- 期刊
Sartorius Microsart® ATMP黴漿菌檢測試劑盒（Mycoplasma Detection Kit）的確效評估
Validation of the Sartorius Microsart® ATMP Mycoplasma Test Kit
摘要
黴漿菌（支原體，Mycoplasma）無處不在，可以感染各種類型的細胞，很容易污染細胞衍生產品和細胞培養基。因此，黴漿菌檢測在工業界和學術界都非常重要。雖然市面上有許多品牌的黴漿菌核酸擴增檢測試劑盒（nucleic acid amplification test, NAAT），但它們大多未經第三方檢驗機構確效。本研究對Sartorius Microsart® ATMP Mycoplasma detection kit（黴漿菌檢測試劑盒；Sartorius，德國）的特異性（專一性，specificity）、敏感性（sensitivity）、檢測極限（limit of detection）和耐變性（穩健性，robustness）進行評估。Mycoplasma pneumoniae（肺炎黴漿菌）ATCC 15531和Mycoplasma arginine（精氨酸黴漿菌）ATCC 23838作為試驗菌株，Clostridium sporogenes（生孢梭狀芽孢桿菌）ATCC 11437和Streptococcus thermophilus（嗜熱鏈球菌）ATCC 19258作為陰性對照。結果顯示，此試劑盒特異性與敏感性良好，無偽陽性反應。如試劑說明書所宣稱，檢測極限為10 CFU/mL。利用在幾種不同的qPCR儀器上測試同一樣本，證實了試劑盒的良好耐變性。根據這些結果，吾等總結Sartorius Microsart® ATMP黴漿菌檢測試劑盒是可靠的，可作為細胞培養的常規檢測。
並列摘要
Mycoplasma organisms are ubiquitous and can infect various types of cells, easily contaminating cell-derivative products and cell culture media. Therefore, mycoplasma testing is of great importance in both industry and academia. Although many brands of mycoplasma nucleic acid amplification test (NAAT) kits are commercially available, most of them have not been validated by third-party organizations. In this study, the Sartorius Microsart® ATMP Mycoplasma detection kit (Sartorius, Germany) was evaluated for specificity, sensitivity limit of detection, and robustness. Mycoplasma pneumoniae ATCC 15531 and Mycoplasma arginini ATCC 23838 were used as test strains, and Clostridium sporogenes ATCC 11437 and Streptococcus thermophilus ATCC 19258 were used as negative controls. Results showed that the kit had good specificity with no false-positive reactions. The detection limit was 10 CFU/mL as stated by the manufacturer. The robustness of the kit was confirmed by testing the same sample on several different qPCR instruments. Based on these results, we conclude that the Sartorius Microsart® ATMP Mycoplasma detection kit is reliable and can be used as a routine test for cell cultures.