Drug & Device Development

Oral fluid assay detects hepatitis B

Last Updated: 2005-08-29 15:45:14 -0400 (Reuters Health)

By David Douglas

NEW YORK (Reuters Health) - The use of oral fluid in combination with a modified version of the commercial ETI-MAK-4-ELISA (DiaSorin; Saluggia) appears to be sensitive enough for use in epidemiological tracking of hepatitis B, Belgian researchers report in the September issue of the Journal of Medical Virology.

Dr. Veronik Hutse of the Scientific Institute of Public Health, Brussels and colleagues note that viral antibodies and antigens are currently detected via serological tests. The use of oral fluids would be much simpler and safer and would allow easy collection of large numbers of samples for epidemiological purposes.

To investigate whether this might be feasible for hepatitis B, the researchers studied 43 paired hepatitis B-positive and 73 hepatitis B-negative oral and serum samples.

Both types of samples were screened using the ETI-MAK-4-ELISA. The main modification introduced to process oral specimens was 16-hour incubation. Other parameters were unchanged.

The researchers note that with a sensitivity of 95% and a specificity of greater than 99.4% the serum test remains the most efficient diagnostic tool. The oral approach yielded a sensitivity of 90.7% and a specificity of 100%.

As Dr. Hutse told Reuters Health, the "oral fluid assay is mainly applicable for epidemiological studies. To use this oral fluid assay as a suitable screening test, further improvement concerning the sensitivity is needed."

However, she added, the "oral fluid assay has already served in Belgium for a prevalence study and it gave good results."

J Med Virol 2005;77:53-56.