分子诊断与治疗杂志
分子診斷與治療雜誌
분자진단여치료잡지
JOURNAL OF MOLECULAR DIAGNOSIS AND THERAPY
2013年
5期
328-332
,共5页
王毅%何咏婷%冯健明%刘银河
王毅%何詠婷%馮健明%劉銀河
왕의%하영정%풍건명%류은하
游离三碘甲状腺原氨酸%时间分辨荧光免疫分析%甲状腺功能
遊離三碘甲狀腺原氨痠%時間分辨熒光免疫分析%甲狀腺功能
유리삼전갑상선원안산%시간분변형광면역분석%갑상선공능
Free triiodothyronine%Time-resolved fluoroimmunoassay%Thyroid function
目的研制一种游离三碘甲状腺原氨酸（free triiodothyronine，FT3）时间分辨荧光免疫分析（time-resolved fluoroimmunoassay，TRFIA）试剂盒。方法采用直接竞争法建立游离三碘甲状腺原氨酸（FT3）检测TRFIA试剂盒（固相包被T3-复合物，与样本中的FT3竞争结合DTTA-Eu3+标记的T3单克隆抗体），并对试剂盒各项指标进行评价。结果该试剂盒的有效检测浓度范围为1.5~70 pmol/L，分析灵敏度为不高于0.7 pmol/L，批内、批间的不精密度分别不高于8.2%与10.5%。与T4、FT4、反T3、反T4交叉反应率分别为：<0.01%、0.11%、<0.01%、<0.01%。稳定性试验表明试剂可以在2~8℃稳定一年，37℃稳定7 d。用该试剂盒对500份正常人血清标本进行测试，统计该试剂盒的正常参考值范围是3.2~6.5 pmol/L。156份血清标本用本试剂盒与国外某知名品牌化学发光法试剂盒同时检测，其相关系数为0.992。结论试剂盒各项指标均达到临床检测要求，可考虑作为国外化学发光法同类产品试剂盒的替代产品。
目的研製一種遊離三碘甲狀腺原氨痠（free triiodothyronine，FT3）時間分辨熒光免疫分析（time-resolved fluoroimmunoassay，TRFIA）試劑盒。方法採用直接競爭法建立遊離三碘甲狀腺原氨痠（FT3）檢測TRFIA試劑盒（固相包被T3-複閤物，與樣本中的FT3競爭結閤DTTA-Eu3+標記的T3單剋隆抗體），併對試劑盒各項指標進行評價。結果該試劑盒的有效檢測濃度範圍為1.5~70 pmol/L，分析靈敏度為不高于0.7 pmol/L，批內、批間的不精密度分彆不高于8.2%與10.5%。與T4、FT4、反T3、反T4交扠反應率分彆為：<0.01%、0.11%、<0.01%、<0.01%。穩定性試驗錶明試劑可以在2~8℃穩定一年，37℃穩定7 d。用該試劑盒對500份正常人血清標本進行測試，統計該試劑盒的正常參攷值範圍是3.2~6.5 pmol/L。156份血清標本用本試劑盒與國外某知名品牌化學髮光法試劑盒同時檢測，其相關繫數為0.992。結論試劑盒各項指標均達到臨床檢測要求，可攷慮作為國外化學髮光法同類產品試劑盒的替代產品。
목적연제일충유리삼전갑상선원안산（free triiodothyronine，FT3）시간분변형광면역분석（time-resolved fluoroimmunoassay，TRFIA）시제합。방법채용직접경쟁법건립유리삼전갑상선원안산（FT3）검측TRFIA시제합（고상포피T3-복합물，여양본중적FT3경쟁결합DTTA-Eu3+표기적T3단극륭항체），병대시제합각항지표진행평개。결과해시제합적유효검측농도범위위1.5~70 pmol/L，분석령민도위불고우0.7 pmol/L，비내、비간적불정밀도분별불고우8.2%여10.5%。여T4、FT4、반T3、반T4교차반응솔분별위：<0.01%、0.11%、<0.01%、<0.01%。은정성시험표명시제가이재2~8℃은정일년，37℃은정7 d。용해시제합대500빈정상인혈청표본진행측시，통계해시제합적정상삼고치범위시3.2~6.5 pmol/L。156빈혈청표본용본시제합여국외모지명품패화학발광법시제합동시검측，기상관계수위0.992。결론시제합각항지표균체도림상검측요구，가고필작위국외화학발광법동류산품시제합적체대산품。
Objective To develop a kit for the detection of human free triiodothyronine (FT3) in serum by time-resolved fluoroimmunoassay (TRFIA). Methods The TRFIA FT3 kit was established by direct competitive method (solid-phase was coated with T3 complex, and competitively binded to T3 monoclonal antibody labeled DTTA-Eu3+with FT3). And the performance of the kit was evaluated. Results The effective working range of the kit was 1.5~70 pmol/L and the analytical sensitivity was not higher than 0.7 pmol/L. The intra-assay and inter-assay coefficients of variation were not higher than 8.2% and 10.5%, respectively. The percentage of cross reactivity with T4, FT4, rT3, rT4 were<0.01%, 0.11%,<0.01%and<0.01%, respectively. The TRFIA FT3 reagents can be stored at 2℃~8℃ for one year and at 37℃ for 7 days. The cutoff value for TRFIA FT3 kit in healthy subjects was 3.2 pmol/L~6.5 pmol/L, in according to 500 cases of health sample serum with this kit. The correlation coefficient of blood samples detection results (n=156) between home-made and CLIA kit of one well-known foreign brands was 0.992. Conclusion FT3 TRFIA kit was a valuable diagnostic kit for clinical application with better sensitivity, specificity, and accuracy.
