Product Manual

MATERIALS REQUIRED BUT NOT PROVIDED
Timer or watch capable of timing 20 to 40 minutes
Clean, disposable, absorbent workspace cover
B
iohazard waste container
A
dditional items required for fingerstick and venipuncture whole blood collection, and plasma specimens:
Antiseptic wipe
Sterile lancet to obtain a fingerstick whole blood specimen, or materials required to obtain a venipuncture whole blood specimen
S
terile gauze pads
L
atex, vinyl or nitrile disposable gloves (optional for oral fluid testing)
Centrifuge to process a plasma specimen
WARNINGS
For in vitro Diagnostic Use
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. Read the package insert completely before using the product. Follow the instructions carefully. Not doing so
may result in inaccurate test results.
2
. Before performing testing, all operators MUST read and become familiar with Universal Precautions for
Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and other Blood-borne
Pathogens in Health-Care Settings.
5,9
3. FDA has approved this kit for use with oral fluid, fingerstick whole blood, venipuncture whole blood, and
plasma specimens only. Use of this test kit with specimen types other than those specifically approved for use
with this device may result in inaccurate test results.
4. This test should be performed at temperatures in the range of (15°- 37°C, 59°- 99°F). If stored refrigerated, ensure
that the Divided Pouch is brought to operating temperature (15°- 37°C, 59°- 99°F) before performing testing.
5. If the test kit is stored at temperatures outside of ambient temperature (2°- 27°C, 36°- 80°F), or used outside
of the operating temperature (15°- 37°C, 59°- 99°F), use the Kit Controls to ensure performance of the test.
6. Individuals infected with HIV-1 and/or HIV-2 who are receiving highly active antiretroviral therapy (HAART)
may produce false negative results.
7. Individuals undergoing preventive treatment for HIV may produce false negative results.
PRECAUTIONS
Safety Precautions
1. Handle blood specimens and materials contacting blood specimens as if capable of transmitting infectious agents.
2. Do not drink, eat, or smoke in areas where specimens are being handled or testing is being performed.
3. Wear disposable gloves while handling blood specimens and performing testing of blood specimens. Change gloves and wash
hands thoroughly after performing each test. Dispose of used gloves in a biohazard waste container.
4. Oral fluid is not considered potentially infectious unless it contains blood.
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Use of gloves for oral fluid testing is optional. Test
administrators with breaks in the skin (cuts, abrasions, or dermatitis) should wear gloves when performing oral fluid testing.
Wash hands thoroughly after performing each oral fluid test and after contact with oral fluid.
5. Dispose of all test specimens and materials used in the test procedure in a biohazard waste container. Lancets and venipuncture
materials should be placed in a puncture-resistant container prior to disposal. The recommended method of disposal of biohazard
waste is autoclaving for a minimum of 1 hour at 121°C. Disposable materials may be incinerated. Liquid wastes may be mixed
with appropriate chemical disinfectants. A freshly prepared solution of 10% bleach (0.5% solution of sodium hypochlorite) is
recommended. Allow 60 minutes for effective decontamination. NOTE: Do not autoclave solutions that contain bleach.
6. Wipe all spills thoroughly with a solution of 10% bleach or other appropriate disinfectant
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. Bleach solutions should be made
fresh each day.
7. For additional information on biosafety, refer to “Universal Precautions for Prevention of Transmission of Human
Immunodeficiency Virus, Hepatitis B Virus, and other Blood-borne Pathogens in Health-Care Settings”
5,9
and “Updated U.S.
Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations
for Postexposure Prophylaxis”.
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Handling Precautions
1. Use all Specimen Collection Loops, Test Devices, and Developer Solution Vials only once and dispose of properly (see Safety
Precautions). Do not reuse any of these test components.
2. Do not use the test beyond the expiration date printed on the Divided Pouch. Always check expiration date prior to testing.
3. Do not interchange Test Devices and Developer Solution Vials from kits with different lot numbers.
4. Avoid microbial contamination and exercise care in handling the kit components.
5. To ensure accurate results, the Test Device must be inserted into the Developer Solution Vial within 60 minutes after introducing
the fingerstick whole blood, venipuncture whole blood or plasma sample.
6. When collecting oral fluid specimens the Test Device must be inserted into the Developer Solution Vial within 30 minutes of
collection. A Test Device containing an oral fluid specimen that is not inserted into the Developer Solution Vial within 10 minutes
of collection should be either stored on a flat surface or returned to the Divided Pouch after the desiccant has been removed from
the Divided Pouch. For a 10-30 minute delay in insertion, return the Test Device containing the oral fluid specimen to the Divided
Pouch after the desiccant has been removed from the Divided Pouch. Ensure that the Divided Pouch containing the Test Device
is kept in a horizontal position until the Test Device is inserted into the Developer Solution Vial.
7. Adequate lighting is required to read a test result.
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