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CMP^(TM) Amies/Charcoal Transwab的效能評估

Evaluation the Efficacy of CMPTM Amies/Charcoal Transwab for Use in the Preservation of Clinical Bacteria

摘要


輸送培養基的使用為避免檢體中的病原菌在輸送過程中死亡或發生菌相的生態改變,因此輸送裝置內培養基的品質與臨床檢驗室從各種檢體分離病原菌的能力息息相關。CMPTM Amies/Charcoal Transwab(啟新生物科技有限公司,台灣)為新上市宣稱同時適用於嗜氧及厭氧菌檢測檢體的輸送並具有維持檢體中菌相的生態及保存挑剔性病原菌的效能,為了驗證其真實性,吾等根據CLSI 之微生物輸送系統之規範M40-A(2003 年)進行評估,測試的菌種為挑剔性嗜氧菌:Neisseria gonorrhoeae(淋病奈瑟氏菌, ATCC 43069)與Streptococcus pyogenes(化膿性鏈球菌, ATCC 19615)以及厭氧菌:Bacteroides fragilis(脆弱凝桿菌,ATCC 25285)與Propionibacterium acnes(痤瘡丙酸桿菌, ATCC 6919)。測試時,分別將約106 CFU 菌量的四種菌接種於棉棒後插入CMPTM Amies/Charcoal Transwab 輸送裝置的培養基中,同時為模擬檢體不同的輸送條件,分別將CMPTM Amies/Charcoal Transwab 保存於室溫及4℃ 環境。除了N. gonorrhoeae 保存時間為0、8 及24 小時外,其它三種測試菌則保存0、24 及48 小時,然後在每個時間點上以生理食鹽水回收,經系列稀釋,接種在適當的培養基及培養在適當環境與時間後,將各不同時間點回收之總菌量與0小時之總菌量做比較。依據CLSI 之標準:在4 ℃環境之下,菌量對數值下降(log reduction) 不大於3,上升值不大於1;在室溫環境之下,則菌量對數值下降不大於3。本試驗結果顯示,CMP^(TM) Amies/Charcoal Transwab 在48 小時之內無論是室溫或者4°C 環境下皆能夠有效保存S. pyogenes、B. fragilis 與P. acnes;至於N. gonorrhoea同樣在24 小時之內於4°C或室溫環境下皆能夠有效保存,因此符合CLSI 規範之要求。基於上述的發現,吾等認為CMPTM Amies/Charcoal Transwab 的品質符合CLSI M40-A 規範之要求,適用於含有嗜氧菌及厭氧菌檢體的輸送。本試驗結果將可供作臨床微生物實驗室選用檢體輸送裝置的參考。

並列摘要


The efficiency of bacteria preservation of CMPTM Amies/Charcoal Transwab (Creative Biotechnology Co., Ltd. Taiwan) was evaluated according to the CLSI approved standard M40- A "Quality control of microbiological transport systems" (2003). The experiments used fastidious clinic bacteria, Streptococcus pyogenes (ATCC 19615), Neisseria gonorrhoeae (ATCC 43069), Bacteroides fragilis (ATCC 25285), and Propionibacterium acnes (ATCC 6919), to evaluate the efficacy of CMPTM Amies/Charcoal Transwab. After inoculated 106 CFU organisms on the transwab, the transwabs were preserved in room temperature or at 4℃ individually to simulate how the clinical specimen is transported. The survived N. gonorrhoeae were recovered by saline after 0, 8 and 24 hours storage, but S. pyogenes, Bacteroides fragilis, and Propionibacterium acnes were recovered after 0, 8, 24 and 48 hours storage. The recovered bacterial suspensions were performed in a ten-fold serial dilution method, and then plating with spreading method and counting the number of the survival bacteria after incubating at suitable conditions. According to CLSI M40-A statement: "In room temperature, there should be no more than a 3 log decline in CFU between the zero-time CFU count and the CFU of the swabs that were stored at different time interval; At 4°C, there should be no more than a 1 log increase in CFU and no more than a 3 log to decline in CFU between the zero-time CFU and the CFU of the swabs that were stored at different time interval." The results of this study showed that CMP^(TM) Amies/Charcoal Transwab can well preserved the S. pyogenes, Bacteroides fragilis, and Propionibacterium acnes up to 48 hours whether stored in room temperature or at 4°C. The CMPTM Amies/Charcoal Transwab can also well-preserved N. gonorrhoeae up to 24 hours both in room temperature and at 4°C. Based on the above findings, we concluded that CMPTM Amies/ Charcoal Transwab fulfills the statement of the CLSI M40-A guideline. The experiment result could be act as reference data when Clinical Microbiology Laboratory choosing their transport device.

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