自制人绒毛膜促性腺激素(HCG)室内质控品及质量评价

Quality Control and Quality Evalution of Homemade Human Chorionic Gonadotropin(HCG)

目的自制人绒毛膜促性腺激素(HCG)室内质控品,对其临床检验实际应用价值进行评价。方法收集日常检测标本中人绒毛膜促性腺激素(HCG)水平含量较高的孕妇血清,用正常男性血清稀释成低值和高值两种浓度,混匀,灭活,过滤,小量分装保存于-30℃。结果保存于-30℃的自制质控血清复融后测定,结果显示其有较好的重复性和稳定性,无明显的批内、批间差异。结论通过此方法制备的低、高浓度HCG质控血清能满足HCG检测室内质控要求,可以作为日常HCG免疫检测的质控品使用。

Objective To evaluate the clinical application value of the homemade human chorionic gonadotropin(HCG)in the laboratory. Methods The serum of pregnant women with high level of chorionic gonadotropin(HCG)in daily test specimens was collected,diluted with normal male serum to 2 concentrations of low value and high value,mixed,inactivated,filtered,and stored at-30 C at a small volume. Results The result showed that it had good reproducibility and stability,and there was no significant difference between batch and batch in-30℃. Conclusion The low quality and high concentration HCG quality control serum prepared by this method can meet the quality control requirements of HCG detection,and it can be used as a quality control product for routine HCG immunoassay.