Fernández E, Rodrigo L, García S, Riestra S, Blanco C
Service of Biochemistry, Hospital de Cabueñes, Gijón, Spain.
Rev Esp Enferm Dig. 2006 Feb;98(2):112-21. doi: 10.4321/s1130-01082006000200006.
To examine the feasibility and to perform a cost benefit analysis of a 5-sample pooling strategy using an enzyme immunoassay (EIA) for the screening of hepatitis B surface antigen (HBsAg).
To assess the sensitivity and specificity of the pooling method, each of the 40 positive sera (from weak to intensely HBsAg-positive) and 250 negative sera were tested in a pool with 4 HBsAg-negative sera. The limit of detection for HBsAg/ad and HBsAg/ay was evaluated using sera from a panel of purified subtypes. A study under real conditions was conducted using pools from 340 pregnant women.
The sensitivity and specificity of this technique were 100%. The correlation coefficient among the sample/cutoff ratios of 40 samples studied in single and in pooled conditions was 0.792 (p < 0.005). The pooling method has lower levels of detection for HBsAg/ad and HBsAg/ay at 0.20 ng/mL and 0.12 ng/mL, and the single method at 0.34 ng/mL and 0.29 ng/mL, respectively. The pooling method loses no sensitivity for values up to 100 IU/L of anti-HBs in the four sera mixed with a positive serum. The cost-benefit analysis showed that the pooling method could save from 30% up to 75% of the cost of HBsAg determination, according to whether seroprevalences were 10% or 1%, respectively.
The pooled HBsAg EIA yielded no worse than the single EIA test, and was a cost-effective and valid strategy in areas with a high, medium or low prevalence.
探讨采用酶免疫分析法（EIA）对5份样本进行混合检测以筛查乙型肝炎表面抗原（HBsAg）的可行性并进行成本效益分析。
为评估混合检测法的敏感性和特异性，将40份阳性血清（从弱阳性到强阳性HBsAg）和250份阴性血清分别与4份HBsAg阴性血清混合进行检测。使用一组纯化亚型的血清评估HBsAg/ad和HBsAg/ay的检测限。对340名孕妇的混合样本进行了实际条件下的研究。
该技术的敏感性和特异性均为100%。在单独检测和混合检测条件下研究的40个样本的样本/临界值比率之间的相关系数为0.792（p<0.005）。混合检测法对HBsAg/ad和HBsAg/ay的检测下限分别为0.20 ng/mL和0.12 ng/mL，单独检测法分别为0.34 ng/mL和0.29 ng/mL。在与阳性血清混合的4份血清中，抗-HBs值高达100 IU/L时，混合检测法不失敏感性。成本效益分析表明，根据血清流行率分别为10%或1%，混合检测法可节省30%至75%的HBsAg检测成本。
混合HBsAg EIA检测效果不低于单独EIA检测，在高、中、低流行地区都是一种具有成本效益且有效的策略。
