自制正常范围质控品用于CA血凝仪室内质控

Self-made normal range control as sysmex CA-coagulant-meter indoor quality control

关键词:  自制正常范围质控品  室内质控  CA-7000血凝仪

Key words:  self-made normal range quality control  indoor quality control  sysmex CA-coagulant-meter

摘要:

［目的］ 用即经济又可靠的方法对本室CA系列血凝仪进行质量控制。［方法］ 收集凝血像正常的住院患者的混和血浆，取出3 mL，其余分装，-70 ℃冰冻保存，按方法学评价的内容进行批内、日间精密度，稳定性观察，并定期用进口定值质控品LEVER1观察其准确性。［结果］批内精密度凝血酶原时间（PT）：1.3% 、部分凝血活酶时间 （APTT）：1.9% 、 纤维蛋白原（Fbg）：3.1%.。日间精密度 CV% PT＜4% 、APTT＜4% 、Fbg＜7% ，符合凝血项目质控要求。定期测定定值质控品值均在定值范围，准确性良好。［结论］ 自制正常范围质控品有良好精密度、稳定性、准确性，可代替进口正常范围质控品用于CA血凝仪室内质控。

Abstract:

［Objective］ To make quality control on sysmex CA-coagulant-meter with an economic and dependable method. ［Methods］ The mixed plasma was collected from hospitalized patients with normal coagulation time. After taking 3 ml plasma out, the rest were kept at -70℃. Intra-run CV%, inter-day CV% and stability were observed according to the contents of methodology evaluation. The accuracy was monitored by the imported packaged control. ［Results］ Intra-run CV% showed that plasma prothrombin time (PT), activated partial thromboplasting time (APTT) and fibrinogen (Fbg) were 1.3%, 4.6% and 3.1% respectively. Inter-day CV% indicated that PT, APTT and Fbg were less than 4%, 4% and 7% respectively. These indexes met the requirement of coagulation item control. All of the periodically measured values were within the assigned value ranges with high accuracy. ［Conclusion］ Self-made normal range control has high precision, accuracy and stability. It is acceptable that self-made normal range control may replace imported package control as sysmex CA-coagulant-meter indoor quality control.