Japanese
Titleサイトケラチン測定キットとして新しく開発された "ボールエルザCYFRA 21-1" の有用性の検討
Subtitle技術報告
Authors木村良子*, 阿多まり子*, 中村誠治*, 藤井崇*, 河村正*, 棚田修二*, 濱本研*
Authors(kana)
Organization*愛媛大学医学部放射線科
Journal核医学
Volume31
Number2
Page199-206
Year/Month1994/2
Article報告
Publisher日本核医学会
Abstract「要旨」 サイトケラチン19フラグメント測定用に新たに開発された "ポールエルザCYFRA21-1" キットの検討を行った. 本キットの操作性は簡便であるがインキュベーション条件を一定にする必要を認めた. キットの再現性, 回収率, 希釈試験は良好であり, 最小測定感度は1ng/mlであった. CYFRA21-1は, TPAと強く相関し, 患者血清のCYFRA21-1活性はTPA固相化抗体で完全に吸収された. カットカフ値を2ng/mlと設定した場合, 健常人0%, 全良性疾患32.7%, 間質性肺疾患以外の良性疾患21.4%の陽性率であった. 悪性腫瘍患者におけるCYFRA21-1陽性率は56.0%と高く, 特に, 肺扁平上皮癌, 肺小細胞癌, 子宮頸癌で高い陽性率を認めた. 結論:CYFRA21-1測定キットの操作性, 信頼性は十分満足でき, 腫瘍マーカーとしての有用性はTPAと類似のものと考えられるが, 間質性肺疾患において高い陽性率を認め, 注意を要すると考えられた.
Practice臨床医学:一般
KeywordsCYFRA21-1, Tumor marker, IRMA, Cytokeratin.
English
TitleThe Evaluation of the Newly Produced Assay Kit for the Cytokeratin Fragment, "Ball ELSA CYFRA21-1"
SubtitleTechnical Reports
AuthorsYoshiko KIMURA, Mariko ATA, Seiji NAKAMURA, Takashi FUJII, Tadashi KAWAMURA, Shuhji TANADA, Ken HAMAMOTO
Authors(kana)
OrganizationDepartment of Radiology, Ehime University School of Medicine
JournalThe Japanese Journal of nuclear medicine
Volume31
Number2
Page199-206
Year/Month1994/2
ArticleReport
PublisherTHE JAPANESE SOCIETY OF NUCLEAR MEDICINE
Abstract[Summary] We evaluated the newly produced tumor marker assay kit, "Ball ELSA CYFRA21-1", which detects cytokeratin 19 fragment in the sera of patients with malignancies, especially lung cancers. The assay procedure is simple based on the one-step radioimmunometric assay method. The measured values depend somewhat on incubation temperature and time. Reproducibility and recovery were good. The minimum measurable level was 1 ng/ml. The dilution test was satisfactory. The CYFRA21-1 levels were gradually decreased by repeated freezing and thawing and after seven such exercises its activity dropped to about 70% of that of first assay. The presence of CYFRA21-1 antigen was strongly correlated with TPA antigen and, although some discrepancies could be observed in clinical samples, CYFRA21-1 activity was completely absorbed by anti-TPA antibody-coated beads in one sample. CYFRA21-1 levels of 44 normal controls were below 1.0 ng/ml. Assuming a cut-off value of 2.0 mg/ml, 32.7% of all cases with benign disease had values greater than 2.0 ng/ml. This fell to 21.4% on exclusion of cases of interstitial pulmonary disease. Those with malignant diseases had high CYFRA21-1 levels whether associated with lung cancer or not. The most high positive ratios were observed in squamous cell lung cancer, small cell lung cancer, and uterine cervical cancer. In conclusion, CYFRA21-1 may be a good tumor marker comparable to TPA not only for lung cancer but also other malignancies as well. High false positives for lung cancer, however, were observed in other pulmonary diseases.
PracticeClinical medicine
KeywordsCYFRA21-1, Tumor marker, IRMA, Cytokeratin.

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