Our study emphasizes the need to develop health policies that can cope with the foreseeable increases in the problems associated with HCV infection in the near future.
The prevalence of CD in Northern Spain is 2.6/1000 (1:389). One-step serologic screening (AEA) is both more economical and more sensitive than the two-step procedure (first AGA and then AEA if AGA is positive).
Objectives: 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).Material and methods: 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.Results: 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.Conclusions: 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.
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