Gerety R J, Hoofnagle J H, Mitchell F D, Barker L F, Meyer H M
Am J Clin Pathol. 1975 Apr;63(4):573-80. doi: 10.1093/ajcp/63.4.573.
Between August 1972 and January 1974, the Burear of Biologics distributed four panels of 20 coded serum samples to all federally licensed blood banks for hepatitis B antigen testing. Initially, all but six blood banks reported results by counterelectrophoresis (CEP) only, but by January 1974, 152 of 247 banks reported results by radioimmunoassay (RIA). On the four panels distributed, correct results were reported for 63 to 83% of all potentially detectable samples by CEP and for 98 to 100% of all samples potentially detectable by RIA. Perfect scores were obtained by only 5 to 25% of blood banks using CEP but by 77 to 100% using RIA. Nonreproducible results on duplicate reactive samples, included to evaluate internal consistency, ranged from 0.5 to 25% by CEP and from zero to 5% by RIA. These results demonstrate greater reliability in addition to greater sensitivity of "third generation" RIA testing in comparison with "second generation" CEP testing.
1972年8月至1974年1月期间，生物制品局向所有获得联邦许可的血库分发了四组共20份编码血清样本，用于乙型肝炎抗原检测。最初，除了六家血库外，其他所有血库仅通过对流电泳（CEP）报告结果，但到1974年1月，247家血库中有152家通过放射免疫测定法（RIA）报告结果。在分发的四组样本中，通过CEP检测，所有潜在可检测样本的63%至83%报告了正确结果；通过RIA检测，所有潜在可检测样本的98%至100%报告了正确结果。使用CEP的血库中只有5%至25%获得了满分，而使用RIA的血库中有77%至100%获得了满分。为评估内部一致性而纳入的重复反应性样本的不可重复结果，通过CEP检测的范围为0.5%至25%，通过RIA检测的范围为0至5%。这些结果表明，与“第二代”CEP检测相比，“第三代”RIA检测除了具有更高的灵敏度外，还具有更高的可靠性。
