Japanese
Title肺癌マーカーとしての血中サイトケラチン19フラグメント測定用CYFRA 21-1 IRMAに関する基礎的ならびに臨床的検討
Subtitle技術報告
Authors濱政明宏*, 杉本佳則*, 前田真紀子*, 木谷仁昭*, 福地稔*
Authors(kana)
Organization*兵庫医科大学病院核医学診療部
Journal核医学
Volume31
Number8
Page969-976
Year/Month1994/8
Article報告
Publisher日本核医学会
Abstract「要旨」肺癌の腫瘍マーカーとしての血中サイトケラチン19測定法CYFRA 21-1 IRMAに関する基礎的, 臨床的検討を行った. 本法の最小検出濃度は0.3ng/mlと優れ, 回収試験, 再現性, 希釈試験等, 基礎的検討成績も満足できた. 本法のカットオフ値はROC curveで求めたところ1.6ng/mlであった. この値を基に臨床的検討成績を評価すると, 健常人47名中3名(6.4%), 良性肺疾患患者30例中9例(30.0%)が偽陽性を示した. これに対し肺癌患者では50例中31例(62.0%)が陽性で, 組織型別では扁平上皮癌, 84.6%, 小細胞癌66.7%, 大細胞癌57.1%, 腺癌44.4%がそれぞれ陽性であった. ステージ分類別陽性率はステージIが50.0%, IIが50.0%, IIIが61.9%, IVが76.9%であった. 本法で得られる測定値はTPA値と相関係数r=+0.86(p<0.01)と良好な相関を示した. 以上の成績から, 本法は肺癌の腫瘍マーカーとして臨床的に有用である.
Practice臨床医学：一般
KeywordsLung cancer, Cytokeratin 19, CYFRA 21-1, IRMA, Tumor marker.
English
TitleBasic and Clinical Studies on Serum Cytokeratin 19 Fragment Assay Using Centocor(R) CYFRA 21-1 Kit in Patients with Lung Cancer
Subtitle
AuthorsAkihiro HAMASE, Yoshinori SUGIMOTO, Makiko MAEDA, Hiroaki KITANI, Minoru FUKUCHI
Authors(kana)
OrganizationDepartment of Nuclear Medicine, Hyogo College of Medicine
JournalThe Japanese Journal of nuclear medicine
Volume31
Number8
Page969-976
Year/Month1994/8
ArticleReport
PublisherTHE JAPANESE SOCIETY OF NUCLEAR MEDICINE
Abstract[Summary] We evaluated the newly developed tumor marker assay kit, "Centocor(R) CYFRA 21-1", an immunoradiometric assay (IRMA) kit for determining the serum cytokeratin 19 fragment using the sera of healthy subjects, patients with benign lung diseases and patients with lung cancer. The assay procedure is simple and based on the one-step IRMA system. There were no problems in reproducibility, dilution test and recovery test. The minimum detectable dose was 0.3 ng/ml. The antigen measured by this kit was immunologically cross-reactive with tissue polypeptide antigen (TPA) and CYFRA 21-1 concentration was closely correlated with TPA concentration in the patient's serum (r=0.86, p<0.01). The cut-off value of serum CYFRA 21-1 based on the assay results of this kit was calculated to be 1.6 ng/ml from the receiver operating characteristic curve. Three of 47 healthy subjects (6.4%) and 9 of 30 patients with benign lung diseases (30.0%) showed a concentration over the cut-off value. By contrast, serum CYFRA 21-1 concentration was elevated in 31 of 50 patients with lung cancer (62.0%), 11 of 13 squamous cell carcinoma patients (84.6%), 8 of 12 small cell carcinoma patients (66.7%), 4 of 7 large cell carcinoma patients (57.1%) and 8 of 18 adenocarcinoma patients (44.4%). In addition, the positive rate of serum CYFRA 21-1 in patients with lung cancer gradually increased with staging of the disease: 50.0% in stage I, 50.0% in stage II, 61.9% in stage III, and 76.9% in stage IV. Thus, our results suggested that the Centocor(R) CYFRA 21-1 kit is a useful assay system for serum cytokeratin 19 fragment as a tumor marker in patients with lung cancer.
PracticeClinical medicine
KeywordsLung cancer, Cytokeratin 19, CYFRA 21-1, IRMA, Tumor marker.

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