普利生LBY—NJ4A全自动血小板聚集仪验收及性能评价

Acceptance and performance evaluation of PRECIL LBY-NJ4A automatic platelet aggregation analyzer

目的对普利生LBY-NJ4A全自动血小板聚集仪（NJ4A）进行验收和性能评估。方法109mmol／L枸橼酸钠真空管采血，分离富含血小板血浆（PRP）和贫血小板血浆，应用NJ4A及配套质控品、诱导剂和清洗液，测定血小板最大聚集率（MAR）、精密度、通道一致性、不确定度、检测限、抗干扰能力等。结果批内不精密度测试变异系数（CV）为3．4％～5．0％；4个不同通道测定均值差异无统计学意义（P〉0．05）；携带污染率2．82％；CV批内≤3．5％，CV批间≤4．2％，CV总≤3．8％；总误差范围为5．6～10．3％，不确定度在可接受范围；2个水平质控品测定值与靶值差异无统计学意义（P〉0．05）；NJ4A与LBY-NJ2比对结果相关良好（r=0．998，P〈0．01）；系统误差（SE）=｜0．01-0．62｜；检测限97．5％，可能性7．85％；Hb≤0．15g／L、TG≤3．80mmol／L、TBIL≤246umol／L对结果无干扰；PRP稀释度与聚集率高低无线性关系；40例健康体检者的参考范围MARADP=68．7±11．2（％）、MAR_AA65．1±16．1（％），与公认的参考范围差异无统计学意义（P〉0．05）。结论NJ4A精密度、准确度、不确定度、灵敏度、携带污染率、抗干扰等性能指标符合CLSI规范，可在临床应用。

Objective To check and evaluate the performance of PRECIL LBY-NJ4A automatic platelet aggregation analyzer（NJ4A）. Methods Blood samples were collected with 109mmol/1 sodium citrate using vacuum tube, then the platelet-rich plasma （PRP） and platelet-poor plasma （PPP） were separated. The NJ4A analyzer with mating quality control, agonists and cleaning solution were used to measure the maximum aggregate rate of platelet （MAR）, precision, channel consistency, inaccuracy, detection limitation and inference. Results The precision ranged from 3.4 to 5.0%. The means of four different channels have no statistically difference （P〉0.05） when carryover rate is 2.82%. The intra, inter batch and total coefficient of variance is less than or equal to 3.5% 4.2% and 3.8%, respectively. The total error ranged from 5.6% to 10.3%, with an acceptable inaccuracy. Two levels of quality control have no statistically difference （P〉0.05） with each target value. The correlation of NJ4 and LBY-NJ2 is 0.998 （P〈0.01）. The different levels of medical decision errors are range from ｜ 0.01 - 0.62 ｜. The detection limit is 97.5% and possibility is 7.85%. Hb, TG and T-Bil will not interfere the results when ≤0.15g/L, 3.80 mmol/L and 246 umol/L respectively. The aggregation rate of PRP has no linear relationship with dilution. The reference range of 40 health individual are MARADP （68.7±11.2）% and MARAA （65.1±16.1）%, with no statistically difference （P〉0.05） compared to the well-recognized reference range. Conclusion The performance indicators of precision, accuracy, uncertainty, sensitivity, carryover rates and anti-inference of NJ4A are reached the requirement of CLSI, and this analyzer can be applied in clinical usage.