Drug & Device Development

Some rapid hep B screening tests highly accurate

Last Updated: 2012-06-07 13:35:28 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Antigen-based point-of-care tests for hepatitis B infection are generally very accurate, but the sensitivity of antibody-based tests needs to be improved, according to the results of a meta-analysis of global data.

In particular, Determine (Alere; Waltham, Massachusetts) and Binax NOW (Binax; Portland, Maine) had high sensitivity and specificity, the researchers found.

"The result of this meta-analysis suggests that these tests could be potentially used in first-line screening initiatives for marginalized populations, and for resource limited settings," they reported in the American Journal of Gastroenterology online May 29.

Dr. Nitika Pant Pai, at McGill University Health Center in Montreal, Quebec, Canada, and colleagues point out that HBV infections are concentrated in populations that are hard to reach, often with limited health resources. Point-of-care (POC) tests offer a rapid and cheap screening option, but their diagnostic accuracy needs to be confirmed.

By pooling data from 17 studies, the research team determined the accuracy of three types of tests, based on the component detected: hepatitis B surface antigen (HBsAg), anti-HBsAg, and HBsAg plus hepatitis B e antigen (HBeAg).

In the HBsAg group, the popular Determine test had sufficient data to be analyzed separately and showed a sensitivity of 98.2% and specificity of 99.9%. Data on the other 20 tests in this category were combined and produced a pooled sensitivity and specificity of 94.8% and 99.5%.

The four tests that measured anti-HBsAg had a combined sensitivity and specificity of 93.2% and 93.1%, the authors report. "The accuracy of antibody-based tests requires refinement," they advise.

The Binax test, the only one that measured both HBsAg and HBeAg, showed a sensitivity of 95.5% and specificity of 99.8%

"The high accuracy of tests such as Determine and Binax is very encouraging," Dr. Pant Pai and colleagues conclude. "Although not yet approved in North America, these tests could safely be approved and integrated for public health screening of at-risk populations."

SOURCE: http://bit.ly/LAT2sh

Am J Gastroenterol 2012