CAJ | 학술논문

目的：制备游离血红蛋白（FHb）室内质控物，并对其性能进行评价。方法①选取5份已知血红蛋白（Hb）浓度的正常人类全血，用蒸馏水分别以1∶500，1∶1000，1∶2000，1∶4000的比例进行稀释，充分混匀后配制成20份 FHb 溶液，检测其 FHb 浓度，并与其理论浓度进行比较。②选择高值、低值溶液各1份，作为日常室内质控物，混匀分装－20℃保存，常规条件下连续检测20天，计算两组的珚x，s 和 CV 值，绘制 Levey-Jennings 质控图；之后每周测定一次，将数据依次标记在质控图上，直至更换试剂批号；计算高值、低值两种质控物整个检测周期内的总体珚x，s 和 CV 值。结果①该20份标本的 FHb 浓度理论值和实测值（-x±s）分别为125.44±93.04 mg／L 和125.22±93.08 mg／L，差异无统计学意义（t＝0．706，P ＞0.05）。②高值、低值质控物连续20天检测结果（-x±s）分别为303.55±3.70 mg／L 和69.29±1.88 mg／L，CV 值分别为1.22％和2.68％；高值、低值质控物整个检测周期内结果均未失控，总体（-x ±s）分别为302.56±3.99 mg／L 和69.04±1.88 mg／L，CV 值分别为1.32％和2.71％。结论FHb 室内质控物制备过程简单，质量可靠，稳定性好，适合在血站和临床实验室中应用和推广。
목적：제비유리혈홍단백（FHb）실내질공물，병대기성능진행평개。방법①선취5빈이지혈홍단백（Hb）농도적정상인류전혈，용증류수분별이1∶500，1∶1000，1∶2000，1∶4000적비례진행희석，충분혼균후배제성20빈 FHb 용액，검측기 FHb 농도，병여기이론농도진행비교。②선택고치、저치용액각1빈，작위일상실내질공물，혼균분장－20℃보존，상규조건하련속검측20천，계산량조적연x，s 화 CV 치，회제 Levey-Jennings 질공도；지후매주측정일차，장수거의차표기재질공도상，직지경환시제비호；계산고치、저치량충질공물정개검측주기내적총체연x，s 화 CV 치。결과①해20빈표본적 FHb 농도이론치화실측치（-x±s）분별위125.44±93.04 mg／L 화125.22±93.08 mg／L，차이무통계학의의（t＝0．706，P ＞0.05）。②고치、저치질공물련속20천검측결과（-x±s）분별위303.55±3.70 mg／L 화69.29±1.88 mg／L，CV 치분별위1.22％화2.68％；고치、저치질공물정개검측주기내결과균미실공，총체（-x ±s）분별위302.56±3.99 mg／L 화69.04±1.88 mg／L，CV 치분별위1.32％화2.71％。결론FHb 실내질공물제비과정간단，질량가고，은정성호，괄합재혈참화림상실험실중응용화추엄。
Objective To prepare an internal quality control substance of free hemoglobin (FHb),and evaluate its perform-ance.Methods ① 5 normal whole human blood samples with known hemoglobin (Hb)concentration was selected and dilu-ted with distilled water in the ratio of 1∶500,1∶1 000,1∶2 000,1∶4 000 respectively.After 20 FHb solutions was fully mixed,the concentration of FHb solutions was tested and compared with its theoretical data.②One of the highest value and the lowest value solutions were chosen as qualitye control substance,packed and stored in -20℃ fridge.Each group was an-alyzed 20 days continuously in the routine conditions,where average (-x )of the groups,standards deviation (s )and coeffi-cients of variation (CV)were calculated and Levey-Jennings control chart was conducted.Then,the test was repeated every week,and the data on the chart was updated accordingly until (CV)of the reagents were changed.The average (-x)of the-groups,standards deviation (s)and coefficients of variation uality control material was calculated during the whole test peri-od.Results ①The theoretical value (-x ±s)of the concentration of free hemoglobin was 125.44±93.04 mg/L,and the actu-al value was 125.22±93.08 mg/L,there was no statistic significance (t value was 0.706,P >0.05).② During 20 continu-ously daystest,the detected values (-x ±s)of the highest quality control material was 303.55±3.70 mg/L;the values of the lowest quality control material was 69.29 ± 1.88 mg/L.The coefficients were 1.22% and 2.68% respectively.Both the highest and the lowest quality control material were under control during the whole detecting period.The (-x ±s )values of the highest was 302.56±3.99 mg/L,the CV value of it was 1.32%;The (-x ±s)values of the lowest was 69.04±1.88 mg/L,the CV value of it was 2.71%.Conclusion The preparation method of internal quality control substance of free hemoglo-bin is convenient and stable,and was applicable in blood station’s and clinical laboratory.