參考區(qū)間確定資料

第二類體外診斷試劑產(chǎn)品注冊資料白蛋白測定試劑盒（溴甲酚綠法）參考區(qū)間確定資料XXXXXX有限公司

參考依據(jù)依據(jù)NCCLSC28-A2如何確定臨床檢驗(yàn)的參考區(qū)間：批準(zhǔn)指南（2000）文件。該文件是確定定量臨床檢驗(yàn)項(xiàng)目的參考區(qū)間的指南。材料與方法1．標(biāo)本來源按健康人群要求選擇XXXXXXXXX醫(yī)院健康體檢者，收取該醫(yī)院檢驗(yàn)科檢測已完成的臨床樣本。樣本采集/檢驗(yàn)時(shí)間：XXXX.XX。對象：在XX地區(qū)居住的性別不限、年齡不限的健康人。健康人的要求：（1）一月內(nèi)無急性感染史；（2）發(fā)育正常，無心血管、肺、腎和肝、膽、胰等器質(zhì)性疾患；（3）半年內(nèi)無輸血和大手術(shù)史；（4）3月內(nèi)未服用影響凝血功能的藥物，2周內(nèi)無中毒史，未接觸毒物及其他有害物質(zhì)；（5）婦女不在妊娠或哺乳期。2．使用儀器HITACHI7020全自動(dòng)生化儀。3．檢測試劑XXXXXX有限公司生產(chǎn)的白蛋白測定試劑盒（溴甲酚綠法）。規(guī)格：XXmL；批號：XXXXXX；生產(chǎn)日期：XXXXXXXX；有效期XXXXXXXX。4.質(zhì)量控制按照技術(shù)要求3.1、3.3~3.6.1、3.7進(jìn)行產(chǎn)品性能的測定，結(jié)果應(yīng)符合要求。5.參考值確定根據(jù)項(xiàng)目制定雙側(cè)界限或單測界限，采用95％參考區(qū)間范圍。6．統(tǒng)計(jì)方法應(yīng)用SPSS20進(jìn)行數(shù)據(jù)統(tǒng)計(jì)分析。正態(tài)性檢驗(yàn)采用Kolmogorov–Smirnov(K-S)檢驗(yàn)。結(jié)果屬于正態(tài)分布的，用正態(tài)分布法計(jì)算參考區(qū)間范圍，其95％參考區(qū)間范圍分別用下式計(jì)算：1039.86040.711038.516044.01140.36140.011140.416143.11241.46240.211241.816241.21341.16341.011342.116340.71440.66440.511440.616447.01540.66540.811541.316541.41640.66641.011638.416641.11740.46740.011742.116743.61840.66840.911840.416839.91941.16941.311940.316941.92040.17040.712037.317044.22139.77140.912140.517141.42239.97241.312239.117240.42341.17341.512338.917340.72439.87441.512440.917438.92541.37539.812541.017541.12642.47641.312641.317641.52741.77741.012741.517739.12842.37840.412841.217843.42938.87940.912939.117943.33043.48040.513039.918042.13139.98139.713142.018141.03241.38241.513241.018240.63340.58339.413339.518343.93438.28439.813440.018441.43540.58541.513543.018541.93640.48639.813642.718639.43740.38740.413743.618739.73840.98841.613842.218842.03940.28943.213939.218940.94040.39040.414039.819038.84141.09139.414141.819140.54239.99240.614240.819241.24342.79345.714337.619342.34442.79440.614444.119443.84542.29542.114543.219540.34642.09640.414643.019641.84741.99737.814738.519