- 學位論文
兩種抗核抗體臨床檢測試劑比較及評估研究
Evaluation and comparison of two serum antinuclear antibodies detection kits
摘要
早期診斷及治療可改善自體免疫疾病的緩解與預後。檢測自體抗核抗體(ANA)是診斷全身性自身免疫性疾病的利器。目前，首選的方法是使用HEp-2細胞做為受質的間接免疫螢光法(IFA)。本研究使用半定量IFA試劑：ANAFAST HEp-2及定性EIA試劑：EliA CTD Screen Well檢測自體抗核抗體。 在2012年8月至2013年6月間，共收集200個血清檢體，分別為50個健康成人及150個北部某醫學中心風濕免疫科門診患者(症狀如：關節疼痛、皮疹、關節腫脹、不明原因發燒等)，分別以ANAFAST HEp-2 及EliA CTD Screen Well兩種檢測方法，檢測血清中自體抗核抗體。以ANAFAST HEp-2做為標準方法，並利用臨床醫師對受試者的臨床疾病診斷結果，進行兩者間對於自體抗體檢測的一致性與差異比較。 在排除EliA CTD Screen Well結果為不確定的6支檢體後，本次實驗結果以ANAFAST HEp-2評估此次研究的陽性率為22.7％(44/194)。EliA CTD Screen Well的Sensitivity為34.1%(15/44)，Specificity為90.6%(136/150)，PPV為51.7％(15/29)，NPV為82.4％(136/165)，LR+為3.63(34.1％/(1-90.6%))，LR-為0.73((1-34.1％)/90.6%)。與ANAFAST HEp-2試驗的總相同率為77.0％(151/196)。 此次的研究我們得知EliA CTD Screen Well在特異性及陰性預測值有不錯的表現，這表示EliA CTD Screen Well為良好的自體疾病診斷試劑。此外，EliA CTD Screen Well所能篩檢的自體抗體，都另有相對的單一自體抗體試劑，可再進行確認，對於自體疾病的診斷應有補強的助益。
並列摘要
Early diagnosis and treatment of systemic autoimmune diseases improve remission rates and prognosis. Antinuclear antibody(ANA) tests are useful for diagnosis of patients with systemic autoimmune diseases. Currently, the method of first choice is indirect immunofluorescence (IFA) test using HEp-2 cells as substrate. The goal of this study was to evaluate and compare two serum antinuclear antibodies detection kits. ANAFAST HEp-2 is a semi-quantitative IFA method using HEp-2 cell line to screen autoantibodies, and EliA CTD Screen Well kit is a qualitative enzyme immunoassay (EIA) method which can screen thirteen autoantibodies. In 2012/08~2013/06, 50 samples from healthy donors and 150 samples from patients with symptoms such as joint pain, rash, swollen joints, unexplained fever were collected in Department of Rheumatology& Immunology of a medical center, Northern Taiwan. Two hundred serum samples were tested utilizing the ANAFAST HEp-2 and EliA CTD Screen Well kit. EliA CTD Screen Well kit was evaluated with ANAFAST HEp-2 as a standard. The agreements and differences of these two detection kits were analyzed combined with the diagnosis of clinical disease. The results showed that positive rate was 22.7％ bases on ANAFAST HEp-2. The sensitivity, specificity, PPV, NPV, LR +, LR- of the EliA CTD Screen Well kit were 34.1%, 90.6%, 51.7％, 82.4％3.63, 0.73 respectively. In conclusion, EliA CTD Screen Well kit revealed good concordance of 77% with ANAFAST HEp-2. EliA CTD Screen Well kit revealed a good performance in specificity and NPV, suggesting it should be a good diagnostic reagents for autoimmune disease. Besides, reagents for detecting individual autoantibody provided by the manufacturer of EliA CTD Screen Well kit is available and helpful to confirm the autoimmune disease.