Comparison Study Between Local TSH IRMA Kit (CRRT) and Imported TSH IRMA Kit (Riakey, Korea)

Gina Mondrida, Triningsih Triningsih, K. D. Purwanti, Sutari Sutari, S. Setyowati, W. Lestari, A. Ariyanto, Puji Widayati
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Abstract

Thyroid Stimulating Hormone (TSH) is one of hormones that our body need for growth of brains, bones and other tissues and regulate the metabolism in the body. Normal range of TSH for adult is from 0.3 to 5.5 µIU/ml, whereas for baby ranged from 3 to 18 µIU/ml. An Immunoradiometricassay (IRMA) is one of immunoassay technique using radionuclide as the tracer to detect low quantity of analyte. This technique is suitable for determine TSH levels in human blood serum which has complex matrix and various concentration. The Center for Radioisotope and Radiopharmaceutical Technology (CRRT)-BATAN has developed a reagent of TSH IRMA kit. The aim of this research is to compare between local TSH IRMA kit (CRRT-BATAN) and imported TSH IRMA kit (Riakey, Korea) toward 110 adult samples obtained from PTKMR - BATAN. The results showed 97 samples as true negative, 5 samples as true positive, 1 sample as false negative and 7 samples false positive. The comparison study gave diagnostic sensitivity as much as 83.33 %, diagnostic spesificity as much as 93.27 % and accuracy as much as 92.72 %.
国产TSH IRMA试剂盒(CRRT)与进口TSH IRMA试剂盒(Riakey, Korea)的比较研究
促甲状腺激素(TSH)是我们身体所需的一种激素,用于大脑、骨骼和其他组织的生长,并调节体内的新陈代谢。成人TSH的正常范围为0.3 ~ 5.5 μ IU/ml,而婴儿TSH的正常范围为3 ~ 18 μ IU/ml。免疫放射测定法(IRMA)是一种利用放射性核素作为示踪剂检测微量分析物的免疫测定技术。该技术适用于基质复杂、浓度多变的人血清中TSH水平的测定。batan放射同位素与放射药物技术中心(CRRT)开发了TSH IRMA试剂盒试剂。本研究的目的是比较本地TSH IRMA试剂盒(CRRT-BATAN)和进口TSH IRMA试剂盒(Riakey, Korea)对从PTKMR -BATAN获得的110个成人样本的影响。结果真阴性97例,真阳性5例,假阴性1例,假阳性7例。对比研究的诊断灵敏度为83.33%,诊断特异性为93.27%,准确率为92.72%。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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