Data Sheet (MSOS) available upon request.

Some reagents may cause toxi<ty. irritaticm, burns have cardnOgenic effect as raw materials. Contact with the
skin and the mucosa *iould be avoided but hted to fc*lowirw reagents: Stop solutim. ttw Chromogens. and Wash
buffer.
The Stop 0.5M H.SO. it' an add. it with Care. Wipe up itnrnet%atdy and wash with water if
cmte blto cmtaa With the skin eyes.
ProClinns 300 0.1% used as preservative. can cause sensatiort the skin. Wipe up One4atety
wash with water if come into cmtact With the skin eyes.
Ready to as supplied. once open, stable for 4 weeks at 2-a•c.
1
9. Colorless liquid in a wfiite vial with white screw cap. Code 4 (I*8ml per vial) Diluted sulfuric
•cid solution (0.5M H*SO.).
Ready to use as supplied. Once open, stable 4 weeks at 2-g•c.

PLASTIC SEALQBLÉ BAG: For enclosing the strips not in use

21.
PACKAGE INSERT t copy
CARDBOARD PLATE COVER I sheet To cover tha Jiates during incubation and
prevent evaporaticn oc contamination of the wells.

MATERIALS REQOIRED BUT NOT PROVIDED

three phases (incubation. added tb the wells. In
Wantai Hepatitis B Virus
acute and conWescent) Of
the iMecUoru Now severd Diagnostics
presence of the anstnfy-
antigm-antibody(HRP)
test are wed ror screening. •sandwich• the cclodess

WÄNTAf HBsAg EL/SA

clinical dagnoås and Ctyornogens are hydrolyzed
management of the disease. by the bound HRP-
Hepatitis B surfx:e antigen coniugate to a b'ue-cdored
or HBsAg. previously broduct. The cdor turns
describéd as Australia yenow after stopping the
HEPATITIS Bantism,
VIRUSisSURFACE the ANTIGEN
most reaction ELISA KIT acid:
with wlfuric
important prote%n of the The arnount of color
WB-*296 envelope of Hepatitis B intensity can be meted and
201501 Eng. J Virus. The surface antigen it is proportional to the
containo the common to arnount antigen æptured in
Tests 011 kncMn Vird subtypes thp and to its amount in
Read the package inært carefugy and irnmunolc»ically Wdls mntalning sarnples
and crynNeteIy b&fore disti0Wished in distinct negative for HBMg rsnain
perfcrrtting assay. Fdlc*
subgroups (ay and ad). HBV
btstructlcxts and do not modify
has 10 serotypes and four
thern. Only by adherence to these
HBsAg subtypes have been
COMPONENTS
instructions. the erroneous
results WCÅded and the optimal recogüzed (adw. ady. ayw,
performance WANTAI HBsAg
ELISA achiwed.
and ayr). IIBsAg can be In Vitro
detected 2 to 4 weeks
before the ALT levels Diagnostic Use
INTENDED USE becorne amorrnd and 3 io 5
weeks before devdop. The Only
ÄNTAJ HBsAg ELISA is an enzyme-
Unked immur•sorbent assay serological detection Ot This kit contains reagents
(ELISA) for quafitaåve detection of HBs.Ag iS a powerfu sufficient for testing of
HBsAg in human serum or method for the diagnosis maxin»xn 91 specimens in a
plasma. it is intended for blood md prwention HBV infec%n test run,
donors and fer ciagrK'sirv of
patients related to Infection With
and ELISA has become an
hepatitis B extensivdy used system strip hdd%
screefü•tg of blØd donors Code 5 (Ix96weIls) is s
SUMMARY arxi clinicel diagnosis HBV in 8X per plate mon
infected iMvidualS. brc*
Hepatitis B virus (HBV) is an Nas
envdoped. double-stranded stab
DNA virus belmging to the PRINCIPLE OF THE
Hepadnaviridae family and
is recognized as the major
TEST Code 8 (Ixlml per qial)
procun'* 300 Prot
cause of ucx:jd transmitted detection Of HB*g. WANTAt
hepatitis together with I-BsAg ELISA uses antibody Rea
•sanOwiCt•.• ELISA rhethod in Code 7 (Ixlml per vial)
hepatitis C Vitus (HCV). which. polystyrer.e Strips are pre-
Infection with HBV induces coated with monodonal HB*
a spectrum of dit#at antithdies specific to HB%.Ag. Rea
Patient's serum liasma sample is Code 6 (Ix7ml per vial)
manifestatims ranging from
mild. inapparent disease to added to the micro,velt together
with a semnd antibody enzyme
fulminant hepatitis, severe peroxidM.e HRP-Conjugate) and Code 1 (Ix30ml per bottle)Rea
Chronic Ever diseaseg, directed aganst a different DILUTE BEFORE USE!
which in sorne cases can epitepe of HBsA9. Durinc
Buffe
lead to errhosis arS incubation, the specific
The
carcinoma of the liver. Erum proteins and Onc
Classificatül of a hepatitis B Unbound HRP.njugate. e
infectim requires the solutions containing ddu
identificatim several tetramethyl-benzidim(TMB) ted.
mÜkers expressed during stau
and urea peroxide are e
 for to dot neturaliy and
1 — the must be
STORAGE AND
wee
k at
separated the dot STABILITY
roq as early as possiole
as to avoid The components of the kit temain
n
staUe.throujh the expirÜn date
tem haemolysisd the indicated on the label and
pera RBC. Care should be package when stored 2-80C. do
ture
, or
taken to ensure not freeze. To maximum
for that the serum pedOtmance of WANTAt HBsAg
specimens are deac ELISA. durjng storage. protect the
2
reagents from contagiination or
wee and not diemicals.
ks contaninated by
whe
Ari,y viSiUe
n
stcy particulate matters PRECAUT:ONS
ed in the specimen be
at remcved by AND SAFETY
2.a• cen#ifugation at
c. TO BE USED ONLY FROM
3000 RPM (round 9t.hL!FlED PROFESSIONALS
Colorz Squid Nog in a white minutes) tor 20
minutes at room
vial with gröen The ELISA essays are tine
temperature or by
Ready [dtraüoo. and temperature
to as 2. Plasma specirnens sensitive. yo avdd
collected into EDTA.
suppli« scdium citrate or (ncorrect result,
L Once heparin can be strictly tottow the test
open, tested, but highly
procedure and do not
•e for 4 IWaemic, ict«ic, or
hanolytic *'ecinfens modMy
illed should not be used
in a as they can give
blac 1. Do not reagents trcyn
tdse results in the dfferent :ots uæ
k
vial Do not heat reagents from other
blac Inactivate cornmerdatty available
k specimens. This can kits. The mmponents
scre the kit are precisely
cause ceterioration matched optjmd
w of the target
cap. performance of the
TMB analyte. Samples tests.
(Tqr With visiUe 2. Make sure thd ail
ame microbial should reagents are within
thyl never be used. the va%dty
benz
indicated on the kit
icfrw 3. WANTAI HBsAg
bsol ELISA is intended box and of the
utio ONLY or testing of s@tne lot. Never
n. individual serum or use reagents
Freshly distilled or deionized plasma Do use the beyond their expiry
water. dsposable gloves and assay for testing of date stated on
timer. appropriate. waste for
potentially contaminat«l caøaver samples, labels or boxes.
materials. dispensing system saliva. unne or 3. CAUTION - CRITICAL
and/or pipette. disposable pipette Other bOdy fh.åds. STEP: Allow the
tips, absorbent tissue or clean or pooled (mixed) reagats and
towel, dry incubator or water Nood. specimens to reach
bath, 37±1 'C. plate reader. sins/e
wavelength 450nm or dud 4. Transportation and ro«n temperature
wavdength 4SOf63(hrn. Storage: Store (18-300C) before
microwtell aspirati0fVwash specimens at 2-8'C. use. Shake gently
system. Specimens not before use. Return
required assaying at Z-8øc
SPECIMEN within t week immediately after
use.
should be stored
COLLECTION, frozen (-20'C or 4. use only sufficient
k:wer) Multiple volume of sample
TRANSPORTATIO freeze-thaw cycles as indicated in
should be avdded. Procedure steps.
N AND STORAGE For shimnent, Failure to do so,
1, Specimen Cotleetioqi' No samples should be may cause in low
special preparation packaged and sensitivity of the
muired. Cdted the labeled In assay.
specimen in a«xordanq. with 5. Do mt touch the
accordance with the the existing loca bottom exterior of the
normal practice. and international "Is; fingerprintg or
Either'e serum or regulations for may interfere
Åasrrta •ecimans transportation of with me reading. When
can be used with d#tical samples and readim the results.
this assay. Blood agents. that the Ciate
cogected by is dry
venipuncture are no air
should be allmt•ed txjbbles inside the
welts.
G. Never the wells to dry after the negative ocntroIS. 36'37/3
washing step. segurt attunin (BBA)
Immediately proceed to 945.
the next stQ. Avoid the
and feta 1
formation of air bubbles
wilen adding re 16. Never eat. drink. smoke. p
reagents. apply in the assay
'aboratoty. Never
h
Avoid assay r
soluåonS by
time interrup€ons. össure mouth. a
same Vcrking s
17. should be handed
8. the pipette frequently e
to the accuracy of and of ody in
s
samÅegreagents Use accordance *4th :
different disposal
pipe«e tips for each the current GLP
specimen and reagents 4
'Good Practices)
in to avdd cross- 3
contarninauorqs. the tocd or
9. Assure that the national
temperature is
SVC inside the regulatinns. PROCEDURE
incubator. 18. The pipette tips, vials.
Reagentd preparation: the
Whm adding specimens. üps and specimen
not totKh theweICs containers st-x,AJtd be reagents to reach room
bottMi With the pipette ccUected and ternperature (18-3"C).
tip. •autoclaved for not less Check the Wai Mer for the
than 2 hours at 12 "C or presence of salt crystals. If
Il. treated with 10%
reader, detennine the absorbance
crystds nave formed,
hypocNorite for 30
at 450nrn at 45(Y630nni. minutes to resdubilize by warrning at
12. The enzymatic activity decontaminate before 37•C until crystals dissolve.
the HRP•coNugate any further the buffer (20X) as in the
might be affected trun INDICATIQNS OF instructions for washing Use
dust md reaceve INSTABILITY distilled Of deionized water
chenicat and substances DETERIORATION OF THE
REAGENT. vaues of the
arW dean vessels to dilute
like sodium
hypochlorite, acidt.. Positive or Negative the buffer. All other
alWis etc. 00 not *form controls. Which are out reageqts are READY TO USE
assay in the preænce of of the indicatod quality AS SUPPLIED.
Wase Wbstances. control range, are inc
%cators pos*ibte
13. If My autanated
deterioration of Stepf Preparation: Mark
equisxnent, during three wells as
reagent' operator or
incubation. do not cover
the øates with the plate
equipment errors. tn Negative
the results be control (e.g. Bf,
cwer. The tapping the
conOdered as Kwalid
rernajnders inside tae
and the samcies must b'
Ct. DI), two
gate after can be
retested. In case of welts as
ornitted. Positive (e.g. El,
cmstant erroneous and
14. AN fro•n hthtan origin vmwen deterioration or FI) and me
should be cuisidered as instability of the Blank (e.g. Al.
potentially iMectious. reagents, bnmediatdy
Strict to GLP (Good samßes nor
substitut9 the reagents
Laboratory Pradico) with new cgTtact HRP-Conjugate
regulations can ensure Wantai technical ftrther sh0"d be added
the persond safety. assistance. soon into thu Blank
15. WARNING: 3 well). if the
Materials from 00 results wiN be
tunan may hwe determined by
been used in the dual plate
Do not
the Négatwe reader,
Control the kit. eat and revøment use
These materiaie drink o' Blank Weil
have been tested cmld be
With tests kits With Ware cmitted. use
accepted protecti only nutlber
performance and ve strips require"
(ound fcx antibodies clothing fcr the test.
to HIV 1/2, HCV, TP Step2 Adding Sample: Add
HBs&g. 'here is 50pI Positive
Biohaza
analyticd method contrd.
th$t •can assure rd
Negative
ttat infe40us agents phrases
cortird. and
in the specimens or : Specimen into
re.gents are thdr wdls
camcietdy absent. at the except the
Therefore. hartdle laboiat Blank. NotO:
reagents and ory Use a separate
spectrnens extrane disposal tip for
caution as it each specimen,
Ware
capable of Negative
transrniR.ing eye
Control,
infectious diseases. protegti
Positive Control
Boüine derived sera on ±6- te avoid cross-
have been uwd 28- contamination.
stabilizing the ard
 by tapping the mix genuy. 4. Assure that the
plate wntly. Intensive yell micros*ate washer
step3 Adding HRP- %V color liquid dispensing
Conjugate: Add dovdops in channels are not
SOP' of HRP- Positive cmtrd bbc*ed and sugicient
Conjugate each and veume Wash is
well except the HB&Agpositive di•ensed •ach time
Blmk, and rrdx sample into the
by tapping the Step8 Measuring the 5. In Of manud wagiing.
Nite gently. Absorbance± we suggest to carry
Step4 Incubating: Coeer Cdibrate the out 5 washing Cycles,
plate with the 350-400pVweg
plate With the plate ccyer
Blank welt and aq»iratirv the liq.id S
and 60 minutes at 37 tirnes. If per results
read the
steps Washing: At the end absorbance at (high background)
&1cubati00, 4SOnm. If a are increase the
renwe and me dual instrunent cydes or time per
cover, Wash is used, set the 6. In any case. the
each-wen times reference uquid aspirated out
with dNuted wa€dength at the strips be treated
Washing Each 630nm. the with hypochlorite
time allow the Cut-off vaue sdution at final
soak for 30-60 and mduate the concentratim 2.5%
seconds. After (Note: read the for 24 hours. tefore
10 mal cyde, absorbance they are wasted in
turn down the Within 10 an apprcpriate way.
plate onto minutes after 7. TM cmæntrated
Uotting pav* stcvpitb9 the Wash buffer shotåd
dean tcwel and reaction). be 1:20 before use. If
tap it to less than a whole
remc*e my plate is pgepÜe the
propMionaI vdume
step6 Coloring: Add 50pI of INSTRUCTIONS sdution.
Chrenogen A
and 50pI FOR WASHING
Chromogen 1. A good washing QUALITY
sdutions into
each including
procedure is essen\
id in order to
CONTROL AND
the Blank.
Incubate the
correa Md CALCULATION OF
Éease analyticd data.
plate at $7'C
2. It is therefore. THE RESULTS
for 15 minutes
reccynmended to Each rNaOplate
avoiding tight.
use a quality ELISA consi&red separately when
The enzymatic
washer. majntdned calculating and intergreting
reaction the
at the tEt IWeI the results of the assay,
solutions and
washing regaidess
the HRP-
performances In
Conjugate
general. do less than "due b the Cut-on vdue
produces blu@
S autmatjc *les of (C.O.) the plate. If Cut-off
cdor in Positive
350-40WwelI are reading is based On single
ccmtrd md
suffiqent to add fdse filter plate reader. tte
BBSAg positive
positive readions rpudts be by the Blank well
sampe wells.
and high A value from the print
step7 Stopping background. repott vdues Of specimens
Reaction: using 3. To avdd of with and In case the reading ts
a rntitidu•nnd specimen or based cn dual filter plate
r*pette or HRP04ugate. after
inajbation, do tÜt discard reader, do not subtract tie
manually, add Blank wen A the print resm
the content the wells but
50pI Stop aJIWd the washer to Wues
Solution irio aspirate it
eaetl wdl and
Steps cf
containin
hypochlo
be auto
Safety
o' and contols.
calculated by a panel of sathples obtained fro-n

based upon reference assays for detection oc HBsAg.

Ot the Cut-off value (C.O.) NC 2.1
(NC • the mean abs«bønce value for three Umtrots). evaluatim results are
Number Confirmed Sensitivity False
itive Negatives
100%
99.75%
100%

Chronic 400
Recwe 70 65 5
given bd..v. Results in k*jividuai laboratories may Offer. Important: It the
mean A value of the negative is lower than 0.05, it as 0.$.
Quality control (assay validation): The test results are valid it the Quality criteria ere fulfilled.
It is recommended that øach laboratory establish quality contrd with quality contrd material
Similar to or identical with the patient sarngie being andyzed.

• The A of the Blank well. Which contains only 0.080

Analyti
Soedfid
The Avdues of ttø Positive
• The Avdues of Negative control must be s at

mebi mth
et e an

at 450mn HCV, HIV, CMV, t-Jæ this

pummar-/ only as a refererx:e and always No reactivity
observed sanples trcm patients Wiected HAV,

@served.

No hig
hook
up to
concen
s of ob
during
•ng
have
tested
Check
interfer
due
codecti

Wash

tan the Reference

Laboratoty
Immunology Product
under tt•n Vlini$ry of
Health' China. The
essay Shows sa'*Pity
at the Cutoff of

Incubate 0.5rWml
(adr) and 0.5ng/rnl
(ae ay),

LIMITATIONS
1.Positive results must be confirmed with emmer avail#ble method md interpreted in gonjunction With the
patient dinicøl i&mäon.
Antigens may be tectable d
Therefore, negative results
*4th WANTAI HBMg Mare mly mca€m that the SanWe does not mntain
detectable levd hepatitis B virus surface artigen and any negative realt not
be widence that the iMividuaI is not infected with HBV or blood urit is
infected
If, after retesting d reactive samøes, the assay result' are negative, the% sarnples
shmdd be maNdered as non•repeatøble (false and integyeted as negMWo. As with many very
sensitive ELISA INTERPRETATIONS OF THE RESULTS assays. false S*'sitive
results occur due to the several reasons. most of are related but hited to
inadequate step. For mere irftrmation Wantai ELISA
Troublest•odlng, refer to Negative Results (A / C.O. I ): Spedrnens giving less than thø
Cut-off are negative for tNs assay, Wmtd's •ELISAs md Trouble*tooting Guide',
or cont*zt Wantä technical for further assistance. which Indicates that hepatitis B virus
IV
surface antigen has been detected with WANT" HBMg ELISA. therem the 4.TtE most D
ccynrnon essay mistakes uSng kits t.yond expiry date, bad weshing patient is probably n«
iMected with HBV and blood unit do contüi hepa%tis B v#us surface antigenreagents, LOT
incorred assay step$. insuffident as—on during wa$hing. failure to add transfused In case
that other infectious diwases markers are alm absent reagent!d. improper operation with
the laboratory equiptnent, errors. the use of hiøiyIn Vitro Diagnostic Medical OeviceStorage
Conditions hemdyzed specimens or specirnøns cnntaining fibrin. dotted s«urn specimens.

The prevalence
the assay's pre<cåve vdues.
Positive
Results (A I
C.O. 1):
Spedmens
giving
±sotbance
equal to or
er than the
Cutdf value
are 6. This
cannot be
utilized to
test pooled
(mixed)
WANTAI
ELISA has
teen
evaluated
only
cmsidered
initidly
reactive,
whie) that
hepatitis B
virus
surfaæ
aitigen
probably
been
detected
using '"th
serum
plasma
WANTAI HBsAg ELISA. All initidy reactive specånene shmAd be retested in duplicates
uülg WANTAI ELISA 7. WANTAI ELi*A is a quanative ,assay and the results be
used to measure antigen before the final assay' results interpretation.
Repeatedly reactive gan be positwe for B virus
arface antigen with WANTAI HBsAg
ELISA.Content Sufficient For TestsFor Use

REFERENCE RE
S F
B'rderline (A / C.O. e 0.9-1.1): Specimens with to
ratio between 0.9 and 1.1 are
consideredCatalog NurnEcr and retesting these
»ecimens in duplicates is required to .71 the iriti4
rewlts.

Stevens. C. E. , P. E. and M. J. Tong. 1988. Vira

 N
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Follow*tp, confirmation and supplementary Of any positive imen with other analytical system
(e.g. 2.
Krugmm. 1987. Yeast-cocotnt*nant T. Tey. G. N,vyas, hepatitis R B V. EmcS%y with
irwnune
Of perin
JAMA 14
P. t P.E.
H. Y. Yip
contrd
infection
vacdnajo
%ection.
90(Subp
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INtTI
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TiO
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Foaow-up
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m
56 53
3
Pad-mts 273 27 26 99.64%