hepatitis b surface antigen detection using pooled sera: a cost-benefit analysis detección de hbsag usando mezcla de sueros: estudio coste-beneficio

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ID: 243774
2006
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Abstract
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.
Objetivos: examinar la fiabilidad y realizar un estudio coste beneficio de una estrategia de mezcla de 5 muestras usando un enzimainmunoanálisis (EIA) para el cribado del HBsAg. Material y métodos: para evaluar la sensibilidad y especificidad del método de mezcla de sueros se determinaron 40 sueros HBsAg positivos (de débil a intensamente positivos) y 250 sueros HBsAg negativos en mezcla con 4 sueros HBsAg negativos. El límite de detección para el HBsAg/ad y HBsAg/ay se evaluó usando suero de un panel de subtipos purificados. Se llevó a cabo un estudio en condiciones reales usando mezcla de sueros de 314 mujeres gestantes. Resultados: la sensibilidad y especificidad de esta técnica fue del 100%. El coeficiente de correlación entre los ratios muestra / punto de corte de las 40 muestras estudiadas en determinación simple y en mezcla fue 0,792 (p < 0,005). El método de mezcla de sueros detectó niveles más bajos de HBsAg/ad y HBsAg/ay (0,20 ng/mL y 0,12 ng/mL) que el método simple (0,34 ng/mL y 0,29 ng/mL, respectivamente). Un análisis coste-beneficio mostró que el método de mezcla puede ahorrar de un 30 a un 75% de el coste de la determinación de HBsAg para seroprevalencias de un 10 y 1%, respectivamente. Conclusiones: el método de determinación de HBsAg en mezcla de sueros no muestra peor rendimiento diagnóstico que el método simple y es una estrategia coste efectiva válida en áreas de baja prevalencia.
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Journal chemistry of heterocyclic compounds
Year 2006
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