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目的监测不同厂家校准品复溶后的稳定性,判断其能否达到说明书要求。方法选取A、B、C、D 4个厂家校准品作为研究对象,采用Olympus AU2700生化分析仪对4个厂家校准品复溶后丙氨酸氨基转移酶(ALT)、梅毒螺旋体(TP)、空腹血糖(Glu)和钙(Ca)水平进行为期40d的监测。结果 A、B、C、D 4个厂家校准品复溶后,-20℃条件下ALT、TP、Glu的40d均值处于较稳定状态,Ca水平在30d内较稳定,30d后呈现出不同程度的下降。结论 A、B、C、D 4个厂家校准品均通过了厂家说明书的验证,即在-20℃条件下可稳定28或30d。
Purpose To monitor the stability of reconstituted samples from different manufacturers and to determine if they meet the specification requirements. Methods The calibrators of A, B, C and D were selected as the research objects. After the four calibrators were reconstituted with Olympus AU2700 biochemical analyzer, the alanine aminotransferase (ALT), Treponema pallidum (TP), fasting Glucose (Glu) and calcium (Ca) levels for a period of 40d monitoring. Results The average values of ALT, TP and Glu at -20 ℃ were relatively stable after reconstitution of four calibrators of A, B, C and D, and the levels of Ca were stable within 30 days after 30 days, showing different degrees after 30 days decline. Conclusion A, B, C, D 4 manufacturers of calibrators have passed the manufacturer’s manual verification, that is, at -20 ℃ under the conditions of stability 28 or 30d.