OraQuick ADVANCE HIV-1/2 Step-By-Step Instructions Download Page 8

Re

ading T

est Result

Test is 

I

NV

ALID

if:

NO

reddish-purpl

e line appe

ar

s ne

xt t

o the tri

angl

e l

abel

ed “

C

” 

(

see Dia

gram a and b

), or

A r

ed ba

ckgr

ound in the Results Windo

w mak

es it difficult t

o r

e

ad the

result 

af

ter 20 minut

es

(

Dia

gram c

), or

If any of the lines 

ar

e

NO

T

inside the “

C

” or “

T

” tri

angl

e ar

e

as 

(

see Dia

gram d1 and d2 

).

An 

Inv

a

lid

test r

esult me

ans tha

t ther

e w

as a pr

obl

em running the t

est, either

rel

at

ed t

o the specimen or t

o the De

vic

e. 

An Inv

a

lid r

esult 

c

anno

t be

int

erpr

et

ed

.

Repe

at the t

est with a ne

w P

ouch and a ne

w or

al f

luid,

fing

er

stick or v

enipunc

tur

e whol

e bl

ood, or pl

asma s

ampl

e. C

ont

ac

Or

aSur

e T

echnol

ogies

’ Cust

omer Servic

e if y

ou ar

e unabl

e t

o g

et a v

alid t

est

result upon r

epe

at t

esting

.

Test is 

R

EACTIVE

if:

A r

eddish-purpl

e line appe

ar

s ne

xt t

o the tri

angl

e l

abel

ed “

C

and

a r

eddish-purpl

e line appe

ar

s ne

xt t

o the tri

angl

e l

abel

ed

“T

”. One of thes

e lines ma

y be dark

er than the o

ther

.

NO

TE:

The t

est is

Re

a

c

tiv

e

if 

any

reddish-purpl

e line appe

ar

s

ne

xt t

o the “

T

” tri

angl

e

and

ne

xt t

o the “

C

” tri

angl

e, no ma

tt

er

ho

w f

aint thes

e lines ar

e.

Re

a

c

tiv

e

test r

esult me

ans tha

t HIV

-1 or HIV

-2 antibodies 

ha

ve been

det

ec

ted

in the specimen. The t

est r

esult is 

int

erpr

et

ed as

PRELIMINAR

Y PO

SITIVE f

or HIV

-1  and/

or HIV

-2

antibodies

. F

ol

lo

w CDC Guidelines t

o inf

orm the t

est subjec

t of

the t

est r

esult and its int

erpr

et

ation.

Test is 

N

ON

-R

EACTIVE

if: 

A r

eddish-purpl

e line appe

ar

s ne

xt t

o

the tri

angl

e l

abel

ed “

C

” 

and

NO

line appe

ar

s ne

xt t

o the tri

angl

e

label

ed “

T

”.

A

Non-Re

a

c

tiv

e

test r

esult me

ans

tha

t HIV

-1 and  HIV

-2  antibodies 

w

er

e

no

t det

ec

ted

in the specimen. The

test r

esult is 

int

erpr

et

ed as

NEGA

TIVE f

or HIV

-1 and HIV

-

2 antibodies

. F

ol

lo

w CDC

Guidelines t

o inf

orm the t

est subjec

t

of the t

est r

esult and its

int

erpr

et

ation.

ADEQUA

TE 

LIGHTING 

REQUIRED

a

b

c

d1

OR

d2

Bethl

ehem, P

A 18015 USA • Ph. 800-ORASURE (800-6

7

2-

7

8

7

3

) • F

ax 6

10.88

2

.35

7

2 • www

.or

asur

e.c

om

L3001-1216 (r

ev

. 10/05)

©2001, 2005 OraSur

e T

echnologies, Inc. 

U.S. Patent # 6,303,081 and various inter

national and U.S. patents pending

OraQuick® is a r

egister

ed trademark of OraSur

e T

echnologies, Inc.

Non-Re

ac

tiv

e

Re

ac

tiv

e

Inv

alid

Int

erpr

et

ation of

Test Result

Re

ad r

esults af

ter 20 minut

es but no

t mor

e than 40 minut

es.

Look a

t the Result Windo

w of the T

est De

vic

e

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

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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