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題 名 | 評估第二代促甲狀腺刺激激素受體抗體之檢測方法於葛瑞夫茲氏症=The Evaluation of the Second Generation Assay for Measuring TSH Receptor Antibody in Graves' Disease |
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作 者 | 王玫君; 林興中; 呂志成; 朱志勳; 孫群欽; 莊明儒; 莊媖婷; 李鎮堃; | 書刊名 | 澄清醫護管理雜誌 |
卷 期 | 2:3 民95.07 |
頁 次 | 頁4-11 |
分類號 | 415.66 |
關鍵詞 | 促甲狀腺刺激激素受體抗體; 葛瑞夫茲氏症; 放射受體法; 酵素免疫分析法; TSH receptor antibody; Graves' disease; RRA assay; ELISA assay; |
語 文 | 中文(Chinese) |
中文摘要 | 目的:葛瑞夫茲氏症(Grave's disease-GD)是 造成甲狀腺機能亢進之重要甲狀腺自體兔 疫疾病,忠者血清中存在異常的免疫球蛋 白,稱為促甲狀腺刺激激素受體抗體(TSH recepter antibody-TRAb) .它可與存在於 甲狀腺濾泡細胞膜上之人促甲狀腺激素受 體結合,促使甲狀腺分泌、荷爾蒙增多並造 成甲狀腺瀰漫性增生(腫大)0 TRAb是 Graves發病的一個重要因素,這些抗體在 Graves病患者中的陽性率約為60-95% '檢 測這些自身抗體可用於Graves症的確診和 區分其他甲狀腺疾病,繼續監測TRAb的 值可有助於判斷疾病的預後及復發,由此 可見檢測TRAb是很重要!但臨床檢測時 亦有1O-40%TRAb未能檢測出TRAb'因此 我們評估更敏之新方法,以期有更安全、 簡便操作、更準確的檢測方法。本實驗將 分析,比較慣用之放射受體法(ridioreceptor assay-RRA)試劑組與新方法酵素兔疫分 析法(enzyme-linkedimmunosorbent assay -ELISA)試劑組之間的精密度、準確 度、敏感度、特異性、相關性,並建立 ELISA法之參考值。 方法:使用RRA法與ELISA法測試甲狀腺疾病之 病人(n=105)及健康人(n=74)之血清 中的TRAb。 結果:RRA法interassay A血清為26.12% :::1::2.04 自(N=lO)'CV=7.66月;B血清為44.69 %+2.81% (N=10) 'CV=6.29%。 Between assay A血清為27.71 % :::1::2.7% (N=10) ,CV=9.74 % ; B血清為44.5 % 土2.32% (N=lO) 'CV=5.21 % 0 ELlSA i去之inter assay A血清為34.27 % :::1::1.98% (N=10) 'CV=5.77 % ; B血清為90.61 % :::1::0.78 % ( N = 10 ) 'C V =0.86 % ; C血清 為73.09% :::1::1.08% (N=10) 'CV=1.47 % 0 Between assayA血清為34.27 %土30? % (N=lO) •CV=8.86 % ; B血清為89.64 % :::1::2.16% (N=IO) 'CV=2.41 % 0 RRA 法與ELISA法R=0.95; P<O.OOI '所以兩 種方法相關顯著。RRA法陽性率為641105 (60.95%) • ELISA法陽性率為78/105 (74.3%) ; ELISA法之參考值為<10%。 結論:因使用豬的促甲狀腺素受體(TS H receptor-TR)之放射受體法,有放射性 使用安全性及放射性廢棄物處理之考 量,且與使用人的促甲狀腺素受體(TSH receptor- TR)之酵素免疫析法比較分析 後,酵素免疫析法具有較高的臨床敏感性 和特異性及操作簡便,且酵:幸免疫分析法 之有效期限較RRA長,更有利於臨床彈性 應用,另外更重要是可提供更準確數值, 所以使用酵素免疫分析法是為很好的考 量。 |
英文摘要 | Background: TSH receptor antibody (TRAb) plays important role in Graves' disease. The measurement ofTRAb is performed currently by radioreceptor assays(RRA) to detect porcine TSH receptor (PTR) . However, TRAb is undetectable in about 10% to 40% of patients Graves' disease by using this method. The second generation assay by using EL1SA to detect human TSH receptor (HTR) as a means to measure TRAb is therefore investigated in the present study. Method: TRAb in the quality control sera were measured by RRA and ELISA respectively to compare their inter-assay and intra-assay. TRAb in the sera of 90 patients (24 females and 66 males with mean age of 39.9 y /0) Graves' disease were measured both by the RRA and ELISA methods.Besides, TRAb in the sera of 74 age and sex matched control subjects were also measured by these two assays method. Result: The inter assay of control serum A and serum B by using RRA methodwas 26.12%士2.04% (N=10, CV = 7.66%)and 44.69% 士2.81%(N=10, CV = 6.29%),respectively The intra assay of control serum A and serum B by RRA was 27.71% Í 2.70% (N=10, CV = 9.74%)αnd 44.5% Í 2.32% (N=lO, CV = 5.21%), respectively whereas the inter assay of control serum A and serum B by using by ELISA method was 34.27%士1.98% (N=10, CV = 5.77%)and 90.61% Í 0.78% (N=10, CV = 0.86%),respectively The intra assay of control serum A and serum B by ELISA was 34.27% Í 3.05% (N=lO, CV = 8.86%),and 89.64% Í 2.16% (N=lO, CV = 2.41%), respectively The correlation coξfficient between RRA and ELISA was signifzcant (r = O.94 P < 0.001). The sensitivity of RRA assay was 65.6% (59/9), and that of ELISA assay was 75.6% (68/90). The specificies of both RRA and ELISA assays were 100% (74/74).The nomal reference value ofTRAb by using ELISA was below 10%. Conclusion:measurement of TRAb by detecting HTR using ELISA METHOD has higher sensitivity and specifzcity than that bydetecting PTR using RRA method. |
本系統中英文摘要資訊取自各篇刊載內容。