凝血4项指标生物参考区间的实验室验证

Laboratory verification of biology reference ranges in four coagulation indexes

目的该实验室使用sysmex CA-7000全自动血凝仪验证厂家推荐的凝血指标参考区间,并建立适用于该实验室的生物参考区间。方法运用日本sysmexCA-7000全自动血凝仪对120例健康体检者进行凝血4项的检测。结果经验证厂家提供的凝血4项参考值范围,凝血酶原时间(PT)、国际标准化比率(INR)、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)的r值均大于0.95,表明厂家推荐的参考区间适用于该实验室,可以继续使用。FIB r<0.95,需要重新制定本室的FIB参考区间。不同性别间凝血4项结果男性与女性差异无统计学意义(P>0.05)。不同年龄间凝血4项结果差异无统计学意义(P>0.05)。结论凝血4项的测定受特定条件影响较大,为了提高质量控制和规范管理。应该建立该实验室特定条件下测定的正常参考区间,为临床提供更精准的检验结果。

Objective To use the sysmex CA-700 full automatic coagulometer to verify the reference ranges of coagulation index recommended by the manufacturer and to establish the biology reference range suitable for our laboratory.Methods The Japanese Sysmex CA-700 full automatic coagulometer was used to detect the four coagulation indicators in 120 individuals undergoing the healthy physical examination.Results After verifying the reference ranges of four coagulation indexes,the r values of prothrombin time（PT）,international standardization ratio（INR）,activeated partial prothrombin time（APTT）and thrombin time（TT）all were〉0.95,the FIB reference range of our laboratory was needed to establish.The results of four coagulation indicators had no statistical difference between different genders and among different ages（P〉0.05）.Conclusion The detection of four coagulation indicators is greatly affected by some specific condition.We should establish normal reference range after testing under specific conditions In order to improve the quality control and standardize the management,the normal reference ranges under the specific condition of our laboratory should be established to provide more accurate detection results.