Study on stability of M, Fya and P1 antigens in antibody screening cells within validity period
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摘要: 目的研究抗体筛查细胞在保存期内M抗原、Fya抗原和P1抗原的稳定性变化。方法应用2个不同厂家的抗体筛查细胞通过倍比稀释法进行单克隆抗体标化(IgG-M/Fya/P1抗体)。收集抗-M/Fya/ P1抗体阳性标本，制备人源抗体血清。自配1%试剂红细胞(10例O型且M/Fya/P1抗原阳性志愿者)验证标化单克隆抗体和人源抗体的稳定性。在有效期最后30 d内，采用微柱凝集法，使用标化单克隆抗体和人源抗体对2厂家抗体筛查细胞(试剂1和2) M/Fya/P1抗原的抗原性进行监测。结果试剂1，M和P1抗原在第21天及Fya抗原在第28天与第0天比较，凝聚强度结果差异有统计学意义(P＜0.05)；M抗原于第28天及P1抗原于第21天出现无法检出现象。试剂2，M和P1抗原在第21天及Fya抗原在第28天出现凝聚强度差异(P＜0.05)；M和P1抗原第28天出现无法检出现象。结论抗体筛查细胞血型抗原稳定性在有效期内逐渐降低，建议抗体筛查细胞保存期间进行质量监测。Abstract: ObjectiveTo study the stability changes of M, Fya and P1 antigens in antibody screening cells during the storage period.MethodsMonoclonal antibody standardization(IgG-M/Fya/P1 antibody) was performed by doubling dilution using antibody screening cells from two different manufacturers. The positive specimens of anti-M/Fya/P1 antibody in our department were collected to prepare human antibody serum. Self-prepared 1% reagent red blood cells(10 volunteers with O type and positive for M/Fya/P1 antigen) were used to verify the stability of standardized monoclonal antibodies and human antibodies. During the last 30 days of validity, the M/Fya/P1 antigen antigenicity of the two manufacturers' antibody screening cells(Reagent 1 and Reagent 2) was monitored by microcolumn agglutination and using standardized monoclonal antibodies and human antibodies.ResultsFor reagent 1, compared with day 0, the results of aggregation strength of M and P1 antigens on day 21 and Fya antigen on day 28 were significantly different(P < 0.05). The M antigen was undetectable on the 28th day and the P1 antigen on the 21st day. For reagent 2, the aggregation intensity of M and P1 antigens was different on the 21st day and the Fya antigen on the 28th day(P < 0.05). The M and P1 antigens were undetectable on day 28.ConclusionThe stability of antibody screening cells blood group antigen gradually decreased during the validity period. It is recommended to monitor the quality of antibody screening cells during storage.
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Key words:
- antibody screening cells /
- stability /
- column agglutination /
- human antibody /
- monoclonal antibody
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表 2 标化单克隆抗体和人源抗体保存稳定性验证
n=10，X±S 验证时间 标化单克隆抗体 人源抗体 试剂1 试剂2 M抗原 Fya抗原 P1抗原 M抗原 Fya抗原 P1抗原 M抗原 Fya抗原 P1抗原 第0天 9.200±0.789 8.200±0.789 8.500±0.707 8.700±0.483 8.400±0.699 8.900±0.539 8.500±0.527 8.600±0.516 8.500±0.527 第30天 9.100±0.737 8.300±0.823 8.600±0.789 8.600±0.516 8.400±0.843 8.600±0.490 8.600±0.517 8.400±0.516 8.700±0.483 第60天 9.300±0.675 8.100±0.738 8.400±0.699 8.800±0.421 8.300±0.823 8.700±0.640 8.600±0.700 8.500±0.527 8.500±0.527 F 0.310 0 0.980 0 0.560 0 1.590 0 0.180 0 1.190 0 0.100 0 0.310 0 0.550 0 P 0.737 0 0.393 0 0.582 2 0.231 6 0.833 7 0.327 4 0.904 3 0.737 0 0.588 9 
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表 3 试剂1的M、P1和Fya抗原稳定性监测表
n=10，X±S 验证时间 单克隆抗体 人源抗体 M抗原 Fya抗原 P1抗原 M抗原 Fya抗原 P1抗原 第0天 9.700±0.483 8.200±0.632 7.500±0.527 6.700±0.483 6.600±0.516 8.100±0.568 第7天 9.600±0.516 8.100±0.568 7.400±0.516 6.600±0.516 6.500±0.527 7.900±0.568 第14天 9.600±0.516 8.000±0.667 7.400±0.516 6.600±0.516 6.500±0.527 7.800±0.632 第21天 6.700±0.675 7.700±0.483 2.900±0.738 4.100±0.738 6.100±0.738 2.700±0.675 第28天 1.100±0.738 6.300±0.823 0.400±0.516 0.900±0.567 4.700±0.949 0.100±0.316 F 368.090 22.340 356.600 331.310 18.470 960.610 P ＜0.001 ＜0.001 ＜0.001 ＜0.001 ＜0.001 ＜0.001
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表 4 试剂2的M、P1和Fya抗原稳定性监测表
n=10，X±S 时间 单克隆抗体 人源抗体 M抗原 Fya抗原 P1抗原 M抗原 Fya抗原 P1抗原 第0天 9.300±0.823 7.700±0.483 7.100±0.738 7.600±0.699 6.400±0.516 8.100±0.876 第7天 9.200±0.919 7.800±0.632 7.000±0.667 7.500±0.527 6.500±0.527 8.000±0.943 第14天 9.200±0.919 7.800±0.632 7.000±0.667 7.700±0.675 6.400±0.516 7.700±0.823 第21天 5.800±0.789 7.400±0.516 2.500±0.527 3.300±0.483 6.100±0.738 0.100±0.316 第28天 1.100±0.738 5.800±0.632 0.300±0.483 0.900±0.738 4.700±0.483 0 F 212.100 38.650 408.710 490.000 38.370 428.910 P ＜0.001 ＜0.001 ＜0.001 ＜0.001 ＜0.001 ＜0.001
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