OraQuick ADVANCE HIV-1/2 Step-By-Step Instructions Download Page 4

S

TEP

1 – COLLECT 

Have the person being tested remove the Device from its Pouch. 

DO NOT allow the person to touch the Flat Pad (

see picture A1

).

Check to make sure that an Absorbent Packet is included with the Device 

(

see picture A2

). If no Absorbent Packet is present, discard the Device and

obtain a new Pouch for testing.

Direct the person to place the Flat Pad above the teeth against the outer gum.

Direct the person to gently swab completely around the outer gums, both

upper and lower, one time around, using the Flat Pad (

see picture A3 

and A4

). 

DO NOT

allow the person to swab the roof of the mouth, the inside

of the cheek or the tongue. NOTE: Both sides of the Flat Pad may be used

during this procedure.

S

TEP

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 will appear and travel up the Result

Window. The pink fluid will gradually disappear as the test develops 

(

see picture A8

).

Read the results after 20 minutes but not more than  40 minutes in a fully

lighted area.

Refer to the 

Reading Test Result and Interpretation of Test Result

sections on

the back of these instructions.

ORAL FLUID – Specimen Collection and Testing Procedure

A2

A1

Flat

Pad

Absorbent

Packet

A3

A4

A5

A6

A7

A8

OQA Eng_SPA_StepbyStep-10-05  10/31/05  4:16 PM  Page 5

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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