国产肿瘤标志物免疫分析药盒质量考察

用美国Ｂｉｏ－ｒａｄ公司、瑞典ＣＡＮＡＧ公司出品的质控样品和国家质量控制血清作为标准物质对１３个国产肿瘤标志物ＩＲＭＡ与ＲＩＡ药盒进行了质量检验。９个ＩＲＭＡ药盒的Ｂｍａｘ／Ｂｍｉｎ比值均大于２０，平均批变异系数（ＡＢＣＶ）小于４％，ｒ〉０．９９００；４个ＲＩＡ药盒的ＮＳＢ／Ｔ％〈５，Ｂ０／Ｔ〉３０，│ｒ│〉０．９９００，ＥＤ（有效剂量值）２５、ＥＤ和ＥＤ７５均在剂量－反应曲线范围内。每种药盒的质

Inspection of Homemade Immunoassay Kits for Tumor Marker

Thirteen homemade IRMA and RIA kits for tumor markers were examined using controls manufactured by Bio-rad Ltd. ,USA and CANAG Ltd. .Sweden,and the national quality control sera for immunoassay prepared by our institute were served as reference materials.It has been observed that ratio of Bmax/T to Bmin/T is>20,average batch coefficient of variation<4% and r>0. 9900 in 9 IRMA kits while fitting by log dose-log B/Bmax mode;NSB/ T%<5,B0/T%>25 and |r|>0. 9900 in 4 RIA kits when fitting by log dose-logit B/B0 mode,effective dose values-ED25,ED50 and ED75 are in the range of dose-response curves, respectively. All of the mean values of the controls determined with each kind of these kits fall onto limits and the intra-assay coefficient of variation did not exceed 15%,the mean values of the controls obtained using kits for carbohydrate antigen and prostatic specific antigen were very close to those supplied by the relative kits listed in Bio-rad instruction,respectively,suggesting that these immunoassay kits have achieved a great deal in their quality.