TSHIRMA（M）药盒临床应用评价

THE EVALUATION OF THYROTROPIN IMMUNORADIOMETRIC ASSAY KIT(MAGNETIC SEPARATION)IN CLINICAL APPLICATION

ＴＳＨＩＲＭＡ（Ｍ）平均回收率为１０４．８±４．１％；批内和批间ＣＶ分别为９．０％和１５．４％；ＡＢＣＶ为０．００７７─０．０２１６。４５例献血员ＴＳＨＩＲＭＡ测定值９５％可信限为０．４１一４．２８ｍＩＵ／１，ｌ１３例甲亢ＴＳＨＩＲＭＡ测定值均低于０．４１ｍｌＵ／ｌ，而ＲＩＡ值正常。５７例甲低ＴＳＨＩＲＭＡ值均高于正常，与ＲＩＡ值呈高度正相关（ｒ＝０．９５６６，Ｐ＜０．０１）。结果表明，ＴＳＨＩＲＭＡ（Ｍ）是检测甲状腺功能的灵敏方法。

The average recovery of the thyrotropin immunoradiometric assay(TSH IRMA ) iS(104.8±4.1)%. The coefficients of variation in intra- and interassay are 9.0%and l 5.4%, respectively.The average batch coefficient of variation is 0.0077─0.02l 6.The 95%confidence interval of serumTSH IRMA was 0.41─4.28 mIU/l in 4 5 bIood donors.The levels of TSH in l l 3 cases with hyper-thyoidism are below 0.41mIU/l in IRMA,but normal inRIA.The lecels of TSH IRMA in57 caseswith hypothyroidism are higher than normal, and have more significant positive correlation with thatof TSH RIA(r=0.9566,P<0.01).The resuIts show that the TSH IRMA with magnetic separationis a sensitive method for thyroid function test.