OraQuick ADVANCE HIV-1 User manual

Step 1. Collect Sample
Oral Fluid
Swab lower and upper gum once.
DO NOT swab the roof of the mouth, cheeks or tongue.
Fingerstick Whole Blood
Cleanse finger. Air dry. Wipe away first drop of blood.
Puncture with lancet. Fill the Collection Loop.
Venous Whole Blood
Validated for EDTA, sodium heparin and sodium citrate
Collect blood using standard Immediately insert the Loop into
phlebotomy procedures. Fill the collection Loop. the Developer Solution. Mix.
Plasma
Validated for EDTA
Collect blood using standard
phlebotomy procedures. Fill the Collection Loop.
• Whole blood may be stored
at 2-30˚C (35-86˚F) for up to
5 days.
• Invert the tube several times
to mix.
• Centrifuge at 1000-1300 x g for
approximately 5 minutes.
• Plasma may be stored up to
7 days at 2-8˚C (35-46˚F).
• Whole blood may be stored
at 2-30˚C (35-86˚F) for up
to 5 days.
Go to Step 2
Go to Step 2
Refer to the Package Insert for
complete instructions.
Advance Awareness™

Step 2. Perform the Test
Insert device into buffer. Start the timer. Pink fluid travels through the Result Window.
Step 3. Read Results between 20 and 40 minutes
Non-reactive: Line in C Zone Invalid: Repeat Test
Line in C Zone CDC recommendations for No Line in Red background Lines are outside of
No HIV antibodies detected. reporting HIV negative results:1C Zone obscures results C or T Zones
Reactive: Lines in C and T Zones. Report as preliminary positive. Order Western blot to confirm.
Examples of preliminary positive results. Line in C Zone in each test. CDC recommendations1
Line in T Zone. Line in T Zone. Faint line in T Zone reporting HIV positive results:
Performance Characteristics2
Multiple clinical studies were conducted to determine sensitivity and specificity of the OraQuick ADVANCE ®HIV-1/2 Test. Confirmation was
performed by a licensed Western blot, with confirmation of indeterminate results by IFA or radioimmunoprecipitation assay (RIPA).
Sensitivity Specificity
Total OraQuick®True OraQuick®Total OraQuick®True OraQuick®
Specimen Samples Reactive Positive Sensitivity 95% CI Samples Non-reactive Negative Specificity 95% CI
Oral Fluid 3917 834 840 99.3% 98.4-99.7% 3755 3674 3682 99.8% 99.6-99.9%
Fingerstick 1146 536 538 99.6% 98.5-99.9% 1875 1856 1856 100.0% 99.7-100%
Plasma 1424 901 905 99.6% 98.9-99.8% 1636 1620 1622 99.9% 99.6-99.9%
Order Description Reimbursement CPT Code
Information Box of 25 tests Information 86703-92
Box of 100 tests
Controls
• Do NOT remove the device from
the Developer Solution while
the test is running.
• HIV-negative test results may be
conveyed without direct personal
contact between the patient and the
health-care provider.
• Persons known to be at high risk
for HIV infection also should be
advised of the need for periodic
retesting and should be offered
prevention counseling or referred
for prevention counseling.
• HIV positive test results should be communicated confidentially
through person contact by a clinician, nurse, mid-level practitioner,
counselor, or other skilled staff.
• Active efforts are essential to ensure that HIV-infected patients
receive their positive test results and linkage to clinical care,
counseling, support and prevention services.
• If the necessary expertise is not available in the health-care venue
in which screening is performed, arrangements should be made to
obtain necessary services from another provider, local health
department, or community-based organization.
220 East First Street
Bethlehem, PA 18015 USA
phone: 800.ORASURE
web: www.OraSure.com
Made in the USA
1Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, September 22, 2006/Vol. 55/No. RR-14.
2OraQuick ADVANCE®Rapid HIV-1/2 Antibody Test Package Insert.
Please refer to the package insert for complete information and instructions on the proper use of the OraQuick ADVANCE® Rapid HIV-1/2 Antibody test. ©2009 OraSure
Technologies, Inc. U.S. Patent #7,192,555 and various international and U.S. patents pending. OraQuick® and OraQuick ADVANCE® are registered trademarks of OraSure Technologies, Inc.
Item# OQA0194 12/08
Advance Awareness™