磁性均相酶联免疫技术对内分泌激素的方法学评价及临床应用

Methodical evaluation and clinical application of magnetic homogeneous ELISA determining endocrine hormones

目的探讨磁性均相酶联免疫技术及SEROZYME-Ⅲ型吸光值测定仪性能的可靠性。方法测促甲状腺激素(TSH)用磁性均相酶联免疫夹心法;测游离三碘甲状腺原氨酸(FT3)、游离甲状腺激素(FT4)用磁性均相酶联免疫竞争法。结果最小检测量:FT3<0.26pg/mL,FT4<0.10pg/mL,TSH<0.03μIU/mL;回收率:FT3为95.93%,FT4为96.53%,TSH为96.36%;批间变异系数(CV):FT3为4.2%,FT4为4.8%,TSH为4.5%;批内变异系数(CV%):FT3为3.4%,FT4为3.2%,TSH为2.9%。用放射免疫法、免疫放射法与本法同时测定30份标本中的TSH、FT3、FT4含量,两种方法结果符合率FT3达0.927、FT4达0.935、TSH达0.936,均呈显著相关性。结论磁性均相酶联免疫技术及SEROZYME-Ⅲ型吸光值测定仪的灵敏度、精密度、准确度、特异性均达到标准要求,适宜中、小型医院临床推广应用。

Objective To explore the reliability of magnetic homogeneous ELISA and performance of SEROZYME Ⅲ optical density detector. Methods Magnetic homogeneous sandwich ELISA was applied to detecting thyroid stimulating hormone （TSH）, while magnetic homogeneous competitive ELISA was applied to detecting free triiodothyronine （FT3） and free thyroxine （FT4）. Results The minimum detection limit was as follows： FT3〈0.26 pg/mL, FT4〈0.10 pg/mL, TSH〈0.03 μIU/mL;the recovery rate：FT3 95.93M, FT4 96.53%, TSH 96.36%; interassay coefficient of variation （CV）：FT3 4. 2%, FT4 4. 8%, TSH 4. 5%; intraassay coefficient of variation （CV%） ： FT3 3.4 %, FT4 3.2%, TSH 2.9 %, Solid phase radioimmunoassay （RIA） and immunoradiometric analysis （IRMA） were adopted to measure TSH, FT3 and FT4 for 30 cases of species simultaneously. The result comparison showed the coincidence rate was as follows： FT3 0. 927, FT4 0. 935, TSH 0. 936. Conclusion The sensitivity, precision, accuracy and specificity of magnetic homogeneous ELISA and SEROZYME Ⅲ optical density detector achieve the standard demand, suitable for clinical application in small and middle hospitals.