The use of the OraSure collection device for hepatitis virus testing in health care settings.

Oral mucosal transudate (OMT) has levels of IgG and IgA that, although lower than in serum, are of the same specificity as serum. Blood can be a difficult sample to take especially from persons with an aversion to the process or with poor veins. There is also a small exposure risk to the phlebotomist. OMT has been shown to be useful in screening for a range of bloodborne viruses, however, the ELISA assays need to be modified, usually by increasing test volumes and incubation times and/or by modifying the substrate. A number of commercial serum kits have been modified successfully in this way. The major roles for these assays are for epidemiology or for screening high risk populations. If used for screening, it is imperative that any positive is confirmed by a serum test. The use of OMT samples using the OraSure(R) collection device, which is FDA approved and with which we have the most experience, has increased in recent years in community health care settings, with positive feedback from users.