OraQuick Advance Manuale utente

•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.”1,2

Complexity: WAIVED for Oral Fluid,

Fingerstick Whole Blood, and

Venipuncture Whole Blood

Complexity: MODERATE for Plasma

Linking People to Care

Step-by-Step Instructions for

OraQuick ADVANCE®HIV Rapid HIV-1/2 Antibody Test

Simple – Accurate – Versatile

The Rapid HIV-1/2 Antibody Test

3001-1216_0912 OQA SBS EN-ES_OQA SbS 1/4/13 10:01 AM Page 1

THE FOLLOWING ITEMS ARE NEEDED TO DO THE TEST:

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 products from OraSure Technologies,

call 1-800-ORASURE (1-800-672-7873) or visit our website: 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.1

Oral fluid is not considered potentially infectious unless it contains blood.3

Developer

Solution Vial

Reusable

Test Stand

Flat

Pad

Test

Device

Specimen Collection

Loop

Absorbent

Packet

Result

Window

The OraQuick ADVANCE ®Rapid HIV-1/2

Antibody Test Consists of a Divided 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

•Subject Information Pamphlet

•Customer Letter

•Specimen Collection Loop (5 microliter)

•Package Insert

Materials Required But Not Provided:

•Timer or watch capable of timing 20 to 40 minutes

•Clean, disposable, absorbent workspace cover

•Biohazard waste container

Additional Items Required for Fingerstick and

Venipuncture Whole Blood Collection, and

Plasma Specimens:

•Antiseptic wipe

•Sterile lancet to obtain a fingerstick whole blood specimen, or

materials required to obtain a venipuncture whole blood specimen

•Latex, vinyl or nitrile disposable gloves (optional for

oral fluid testing)

•Sterile gauze pads

•Centrifuge to process a plasma specimen

1. See “Universal Precautions,”CDC, MMWR, 1988; 37(24):377-388. 2. “Guideline for Isolation Precautions, ”CDC, HICPAC, 2007; 12-93. 3. CDC, MMWR, 2005; 54 (RR-9): 1-17.

3001-1216_0912 OQA SBS EN-ES_OQA SbS 1/4/13 10:01 AM Page 2

GENERAL TEST PREPARATION

Two Chambers

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 (36°– 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.

SET UP YOUR WORKSPACE

•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.

•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 pictures 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 NOT force 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).

a b

NOTE: DO NOT cover the two holes in the back of the Device

with labels or other materials. Blocking the holes may cause

an Invalid result.

Prior to testing, provide

the “Subject Information”

pamphlet to the person

being tested.

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Step 1 – COLLECT

•Ensure prior to testing that the subject has not had anything to eat or drink,

or has chewed gum for at least 15 minutes. Have the subject wait for at

least 30 minutes prior to testing if they have used any oral care products.

•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 pictures 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

•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

Flat

Pad

Absorbent

Packet

A3 A4

A5 A6

A7 A8

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Step 1 – COLLECT

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

cleansing the skin puncture site, allow the area to air dry, so the antiseptic

action of the alcohol can take effect.

•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 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 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.

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.

FINGERSTICK WHOLE BLOOD – SPECIMEN COLLECTION AND TESTING PROCEDURE

B1 B2

B3 B4

Flat

Pad

Absorbent

Packet

B5 B6

B8 B9

B10 B11

B12 B13

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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°C (36°– 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.

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.

VENIPUNCTURE WHOLE BLOOD – SPECIMEN COLLECTION AND TESTING PROCEDURE

Flat

Pad

Absorbent

Packet

C4 C5

C7 C8

C9 C10

C11 C12

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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 (36°– 86°F) or as

plasma for up to 7 days at 2°– 8°C (36°– 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.

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.

PLASMA – SPECIMEN COLLECTION AND TESTING PROCEDURE

Flat

Pad

Absorbent

Packet

D4 D5

D6 D7

D8 D9

D10 D11

NOTE: Testing of plasma samples may only

be performed by laboratories certified to

perform moderate complexity tests.

GENERAL TEST CLEANUP

•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.

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Test is INVALID if:

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

(see pictures a and b), or

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

after 20 minutes (see picture c), or

•If any of the lines are NOT inside the “C” or “T” triangle areas

(see pictures d1 and d2), or

•Any partial line on one side of the “C” or “T” triangle areas

(see pictures e and f).

Interpretation of Test Result:

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 NON-REACTIVE if:

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

appears next to the triangle labeled “T.”

Interpretation of Test Result:

A Non-Reactive test 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.3

READING TEST RESULT – LOOK AT THE RESULT WINDOW OF THE TEST DEVICE

CAUTION: ADEQUATE LIGHTING REQUIRED.

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

NON-REACTIVE

INVALID

a b c

e f

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 Reactive if a complete reddish-

purple line appears next to the “T” triangle and next to the “C” triangle, no

matter how faint these lines are.

Interpretation of Test Result:

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.

REACTIVE

220 East First Street

Bethlehem, PA 18015

Tel : 1-800-ORASURE

Fax: (610) 882-3572

Web: www.orasure.com

#7,192,555, #7,541,194 and various international and

U.S. patents pending. OraQuick ADVANCE ® is a registered trademark

of OraSure Technologies, Inc. Item #3001-1216 rev. 09/12

3001-1216_0912 OQA SBS EN-ES_OQA SbS 1/4/13 10:01 AM Page 8

•Estas instrucciones son tan sólo una guía de consulta.

Para obtener información completa, consulte el

instructivo de la prueba rápida de detección de

anticuerpos anti VIH-1/2 OraQuick ADVANCE ®.

•Lea estas instrucciones en su totalidad antes de usar el

producto. Siga las instrucciones al pie de la letra al

realizar la prueba. De lo contrario, los resultados de la

prueba podrían ser inexactos.

•Antes de realizar las pruebas, todos los operadores

DEBEN leer y familiarizarse con las “Precauciones

universales para prevenir la transmisión del virus de la

inmunodeficiencia humana, el virus de la hepatitis B y

otros patógenos transmitidos por la sangre en los

entornos de atención de la salud”.1,2

Complejidad de la prueba: EXENTA para fluido

oral, sangre obtenida por pinchazo del dedo

y sangre obtenida por venopunción

Complejidad de la prueba: MODERADA

para plasma

Instrucciones Paso a Paso para

La prueba rápida de detección de anticuerpos

anti VIH-1/2 OraQuick ADVANCE®

Prueba rápida de detección de anticuerpos anti VIH-1/2

Personas vinculadas en

el cuidado de la salud

Simple – Preciso – Versátil

3001-1216_0912 OQA SBS EN-ES_OQA SbS 1/4/13 10:01 AM Page 9

SE REQUIEREN LOS SIGUIENTES ARTÍCULOS PARA HACER LA PRUEBA:

USO PREVISTO:

La prueba rápida de detección de anticuerpos anti VIH-1/2

OraQuick ADVANCE®es un inmunoensayo cualitativo, de un solo

uso, para detectar anticuerpos contra el virus de la

inmunodeficiencia humana tipo 1 (VIH-1) y tipo 2 (VIH-2) en

muestras de fluido oral, sangre obtenida por pinchazo de dedo,

sangre obtenida por venopunción y plasma.

Para usar en diagnóstico in vitro

Este es un dispositivo restringido. Corresponden

restricciones en la venta, distribución y empleo.

Consulte la carta al cliente y el instructivo.

Para obtener respuestas a preguntas sobre la prueba rápida de detección de anticuerpos

anti VIH-1/2 OraQuick ADVANCE ®o para obtener más información sobre otros productos de OraSure Technologies,

llame al 1-800-ORASURE (800-672-7873) o visite nuestro sitio web: www.orasure.com

NOTA: Maneje todas las muestras de sangre y los materiales que entren en contacto con las muestras como si fuesen capaces

de transmitir agentes infecciosos. Elimine todas las muestras de prueba y los materiales utilizados en las pruebas en un

envase para peligros biológicos1. El fluido oral no se considera potencialmente infeccioso a menos que contenga sangre.3

Frasco de solución

reveladora

Soporte para

pruebas reutilizable

Paleta

Dispositivo

para pruebas

Aro para obtención

de muestras

Paquete de

absorbente

Ventanilla de

resultados

La prueba rápida de detección de anticuerpos anti

VIH-1/2 OraQuick ADVANCE ®consiste en una bolsa

dividida que contiene lo siguiente:

•Dispositivo de prueba (incluido un paquete de absorbente)

•Frasco de solución reveladora (contiene 1 ml)

NOTA: La bolsa está dividida en dos. En una división se

encuentra el dispositivo de prueba mientras que en la otra

hay un frasco de solución reveladora.

Materiales proporcionados en la caja de envío:

•Soporte para pruebas reutilizable

•Folleto de información para el paciente

•Carta al cliente

•Aro para obtención de muestras (5 microlitros)

•Instructivo

Materiales necesarios no suministrados:

•Cronómetro o reloj capaz de medir 20 a 40 minutos

•Manto protector limpio, desechable, absorbente sobre el área

de trabajo

•Envase para desechar peligros biológicos

Otros artículos que se requieren para la obtención de

muestras de sangre por pinchazo de dedo, sangre por

venopunción y muestras de plasma:

•Toallita antiséptica

•Lanceta estéril para obtener una muestra de sangre por

pinchazo o los materiales requeridos para obtener la muestra de

plasma una muestra de sangre por venopunción

•Guantes desechables de látex, vinilo o nitrilo (optativos para la

prueba de fluido oral)

•Gasas estériles

•Centrifugadora para procesar

1. Vea “Universal Precautions,”CDC, MMWR, 1988; 37(24):377-388. 2. “Guideline for Isolation Precautions, ”CDC, HICPAC, 2007; 12-93. 3. CDC, MMWR, 2005; 54 (RR-9): 1-17.