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为了提高 HBs Ag的检测质量 ,鉴别和控制诊断试剂的质量和操作误差 ,我们试制了乙型肝炎 HBs Ag室内质控血清。采用不同品牌 ,同一批号和不同批号的诊断试剂盒 ,随标本同时检测试制的 HBs Ag室内质控品。将质控品置不同的温度下保存 ,观察其稳定性 ,精密性。实验证明 :试制的 HBs Ag室内质控品放 - 2 0℃保存 ,第一次打开使用后放 4℃保存 ,直至用完 ,以这种方式保存的 HBs Ag质控品在三个月内其稳定性良好 ,可适应于上海地区开展 HBs Ag室内质控使用。用质量较好的进口 HBs Ag诊断试剂 ,全自动机器操作 ,重复性较好 ,CV值为 5 %左右 ,用国产 HBs Ag诊断试剂 ,手工操作 ,CV值为 2 5 %左右 ,为医院检验科开展 HBs Ag室内质控提供了较好的质控品和参照方法。
In order to improve the quality of HBsAg detection, identify and control the quality of diagnostic reagents and the operational errors, we developed a hepatitis B HBsAg serum control laboratory. Using different brands, the same lot number and different batch number of diagnostic kits, with the specimen at the same time testing the prototype HBs Ag indoor quality control. Quality control products will be stored at different temperatures, observe its stability, precision. The experiment proves that the HBsAg indoor quality control product put in the trial is stored at -20 ℃ and stored at 4 ℃ for the first time and then stored until it runs out. Good stability, can be adapted to the Shanghai area HBsAg indoor quality control use. With better quality imported HBs Ag diagnostic reagents, automatic machine operation, good reproducibility, CV value of about 5%, with domestic HBsAg diagnostic reagents, manual operation, CV value of about 25% for the hospital laboratory To carry out HBs Ag indoor quality control provides a better quality control and reference methods.