B型肝炎表面抗原項目確認試驗的適合性評估

Hepatitis B Surface Antigen Evaluation on the Suitability of Confirmatory Test

林君萍(Chun-Ping Lin) ； 陳尚延(Shang-Yan Chen) ； 傅文玫(Wen-Mei Fu) ； 李慶孝(Ching-Hsiao Lee) ； 薛裕琪(Yu-Chi Hsueh) ； 蕭慧甄(Hui-Chen Hsiao) ； 李津津(Chin-Chin Lee) ； 陳家綺(Chia-Chi Chen) ； 陳淑珍(Shu-Chen Chen) ； 林祐君(You-Chung Lin) ； 陳怡君(Yi-June Chen) ； 張凱潔(Kai-Jie Chang) ； 許新茂(Shin-Mau Shiu) ； 吳宇暉(Yu-Hui Wu) ； 王紅英(Hung-Ying Wang)

《檢驗及品保雜誌》 5卷1期 (2016/02) Pp. 35-40

https://doi.org/10.6573/JTQA.201602_5(1).05

摘要

根據衛福部疾病管制署(CDC)對B型肝炎表面抗原(HBsAg)檢測指引，若結果為弱反應性時，建議再重測二次以確保檢驗報告的正確性；臨床上有些弱反應檢體確實反映病人體內HBsAg存在的狀況，但因可能由非特異性反應所造成，因此檢驗室需再次確認而導致延遲報告、增加人力負擔及額外檢驗費用支出。吾等蒐集2014年1月至2014年6月有呈現HBsAg有反應性的檢體，依試劑說明書指出對於不同COI(臨界值指數)檢體有不同稀釋倍數的要求，因此人為地將檢體分成三組：分別是COI 0.9~7.0、COI 7.0~30.0與COI ≧ 30.0，在cobas e 601免疫分析儀進行HBsAg確認試驗分析。分析結果指出COI 0.9~7.0、COI7.0~30.0與COI ≧ 30.0確認分析檢體的符合率分別為88.6%、100%與100%。基於上述的發現，吾等建議修訂現行HBsAg作業流程的重覆測試區間：若COI ＜ 0.9的檢體可直接報告為(-) Non-reactive；若COI＞ 7.0檢體則報告為(+) Reactive；若COI 0.9~7.0的檢體則需進行HBsAg確認試驗，如此的運作方式將可減少檢驗室的試劑成本與人力負擔，進而提高工作效益。

關鍵字

B型炎表面抗原 ； 確認試驗 ； 臨界值指數

並列摘要

CDC proposed that initial weakly reactive samples should be repeated twice by the same test in HBsAg detection. Some weakly reactive specimens indicate that hepatitis B surface antigen is present , but some are caused by nonspecific reaction. Repeat testing is labor intensive, time consuming and expensive. To establish a standard determination to COI gray zone for initial HBsAg testing, confirm hepatitis B surface antigen final data when a weak result response. From January 2014 to June 2014 have presented hepatitis B surface antigen according to the specimen reactive reagent instructions for different cut off value index(COI) have different requirements for specimen dilution of the specimen will be divided into three group, respectively, COI 0.9~7.0, COI 7.0~30.0 and COI≧ 30.0, were HBsAg confirmatory test analysis using by cobas e 601 immunoassay analyzer. We determined compliance rate of three group ( COI 0.9~7.0, 7.0~30 and≧30.0 ) were 88.6%, 100% and 100% respectively. The proposed amendments to existing processes repeat HBsAg testing interval COI ＜ 0.9 without having to retest specimen, reported as (-) Non-reactive; COI ＞ 7.0 without having to re-test specimen, reported as (+) Reactive. It indicates that the value of COI between 0.9 to 7.0 should be repeated by confirmatory test. It will reduce the cost of reagent and workload of staff, and increase the efficiency of laboratory.

並列關鍵字

Hepatitis B surface antigen ； Confirmatory test ； Cut off value index