上海地区肝癌标志物AFP、PIVKA、AFU生物参考区间的建立

目的初步建立上海地区肝癌标志物甲胎蛋白(AFP)、异常凝血酶原(PIVKA-Ⅱ)、α-L岩藻糖苷酶(AFU)的生物参考区间。方法收集498例受试者的血清,对其分别通过电化学发光法检测AFP、酶联免疫吸附法检测PIVKA-Ⅱ、速率法测定AFU,并对结果进行统计学分析。结果 AFP的95%参考范围为:18~29岁男性1.12~5.93μg/L,30~49岁男性1.25~9.72μg/L,≥50岁男性1.18~9.93μg/L;18~29岁女性1.00~7.18μg/L,30~49岁女性1.00~6.23μg/L,≥50岁女性1.08~16.23μg/L。PIVKA-Ⅱ的95%参考范围为:18~29岁男性9.28~39.47 mAU/ml,30~49岁男性10.89~35.44mAU/ml,≥50岁男性8.64~35.48mAU/ml;18~29岁女性10.56~38.51mAU/ml,30~49岁女性11.02~27.45mAU/ml,≥50岁女性9.43~49.74mAU/ml。AFU的95%参考范围为:男性9.69~34.15U/L,女性9.78~32.16 U/L。结论上述结果初步构建了上海地区健康成人血清AFP、PIVKA-Ⅱ、AFU的参考区间。在原发性肝癌的临床初筛以及辅助确诊具有临床实用价值。

Reference intervals for tumor biomarkers AFP,PIVKA-II and AFU in Shanghai area

Objective To establish the the biological reference intervals of biomarker alpha-fetoprotein(AFP),protein induced by Vitamine K antagonist-Ⅱ(PIVKA-Ⅱ) and serum α-L-fucosidase(AFU) in Shanghai area.Methods The serum of 498 subjects were collected,and the levels of AFP,PIVKA-Ⅱ and AFU were examined by electrochemiluminescence,enzyme-linked immunosorbent assay and rate assay,respectively.And the results were statistically analyzed.Results The 95% reference interval of AFP was:1.12~5.93 μg/L for men aged 18~29 years,1.25~9.72 μg/L for men aged 30~49,and 1.18~9.93 μg/L for men aged above 50;1.00~7.18 μg/L for women aged18~29,1.00~6.23 μg/L for women aged 30~49 and 1.08~16.23 μg/L for women aged above 50.The 95% reference interval of PIVKA~Ⅱ was:9.28~39.47 mAU/ml for men aged 18~29,10.89~35.44 mAU/ml for men aged 30~49,and 8.64~35.48 mAU/ml for men aged above 50;10.56~38.51 mAU/ml for women aged 18~29,11.02~27.45 mAU/ml for women aged 30~49,and 9.43~49.74 mAU/ml for women aged above 50.The 95% reference intervals of AFU was:9.69~34.15 U/L for men and 9.78~32.16 U/L for women.Conclusion This study preliminarily establishes the reference intervals of AFP,PIVKA-Ⅱ and AFU for healthy adults in Shanghai.It is valuable for screening and diagnosis of primary liver cancer.