梅毒螺旋体抗体快检试剂国家参考品的研制

Development of national reference panel for rapid detection of Treponema pallidum antibody

目的建立梅毒螺旋体(Treponema pallidum,TP)抗体快检试剂国家参考品,确定其质量标准。方法通过对134批TP血浆的复核、确证,组建TP抗体快检试剂国家参考品,经多家实验室协助标定,确定参考品的质量标准,并对参考品进行均匀性及稳定性评估。结果 TP抗体快检试剂国家参考品由20份阴性、10份阳性、3份最低检出限及1份重复性样品组成。质量标准为20份阴性参考品中应至少18份为阴性,10份阳性参考品中应至少9份为阳性,最低检出限参考品中应至少1份为阳性,且稀释用血浆应为阴性,重复性参考品检测10次,应均为TP抗体阳性,其颜色反应应一致。参考品的均匀性及稳定性均符合国家参考品标准。结论研制的参考品可作为TP抗体快检试剂的质量控制及评价使用。

Objective To establish a national reference for rapid detection of Treponema pallidum(TP)antibody as well as its quality standard.Methods By check-up and confirmation of 134 batches of TP plasma,the composition of the candidate reference was determined.The quality standard of the reference was determined by cooperative calibration by several laboratories,while the uniformity and stability were evaluated.Results The reference consisted of 20 negative,10 positive,3 minimum detection limit and one repetitive samples.The quality standard should be at least 18 negative for20 negative reference,at least 9 positive for 10 positive reference,at least one positive for minimum detection limit reference,and the dilution plasma should be negative.The repetitive reference should be positive for TP antibody in10 repeat tests,and the color response was consistent.The uniformity and stability of the reference met the requirements for O national reference.Conclusion This reference may be used for quality control and evaluation of rapid detection kits for T.mapallidum antibody.