Sapin R, Gasser F, Schlienger J L, Chambron J
Institut de physique biologique, faculté de médecine, Hôpital de Hautepierre, CHRU, Strasbourg, France.
Ann Biol Clin (Paris). 1993;51(1):13-8.
We evaluated analytically and clinically two new one-step labelled antibody assays for measuring free triiodothyronine (FT3): the first, radiolabelled with 125I, Amerlex-MAB (MAB) from Kodak Diagnostic, and the second, labelled with peroxidase, Enzymun-test FT3 (BM) from Boehringer Mannheim adapted for the Boehringer ES 600 analyser. The clinical results were compared with those obtained with a radiolabelled analog tracer kit, Amerlex-M (M) from Kodak Diagnostic. The latter kit is known to give low FT3 results in sera with low albumin concentrations. Analytical performances of the automated method (BM) were better than those obtained with the manual method (MAB): intra-assay reproducibility (CV < 3% vs CV about 5%), inter-assay reproducibility (CV < 4% vs CV between 4 and 8%) and mean drift (+1.25% vs -4.3%). The detection limit was low for both kits (< 1 pmol/l). In the euthyroid reference group (n = 98) we observed a significant difference between outpatient and hospitalized patient FT3 concentrations as measured with the M kit only. The reference range was 3.2-6.5 pmol/l for the MAB kit vs 5.4-9.2 pmol/l for the BM kit. This result underlines the problem of standardisation with the FT3 assays. Clinical sensitivity for hyperthyroidism (n = 38) was better for the MAB (92%) than for the BM kit (76%). Specificity in euthyroid L-thyroxine (T4) treated patients (n = 26) was good for both kits (MAB: 92%; BM: 88%).(ABSTRACT TRUNCATED AT 250 WORDS)
我们对两种用于测定游离三碘甲状腺原氨酸（FT3）的新型一步标记抗体分析法进行了分析和临床评估：第一种用125I进行放射性标记，即柯达诊断公司的Amerlex-MAB（MAB）；第二种用过氧化物酶进行标记，即勃林格殷格翰公司适用于勃林格ES 600分析仪的Enzymun-test FT3（BM）。将临床结果与用放射性标记类似物示踪剂试剂盒（柯达诊断公司的Amerlex-M，即M）获得的结果进行比较。已知后一种试剂盒在白蛋白浓度低的血清中FT3结果偏低。自动化方法（BM）的分析性能优于手工方法（MAB）：批内重复性（变异系数[CV]<3% 对比 CV约5%）、批间重复性（CV<4% 对比 CV在4%至8%之间）和平均漂移（+1.25% 对比 -4.3%）。两种试剂盒的检测限均较低（<1 pmol/l）。在甲状腺功能正常的参考组（n = 98）中，仅用M试剂盒测量时，我们观察到门诊患者和住院患者的FT3浓度存在显著差异。MAB试剂盒的参考范围为3.2 - 6.5 pmol/l，而BM试剂盒为5.4 - 9.2 pmol/l。这一结果凸显了FT3检测方法标准化的问题。对于甲状腺功能亢进患者（n = 38），MAB的临床敏感性（92%）优于BM试剂盒（76%）。在接受L-甲状腺素（T4）治疗的甲状腺功能正常患者（n = 26）中，两种试剂盒的特异性都较好（MAB：92%；BM：88%）。（摘要截选至250字）
