Schmitt U M, Stieber P, Hasholzner U, Pahl H, Hofmann K, Fateh-Moghadam A
Institut für Klinische Chemie, Klinikum Grosshadern, Ludwig-Maximilians-Universität München, Germany.
Eur J Clin Chem Clin Biochem. 1996 Aug;34(8):679-82.
We evaluated the clinical and methodological features of the neuron-specific enolase radioimmunoassay (NSE RIA) (Pharmacia = Ph) with the neuron-specific enolase enzyme immunoassay (NSE EIA) on the ES 700 (Boehringer Mannheim = BM) and the NSE EIA on the Cobas Core System (Roche = Ro). A total of 253 serum samples obtained from 37 healthy persons, 45 patients with benign lung diseases, 124 patients with lung cancer (42 with small cell lung cancer, 23 with adenocarcinoma, 21 with squamous cell carcinoma, 11 with large cell carcinoma, and 27 with unknown histology), 34 with lung metastases, 7 patients with sarcoma and 6 patients with malign lymphatic diseases were stored at -80 degrees C and assayed retrospectively. The intra- and inter-assay imprecisions were lower for the automatized test systems than for the RIA. Correlation between the EIA's and the RIA was better for NSE (Ro) than for NSE (BM) (BM/Ph: r = 0.93 and slope = 0.54; Ro/Ph: r = 0.95, slope = 0.79), but weaker than the correlation between the two EIA's: over the whole range r = 0.96, neuron-specific enolase < 50 micrograms/l: r = 0.97, neuron-specific enolase < 20 micrograms/l: r = 0.92. Fixing the specificity at 95% versus benign lung diseases we found a cut off value of 11.9 micrograms/l for NSE RIA (Ph), 15.9 micrograms/l for NSE EIA (BM) and 13.5 micrograms/l for NSE EIA (Ro). Based on this specificity of 95% versus benign lung diseases as the clinically relevant reference group, the sensitivity for NSE RIA was 32% for all lung cancer and 45% for small cell lung cancer, for NSE EIA (BM) 35% for all lung cancer and 43% for small cell lung cancer, the NSE EIA (Ro) had a sensitivity of 42% for all lung cancer and 57% for small cell lung cancer. In a follow-up study of two patients with small cell lung cancer a good comparability for all three assays in the kinetics, but a marked difference in the neuron-specific enolase value levels was found. The results show that the NSE EIA (Ro) on Cobas Core system is the most sensitive assay for the detection of small cell lung cancer.
我们采用ES 700（宝灵曼公司=BM）上的神经元特异性烯醇化酶酶免疫测定法（NSE EIA）以及Cobas Core系统（罗氏公司=Ro）上的NSE EIA，对神经元特异性烯醇化酶放射免疫测定法（NSE RIA）（法玛西亚公司=Ph）的临床和方法学特征进行了评估。我们从37名健康人、45名良性肺病患者、124名肺癌患者（42名小细胞肺癌患者、23名腺癌患者、21名鳞状细胞癌患者、11名大细胞癌患者以及27名组织学类型不明的患者）、34名肺转移患者、7名肉瘤患者和6名恶性淋巴疾病患者身上采集了253份血清样本，并将其保存在-80℃下进行回顾性检测。自动化检测系统的批内和批间不精密度低于放射免疫测定法。NSE（Ro）的酶免疫测定法与放射免疫测定法之间的相关性优于NSE（BM）（BM/Ph：r = 0.93，斜率 = 0.54；Ro/Ph：r = 0.95，斜率 = 0.79），但弱于两种酶免疫测定法之间的相关性：在整个范围内r = 0.96，神经元特异性烯醇化酶<50微克/升：r = 0.97，神经元特异性烯醇化酶<20微克/升：r = 0.92。以与良性肺病相比95%的特异性为标准，我们发现NSE RIA（Ph）的临界值为11.9微克/升，NSE EIA（BM）为15.9微克/升，NSE EIA（Ro）为13.5微克/升。以与良性肺病相比95%的特异性作为临床相关参照组，NSE RIA对所有肺癌的敏感性为32%，对小细胞肺癌为45%；NSE EIA（BM）对所有肺癌的敏感性为35%，对小细胞肺癌为43%；NSE EIA（Ro）对所有肺癌的敏感性为42%，对小细胞肺癌为57%。在对两名小细胞肺癌患者的随访研究中，发现三种检测方法在动力学方面具有良好的可比性，但在神经元特异性烯醇化酶值水平上存在显著差异。结果表明，Cobas Core系统上的NSE EIA（Ro）是检测小细胞肺癌最敏感的检测方法。
