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INTENDED
USE: BACKGROUND
Hepatitis C (HepC or HCV) is a viral infection
which causes inflammation and cell deterioration in the liver. Hepatitis C is a
blood borne infection, and may result from exposure to blood or body fluids that
contain the hepatitis C virus. Consequently, exposure and method of infection is
similar to that of the HIV virus. Approximately 4.1 million Americans are
infected with hepatitis C. Currently, Hepatitis C is responsible for an
estimated 9,000-10,000 deaths annually resulting from chronic liver failure.
Hepatitis C is the leading cause for liver transplant and the 10th leading cause
of death in the U.S. Comparatively, hepatitis C is five times more prevalent
than HIV. According to the National Institute of Health, the highest rates of
HCV infection are found among injection drug users and hemophilia patients
(60%-90%); moderate rates among hemodialysis patients (20%); and lower rates
among persons with numerous sexual partners (>50). Hepatitis C infection affects
persons of all ages, but highest prevalence is among middle-age adults. The
immune system of infected individuals is seldom able to clear the virus
completely. Over 70% of Hepatitis C cases become chronic, meaning liver enzyme
levels remain elevated for at least six months after infection. The enzymes
alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are released
when liver cells are injured or die. Elevated ALT and AST levels may appear and
disappear throughout the course of the infection. TEST COMPONENTS PROVIDED
TEST PROCEDURE The complete test procedure is accomplished in a few easy steps using the materials provided in the kit package. Prior to testing, a special toll free number is called to activate the 14 digit test code and to obtain anonymous access to professional counselors to insure the entire test process is understood. Using the spring loaded lancet device, the finger is pricked and two drops of blood are deposited on a specially treated test card. The sample test card is then sealed and placed in the self addressed postage prepaid mailer. In approximately 10 business days, the special access toll free number is called for test results. Using only the assigned 14 digit code PIN number, the caller is given the test results and if necessary, has the option to receive professional post-test counseling and medical referrals.
The Home Access® Hepatitis C Screening Test is FDA approved and available for home or professional use in the following standard sales units. Each test kit is all inclusive and individually boxed with all the components required to perform one whole blood Hepatitis C screen. There are no additional costs beyond the kit purchase price and all laboratory processing fees and mailing costs are prepaid and included. Professional and reseller volume discounts may apply to quantity purchases above the sale units listed. Contact Customer Service for volume quotations.
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