Borner K, Colombo J P, Bachmann C, Haeckel R, Oellerich M, Westerink D, Fischer M, Wimmer P, Vogt W, Tausch A, Knedel M, Minder W, Blum J, Portenhauser R
J Clin Chem Clin Biochem. 1979 Jul;17(7):471-81.
This paper describes the evaluation of a heterologous enzyme immunoassay for the determination of total thyroxine in serum by a group of seven clinical chemical laboratories. The test follows the principles of the enzyme linked immunosorbent assay (ELISA) and uses peroxidase as a marker. The evaluation of analytical reliability yielded the following results within the analytical range from 39 unto 322 nmol/l: 1. Within-batch precision ranged from 3.1 unto 10.4% (coefficient of variation) with single analyses. 2. Between-batch precision ranged from 3.7 unto 20.4% with single analyses. 3. Between-laboratories precision ranged from 5.4 unto 6.8%. 4. Pure thyroxine, added to serum or thyroxine-free serum, gave recoveries between 93 and 120%. 5. Analysis of control sera gave results essentially comparable to the assigned values based upon radioimmunoassays. 6. Analysis of 288 clinical sera gave slightly higher results by the enzyme immunoassay than by the analogous radioimmunoassay from the same manufacturer. 7. Comparison with other methods of analysis (radioimmunoassays, competitive protein ligand assays, hormonal iodine assay) yielded partly comparable, partly higher results. 8. Comparison with the homogenous enzyme immunoassay (EMIT) led to comparable results. 9. Interference due to hyperlipemia or hemolysis was not observed. 10. There might be an interference in hyperbilirubinaemic sera, due to an as yet unknown factor. With respect to practicability the ELISA-test compares favourably with the analogous solid phase radioimmunoassay. The main differences are the absence of radioactive material and a longer shelf-live of reagents. Following the manual procedure the time taken to perform the enzyme immunoassay is slightly longer than for the analogous radioimmunoassay.
本文描述了一组七个临床化学实验室对用于测定血清总甲状腺素的异源酶免疫测定法的评估。该测试遵循酶联免疫吸附测定（ELISA）的原理，并使用过氧化物酶作为标记物。在39至322 nmol/l的分析范围内，对分析可靠性的评估得出以下结果：1. 单次分析时，批内精密度范围为3.1%至10.4%（变异系数）。2. 单次分析时，批间精密度范围为3.7%至20.4%。3. 实验室间精密度范围为5.4%至6.8%。4. 添加到血清或无甲状腺素血清中的纯甲状腺素回收率在93%至120%之间。5. 对照血清分析结果与基于放射免疫测定法指定的值基本相当。6. 对288份临床血清进行分析，酶免疫测定法得到的结果略高于同一制造商的类似放射免疫测定法。7. 与其他分析方法（放射免疫测定法、竞争性蛋白质配体测定法、激素碘测定法）比较，结果部分相当，部分更高。8. 与均相酶免疫测定法（EMIT）比较，结果相当。9. 未观察到高脂血症或溶血引起的干扰。10. 由于一个未知因素，高胆红素血症血清中可能存在干扰。就实用性而言，ELISA测试与类似的固相放射免疫测定法相比具有优势。主要区别在于不存在放射性物质且试剂保质期更长。按照手动操作程序，进行酶免疫测定所需的时间比类似的放射免疫测定法略长。
