| 王玉梅,刘艳,邵安良,杨昭鹏.游离前列腺特异性抗原检测试剂盒质量状况分析[J].中国药事,2018,32(5):631-636 |
| 游离前列腺特异性抗原检测试剂盒质量状况分析 |
| Analysis of Quality Status of Free Prostate Specifc Antigen Test Kit |
| 投稿时间：2017-11-10 |
| DOI：10.16153/j.1002-7777.2018.05.010 |
| 中文关键词: 肿瘤标记物 前列腺特异性抗原 检测试剂盒 质量分析 产品标准 行业标准 性能指标 |
| 英文关键词: tumor marker prostate specifc antigen test kit quality analysis product standard industry standard performance index |
| 基金项目: |
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| 摘要点击次数: 1253 |
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| 中文摘要: |
| 目的：对肿瘤标记物游离前列腺特异性抗原（f-PSA）检测试剂盒质量状况进行分析评价。方法：采用企业产品标准与行业标准，对国家监督抽验来源的15家22批次国产和7家7批次进口f-PSA检测试剂盒的准确度、线性、检测限、重复性4个性能指标进行评价分析。结果：本次共抽检22批次效期内产品，7批次近效期产品。采用产品标准检测结果显示，22批次效期内抽样产品中，20批次产品达到要求；7批次近效期抽样产品有6批次达到要求。采用行业标准检测结果显示，22批次效期内抽样产品，按校准品的平均效价评价准确度，有21批次产品符合要求；按每个校准品的效价评价准确度，有14批次产品符合要求。对效期内15家国产试剂盒和7家进口试剂盒的性能进行比较，统计学结果显示，国产、进口试剂盒质量无显著性差异（P>0.05）。结论：目前上市的f-PSA检测试剂盒整体质量较好，国产、进口同类试剂盒质量风险差别不大，部分产品尚存在质量标准及质量方面的问题。 |
| 英文摘要: |
| Objective:To analyze the quality status of tumor marker free prostate specifc antigen (f-PSA) test kit. Methods:Accuracy, linearity, limit of detection and repeatability of 22 batches of f-PSA test kits from 15 domestic enterprises and 7 batches of f-PSA test kits from 7 oversea enterprises were analyzed and evaluated according to enterprise product standards and industry standards. Results:22 batches of kits were within validity period and 7 batches of kits were close to the expiry date in this sampling inspection. 20 of 22 batches of kits within validity period and 6 of 7 batches of kits closed to the expiry date met the requirements according to the enterprise product standards. 21 of 22 batches of kits within validity period met the provisions of the industry standards according to the average potency evaluation accuracy of the calibrators. 14 of 22 batches of kits within validity period met the provisions of the industry standards according to the potency evaluation accuracy of each calibrator. The performance of 15 domestic kits and 7 imported kits within validity period was compared and the statistical results showed that there was no signifcant difference between domestic and imported kits (P>0.05). Conclusion:The overall quality of f-PSA test kits in the market is good and there is no signifcant difference in quality risk between domestic and imported kits, while there still exist some problems in terms of quality standards and quality. |
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