Asante HIV-1/2 Oral Fluid Operating instructions

Brand: Asante

Model: HIV-1/2 Oral Fluid

Type: Operating instructions

LN-6027.05

Wait 20 to

45 minutes

HIV-1

1-VIH

12-16 hr

0 : 20

3. Insert the Test Strip into

the liquid in the Sample

Buffer tube with the arrows

pointing down toward the

liquid. Set a timer to 20

minutes, or note the time

on a watch.

4. Wait for a minimum of 20

minutes, to a maximum of

45 minutes, and remove

the Test Strip from the tube

of Sample Buffer.

packet is present, discard the Test Strip and obtain

another Test Strip.

HIV-1

1. Remove the gray cap from

the specimen/Sample

Buffer mixture prepared as

described above and set

aside.

2. Open the foil pouch

containing the Test Strip

and remove the strip. Do

not touch the middle of the

Test Strip where the results

are read. Check to see

that there is a desiccant

packet inside the foil

pouch. If no desiccant

Testing Procedure

Once the oral fluid has been collected and mixed with

the Sample Buffer, the test can be performed on the

diluted specimen.

Invert 3-5

times to mix

6 to 8

Times

5. Place the swab into the

open tube of Sample

Buffer and mix by moving

the swab up and down in

the buffer solution 6 to 8

times.

6. Carefully wring out the

swab head by pressing it

on the inside of the tube

several times, removing as

much liquid from the swab

as possible. Next, remove

the swab and discard.

7. Place the gray cap back on

the Sample Buffer tube,

sealing tightly so that it will

not leak. Invert the tube

3-5 times to thoroughly

mix. The sample is now

ready for testing with the

Test Strip.

1. Remove the cap from the

Sample Buffer tube and set

the tube on a flat work

surface.

2. Have the subject being

tested remove the Oral

Specimen Collection Swab

from the plastic Test Set

pouch by grasping the

handle.

3. The subject should swab

their upper gums along the

gumline, going back and

forth one time.

4. Using the same swab, but

rotating it so that the

opposite surface of the

swab is used, the subject

should now swab their

lower gums along the

gumline, going back and

forth one time.

7. Test Strips and Sample Buffer tubes are matched

to work with each other in each kit. Don’t inter-

change or use Sample Buffer and Test Strips with

a different lot of kits.

8. Avoid handling kit components to avoid microbial

contamination. In particular, avoid handling the

swab end of the Oral Specimen Collection Swab or

handling the read area (i.e. membrane) of the Test

Strip.

9. Perform the test and read the results using

adequate lighting to ensure accurate results.

10. If a second oral specimen is to be collected from a

subject, wait at least 60 minutes after the previous

oral fluid specimen collection before collecting

another specimen.

11. Do not collect an oral specimen from a subject

who has been eating, drinking, smoking or

chewing gum, tobacco or other products for at

least 15 minutes, or using oral care products for at

least 30 minutes afterwards.

STORAGE CONDITIONS

Unused Asanté™ HIV-1/2 Oral Fluid tests may be

stored unopened at 2-30°C until the product expiration

date. Do not open the Test Strip pouch or other

component outer packaging until ready to perform a

test. If the test is stored refrigerated, bring the test out

of the refrigerator and bring to ambient temperature

(15-37°C) before opening the component packaging.

INSTRUCTIONS FOR USE

Preparation for Testing

• Ensure you have all specimen collection and test

materials needed.

• Allow the Test Set to come to ambient temperature

(15-37°C) before running the test.

• Prepare to run Kit Controls or known positive and

negative specimens as controls when required.

Oral Specimen Collection Procedure

PRECAUTIONS

1. This test should be performed at ambient temperature

(i.e. 15-37°C).

2. Do not drink, eat, smoke, or apply cosmetics in areas

where specimens are handled.

3. Disposal of oral fluid specimens and materials in a

biohazard waste container is not required but

recommended. Liquid waste should be first mixed

with appropriate chemical disinfectants such as 10%

household bleach (0.5% sodium hypochlorite) at least

before disposal. (CAUTION: Do not autoclave

solutions containing bleach). For additional biosafety

procedures and information, refer to Universal

Precautions standards

. Use of disposable gloves is

recommended.

4. Wipe all work areas before and after testing with an

appropriate chemical disinfectant such as 10%

household bleach. Wipe all spills thoroughly with

disinfectant.

5. Each test component (Test Strip, Sample Buffer and

Oral Specimen Collection Swab) is intended for a

single use. Do not use more than once. If a test must

be repeated, use all new components for the retest.

6. Check the expiration date of the kit and each dated

component (Test Strip and Sample Buffer) prior to

use. Don’t use any materials after the expiration date

printed on the material’s package labeling.

Test Set Components

1-VIH

2/1-VIH

The Asanté™ HIV-1/2

Oral Fluid rapid antibody

Test is packaged as an

individual test set. Each

test pack contains an

Oral Fluid Collection

Swab, a capped tube

containing Sample

Buffer and a Test Strip

will have had adequate time to migrate up the entire

strip encountering both the colored protein A-gold

colloid conjugate and the test and control lines to give

a test result. The test line if visible (when a valid

control line is also present) indicates that HIV antibod-

ies are present and represents a presumed positive for

HIV antibodies in the specimen. If the test line is not

visible (when a valid control line is present), then HIV

antibodies are not present and the result is negative for

the presence of HIV antibodies in the specimen.

(Refer to the Interpretation of Results section below).

MATERIALS PROVIDED

sealed in a foil pouch

. The Asanté™ HIV-1/2 Oral Fluid

rapid antibody Individual Test Sets are available in kits

of 50 (Cat no. 1100-50) and 100 (Cat. no. 1100-100).

MATERIALS AVAILABLE AS AN ACCESSORY TO

THE KIT

Asanté™ HIV-1/2 Controls Kit (Cat. No. 1101)

Package contains one (1) Positive Control (0.25 mL)

and one (1) Negative Control (0.25 mL) and a

Product Insert.

MATERIALS REQUIRED BUT NOT PROVIDED

Timer or watch

Tube stand or rack (for 13 mm tubes)

WARNINGS

1. This product is for diagnostic use only.

2. Be sure to read this product insert completely

before performing the test. It is important to follow

the instructions carefully to avoid obtaining

inaccurate results.

3. This product is intended only for use with oral fluid

specimens. Testing with any other specimen type

will not give accurate results.

4. Oral fluid specimens must be collected and tested

using the procedure described herein, using only

the materials provided with this test. Use of other

collection swabs may not give accurate results.

BIOLOGICAL PRINCIPLES OF THE TEST

The Asanté™ HIV-1/2 Oral Fluid rapid antibody test is

a manual point-of-care, visually read immunoassay for

the qualitative detection of antibodies to HIV-1 and

HIV-2 in human oral fluid. Results can be obtained in

as little as 20 minutes. The Asanté™ test is com-

prised of an Oral Sample Collection Swab, a tube

containing a pre-measured volume of Sample Buffer

and a Test Strip. The Test Strip itself is composed of

several materials which in combination are capable of

detecting HIV antibodies when those antibodies are

added to the tube of Sample Buffer.

After the oral fluid specimen has been collected

according to the instructions and mixed with the

Sample Buffer, the test is initiated by simply placing

the Test Strip into the tube of Sample Buffer containing

the specimen, with the arrows on the Test Strip

pointing down.

When the Test Strip is placed into the specimen/

Sample Buffer mixture, the specimen/Sample Buffer

mixture is absorbed into the absorbent pad at the end

of the Test Strip. This absorbent pad contains

additional reagents to condition the specimen and

prepare it for optimal reactivity in the remainder of the

Test Strip. The liquid mixture continues to migrate up

the Test Strip by a wicking action, until it encounters a

dehydrated reagent composed of protein A conjugated

to a colloidal gold reagent (“conjugate”), which is

rehydrated by the liquid. The conjugate confers a

reddish-purple coloration to the reagent which is used

later in the Test Strip to visualize the results. Protein A

will bind to both HIV-positive (if any) and HIV-negative

antibodies that may be present in the liquid containing

the specimen.

The liquid continues to wick up the strip onto a

nitrocellulose membrane which contains two invisible

reagent lines (a test and control line), where the test

results are read. Once the liquid starts to appear on

the membrane, the user will see a reddish-purple

cloud migrate up the strip with the liquid, due to the

presence of the conjugate bound to antibodies in the

sample. The liquid will continue to be drawn up to the

top of the strip until the reddish-purple cloud on the

membrane has cleared 20 minutes after the start of

the test.

As the liquid containing antibodies bound to the

conjugate crosses the membrane, it first encounters

the test line, which contains HIV proteins bound to the

membrane that will also bind any HIV antibodies

present in the specimen. Since these HIV antibodies

will also be bound to the conjugate, the reddish-

purplish colored reagent will accumulate on the test

line by means of the capture of the HIV antibodies to

the viral proteins. A reddish-purple line will form

indicative of the presence of HIV antibodies.

The liquid specimen will continue to wick up the strip,

next encountering the control line. The control line

contains goat antibodies reactive to human antibodies

(“goat anti-human ab”) which will bind human antibod-

ies in the liquid regardless of whether those antibodies

are HIV positive or negative. If an adequate sample

has been collected and the test is run correctly,

antibodies will be present in the specimen, and will

have bound to the conjugate and captured on the

control line, giving a visible reddish-purple control line.

In the case of both the control line and the test line, the

color intensity of the lines does not necessarily

correlate to the amount of antibody captured or to the

severity of the infection, if present.

The results of the test are interpreted no sooner than

20 minutes but no later than 45 minutes after adding

the Test Strip to the Sample Buffer containing the

specimen. At this time, the antibodies in the specimen

SUMMARY AND EXPLANATION OF THE TEST

The Human Immunodeficiency Virus (HIV) causes

Acquired Immune Deficiency Syndrome (AIDS), AIDS

related complex (ARC) and pre-AIDS

1,2

. Multiple

subtypes have been documented through the use of

genetic analysis. The strains of HIV-1 can be classified

into four groups: the "major" group M, the "outlier"

group O and the "new" groups N and P. Within group

M there are known to be at least nine genetically

distinct subtypes (or clades) of HIV-1 as well as

occasionally appearing but short-lived recombinant

forms known as “circulating recombinant forms” or

CRF’s. The known HIV-1 subtypes are A, B, C, D, F,

G, H, J and K

. Group O, discovered in 1994, appears

to be restricted to west-central Africa

and group N -

discovered in 1998

and group P discovered in 2009

both in Cameroon - are extremely rare. More than

90% of HIV-1 infections belong to HIV-1 group M

HIV-2 is predominantly found in Africa and rarely

elsewhere. HIV-1 and HIV-2 share a number of

conserved sequences. However, serological cross-

reactivity between HIV-1 and HIV-2 has been shown to

be highly variable from sample to sample

. HIV-2 can

be classified into at least 7 subtypes (A-G) but only A

and B are prevalent

HIV transmission occurs predominantly through

exposure by sexual contact, exposure to blood

including shared usage of contaminated needles and

syringes, and contaminated blood products. Transmis-

sion may also occur from an infected mother to her

unborn child during the prenatal period. When

individuals are infected with HIV, their body produces

antibodies to proteins in the HIV virus. The presence

of these antibodies in various body fluids, including

blood and oral fluid, are indicative of exposure to the

HIV virus and can be used as an aid in the diagnosis of

HIV infection when used in the context of other clinical

indications. There are, however, situations where HIV

antibodies may be absent even though an infection is

present. The development of antibodies to HIV (i.e.

“seroconversion”) in a person exposed to the virus may

take several weeks to months during which time the

person may be infected and capable of transmitting the

virus. Conversely, the presence of HIV antibodies in

neonates may not necessarily indicate HIV infection,

but may reflect acquisition of maternal antibodies.

The Asanté™ HIV-1/2 Oral Fluid rapid antibody test is

a single use, qualitative immunoassay for the detection

of antibodies to Human Immunodeficiency Virus Type

1 (HIV-1) and Type 2 (HIV-2) in oral fluid specimens.

The Asanté™ HIV-1/2 Oral Fluid rapid antibody test is

intended as a point-of-care test to aid in the diagnosis

of infection with both HIV-1 and HIV-2. The test may

be used in multi-test algorithms when multiple ap-

proved rapid tests are available when use of such

multi-test algorithms has been validated and approved

by local regulations.

NAME AND INTENDED USE

The Asanté™ HIV-1/2 Oral Fluid test is a rapid,

visually read, in vitro immunoassay for the

qualitative detection of antibodies to Human

Immunodeficiency Virus Type 1 (HIV-1) and

Type 2 (HIV-2) in oral fluid specimens.

HIV-1/2 Oral Fluid

™

Asanté

July 2015 LN-6027.05

SEDIA Biosciences Corporation

4900 NE 122

Avenue

Portland, OR 97230 USA

Ph: +1 (503)-459-4159

Fax: +1 (503)-459-4168

Webpage: ww

w.sediabio.com

Email: [email protected]

/21HIV-

Oral Fluid

™

Asanté

Consult instructions for use

(temperature storage)

Temperature Limitation

Use by (expiration date)

Lot number (batch code)

Part Number

In Vitro Diagnostics

Fluid product labeling.

The following symbols appear in Asanté™ HIV-1/2 Oral

SYMBOLS AND ABBREVIATIONS

5. Simon F, Mauclère P, Roques P, Loussert-Ajaka I,

Müller-Trutwin MC, et al. Identification of a new

human immunodeficiency virus type 1 distinct from

group M and group O. Nature Medicine. 1998;

4:1032-1037.

6. Plantier J-C, Leoz M, Dickerson JE, De Oliveira F,

et al. A new human immunodeficiency virus

derived from gorillas. Nature Medicine. 2009;

15:871-872.

7. Schim van der Loeff, MF, and Aaby P. Towards a

better understanding of the epidemiology of HIV-2.

AIDS. 1999; 13 (Suppl A):S69–84.

8. Simon F, Gueudin M, De Oliveira F, Damond F, and

Plantier JC. Discrimination of HIV-2 subtypes A

and B by real time PCR. Intl. Conf. AIDS, 2004.

Abstr. No. TuPeA4384.

9. CDC. Universal precautions for prevention of

transmission of human immunodeficiency virus,

hepatitis B virus and other bloodborne pathogens

in health-care settings. MMWR. 1988: 37:377-388.

10. Burtis CA and Ashwood ER. Tietz Fundamentals

of Clinical Chemistry, 5th Edition. W.B. Saunders,

Philadelphia PA. 2001.

11. George JR. Alternative specimen sources:

methods for confirming positives. 1998 Conference

on the Laboratory Science of HIV. pp. 47-60.

12. Sedia Biosciences Corporation. 2010. Data on

file.

2. Curran JW, Morgan WM, Hardy AM, et al. The

epidemiology of AIDS: current status and future

prospects. 1985; 224:1352-1357.

3. Robertson DL, Anderson JP, Bradac JA, et al.

HIV-1 nomenclature proposal: A reference guide to

HIV-1 classification In: Kuiken CL Foley B, Hahn

BH, et al, editor. Human retroviruses and AIDS: A

compilation and analysis of nucleic and amino

acid sequences. Los Alamos, NM: Los Alamos

National Laboratory; 2000. pp. 492-505.

4. Gurtler LG, Hauser PH, Eberle J, von Brunn A,

Knapp S, Zekeng L, et al. A new subtype of

human immunodeficiency virus type 1 (MVP-5180)

from Cameroon. J. Virol. 1994; 68:1581-1585.

BIBLIOGRAPHY

1. Gallo RC, Salahuddin SZ, Popovic M, et al.

Frequent detection and isolation of cytopathic

retroviruses (HTLV III) from patients with AIDS and

at risk for AIDS. Science 1984, 224:500-503.

Commercial panels were used to prepare contrived

specimens by diluting each panel member 1:1000 into

Sample Buffer and testing the panel member/Sample

Buffer mix following the procedure in this insert.

Contrived positive clinical specimens were prepared

and tested in like manner, using known positive serum

specimens, except that the dilution was made into

known negative oral specimens collected using the

Asanté HIV-1/2 Oral Fluid Specimen Collection Swab.

No specimen pooling was done, and each result

represents an individual unpooled sample. The

dilution factor use is based on observed correlations

and established clinical data on the relative concentra-

tion of antibody in oral fluid versus serum.

10, 11, 12

Sample ID

Days since

first bleed

Asanté

HIV-1/2

Oral Fluid

Abbott HIV 1+ 2

EIA (S/C)

Biorad HIV-1

Western Blot

PBR924-01 0 - 0.2 neg

PBR924-02 2 - 0.2 neg

PBR924-03 8 - 0.2 neg

PBR924-04 10 - 0.2 neg

PBR924-05 26 - 0.3 neg

PBR924-06 33 +

13.1

neg

PBR924-07 35 +

11.3

IND

PBR924-08 40 + 6.6 IND

PBR929-01 0 - 0.2 neg

PBR929-02 4 - 0.2 neg

PBR929-03 14 - 0.2 neg

PBR929-04 18 - 0.2 neg

PBR929-05 21 - 0.9 neg

PBR929-06 25 +

16.3

neg

PBR929-07 28 +

>16.3

IND

PBR933-01 0 - 0.1 neg

PBR933-02 21 +

>17.7

neg

PBR933-03 27 +

16.0

POS

PBR935-01 0 - 0.1 neg

PBR935-02 10 - 0.1 neg

PBR935-03 16 - 0.1 neg

PBR935-04 21 - 0.1 neg

PBR935-05 24 - 0.1 neg

PBR935-06 28 - 0.1 neg

PBR935-07 43 + 3.9 POS

PBR950-01 0 - 0.2 neg

PBR950-02 18 - 0.2 neg

PBR950-03 21 - 0.2 neg

PBR950-04 28 + >15.5 neg

BBI Seroconversion Panels

ID Genotype*

Origin

Asanté

HIV-1/2

Oral Fluid

Abbott HIV 1+ 2

EIA (S/C)

Genetic Systems

HIV-1/2 EIA (S/C)

1 O Spain + 1.8 5.6

2 A Ghana + >16.1 8.7

3 G Ghana + >16.1 8.8

4 G Ghana + >16.1 8.8

5 A Ghana + >16.1 8.7

6 G Ghana + >16.1 8.8

8 G Ivory Coast + >16.1 8.7

9 A Ivory Coast + >16.1 8.6

10 NEG Ivory Coast - 0.2 0.4

11 HIV-2 Mozambique + >14.6 9.7

12 C Mozambique + >16.1 8.9

13 A Uganda + >16.1 8.8

14 D Uganda + >16.1 8.5

15 D Uganda + >16.1 8.1

16 D Uganda + >16.1 8.8

17 D Uganda + >16.1 9.8

19 C Zimbabwe + >16.1 9.9

21 B China + >16.1 8.8

22 E Thailand + >16.1 9.8

24 E Thailand + >16.1 9.8

25 HIV-2 India 15.4+ 10.0

26 B USA + >16.1 9.8

27 B/D USA + >16.1 9.8

28 F Argentina + >16.1 8.9

29 B Argentina + >16.1 8.5

30 NEG Argentina - 0.2 0.2

26/26 26/26 26/26

*Genotype based on sequencing by PCR

BBI Worldwide HIV Performance Panel WWRB302 (Modified)

Number Correct

Sensitivity of the Asanté HIV-1/2 Oral Fluid rapid test

across multiple genotypes of HIV was assessed using

the commercial BBI Worldwide HIV Performance

Panel (WWRB302 Modified). Simulated specimens

from commercial seroconverter panels were diluted as

described below and tested in the Asanté HIV-1/2

Oral Fluid test according to the procedure in this

insert. Results were comparable to those obtained

with commercially available blood HIV EIA results,

provided by the panel manufacturer.

Seroconverter sensitivity was assessed by diluting

simulated specimens from commercial seroconverter

panels as described below and testing in the Asanté

HIV-1/2 Oral Fluid test according to the procedure in

this insert. Results were comparable to those ob-

tained with a commercially available blood HIV EIA

and Western blot, provided by the panel manufacturer.

Sensitivity (n=159): 100%

Specificity (n=484): 100%

Accuracy (n=643): 100%

True

Positive

True

Negative

Asanté HIV-1/2 Oral Fluid Positive

159

Asanté HIV-1/2 Oral Fluid Negative

0 484

Overall Performance

Oral fluid specimens were collected from subjects in

Thailand and tested with the Asanté HIV-1/2 Oral Fluid

test according the procedure in this product insert. A

total of 84 known negative specimens were tested and

resulted in 84 true negatives and no false positives, for

a specificity of 100%. A total of 62 contrived known

HIV-1 positive oral fluid specimens were prepared as

described below

and resulted in 62 true positives and

no false negatives, for a sensitivity of 100%. Overall

test accuracy in this population was 100%.

algorithm. AIDS and AIDS-related conditions are

clinical syndromes and can only be diagnosed by

clinical examination.

6. The intensity of either the test line or control line

does not necessarily correlate with the levels of

any antibodies that may be present or with the

severity of disease, if present.

7. A non-reactive result does not exclude the possibil-

ity of exposure to HIV or the presence of HIV

infection. Antibody response to recent HIV

exposure may take several weeks to several

months to reach detectable levels.

8. The presence of HIV-1 or HIV-2 antibodies in an

individual is presumed to be an indication of viral

infection. However, individuals who have partici-

pated in HIV vaccine studies may have antibodies

present as a result of vaccination, but may not be

infected. Individuals who have participated in HIV

vaccine trials who test reactive in this test should

undergo additional testing to determine if a

diagnosis of HIV infection is appropriate.

CLINICAL TEST RESULTS

Oral fluid specimens were also collected from subjects

in India and tested with the Asanté HIV-1/2 Oral Fluid

test. A total of 400 known negative specimens were

tested and resulted in 400 true negatives and no false

positives, for a specificity of 100%. A total of 97 known

HIV-1 positive oral fluid specimens were also collected

and tested with the Asanté HIV-1/2 Oral Fluid test and

gave 97 true positive results and no false negatives, for

a sensitivity of 100%. Overall test accuracy in this

population was 100%.

The combined data of the two studies above is

presented in the table below:

LIMITATIONS OF THE TEST

1. The Asanté™ HIV-1/2 Oral Fluid rapid antibody test

must be used according to the instructions in this

product insert to obtain accurate results.

2. Results must be read no earlier than 20 minutes

nor later than 45 minutes after inserting the Test

Strip into the Sample Buffer containing the

specimen. Reading results outside of this window

may give inaccurate results.

3. This test is intended for use only with oral fluid

specimens. Oral fluid specimens collected

following procedures other than those specified in

this product insert may yield erroneous results.

4. Individuals infected with HIV but who are on

antiretroviral therapy may produce false negative

results.

5. A reactive result using the Asanté™ HIV-1/2 Oral

Fluid test indicates the presence of HIV-1 and/or

HIV-2 antibodies in the specimen. The Asanté™

HIV-1/2 Oral fluid test should not be used alone to

form a diagnosis of HIV, but used as an aid in such

diagnosis. Confirmation of test results should be

obtained using the appropriately approved testing

Repeat the test with a new Test Strip on the

sample specimen/Sample Buffer. If an invalid

result is obtained again, repeat using another new

Test Strip but on a new freshly collected sample.

1-VIH

Invalid

1-VIH

Invalid

INVALID

The figures at right show

examples of invalid test

results. A test is invalid if

no reddish-purple line

appears in the control line

region of the Test Strip,

regardless of whether or not

there is a test line present.

An invalid test result means

that there was a problem

with the test. This may

include an inadequate or

improper sample collection,

an improperly performed

test or a Test Strip failure.

An INVALID result cannot

be interpreted and used

for diagnostic purposes.

A reactive test result means that HIV antibodies

were detected in the specimen. A reactive result is

interpreted as PRELIMINARY POSITIVE for HIV-1

and/or HIV-2 antibodies. Preliminary positive

results should be confirmed using a suitable

algorithm as required by local regulations.

1-VIH

larO-doolB

Reactive

1-VIH

larO-doolB

Reactive

REACTIVE

The figures at right show

examples of reactive test

results. A test is reactive if

both a reddish-purple line

appears in the control line

region and a reddish-

purple line appears in the

test line region of the Test

Strip.

Note: the test is reactive if

any reddish-purple line

appears in both the test

line and control line

regions of the Test Strip,

regardless of how faint

these lines are. One line

may be significantly darker

than the other. This is not

abnormal.

A non-reactive test result means that no HIV

antibodies were detected in the specimen. A

non-reactive result is interpreted as NEGATIVE for

HIV-1 and HIV-2 antibodies.

Non-Reactive

1-VIH

The figure at right shows

an example of a non-

reactive test result. A test

is non-reactive if a reddish

purple line appears in the

control line region but no

line appears in the test line

region of the Test Strip.

INTERPRETATION OF RESULTS

Refer to the Result Region of the Test Strip

NON-REACTIVE

QUALITY CONTROL

The Asanté™ HIV-1/2 Oral Fluid rapid antibody test

has a built-in procedural control that establishes assay

validity. A reddish-purple line in the control line region

of the Test Strip membrane indicates that a proper

specimen was collected and run in the test, and that

the Test Strip functioned properly. This control line will

appear on all valid tests whether or not the test line

gives a reactive or non-reactive result.

Asanté™ HIV-1/2 Controls Kit is available separately

for use with the Asanté™ HIV-1/2 Oral Fluid rapid test.

These controls are formulated specifically to ensure

the performance of the Asanté™ HIV-1/2 Oral Fluid

rapid test and are used to verify that the user can

perform the test correctly and that the test is working

properly. The Positive Control will produce a reactive

test result and has been designed to give a visible test

line. The Negative Control will produce a non-reactive

test result. Alternatively, known positive or negative

specimens validated to perform in the Asanté™

HIV-1/2 Oral Fluid test may be used. Use of kit

controls other than those provided by Sedia or

properly validated with the Asanté™ HIV-1/2 Oral Fluid

test may not produce the desired results and may not

provide an adequate quality assurance program for the

Asanté™ HIV-1/2 Oral Fluid rapid test.

Sedia recommends that controls be run: a) with each

new operator prior to beginning testing on clinical

specimens, b) when opening a new test kit lot, c)

whenever a new shipment of test kits is received, d)

anytime the condition of test kits is suspect, for

example, due to short-term exposure to improper

temperature, and e) at periodic intervals during testing

as established by the user’s quality assurance

program.

containing the specimen. If the results are read

outside of this window, inaccurate results may be

obtained.) After reading the results, dispose of the

used Test Strip and tube of Sample Buffer. If the

sample is to be retested, a new Test Strip may be

used on the same specimen/Sample Buffer

mixture. Diluted specimens in Sample Buffer may

be stored at 2-8°C for up to one week for addi-

tional testing.

Blood-Oral

HIV-1

5. Read the test results on

the Test Strip. Refer to

Interpretation of Results

section below. (Note: It is

important to read the

results only between 20

minutes and 45 minutes

after placing the Test Strip

into the Sample Buffer

/2 Oral Fluid1HIV-

™

Asanté

Page 2

Sedia Artwork LN-6027.05 (Back Page)

Art Size: 297 x 420 mm (to fit A3 paper)

Asante HIV-1/2 Oral Fluid Operating instructions

Asante HIV-1/2 Oral Fluid Operating instructions

Asante HIV-1/2 Oral Fluid Operating instructions

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