OraQuick ADVANCE HIV-1/2 User manual

ADVANCE

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

THE FOLLOWING ITEMS ARE NEEDED TO DO THE TEST:

THE ORAQUICK®ADVANCE™RAPID HIV-1/2 ANTIBODYTEST CONSISTS OF ADIVIDED POUCH CONTAINING THE FOLLOWING:

•Test Device (including an absorbent packet) •Developer Solution Vial (containing 1 mL)

NOTE: The pouch is divided into two chambers. One chamber holds the Test Device while the other

chamber holds the Developer Solution Vial.

MATERIALS PROVIDED IN THE MASTER SHIPPING CARTON:

•Reusable Test Stand •Specimen Collection Loop ( 5 microliter)

•Subject Information Pamphlet •Package Insert

•Customer Letter

MATERIALS REQUIRED BUT NOT PROVIDED:

•Timer or Watch capable of timing 20 to 40 minutes •Biohazard Waste Container

•Clean, Disposable, Absorbent Workspace Cover

Additional items required for fingerstick and venipuncture whole blood collection, and plasma specimens:

•Antiseptic Wipe •Latex, Vinyl or Nitrile Disposable Gloves (Optional for Oral Fluid Testing)

•Sterile Lancet to Obtain a Fingerstick Whole Blood •Sterile Gauze Pads

Specimen, or Materials Required to Obtain a •Centrifuge to process a plasma specimen

Venipuncture Whole Blood Specimen

INTENDED USE:

The OraQuick® 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 answers to questions regarding the OraQuick® ADVANCE™Rapid HIV-1/2 Antibody Test

or for more information on other OraSure Technologies’ products, call:

1-800-ORASURE (800-672-7873) or visit our web site:www.orasure.com

NOTE: Handle all blood specimens and materials contacting specimens as if capable of transmitting infectious agents. Dispose of all test specimens and materials

used in the test procedure in a biohazard waste container.1Oral fluid is not considered potentially infectious unless it contains blood.2

1See “Universal Precautions,”CDC, MMWR, 1988; 37(24):377-388. 2CDC, MMWR, 2001: 50(RR-11):1-42.

Developer

Solution

Vial

Reusable

Test Stand

Flat

Pad

Test

Device

Specimen

Collection

Loop

Absorbent

Packet

Result

Window

Developer

Solution

Vial

Reusable

Test Stand

Flat

Pad

Test

Device

Specimen

Collection

Loop

Absorbent

Packet

Result

Window

OQA Eng_SPA_StepbyStep-10-05 10/31/05 4:16 PM Page 3

NOTE: DO NOT cover the

two holes in the back of the

Device with labels or other

materials. Doing so may cause

an Invalid result.

Set Up Your Work Space

General Test Preparation

Two Chambers

•Gather the materials you will need.

•Allow the test kit to come to operating temperature (15˚– 37˚C; 59˚– 99˚F) before use.

•Refer to the External Quality Control section above to determine when the Kit Controls should be run.

•Cover your workspace with a clean, disposable, absorbent workspace cover.

•Set an OraQuick® ADVANCE™Reusable Test Stand (“Stand”) up on your workspace cover. Use only the Stand provided.

•Put on your disposable gloves if you are planning to perform the test using a blood specimen. Use of gloves is optional for oral fluid testing.

External Quality Control

OraQuick® ADVANCE™Rapid HIV-1/2 Antibody Test Kit Controls are available separately for use only with the OraQuick® ADVANCE™

Rapid HIV-1/2 Antibody Test. The Kit Controls are specifically formulated and manufactured to ensure performance of the Test, and are

used to verify your ability to properly perform the test and interpret the results. Refer to the Kit Control Package 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 periodic intervals as dictated by the user facility.

Prior to testing, provide the “Subject Information” pamphlet

to the person being tested.

•Open the two chambers of the OraQuick® ADVANCE™Divided Pouch

(“Pouch”) by tearing at the notches on the top of each side of the Pouch

(see picture a and b ).

•To prevent contamination, leave the Test Device (“Device”) in the Pouch until

you are ready to use it.

•Remove the Developer Solution Vial (“Vial”) from the Pouch.

•Hold the Vial firmly in your hand.

•Carefully remove the cap from the Vial by gently rocking the cap back and

forth while pulling it off.

•Set the cap on your workspace cover.

•Slide the Vial into the top of one of the slots in the Stand (see picture c ).

•DO NOTforce the Vial into the stand from the front of the slot as splashing

may occur.

•Make sure the Vial is pushed all the way to the bottom of the slot in the stand

(see picture c ).

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

STEP 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.

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 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

A2A1 Flat

Pad Absorbent

Packet

A3 A4

A5 A6

A7 A8

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

STEP 1 – COLLECT

•

Using an antiseptic wipe, clean the finger of the person being tested. Allow the finger

to dry thoroughly or wipe dry with a sterile gauze pad.

•

Using a sterile lancet, puncture the skin just off the center of the finger pad.

•

Hold the finger downward. Apply gentle pressure beside the point of the puncture.

Avoid squeezing the finger to make it bleed (see picture B1 ).

•

Wipe away this first drop of blood with a sterile gauze pad. Allow a new drop of blood

to form.

•

Pick up an unused Specimen Collection Loop (“Loop”) by the thick “handle” end

(see picture B2 ).

•

Put the “rounded” end of the Loop on the drop of blood (see picture B3 ).

Make sure that the Loop is completely filled with blood (see picture B4 ).

STEP 2 – MIX

•

Immediately insert the blood-filled end of the Loop all the way into the Vial

(see picture B5 ).

•

Use the Loop to stir the blood sample in the Developer Solution (“Solution”)

(see picture B6 ).

•

Remove the used Loop from the Solution. Throw the used Loop away in a biohazard

waste container.

•

Check the Solution to make sure that it appears pink. This means that the blood was

correctly mixed into the Solution (see picture B7 ). If the Solution is not pink, discard

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 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 Vial containing the blood sample

(see picture B10 ). 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 B11 ).

•

Start timing the test (see picture B12 ). DO NOTremove 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 B13 ).

•

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.

FINGERSTICK - WHOLE BLOOD – Specimen Collection and Testing Procedure

B3 B4

Handle

NOTE: If the Loop is dropped or comes in contact with any

other surface, discard it in a biohazard waste container. Get a

new Loop for the collection of the blood sample.

B6 B7

B9B8

B11B10

B13B12

Flat

Pad Absorbent

Packet

OQA Eng_SPA_StepbyStep-10-05 10/31/05 4:16 PM Page 6

STEP 1 – COLLECT

•

Using standard venous phlebotomy procedures, collect a whole blood sample using

a tube containing any of the following anticoagulants: EDTA (lavender top), sodium

heparin (green top), or sodium citrate(light blue top). Other anticoagulants have

not been tested and may give an incorrect result. If the specimens are not

tested at the time of collection, the whole blood may be stored at 2

–30

(35

–86

F) for up to 5 days.

•

Prior to testing, mix the blood tube gently by inversion several times to ensure a

homogeneous sample.

•

Pick up an unused Specimen Collection Loop ("Loop") by the thick "handle"

end (see picture C1 ).

•

Put the "rounded" end of the Loop into the tube of blood (see picture C2 ).

Make sure the Loop is completely filled with blood (see picture C3 ).

STEP 2 – MIX

•

Immediately insert the blood-filled end of the Loop all the way into the Vial

(see picture C4 ).

•

Use the Loop to stir the blood sample in the Developer Solution (“Solution”)

(see picture C5 ).

•

Remove the used Loop from the Solution. Throw the used Loop away in a biohazard

waste container.

•

Check the Solution to make sure that it appears pink. This means that the blood was

correctly mixed into the Solution (see picture C6 ). If the Solution is not pink, discard 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 Device all the way into the Vial containing the blood sample

(see picture C9 ). 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 C10 ).

•

Start timing the test (see picture C11 ). 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 C12 ).

•

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.

VENIPUNCTURE - WHOLE BLOOD – Specimen Collection and Testing Procedure

NOTE: If the Loop is dropped or comes in contact with any

other surface, discard it in a biohazard waste container. Get a

new Loop for the collection of the blood sample.

Handle

C5 C6

C8C7

C10C9

Flat

Pad Absorbent

Packet

C12C11

OQA Eng_SPA_StepbyStep-10-05 10/31/05 4:16 PM Page 7

STEP 1 – COLLECT

•

Using standard venous phlebotomy procedures, collect a whole blood sample

using a tube containing EDTA (lavender top) anticoagulant. Other

anticoagulants have not been tested and may give an incorrect result. If

the specimens are not tested at the time of collection, the specimen may be

stored as whole blood for up to 5 days at 2

–30

C (35

–86

F) or as plasma

for up to 7 days at 2

–8

C (35

–46

F).

•

Centrifuge the tube of blood (1000-1300 x g, for approximately 5 minutes, no

refrigeration required) to separate the cells from the plasma.

•

Carefully uncap the tube by gently rocking the stopper towards you so that it vents

away from you.

•

Pick up an unused Specimen Collection Loop (“Loop”) by the thick “handle” end

(see picture D1 ).

•

Put the “rounded end” of the Loop into the tube of plasma (see picture D2 ).

•

Make sure that the Loop is completely filled with plasma (see picture D3 ).

STEP 2 – MIX

•

Immediately insert the plasma-filled end of the Loop all the way into the Vial

(see picture D4 ).

•

Use the Loop to stir the plasma sample in the Developer Solution (“Solution”)

(see picture D5 ).

•

Remove the used Loop from the Solution. Throw the used Loop away in a biohazard

waste container.

STEP 3 – TEST

•

Remove the Device from the Pouch. DO NOT touch the Flat Pad (see picture D6 ).

•

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

(see 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 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 D11 ).

•

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.

D4 D5

D7D6

D9D8

D11D10

Flat

Pad Absorbent

Packet

PLASMA – Specimen Collection and Testing Procedure

D1 Handle

NOTE: If the Loop is dropped or comes in contact with any

other surface, discard it in a biohazard waste container. Get a

new Loop for the collection of the plasma sample.

General Test Clean Up

•

Dispose of the used test materials in a biohazard waste container.

•

When using gloves, change your gloves between each test to prevent contamination. Throw away the used gloves in a biohazard waste container.

•

Use a freshly prepared 10% solution of bleach to clean up any spills.

NOTE: Testing of plasma samples may only be performed by

laboratories certified to perform moderate complexity tests.

OQA Eng_SPA_StepbyStep-10-05 10/31/05 4:16 PM Page 8

Reading Test Result

Test is INVALID if:

•NO reddish-purple line appears next to the triangle labeled “C”

(see Diagram a and b ), or

•A red background in the Results Window makes it difficult to read the

result after 20 minutes (Diagram c ), or

•If any of the lines areNOTinside the “C” or “T” triangle areas

(see Diagram d1 and d2 ).

•

An Invalid test result means that there was a problem running the test, either

related to the specimen or to the Device. An Invalid result cannot be

interpreted.Repeat the test with a new Pouch and a new oral fluid,

fingerstick or venipuncture whole blood, or plasma sample. Contact

OraSure Technologies’ Customer Service if you are unable to get a valid test

result upon repeat testing.

Test is REACTIVE if:

•A reddish-purple line appears next to the triangle labeled “C”

and a reddish-purple line appears next to the triangle labeled

“T”. One of these lines may be darker than the other.

NOTE: The test is Reactiveif any reddish-purple line appears

next to the “T” triangleand next to the “C” triangle, no matter

how faint these lines are.

•

A Reactivetest 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 NON-REACTIVE if:

•

A reddish-purple line appears next to

the triangle labeled “C” and NO

line appears next to the triangle

labeled “T”.

•

ANon-Reactivetest result means

that HIV-1 and HIV-2 antibodies were

not detected in the specimen. The

test result is interpreted as

NEGATIVE for HIV-1 and HIV-

2 antibodies. Follow CDC

Guidelines to inform the test subject

of the test result and its

interpretation.

ADEQUATE

LIGHTING

REQUIRED

abc

Bethlehem, PA 18015 USA • Ph. 800-ORASURE (800-672-7873) • Fax 610.882.3572 • www.orasure.com L3001-1216 (rev. 10/05)

U.S. Patent # 6,303,081 and various international and U.S. patents pending

OraQuick® is a registered trademark of OraSure Technologies, Inc.

Non-ReactiveReactiveInvalid

Interpretation of Test Result

Read results after 20 minutes but not more than 40 minutes.

Look at the Result Window of the Test Device

OQA Eng_SPA_StepbyStep-10-05 10/31/05 4:16 PM Page 1

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