戊型肝炎病毒IgG抗体国家参考品的建立

Establishment of national reference panel for anti-hepatitis E virus IgG

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 the national reference panel for anti-hepatitis E virus（HEV）IgG. Methods A total of300 plasma or serum samples were collected from blood centers and plasma collection station in various provinces in China, and screened with domestic and imported HEV IgG diagnostics kits, based on which the national reference panel for anti-HEV IgG was prepared, and evaluated for stability and suitability. Results The national reference panel for antiHEV IgG was prepared, including 30 negative, 10 positive reference panels, one sensitivity and one precision reference panels. The HEV IgG content in sensitivity reference panel was defined as 3 U / ml by calibration with international standard for HEV IgG. The determination results of reference panels after storage at 4 ℃ or room temperature for 10 d,37 ℃ for 7 d and after three cycles of freezing and thawing were consistent with that after storage at-20 ℃, indicating a high stability. The test results by kits from five manufacturers showed good suitability of the reference panel. Conclusion The national reference panel for anti-HEV IgG was established, which laid a foundation of improving the quality of HEV IgG diagnostic kit.