超敏CRP室間質評偏倚較大的原因及對策分析

　　摘   要：目的  探討我科室超敏CRP檢測系統(tǒng)室間質評偏倚較大的原因及對策。方法  將衛(wèi)生部臨檢中心室間質評成績回報主頁中超敏CRP的臨檢中心數據按方法、試劑、校準物及EQA分組統(tǒng)計后，分別觀察5個EQA樣品在各組中的中位數，并與我科室檢測系統(tǒng)所屬組的中位數進行比較，并以重新分組后的中位數為靶值，分別計算我科室EQA網絡回報結果和凍存樣品復測結果與此靶值的bias%和正確度。結果  EQA網絡回報結果與凍存樣品復測的結果一致，以試劑和校準物生產廠家進行分組時，兩次檢測結果與中位數的bias%均<1/3TEa，正確度驗證通過;而以方法和EQA分組方法分組時bias%則明顯增高，雖然均1/2TEa，正確度驗證未通過。結論  超敏CRP室間質評時以儀器進行分組計算靶值的方式可能不適當，建議按試劑廠家進行分組或以參考方法對EQA樣品賦值后進行偏倚的評估，以正確指導臨床實驗室進行質量改進;同時，試劑廠家應加強校準品的溯源性及互通性，且校準品的濃度應包含不同醫(yī)學決定水平處的濃度。
　　關鍵詞：超敏CRP;室間質評;偏倚
　　中圖分類號：R446.1                                   文獻標識碼：A                               DOI：10.3969/j.issn.1006-1959.2018.05.028
　　文章編號：1006-1959（2018）05-0087-04
　　Analysis of the Reasons and Countermeasures for the Bias of Ventricular Quality Evaluation in Hypersensitive CRP
　　LUO Ying-jie，LIU Yan-ting，XIAO Guang-jun
　�。―epartment of Laboratory，Suining Central Hospital，Suining 629000，Sichuan，China）
　　Abstract：Objective  To explore the causes and countermeasures of the bias of the room quality evaluation in the hypersensitive CRP detection system in our department.Methods  The Ministry of health clinical center of clinical laboratory data results in return home HS CRP inspection center EQA according to statistical method，reagents，calibrators and EQA packet，5 EQA samples were observed in each group of the median，and compared with the median of our department detection system belongs to the group，and median again after grouping as the target value were calculated in our department EQA network return results and frozen sample survey results and the target value and accuracy of bias%.Results  EQA network returns with the results of frozen sample survey，grouped by the reagent and calibrator manufacturer，the two test results with a median of bias%<1/3TEa，the accuracy is verified by the method;and EQA packet bias% grouping method was significantly increased，although the<TEa，there still are 3 or more samples of bias%>1/2TEa， accuracy verification failed.Conclusion  It may not be appropriate to use instruments to calculate the target values in the room quality assessment of hypersensitive CRP.It is suggested that the bias of EQA samples should be evaluated by the group of reagent manufacturers or by reference method.At the same time，the traceability and interoperability of calibration products should be strengthened by reagent manufacturers，and the concentration of calibration products should include the concentration of different medical decision levels.

相關熱詞搜索：對策 較大 原因 間質 分析