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31112 13501 H - en· 201 10 Vl<IA•HJV 112 l l501 H • et1 • 2014110

VIKIA® HIV 1/2 WARNINGS ANO PRECAUTIONS !1

• For Jn vitro diagnostic use only. \
• For profossk>nal use only.
INTENDED USE • This kit contains products of animal origin. Certified knowledge of the origin al"ld/or s.JnJtary st<ite of the animals does
noc totoUy guarantee the absence of transmissible pathogenic agents. ItIs therefOfe recommended fhat these prodL.lcis
Rapid diagnostic test fOf the detection of serum ant bodies to HIV in humanserum, plasma°' whote blood.
be tre01ted as potonballyinfectk>us.and handled observing the usual safety precautions.
The testisintended fOf' use only by healthcare profes!.ionals in labol"atories or fOf decentralt zed near-patient diagnostic • Donot ingetL Do notinhale.
testing. • All specimens should be considered potentialy infectlOV1ind handled following the recommended precaut.oos (CLs1•
M29-A, Protection of laboratory Wo.11.ers from Ocx:upat1onalfy Acqwred In fections; Approved Guideline - Current
PRINCIPLE reVl$)C)l'I). For additional inrormation on handling prec;auttOOS, refer to "Biosafety in Microbiok>gtcal ..xt B.omedieal
VIKIA• HIV 112 is an invn\.noc:hromatographlc test for the qualitative detection of antibodies to HIV·land HIV-2 Laboratories- CDC/NIH-Latcsl Edition.Of the current regulations In the country of use.
The test consists of a plaSbC deVI08 containing: • As the speomens are po4entialy infectious, wear gloves when handling lhem
• Do not use reagents aft.er the exp.y dale indbted on tM bent.
• Do nol UM lt'f:test device if the pouch is d3maged.
1. A dYomatography membrane to which are fixed·
lrl the test region (T)·synthetic peptides speafic fOf HIV-1(gp41 of group M and group 0). and HIV-2 (gp36):
• Thelest devteie and speemnen pipette are fOf sng use onty. these c:ornponenls should not be reused.
• Do not IOUCh thelest device dtxing the test.
inthe control region (C):two color indicators. • Do not m!x reagents from d fferent lots.
2.A test strip impregnated w1lh a oonrugate consisting of a murture of synthetic peptides specific for HIV-1 group M (gp41
• Test validation Is perlormed by the color change of the hne in the control region (C) from blue to pink /rod. f the
of group Mandgroup 0). 3lld HIV·2 (gp36). couP'ed toblue<(tyed pofystyrene microsphcres.
control hne does not change color, the test result isin valid.People who have problems recognizlng COIOfs may find it
The sample is added tothe sample well 21nd migrates by capdlanty along the membrane. difficult to see the color change inthe control region (C).
If the sample contains anti-HIV antibodies they form an antigen.antibody complex with the peptides, specific to this
STORAGE AND STABILITY
virus.present on the blue-dyed polystyrene microspheres..
The antigen-antibody comple)(es migrate and bind to the synthetic pepbdes immobilized on the nitrocellulose membrane • Store the k t at +4lo +30"C.
• 00 NOT FR EEZE.
Thisis revealed by a bluelin e 1n the test region (T).
• If stored according to the recommended condlllQfli, all components are stable untilthe expiry date indicated on the
box.Do not use after the expiry date.
CONTENT OF THE KIT (25 TESTS):
• The H Idevice shotAd remain in the sealed pouch uni.ii use.
25 Sealed pouches J R1 I- a ready-to-use test deW:e (three synthetic peptides: Hrv-1 group M,HIV-1
group o and Hrv-2) SPECIMEN COLLECTION AND PREPARATION
• a pipette Seecimen txDt and coUectlon

1 Coating buf'l'er dropper botde

tor whote blood saml)M
I I - adeSK:Cat'll
R2 Read)'-to-use.
PBS buffet"" pH 7 4 EOTA • ..,.ett,ng 9gCf1t
It cs the sibiltly of each user o validcite the Nmpling tlA>e andlor capilary used
If the capllary tube ls used with a non disposab bulb.the user is rHPQns'.ble tor checking that the bulb has not been
contaminated by prevlOUSly collected samples.
analysis: 3 ml 1.Serum or plasma
1User quick guide pmted on the box Use sera or plasma collectedinlithtum heparin. EDTA °' sodium crtrate. The other anticoagulants have not been
1Packageinsert valklated.
Store the scrum or plasma separated from lhe pellet. If necessary, darify samples by centrifugation before teslng.
MATERIA LS REQUIRED BUT NOT PROVIDED Nooe of the following factors have been found tosignificantlyln noenoe th
is assay:
nmer • hemotya1s (aftor spiking samples with hemoglobin, up to 5 gll).

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Dispouble gloves .hpemla (after spiking samples with lipids, up to 30 mg/ml equivalent in trigtyc@rides),
• Alcohol swabs • bilirvb
inem1;i(after spiking samples with biJirubtn. up to 300 mgA.).
Wale di c:tcvlc4' - biotin (after sp11dng samples withbiotin. upto 20 µgtmL).
Donot inactivate samples
2. Whole blood by venipunc ure
Equipment for blood c;ol\ecnon by venfpuncture: or by fingerstick. CoUe<:t inlttuum heparin. EDTA or sodium c:i'".rnte.
75 J.1 EOTA Qpilary tubes. tMJbs. or other devices with or Wdhoul EOTA. to collect and dispense 75 vi of wtdt The other anticoagulants have not been validated.
blood
3. Who..bk>od by flngerstick
Use an EDTA capilary tube (75 µL) or another device (please refer to the section MATERtAL REQUIRED BUT NOT
PROVIDED)to cot\ect blood from the fingertip. The sample should be tested extemporaneously.

Soocimon stability
• Samples (serum ar'\d plasma) can be slored fof 5 days at +2 to +S"C and 4 hour$ at •15 to •37"C . flonger storageIs
required, freeze at 25 J; S-C. A study pe<formed on samples frozen for nine months sh<Ywed that the quality of results
is not affectod. Avok:I succtssive freezing and thawing
• The whole blood collected by ven puncture e<1n be stored lot 4 hours at +15 to 1-37"C Do not frcoze whole blood
samples.
•Whole blood collected by fingerstiek should be tested Im mediately.

bioMffieux SA Enghth 1 t*:>M11 SA Engltstl • 2

VIKIA HJV 1f2 135.:1 H- en - 20..·to 13501 H -«i-2014110

INSTRUCTIONS FOR USE R.es••••':"'S A.c ..A

POSlTIVE: the n
li ein the control region (C} chang" from
• JUiaw lhe req1.11red reto oome to room temperature before use
• RcmcMt the IHt deYICe from tho sealed pouch and use tt immedalitety
• Perform the &e-M ona Rat deanvi>ration-fr ee sutfa<e-
Serum or plasma Whole blood by vonipuncturt
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Whoa. b5ood bytlngwslk:ll:
(1 11 1(
:
I :
( -ID pnkl,.. ond a blue line appea"in the'"' .ogion
_ biue10d•l1<blue"'1e!neven •very1tw1,ondQ1n
( r
-
•...-...u1.
1 To t*>oc:Ot»i::r'latlon,
massage t'ie ht

.lEJ .
base to the
Collecl 75µlof ..,,.,,...-.gtne NEGATTVE: the linein the control region {C) changes from
c- blue to pink/red •nd noline appearsin the ost rogion (T).

:F =°::or (1 1(

Fil
PROVIDED)

(1 I t{
: ( ( INVAUIU-slbllttltt '
the line n the control region
color,
(C) does not change
°'
oent sa.mple vobne incorrect procedural
18CtnqueS ate the most ikety reasons 1.fflCUftles may
be wt:h ccrt<m sarnJ>'eS· lflCOn1)tctc

2 a} Usng the pipette.iransfer 3

- highly V1S001JS sa1T1)1e:S. presence of fit>M.
Re\l'lltw lhe procedure <.Ind repeat the Mst •fter

CPi1 -
2. UsingIlle: pipette. trant:fe< 3
drops of sample (75 µL)lo the
sample well(S) on the 1es1 deVJOe
without 1ra?Ping bubbles.
drops of whofe btood (75 µI.) lO
the samp6e welt (S) on the tut
device wrthout trapping bubbles
2. a) Oepo$lt the sample'" the
sample well (S) on the tttt deYtOt ""'""1>!ug.ng tnesample.
wTthout trappng bubb'es The th<t IM In the control region (C) does not ch•nge
sam well turns red. co6or' and a blueline appears in the test region (T).
Repeat the test after recentrifuging the sample

._
NOTES.
fcx HIVdiagnostics must be taken into account
AJI ...,....alloiAd be retested using complementary tests.
The m: ;;w::w f ..::..can bt Western.Slot anatysis and/or a sec.ond screening test for detection of anti-HIV
2 b) Otspense one drop of buffer (.i40 µL) without trapping bubbles'" the
anliboclm._ P.:.' ....- and/or th<t determination of vi,..1to..d.
These --...ts ·S'Cl.i: tie no ac:cx:uit N overal c:lnlCll evaluation and the restlls oC any other le$t$
......._.($
per1or-e::.
If
:ieboe•-
'f'JOlt :.xx:. :Na tJo a red c:r:>k:lr ., me saf'f"C)le wet 'Nhd'I indicates that the S3f'llPe has defirutely been
"'-
QUAUTY
I
n (l)f9C* .eft::orpor.r-ed Iilhe device. The line 1n the control regio n (C) should change from blue to
pink/reef_ -.._ i::t*7 ="*'9l' proper rr.gl'lltion. If the control line d not change WOf, the test result is
invabd
Note
It is the :1e.:.aer IOperform Ouaiity Control in aceo«lance with any applicable localregulations.
• Start the timer. Road the resultat 30 minutes.
• Do not in erpret the result after 60 mriutes
• During the migration period, the test delrice must not be handled or moved.

j\'\
Note: For most pos. Ne semples.!he line in the tesl region (T) can appear before 30 m1n1Jles . Howeve<, test reading and I
interpret<1tion .slioukl only be performed after 30 minutes fol owing .ample or swab deposit.

tMoMerieux SA Englh - 3 bioM6rieux SA Engli:s,h •4'