本文選題：量值傳遞 + 溯源��； 參考：《臨床檢驗雜志》2017年02期

【摘要】：目的研究基于參考實驗室網(wǎng)絡定值的人血清樣本對改進臨床實驗室丙氨酸氨基轉(zhuǎn)移酶(ALT)、天門冬氨酸氨基轉(zhuǎn)移酶(AST)、γ-谷氨�；D(zhuǎn)移酶(GGT)、乳酸脫氫酶(LDH)、肌酸激酶(CK)、α-淀粉酶(Amy)、堿性磷酸酶(ALP)等7個酶學指標量值傳遞的效果。方法依托華北、華南、華東、西南4個區(qū)域的5家參考實驗室輻射區(qū)域內(nèi)的各級醫(yī)療機構(gòu),建立相應的常規(guī)實驗室量值傳遞/溯源網(wǎng)絡;北京航天總醫(yī)院提供互換性良好、具有標準物質(zhì)特性的冰凍人血清樣品(校準品、評估樣品1、評估樣品2),由4個區(qū)域5家參考實驗室聯(lián)合賦值;將樣品發(fā)送至全國48家實驗室,各實驗室按各自的標準操作規(guī)程先測量2個評價樣品,再用提供的冰凍人血清樣品作為校準品校準廠家系統(tǒng)后再次測量2個評價樣品,依據(jù)WS/T 403-2012衛(wèi)生行業(yè)標準判斷各實驗室測量結(jié)果正確度的變化,ALT、AST觀察結(jié)果一致性的變化。結(jié)果 Amy、ALP、GGT、CK、LDH的校準品、樣品1及樣品2網(wǎng)絡定值結(jié)果分別為138.7 U/L、278.5 U/L、68.3 U/L,265.3 U/L、94.5 U/L、134.4 U/L,195.8 U/L、89.0 U/L、158.9 U/L,393.7U/L、260.0 U/L、645.3 U/L,302.0 U/L、250.0 U/L、452.7 U/L;常規(guī)測量系統(tǒng)Amy、ALP、GGT量值傳遞前樣品1及樣品2滿足WS/T 403-2012偏移要求的百分率分別為65.9%、61.0%,76.6%、78.7%,66.7%、70.8%,量值傳遞后分別為89.2%、83.8%,86.7%、80.0%,85.4%、91.7%,CK、LDH量值傳遞前樣品2滿足行標要求的百分率為64.6%、58.3%,量值傳遞后為93.5%、84.8%;ALT、AST實驗室常規(guī)測量系統(tǒng)量值傳遞前后一致性:量值傳遞前樣品1及樣品2為12.9%、11.3%,10.2%、8.9%,量值傳遞后為9.3%、8.2%,5.6%、5.9%。結(jié)論基于參考實驗室網(wǎng)絡定值人血清樣本建立的校準常規(guī)系統(tǒng)量值傳遞路徑明顯提高了我國各級醫(yī)療機構(gòu)臨床實驗室Amy等7個酶學項目檢驗結(jié)果的可比性,值得進一步推廣。
[Abstract]:Objective to study the effects of human serum samples based on reference laboratory network on alanine aminotransferase (alt), aspartate aminotransferase (AST), 緯 -glutamyl transferase (GGTT), lactate dehydrogenase (LDH), creatine kinase (CK), 偽 -starch. The transmission effect of seven enzyme indexes including amylase, alkaline phosphatase (ALP) and so on. Methods based on the medical institutions at all levels in the radiation areas of four reference laboratories in North, South, East and Southwest of China, the corresponding network of quantity transfer / traceability of conventional laboratories was established, and the interchangeability of Beijing Aerospace General Hospital was good. Frozen human serum samples with standard substance properties (calibrator, assessment sample 1, assessment sample 2), jointly assigned by 5 reference laboratories in 4 regions; samples sent to 48 laboratories throughout the country, Each laboratory measured two evaluation samples according to their respective standard operating procedures, and then measured two evaluation samples using frozen human serum samples provided as calibration products for calibration manufacturer's system. According to WS/T 403-2012 health industry standard, the change of accuracy of measurement results in each laboratory was judged. Results the calibration products of Amylla ALP GGTCK and LDH were analyzed. 鏍峰搧1鍙婃牱鍝，

本文編號：1882347