Nath N, Fang C T, Pielech M, Lawson W, Dodd R Y
Vox Sang. 1982;43(2):105-12.
Eight hepatitis B surface antigen (HBsAg) proficiency panels were tested using a radioimmunoassay (RIA) test kit during 1978 and 1979 by routine processing laboratories within the 57 American Red Cross Blood Services Regions. The test results were analyzed and it was found that lot-to-lot variability in the reagents may result in a measurable loss of sensitivity of the test leading to an increased error rate. On the basis of these studies, it is recommended that the positive to negative (P/N) ratio for validation of the test be raised to at least 25.
1978年至1979年期间，美国红十字会血液服务部的57个地区内的常规检测实验室使用放射免疫分析（RIA）试剂盒对8个乙型肝炎表面抗原（HBsAg）能力验证样本进行了检测。对检测结果进行分析后发现，试剂的批次间差异可能导致检测灵敏度出现可测量的下降，从而导致错误率增加。基于这些研究，建议将用于检测验证的阳性与阴性（P/N）比值提高到至少25。
