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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、ＥＤ５０和ＥＤ７５均在剂量－反应曲线范围内。每种药盒的质控样品测定均值都落在各自的参考范围内，且批间变异系数均不超过１５％。糖类抗原和前列腺特异抗原药盒的质控样品测定均值与国外同类药盒提供的数据非常接近，提示这些国产药盒的质量已有了长足的进步。号者为Ｃ公司产品，有＊号者为Ｄ所产品表２给出３家３批４个ＲＩＡ药盒的剂量－反应曲线参数、ｌｏｇｄｏｓｅ－ｌｏｇｉｔＢ／Ｂ０线性回归拟合参数以及国外质控样品与本所质控血清测定值均值的统计学分析资料。１．ＮＳＢ／Ｔ％：均小于５，符合检验要求。２．Ｂ０／Ｔ％：均大于３０，符合检验要求。３．ＡＢＣＶ％：均小于４，符合检验要求。４．｜ｒ｜：均大于０．９９００，符合检验要求。５．ＥＤ２５、ＥＤ５０和ＥＤ７５：除ＣＡ２７－２９的ＥＤ７５（１?
The quality of 13 domestically produced tumor markers IRMA and RIA kits was tested with quality control samples produced by Bio-rad in the United States, CANAG in Sweden, and national quality control serum as standard materials. The Bmax/Bmin ratios of the 9 IRMA kits were all greater than 20, the average batch coefficient of variation (ABCV) was less than 4%, r> 0.9900, and the 4 RIA kits had an NSB/T% <5, B0/T>30. |r|>0.9900, ED (effective dose value) 25, ED50, and ED75 are all within the dose-response curve. The mean value of quality control samples for each kit was within the respective reference range, and the inter-assay coefficient of variation did not exceed 15%. The mean value of quality control samples for carbohydrate antigens and prostate specific antigen kits is very close to that provided by similar foreign kits, suggesting that the quality of these domestic kits has come a long way. No. is the product of company C, and * is the product of D. Table 2 shows the dose-response curve parameters, logdose-logitB/B0 linear regression fitting parameters and foreign quality control samples for three 3-batch four RIA kits. Statistical analysis data with the mean value of the quality control serum. 1. NSB/T%: all less than 5, in line with inspection requirements. 2. B0/T%: all greater than 30, in line with inspection requirements. 3. ABCV%: both less than 4, meet the inspection requirements. 4. |r|: Both are greater than 0.9900 and meet inspection requirements. 5. ED25, ED50, and ED75: In addition to the CA27-29 ED75 (1?