Rapid Antibody Test Strip Diagnoses Chronic Viral Infections

It requires no instrumentation and gives a result in about 20 minutes. The test can be used with oral fluid, blood, serum, or plasma samples.

The OraQuick HCV Rapid Antibody Test is portable, easy to use, and tests for all HCV genotypes. OraSure Technologies Inc (Bethlehem, PA, USA) manufactures the device. The assay utilizes an indirect immunoassay method in a lateral flow device to detect antibodies to HCV. In this device, antigens from the core, NS3 and NS4 regions of the HCV genome are immobilized on a single test line on a nitrocellulose strip and antibodies reactive with these antigens are visualized by colloidal gold labeled with protein-A. Oral fluid samples are collected directly on a collection pad protruding from the device, before placing the device in a vial of pre-measured developer solution that transports the sample into the device and allows it to run. Alternatively, finger stick or venous whole blood, serum, or plasma are collected using a specimen loop and mixed in the developer solution before inserting the device in the vial. Reactive results generate a reddish-purple line at the test zone. A second control line, which detects human immunoglobulin (IgG) ensures that the patient sample has been collected and has migrated beyond the test zone.

HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. HCV is one of the important causes of chronic liver disease in the United States and approximately 75% to 85% of people who become infected with the hepatitis C virus develop chronic infection. The virus can also be transferred from an infected mother to her child. In the United States, 3.2 million are chronically infected with HCV and each year, about 17,000 people are newly infected.

The U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) has approved the device. Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health said, "Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures."

Related Links:
OraSure Technologies Inc.
U.S. Food and Drug Administration