Product Manual

ManualsBrandsOraSure ManualsHCV TestOraquick HCV Rapid Antibody Test Kit

Step-by-Step Instructions

For OraQuick

HCV Rapid Antibody Test

Complexity: WAIVED for fingerstick whole

blood and venipuncture whole blood.

• These instructions are only a Reference Guide.

For complete information including Restrictions,

Precautions, and Limitations of the Test, refer to the

OraQuick

HCV Rapid Antibody Test Package Insert.

• Read these instructions completely before using

the product. Follow the instructions carefully when

performing testing. Not doing so may result in

inaccurate test results.

• Before performing testing, all operators MUST read

and become familiar with Universal Precautions for

Prevention of Transmission of Human Immunodeficiency

Virus, Hepatitis A Virus, Hepatitis B Virus, and other

Bloodborne Pathogens in Health-Care Settings.

1,2

Accurate – Rapid Result – Easy to Use

A Certificate of CLIA Waiver is required to perform the test in a waived

setting. Additional CLIA waiver information is available at the Centers for

Medicare and Medicaid website at www.cms.hhs.gov/CLIA or from your

state health department.

Failure to follow the instructions, or modifications to the Test instructions,

will result in the Test no longer meeting the requirement for Waived

Classification and will be subject to all applicable CLIA requirements.

Item#3001-1529-70 rev. 11/11

OQ HCV Step-by-Step, US

3001-1529 Step-by-Step HCV U.S._Layout 1 12/7/11 4:00 PM Page 2

Summary of content (8 pages)

PAGE 1
3001-1529 Step-by-Step HCV U.S._Layout 1 12/7/11 4:00 PM Page 2 Step-by-Step Instructions For OraQuick® HCV Rapid Antibody Test Complexity: WAIVED for fingerstick whole blood and venipuncture whole blood. A Certificate of CLIA Waiver is required to perform the test in a waived setting. Additional CLIA waiver information is available at the Centers for Medicare and Medicaid website at www.cms.hhs.gov/CLIA or from your state health department.
PAGE 2
3001-1529 Step-by-Step HCV U.S._Layout 1 12/7/11 4:00 PM Page 3 INTENDED USE: Developer Solution Vial Reusable Test Stand The OraQuick® HCV Rapid Antibody Tests is a single-use Specimen Collection Loop immunoassay for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in fingerstick whole blood specimens and venipuncture whole blood specimens Result Window (EDTA, sodium heparin, lithium heparin, and sodium citrate) from individuals 15 years or older.
PAGE 3
001-1529 Step-by-Step HCV U.S._Layout 1 12/7/11 4:00 PM Page 4 FOR IN VITRO DIAGNOSTIC USE THE FOLLOWING ITEMS ARE NEED TO DO THE TEST: The OraQuick® HCV Rapid Antibody Test Consists of a Divided Pouch Containing the Following: • Single-Use Test Device (including an absorbent packet) • Developer Solution Vial (containing .750 mL) NOTE: The pouch is divided into two chambers. One chamber holds the Test Device while the other chamber holds the Developer Solution Vial.
PAGE 4
3001-1529 Step-by-Step HCV U.S._Layout 1 12/7/11 4:01 PM Page 5 SET UP YOUR WORKSPACE • Gather the materials you will need. • Allow the test kit to come to operating temperature (15°–37°C; 59°–99°F) before use. • Refer to the External Quality Control section above to determine when the Kit Controls should be run. • Set an OraQuick® HCV Reusable Test Stand (“Stand”) on your workspace. Use only the Stand provided. • Disposable gloves are needed when performing the test.
PAGE 5
3001-1529 Step-by-Step HCV U.S._Layout 1 12/7/11 4:01 PM Page 6 SPECIMEN COLLECTION PROCEDURE – FINGERSTICK WHOLE BLOOD B2 B1 Step 1A – COLLECT Handle • Using an antiseptic wipe, clean the finger of the person being tested. Allow the finger to air dry. • Using a sterile lancet, puncture the skin just off the center of the finger pad. B3 B4 • Hold the finger downward. Apply gentle pressure beside the point of the puncture. Avoid squeezing the finger to make it bleed (see picture B1).
PAGE 6
3001-1529 Step-by-Step HCV U.S._Layout 1 12/7/11 4:01 PM Page 7 TESTING PROCEDURE B8 Step 2 – MIX B9 • Immediately insert the blood-filled end of the Loop all the way into the Vial (see picture B8). • Use the Loop to stir the blood sample in the Developer Solution (“Solution”) (see picture B9). • Remove the used Loop from the Solution. Throw the used Loop away in a biohazard waste container. B10 B11 B12 B13 Flat Pad • Check the Solution to make sure that it appears pink.
PAGE 7
3001-1529 Step-by-Step HCV U.S._Layout 1 12/7/11 4:01 PM Page 8 TEST RESULT AND INTERPRETATION – Refer to the Result Window on the Test Device CAUTION: Adequate lighting required. Color blindness may affect the ability to interpret Test results. REACTIVE: Lines in C and T Zones Test is Reactive if: • A line appears in the C Zone and a line appears in the T Zone. Lines may vary in intensity. Two lines must be present for a “reactive” result.
PAGE 8
3001-1529 Step-by-Step HCV U.S._Layout 1 12/7/11 4:00 PM Page 1 GENERAL TEST CLEAN UP • Dispose of the used test materials in a biohazard waste container. • Change your gloves between each test to prevent contamination. Throw away the used gloves in a biohazard waste container. • Use a freshly prepared 10% solution of bleach to clean up any spills.