinjuku-ku, Tokyo, 162-8666, ⁶Department of Nephrology, School of Medicine, Toho University, Omori-nishi 6-11-1, Ohata-ku, Tokyo 143-8541, and ⁷AIDS Clinical Center, International Medical Center of Japan, Toyama 1-21-1, Shinjuku-ku, Tokyo 162-8655, Japan

(Received September 12, 2000. Accepted January 31, 2001)

SUMMARY: 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.

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