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A D VA N C E

Rapid HIV-1/2 Antibody Test

STEP-BY-STEP INSTRUCTIONS

FOR

ORAQUICK

®

ADVANCE

RAPID HIV-1/2 ANTIBODY TEST

These instructions are only a Reference Guide. For complete
information, refer to the OraQuick

®

ADVANCE

Rapid HIV-1/2 

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 B Virus, and other 
Blood-borne pathogens in Health-Care Settings.

1

Complexity: WAIVED for Oral Fluid, Fingerstick 
Whole Blood, and Venipuncture Whole Blood
Complexity: MODERATE for Plasma 

OQA Eng_SPA_StepbyStep-10-05  10/31/05  4:16 PM  Page 2

Summary of Contents for ADVANCE HIV-1/2

Page 1: ...uct 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 B Virus and other Blood borne pathogens in Health Care Settings 1 Complexity WAIVED for Oral Fluid Fingerstick Whole ...

Page 2: ...raQuick ADVANCE Rapid HIV 1 2 Antibody Test is a single use qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 HIV 1 and Type 2 HIV 2 in oral fluid fingerstick whole blood venipuncture whole blood and plasma specimens FOR IN VITRO DIAGNOSTIC USE THIS IS A RESTRICTED DEVICE SALES DISTRIBUTION AND USE RESTRICTIONS APPLY SEE CUSTOMER LETTER AND PACKAGE INSERT For answ...

Page 3: ...ackage Insert for complete instructions Run the Kit Controls under the following circumstances Each new operator prior to performing testing on patient specimens When opening a new test kit lot Whenever a new shipment of test kits is received If the temperature of the test kit storage area falls outside of 2 27 C 35 80 F If the temperature of the testing area falls outside of 15 37 C 59 99 F At pe...

Page 4: ...sed during this procedure STEP 2 TEST Instruct the person being tested to insert the Flat Pad of the Device all the way into the Vial see picture A5 Make sure that the Flat Pad touches the bottom of the Vial The Result Window on the Device should be facing towards you see picture A6 Start timing the test see picture A7 DO NOT remove the Device from the Vial while the test is running Pink fluid wil...

Page 5: ...biohazard waste container Start the test over Use a new Pouch and a new blood sample STEP 3 TEST Remove the Device from the Pouch DO NOT touch the Flat Pad see picture B8 Check to make sure that an Absorbent Packet is included with the Device see picture B9 If no Absorbent Packet is present discard the Device and obtain a new Pouch for testing Insert the Flat Pad of the Device all the way into the...

Page 6: ...all the test materials in a biohazard waste container Start the test over Use a new Pouch and a new blood sample STEP 3 TEST Remove the Device from the Pouch DO NOT touch the Flat Pad see picture C7 Check to make sure that an Absorbent Packet is included with the Device see picture C8 If no Absorbent Packet is present discard the Device and obtain a new Pouch for testing Insert the Flat Pad of the...

Page 7: ...picture D7 If no Absorbent Packet is present discard the Device and obtain a new Pouch for testing Insert the Flat Pad of the Device all the way into the Vial containing the blood sample see picture D8 Make sure that the Flat Pad touches the bottom of the Vial The Result Window on the Device should be facing towards you see picture D9 Start timing the test see picture D10 DO NOT remove the Device ...

Page 8: ...these lines are A Reactive test result means that HIV 1 or HIV 2 antibodies have been detected in the specimen The test result is interpreted as PRELIMINARY POSITIVE for HIV 1 and or HIV 2 antibodies Follow CDC Guidelines to inform the test subject of the test result and its interpretation Test is N ON R EACTIVE if A reddish purple line appears next to the triangle labeled C and NO line appears ne...

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