应用EP10—A对Bayer脱氧吡啶酚试剂盒的评价

目的评价Bayer脱氧吡啶酚(DPD)试剂盒相关指标。方法应用美国临床实验室标准化委员会(NCCLS)颁布的《定量临床实验室方法初步评价核准指南(EP10-A》对Bayer DPD试剂盒进行初步评价。结果低、中、高三种浓度的DPD质控检测偏差分别为0．94nmol／L,1．25nmol／L和3．88nmol，L．远低于标定偏差的10．70nmol／L,16．40nmol／L和42．00nmol/L；检测三种浓度的DPD质控总不精密度CV分别为4．618％。1．819％和1．175％，均小于NCCIS文件规定的5％。与ELISA法相关良好(r=0．9247)。结论Bayer DPD试剂盒准确度和精密度良好，未见交叉污染、线性漂移等因素有明显影响，性能指标可靠，适合临床实验室使用。

Evaluation of Bayer deoxypyridinoline kit according to EP10-A

Objective To evaluate the performance of Bayer deoxypyridinoline(DPD) kit. Method The imprecision and accuracy of Bayer DPD kit were tested, and evaluated according to the NCCLS Document EP10-A,i.e. Preliminary Evaluation of Quantitative Clinical Laboratory. Methods; Approved Guideline. Results Deviations by measuring low, middle and high concentrations of DPD control were 0.94nmol/L, 1.25 nmol/L and 3.88 nmol/L respectively, and were lower than those of 10.70 nmol/L, 16.40 nmol/L and 42.00 nmol/L. Total CVs were respectively 4.618%, 1.819% and 1.175%, all lower 5%(NCCLS). Chemiluminescence immunoassay correlates well with ELISA(Correlation is 0.9247). Conclusions It has not found that the factors of carryover and drift influence the imprecision and accuracy significantly. The performance of Bayer deoxypyridioline kit is suitable for clinical laboratory.