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OraQuick ADVANCE HIV-1 - User Manual

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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
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Summary

Step 1. Collect Sample

Oral Fluid Sample Collection

Swab lower and upper gum once. Do not swab roof of mouth, cheeks, or tongue.

Fingerstick Whole Blood Sample Collection

Cleanse finger, puncture with lancet, wipe away first drop, and fill the Collection Loop.

Venous Whole Blood Sample Collection

Collect using standard phlebotomy procedures, store whole blood up to 5 days at 2-30°C.

Plasma Sample Collection

Collect using phlebotomy, centrifuge, and store plasma up to 7 days at 2-8°C.

Step 2. Perform the Test

Step 3. Read Results

Non-reactive Result Interpretation

A single line in the C Zone indicates no HIV antibodies detected. Follow CDC recommendations.

Invalid Result Interpretation

No line in C Zone or obscured results require the test to be repeated.

Reactive Result Interpretation

Lines in both C and T Zones indicate a preliminary positive result. Order Western blot.

Performance Characteristics

Details on sensitivity and specificity studies for Oral Fluid, Fingerstick, and Plasma.

OraQuick ADVANCE HIV-1 Specifications

General IconGeneral
Result Time20 minutes
FDA ApprovedYes
Sample TypeOral fluid, fingerstick whole blood, venipuncture whole blood
Sensitivity99.3%
Specificity99.8%
Storage Temperature2°C to 30°C (36°F to 86°F)
Test TypeRapid diagnostic test
Intended UseDetection of antibodies to HIV-1 in oral fluid, fingerstick whole blood, venipuncture whole blood, or plasma specimens