随机质控加样方法在献血者血液ELISA法检测中的应用与评价

Application andevaluation of random quality control sampling in donor blood detetion by ELISA

目的 评价将随机质控加样方法应用于献血者血液ELISA法筛查的质控效果。方法 选择本站2022年5月-2022年7月的献血者血样5 mL/(人)份,在全自动加样仪上常规加样操作,将J标准物质(3.0 mL/支)作为日常标本分别加入HBsAg、抗-HCV、抗-HIV和抗-TP酶标板A1孔、H12孔以及随机孔位后,置于全自动酶免分析仪中检测:以随机孔位质控作为室内质控判定标准,连续检测20次,按照孔位不同分为A1(孔位)组、H12(孔位)组和随机(孔位)组3个组,以随机组质控为框架,利用Levey-Jennings质控图法绘制质控图,再以实验室当日相对应的A1、H12组检测结果绘制在质控图并与随机组比较。结果 献血者输血感染性指标ELISA检测质控水平均值:HBsAg为3.87±0.28,抗-HCV为3.79±0.38,抗-HIV为3.64±0.30,抗-TP为4.53±0.51;随机组、A1组、H12组比较:HBsAg(3.87±0.28、4.09±0.30、3.64±0.26),抗-HCV(3.78±0.37、3.96±0.38、3.63±0.38),抗-HIV(3.63±0.31、3.82±0.32、3.48±0.28),抗-TP(4.51±0.51、4.71±0.52、4.36±0.51),每项指标S/CO值均为H12(孔)组<随机(孔)组<A1(孔)组(P<0.05),其中随机组与每项检测指标的质控水平均值相近(P>0.05)。以随机组为质控框架(标准),A1组中有5个点落在■+2s外,H12组中有1个点落在■-2s外,亦即发生6次“告警”,这意味着只要将质控物置于酶标板A1孔,势必会影响到对整个酶标板检测结果的判断,特别是对酶标板最后1排低浓度病毒标志物标本的结果判断有一定影响。结论 随机质控加样方法应用在献血者血液ELISA检测中,不仅有效减少了人为设置酶标板固定孔位质控引起的系统误差,还可能发现影响检测结果的边缘效应,是很适合血站的1种科学、合理的质控方法。

Objective To evaluate the effectiveness of random quality control sampling in blood sample detetion by ELISA.Methods Blood samples of 5 mL specification of blood donors from our blood station from May to July 2022 were selected for routine operation on a fully automated sampler.J standard substances(3 mL specification)as daily samples were added to A1 well,H12 well and random wells of HBsAg,anti⁃HCV,anti⁃HIV,and⁃TP,and then placed in a fully automa⁃ted enzyme immunoassay analyzer for testing.With random well quality control as the internal quality control judgment stand⁃ard,20 consecutive tests were conducted and were divided into A1(well)group,H12(well)group and random(well)group according to different well positions.Quality control maps were drawn using Levey⁃Jennings quality control chart with random group as the framework,and were compared with the quality control map of A1 well and H12 well results in the same day.Results The mean quality control levels of infectious indicators of blood transfusion in blood donors by ELISA were:HBsAg 3.87±0.28,anti⁃HCV 3.79±0.38,anti⁃HIV 3.64±0.30 and anti⁃TP 4.53±0.51.Comparison of HBsAg,anti⁃HCV,anti⁃HIV and anti⁃TP,between random group,A1 group and H12 group were HBsAg 3.87±0.28 vs 4.09±0.30 vs 3.64±0.26,anti⁃HCV 3.78±0.37 vs 3.96±0.38 vs 3.63±0.38,anti⁃HIV 3.63±0.31 vs 3.82±0.32 vs 3.48±0.28 and anti⁃TP 4.51±0.51 vs 4.71±0.52 vs 4.36±0.51,The S/CO value of each indicator were H12 group<random group<A1 group(P<0.05),and the mean quality control levels of random group were similar to each detection indicator(P>0.05).Using random group as the quality control framework standard,5 points in group A1 fell outside ofx+2s,and 1 point in group H12 fell outside ofx-2s,resulting in a total of 6 alarms.With the quality control substance placed in A1 well of the ELISA plate,the judgment of de⁃tection results of the entire ELISA plate could be inevitably affected,especially the last row of low concentration virus marker samples on the ELISA plate.Conclusion The application of random quality control sampling method in donor blood by ELISA is scientific and reasonable,which can reduce the systematic error caused by artificial setting of ELISA plate fixed well positions and can also discover edge effects that affect the detection results.