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目的制备戊型肝炎病毒IgG抗体国家参考品。方法从我国多省血液中心、采浆站收集血清、血浆样品300份,应用国内外5家HEV IgG抗体诊断试剂进行筛选,制备HEV IgG国家参考品,并对参考品的稳定性及适用性进行检测。结果制备了HEV IgG国家参考品,其中阴性参考品30份;阳性参考品10份;灵敏度参考品1份,依据HEV IgG国际标准品进行标化,定量为3 U/ml;精密性参考品1份。参考品经4℃及室温放置10 d,37℃放置7 d,以及反复冻融3次后,测定结果与-20℃放置参考品检测结果一致,稳定性良好。5个厂家试剂对参考品的检测结果显示该参考品具有较好的适用性。结论制备了戊型肝炎病毒IgG抗体国家参考品,为提高诊断试剂的质量奠定了基础。
Objective To prepare hepatitis E virus IgG antibody reference material. Methods 300 serum and plasma samples were collected from many blood centers and plasma collection stations in China. Five domestic and foreign HEV IgG antibody diagnostic reagents were screened to prepare HEV IgG national reference samples. The stability and applicability of reference samples Detection. Results HEV IgG national reference materials were prepared, of which 30 were negative reference materials, 10 positive reference materials and 1 sensitivity reference material, which were standardized according to HEV IgG international standards with the quantification of 3 U / ml. The precision reference 1 Copies The reference products were placed in 4 ℃ and room temperature for 10 days, placed in 37 ℃ for 7 days, and frozen and thawed repeatedly for 3 times. The results were in good agreement with the results of reference samples placed at -20 ℃. The stability was good. The test results of 5 manufacturers reagents on the reference products show that this reference product has good applicability. Conclusion The national reference antibody of Hepatitis E virus IgG was prepared, which laid the foundation for improving the quality of diagnostic reagents.