Saliva Test Developed to Detect Presence of Hepatitis C
Epitope of Beaverton, OR, and LabOne of Lenexa, KS, hope to obtain approval from the U.S. Food and Drug Administration for the product by next summer. Both companies hope to encourage screening for the hepatitis C virus by eliminating the discomfort associated with blood tests.
The test will be sold to public health institutions including hospitals, clinics and community health centers. It also will be made available to drug rehabilitation programs and AIDS treatment centers that serve clients with an elevated risk of contracting the hepatitis C virus.
The oral screening test identifies the presence of antibodies to the hepatitis C virus rather than the virus itself. Because antibodies take time to develop, there can be a six-month "window" between infection and positive test results with either type of screening.
The new test will feature Epitope's OraSure oral fluid collection device, which is already used in tests for HIV and drugs of abuse. A flat cotton swab attached to a short tube is held between the gum and cheek for about four minutes, and then is placed in a preservative-filled test-tube for delivery to the lab. The new method helps eliminate the danger of health care workers picking up the virus through needlestick injuries, the firms note.
Along with the saliva collection equipment, each kit will include instructions for use, a return air-express mailer and a patient identification form. Negative test results will be available to health care institutions in about 24 hours, while positive results will take about 72 hours.
According to the National Institutes of Allergies and Infectious Disease, about four million people carry the hepatitis C virus in the U.S. and about 120 million people are infected worldwide.
Edited by Chris Smith
Source: E-Dental.com, sister website to Medical Design Online.