| 甲胎蛋白酶联诊断试剂盒的质量分析 |
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| 引用本文： | 沈琦,刘大英.甲胎蛋白酶联诊断试剂盒的质量分析[J].微生物学免疫学进展,1999,27(2):44-49. |
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| 作者姓名： | 沈琦 刘大英 |
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| 作者单位： | 中国药品生物制品检定所 |
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| 摘 要： | 对国内６个厂家２８批ＡＦＰ ＥＬＩＳＡ诊断试剂盒的精密性、灵敏度、特异性、线性和盒内ＡＦＰ工作标准品的准确性进行全面质量的考查。结果表明目前我国大多数ＡＦＰ ＥＬＩＳＡ诊断试剂盒的灵敏度均能达到≤５ＩＵ／ｍｌ，精密性（孔间差）为１５％～２０％；线性ｒ值≥０９８；特异性良好。但存在的主要问题是盒内ＡＦＰ工作标准品的标示量与ＡＦＰ国家标准品标示量不符。不符合率占４２８％。
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| 关 键 词： | 甲胎蛋白 诊断试剂 标准品 |
Quality Analysis of Alpha Fetoprotein(AFP)ELISA Kits |
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| Shen Qi,Liu Daying.Quality Analysis of Alpha Fetoprotein(AFP)ELISA Kits[J].Progress In Microbiology and Immunology,1999,27(2):44-49. |
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| Authors: | Shen Qi Liu Daying |
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| Abstract: | We analysed the quality of 28 lots AFP ELISA kits from domestic manufactures.Including precision,sensivivity,spcificity,correlation coefficients(r value)and quantity of AFP working standard in kits.The results showed that the sensitivity of AFP ELISA kits is ≤5 IU/ml,precision(the differences of well)is 15～20%,r≥0.98,specificity is good.But the main problem of the kits is that the quanity of AFP working standard is inconsistent with national standard for AFP.The percentage of inconsistency is 42.8% |
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| Keywords: | AFP(Alpha fetoprotein) Diagnostic reagent National standard |
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