国际旅行卫生保健中心实验室生化定量试剂盒分析性能验证

Verification report of biochemical quantitative kit for laboratories of international travel healthcare centers

目的对实验室生化定量试剂盒主要分析性能进行方法学验证。方法依据《WS/T 420-2013临床实验室对商品定量试剂盒分析性能的验证》,用日立7100全自动生化分析仪和宁波美康生化检测试剂,从精密度、准确度和线性范围方面对实验室丙氨酸氨基转移酶(Alanine aminotransferase,ALT)等6项生化检测项目进行性能验证。结果 6项生化检测项目预处理质控结果均在控。低浓度质控品总胆固醇(Cholesterol,TC)厂家声称重复精密度(δ_r)<实验重复精密度(Sr)<Sr验证值(Sr_(验证值)),其余项目Sr<δr;ALT、葡萄糖(Glucose,GLU)和TC厂家声称期间精密度(δ_1)<实验期间精密度(S_1)<S_1验证值(S1_(验证值)),其余项目S1<δ1。高浓度质控品6项生化检测项目Sr<δr;ALTδ1<S1<S1验证值,其余项目S1<δ1。正确度GLU和TC参考物质测量偏移值(b_参)>参考物质赋值不确定度(S_a),参考物质赋值(X_赋)在b_参的验证区间(VI)内,其余项目b_参<S_a。生化6项线性范围相关系数(R^2)>0.995,差值与理论值的比值≤10%。结论宁波美康生化检测试剂在日立7100全自动生化分析仪上进行ALT等6项生化检测,方法学性能良好,测量结果准确可靠且重复性好,能满足工作需要。

Objective To verify the biochemical quantitative kit in laboratories. Methods According to WS/T 420- 2013 standard,the precision,accuracy and linear range of Alanine aminotransferase （ALT） and other five biochemistry items were quantitative detected by using Hitachi 7100 automatic biochemical analyzer and Ningbo Meikang biochemical testing reagents. Results Pretreatment quality control of six biochemical tests were in control. Among quality control material with low concentration,repetitive precision of manufacturer claimed（Sr） about total cholesterol （TC） was less than repetitive precision tested （Sr） ,and Sr was less than the verification value of repetitive precision （Srvalve） ,Sr of the others was less than the respective δr,period precision of manufacturer claimed （S1） about Alanine aminotransferase（ALT）,TC and Glucose（GLU） was less than the respective period precision tested （Sl）,and S1 was less than the respective verification value of repetitive precision （S1value）,S1 of the others was less than the respective δ1. Among quality control material with high concentration,Sr about six biochemical tests was less than the respective δr,δ1 about ALT was less than S1,and S1 was less than St value,S1 of the others was less than the respective δ1. For accuracy,the reference material deviation value measured （breference） about GLU and TC was more than the respective reference material uncertainty value（Sa）,reference material assignment Xassignment was in the inside of verification interval of breference （VI）. breference of the others was less than the respective S,, The correlation coefficient （R2） of linear range about six biochemical tests was more than 0.995. The ratio of the difference and the theoretical value was less than 10%. Conclusion Ningbo Meikang biochemical testing reagents such as ALT tested on Hitachi 7100 automatic biochemical analyzer,this methodology showed good measurement including accuracy and reliable repeatability,which meet the needs of laboratories.