血清盘在HBsAg酶联免疫吸附试验灰区设置中的应用  

Application of serum plate in the grey area setting of HBsAg ELISA

作　　者：盛丹 王克成 SHENG Dan;WANG Kecheng(Nantong Central Blood Station,Nantong 226014,China)

机构地区：[1]南通市中心血站,江苏南通226014

出　　处：《中国输血杂志》2022年第11期1170-1173,共4页Chinese Journal of Blood Transfusion

摘　　要：目的 探讨本实验室HBsAg ELISA 2种试剂灰区设置为0.7倍临界值(CO值)的必要性及合理性,为灰区设置提供依据。方法 采用2种ELISA试剂重复性检测HBsAg灰区评价血清盘60份标本,根据检测结果计算C50、C5、C95浓度值及对应被测物吸光度与Cut off的比值(S/CO值),并验证C5、C95是否在C50±20%以内;计算2种试剂的真阳性检出率、灰区标本确证阳性率。结果 灰区评价血清盘确认结果:试剂A的C50、C5、C95浓度值分别为为0.090 IU/mL、0.075 IU/mL、0.105 IU/mL,真阳性检出率为99.1%(436/440),灰区标本确证阳性率为37.8%(136/360);试剂B的C50、C5、C95浓度值分别为为0.112 IU/mL、0.091 IU/mL、0.133 IU/mL,真阳性检出率为97.1%(233/240),灰区标本确证阳性率为35.8%(129/360)。经验证试剂A和试剂B的C5、C95均在各自的C50±20%以内,HBsAg ELISA试剂灰区验证有效。结论 本实验室2种HBsAg ELISA试剂有必要设置灰区,但所设灰区值0.7 CO不合理,试剂A应为0.75 CO,试剂B应为0.63 CO。Objective To evaluate the necessity and rationality of setting 0.7 CO of the gray area of HBV surface antigen reagent(ELISA) in our laboratory, and to provide the basis for the grey area setting. Methods A total of 60 samples of serum plate were repeatability tested by two kinds of ELISA HBsAg reagents. Based on the test results, C50, C5, C95concentrations and corresponding S/CO values were calculated, and whether C5and C95were within C50±20% was verified. At the same time, the true positive rate and the confirmed positive rate of gray area samples revealed by two reagents were calculated. Results The confirmation results of serum plate were as follows: The C50,C5and C95concentrations of reagent A were 0.090 IU/mL, 0.075 IU/mL, 0.105 IU/mL. The true positive rate was 99.1%(436/440),the confirmed positive rate of grey area was37.8%(136/360). The C50, C5and C95concentrations of reagent B were 0.112 IU/mL, 0.091 IU/mL, and 0.133 IU/mL;the true positive detection rate was 97.1%(233/240);the confirmed positive rate of grey area was 35.8%(129/360). It was verified that C5and C95of reagent A and reagent B were within their respective C50±20%, and the gray areas of the HBsAg ELISA were verified to be effective. Conclusion It is necessary to set the gray area for these two HBsAg ELISA reagents in our laboratory, but the gray area value setting to 0.7 CO is unreasonable. The best gray area value was 0.75 CO in reagent A and 0.63 CO in reagent B.

关 键 词：乙型肝炎病毒表面抗原 酶联免疫吸附试验 灰区 

分 类 号：R457.1[医药卫生—治疗学] R446[医药卫生—临床医学]