查詢結果分析
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頁籤選單縮合
題 名 | Qualitative Application of COBAS Amplicor HCV Test Version 2.0 Assays in Patients with Chronic Hepatitis C Virus Infection and Comparison of Clinical Performance with Version 1.0=第二代C型肝炎病毒RNA定性檢驗套組的臨床應用及與第一代檢驗套組於臨床應用之比較 |
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作 者 | 謝明彥; 李立柏; 侯乃仁; 楊正福; 黃志富; 戴嘉言; 莊萬龍; 林子堯; 陳信成; 謝明裕; 王良彥; 張文宇; 余明隆; | 書刊名 | The Kaohsiung Journal of Medical Sciences |
卷 期 | 23:7 2007.07[民96.07] |
頁 次 | 頁332-338 |
分類號 | 415.5332 |
關鍵詞 | C型肝炎病毒; C型肝炎病毒RNA; 干擾素治療; RNA定性檢驗; Hepatitis C virus; Hepatitis C virus RNA; Interferon therapy; Qualitative hepatitis C virus RNA assay; |
語 文 | 英文(English) |
中文摘要 | 本研究是評估第二代 C 型肝炎病毒 RNA 定性檢驗套組 (COBAS AMPLICOR HCV TEST Version 2.0 Assays [CA V2.0]) 的臨床應用。使用標準血清盤 (AcroMetrix、USA),每盤有 8 支檢體都經過以 CA V2.0 重複三次檢測。將含 HCV RNA 500 IU/mL 之檢體稀釋後,經 CA V2.0 檢測三次。證實本套組的偵測下限在 HCV RNA 50 IU/mL。敏感度及專一度測試使用三組檢體:第一組慢性 C 型肝炎共 100 支,第二組為慢性 B 型肝炎共 60 支,第三組為健康之捐血者共 60 支,三組血清都以 CA V2.0 檢測。發現本套組的偵測敏感度為 99%;特異性為 98.3%。84 位慢性 C 型肝炎患者接受干擾素及 ribavirin 合併治療 24 週,開始治療後之第 2、4、8 週將 84 位患者之血清分別以第一代 (CA V1.0) 及第二代 (CA V2.0) C 型肝炎病毒 RNA 檢驗套組加以檢測。於第 2 及第 8 週,CA V2.0 之檢測率高於 CA V1.0 (60.7% vs. 51.2%,p < 0.01;27.4% vs. 21.4%,p < 0.05)。在對合併治療之持續反應率 (sustained virologic response [SVR]) 預測方面:第2、4、8 週 CA V2.0 之陽性預測值為 90.91%、83.02%、78.69%,CA V1.0 之陽性預測值為 90.24%、82.14%、72.73%。第 2、4、8 週 CA V2.0 之陰性預測值為 58.82%、77.42%、86.96%,CA V1.0 之陰性預測值為 67.44%、82.14%、83.33%。CA V2.0 和 CA V1.0 在預測合併治療之 SVR 上無顯著差異。 |
英文摘要 | The objective of this research was to investigate the clinical performance of COBAS AMPLICOR hepatitis C virus (HCV) test version 2.0 Assays (CAV2.0). Eight serial samples with standard HCV ribonucleic acid (RNA) concentration and 10 times serial dilution of the 500 IU/mL samples were tested in triplicate by CAV2.0 (the limit of detection was 50 IU/mL). HCV RNA was investigated with CAV2.0 in 220 specimens from 100 chronic hepatitis C (CHC) patients, 60 chronic hepatitis B patients, and 60 healthy blood donors. The sensitivity was 99% and the specificity was 98.3%. Sera of 84 naïve CHC patients receiving standard interferon plus ribavirin for 24 weeks were tested by CAV2.0 and CAV1.0 at weeks 2, 4 and 8. The positive detection rates of CAV2.0 were significantly higher than CAV1.0 at week 2 (60.7% vs. 51.2%; p < 0.01) and week 8 (27.4% vs. 21.4%; p < 0.05). At weeks 2, 4 and 8, the positive predictive values were 90.91%, 83.02% and 78.69% with CAV2.0, and 90.24%, 82.14% and 72.73% with CAV1.0. The negative predictive values were 58.82%, 77.42% and 86.96% with CAV2.0, and 67.44%, 82.14% and 83.33% with CAV1.0. However, there was no significant difference between CAV2.0 and CAV1.0 for predicting sustained virologic response. |
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