HCG检测溯源问题

[36，37]

（表3）。如果在进行妊娠监测或在一些疾病的治疗效果监测时分别使用了

这两种不同的试剂，将可能会导致非常严重的错误结论。

表3.强生总βHCG、罗氏HCG＋β参考值比较

强生 罗氏 中位数 范围（5-95%） 1110 8050 40-4480 270-28700 3700-84900 9700-120000 31100-184000 61200-152000 22000-143000 孕周 平均值 范围 4 5 6 7 8 9 10 50584 51517 72671 87943 4700-132800 3660-134000 22600-135000 29700 44800-148600 58800 103486 52600-191800 79500 103783 57400-196000 91500 88250 51000-189400 71000 综上所述，HCG测定的溯源及检验结果的实验室间互相认可还存在许多问题。HCG与LH、FSH、TSH等具有相同的α亚基，与LH具有类似的β亚基；HCG具有众多的变异体。HCG及其变异体具有广泛而不同的功能,对于HCG及其变异体的测定具有众多的临床应用。现行的HCG国际标准品存在部分裂解和杂质，且在无活性亚基的赋值方面存在问题。由于厂家标签不清楚、检验人员知识不足、收费项目名称等原因错报HCG类检验项目的事情经常发生。由于抗体特异性等问题，不同厂家的试剂测定HCG类物质的结果差异很大。如果新的HCG国际参考物质作为以摩尔浓度定标的国际标准品发布以后，各试剂厂商以此标准品免疫动物制备相应的HCG抗体，并以此抗体生产相应的HCG检测试剂，同时使试剂的标准品溯源至新的国际标准品以后，将会在某种程度上降低不同厂家试剂间的差异。当然，要进一步改善HCG检测的不同实验室间互相认可，还要普及HCG类物质方面知识的宣传。

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35、山东省部、省属医疗机构医疗服务价格表

36、罗氏ElecsysQ Systems 1010/2010/MODULAR ANALYTICS E170人类绒毛膜促性腺激素＋β亚单位说明书

37、强生总β-hCG试剂包说明书