根據CLSI之微生物運輸系統規範M40-A(2003年)評估啟新生物科技有限公司生產之CMPTM嗜氧檢體輸送管的菌種保存效能。選用挑剔菌Neisseria gonorrhoeae(ATCC 43069)與Streptococcus pyogenes(ATCC 19615)進行測試,將約10^6 CFU之菌量接種於檢體輸送棒插入管中之培養基後,分別保存於室溫及4℃環境,模擬檢體運送環境過程。N. gonorrhoeae於保存0、8及24小時後以生理食鹽水回收存活菌體,而S. pyogenes則於保存0、8、24及48小時後以生理食鹽水回收,取回收菌液進行十倍序列稀釋,並塗盤培養於35℃,5% CO_2培養箱24~48小時後,計數生長之菌落數量,然後將回收菌量與0小時之菌量做比較。依據CLSI之標準:在4℃環境之下,菌量對數下降值(Log reduction)不可大於3,且上升值不可大於1;若在室溫環境之下,則菌量對數下降值不可大於3。本試驗結果顯示,CMPTM嗜氧檢體輸送管在48小時之內無論是室溫或者4℃環境下皆能夠有效保存S. pyogenes,符合CLSI M40-A規範之要求。至於N. gonorrhoea保存於室溫環境下24小時之內,均能夠符合規範之要求;而保存於4℃環境下,則可在8小時內符合要求。本試驗結果將可提供臨床微生物實驗室相關部門在選用檢體輸送管時之參考依據。
The efficiency of bacteria preservation of CMPTM Transtube (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 clinical bacteria, Neisseria gonorrhoeae and Streptococcus pyogenes, to evaluate the efficacy of CMPTM transtube. After inoculated 106 CFU organisms on the transtube, the transtubes were preserved in room temperature or at 4℃ to simulate how the clinical specimen is transported. The survived N. gonorrhoeae were recovered by saline after 0, 8, 24 hours storage, and S. pyogenes were recovered after 0, 8, 24, 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℃, 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 CMPTM Transtube can well preserved the S. pyogenes up to 48 hours whether stored in room temperature or at 4℃. It fulfills the CLSI M40-A guideline. The CMPTM Transtube can also well-preserved N. gonorrhoeae up to 24 hours in room temperature, but only last 8 hours at 4℃. The experiment result could be act as reference data when Clinical Microbiology Laboratory choosing their transport device.