Product Manual

Developer

Solution Vial

Specimen

Collection Loop

Reusable Test

Stand

Result

Window

OraQuick

HCV Test Device

Flat Pad (built-in collection pad)

Absorbent

Packet

INTENDED USE:

The OraQuick

HCV Rapid Antibody Tests is a single-use

immunoassay for the qualitative detection of antibodies

to hepatitis C virus (anti-HCV) in fingerstick whole blood

specimens and venipuncture whole blood specimens

(EDTA, sodium heparin, lithium heparin, and sodium

citrate) from individuals 15 years or older. The OraQuick

HCV Rapid Antibody Test results, in conjunction with other

laboratory results and clinical information, may be used to

provide evidence of infection with HCV (state of infection

or associated disease not determined) in persons with signs

or symptoms of hepatitis and in persons at risk for

hepatitis C infection.

WARNING: This assay has not been FDA approved for use in patient populations without signs, symptoms, or not at risk for

hepatitis C infection.

Not for use in screening whole blood, plasma, or tissue donors. Performance characteristics have not been established for

testing a pediatric population less than 15 years of age or for pregnant women.

NOTE: Handle all blood specimens and materials contacting specimens as if capable of transmitting infectious agents. Dispose of

all test specimens and materials used in the test procedure in a biohazard container.

1 See “Universal Precautions,” CDC, MMWR, 1988; 37(24):377-388. 2 “Guideline for Isolation Precautions,“ CDC, HICPAC, 2007; 12-93.

If you are a new operator, before proceeding you MUST be able to correctly interpret the OraQuick

HCV Visual Reference

Panel prior to using the OraQuick

HCV Rapid Antibody Test.

Failure to read at low intensities can result in the inability to detect specimens near the limit of detection of the OraQuick

HCV Rapid Antibody Test and may result in false negative results.

3001-1529 Step-by-Step HCV U.S._Layout 1 12/7/11 4:00 PM Page 3