BCYE琼脂培养基行业标准的验证试验

Verification Test of BCYE Agar Medium Standard

目的对制、修订的BCYE琼脂培养基行业标准进行试验验证,探讨该标准的可操作性。方法取不同厂家生产的培养基,按照说明书配制待检培养基,根据BCYE琼脂培养基行业标准的要求,进行理化试验和微生物试验。首先测定了培养基的pH值和水分等理化指标。然后复苏标准规定的质控菌株,经过菌种传代和菌液扩增等,将其培养物接种到待验证的BCYE琼脂培养基平皿中进行微生物试验。结果 BCYE琼脂培养基的pH值和水分均在标准规定的范围内,且各质控菌株生长良好,形态典型。结论制、修订的BCYE琼脂培养基行业标准,可以作为一种推荐性的国家行业标准,能够满足我国医疗器械BCYE琼脂培养基监管的需要。

Objective To verify the operability of professional standard for BCYE agar medium.Methods Obtained the BCYE agar medium produced by different factories and dissolved the medium according the instruction book for physical and chemical experiments and microbiological test in according with the formulated medium standard.First,assayed pH value and solution of medium.Then the control strains were recovered and the bacteria were amplified.Inoculated the bacterial culture in the medium and detected the bacterial growth.Results pH value and solution of medium were within the specified range.The control strains growed well.Conclusion The formulated BCYE agar medium standard will be applied as recommended professional standard to supervise the BCYE agar medium quality of Diagnostic Reagent in our country.