Cenogenics

BENGAL
ROSE ANTIGEN
BRUCELTA
@C€

IN T E N D E D
USE
C E N OGE N IC S 'ROSEBENGAL BRUCELLAANTIGEN iS A
bacterialsuspension testto detect
for use in the slideagglutination
the presenceof bacterialagglutininsassociatedwith Brucella
infections or previousexposure.

P R IN C IP L EOF
S THE PROCEDURE
When viable bacteriaare introducedinto a susceptiblehost, an
immuneresponsegenerallyoccurs.This immuneresponseresults
in the production The principleof
of antibodiescalledagglutinins.
the test is an immunological reaction(agglutination)
betweenthe
antibodiesproducedto the viable bacteria(agglutinins) and the
corresponding bacterialantigen.

MA T E R IA L P
S R OVIDED
FOR CATALOGNO. FA-43AND FA.44
ROSE BENGAL BRUCELLAANTIGEN:ConcentratedBrucella
abortus,strain11'19-3,
suspendedin a buffereddiluentand stained
with RoseBengalDye.
Productinstructions

FOR CATALOGNO. FK.45

ROSEBENGALBRUCELLA ANTIGEN:Concentrated Brucella
abortus,strain'1119-3,
suspendedin a buffereddiluentand stained
with RoseBengalDye.
BRUCELLA P OS ITIVE CONTROL: Stabilized
dilutedr abbitser um
containingantibodies
to Brucellaantigen.
BRUCELLANEGATIVECONTROL: Stabilizeddiluted human
serumnonreactive for Brucellaantigen.
6-Wellwhiteslide
Productinstructions

MA T E R IA L R
S E QUIREDBUT NOT PROVIDED
Pipetsfor dispensingpatient
serum
MixingSticks
Timer
ROSEBENGALBRUCELLA
ANTIGEI{ PAGE1 OF 4
STORAGE
Storeall reagentsat 2"-8'C.Do not freeze.

PRESERVATIVES
R OS E B E N GA LBRUCELLAANTIGEN:Pr eser vedwith 0.5%
phenol.BRUCELLAPOSITIVECONTROL:Preserved withsodium
a zi d e ,0 .1 %.B R UCELLANEGATIVECONTROL:Pr eser ved
with
so d i u ma zi d e 0
, j%

PRECAUTIONS
1. The sourcematerialfromwhichthe negativecontrolwas
preparedwas testedand foundto be nonreactive for HBsAg,
HCV and HlV.No knownmethodcan offerassurance thatthe
productderivedfrom humanbloodwill not transmit
infectious agents.HANDLEAS lF CAPABLEOF
T R A N S MIT TING
INFECTIOUS DISEASE.
2. For in vitrodiagnostic
use.
3. The Brucellapositiveand negativecontrolscontainsodium
azideas a preservative.This materialis knownto form
explosivemixturesin the presenceof leadcompounds. Use
copiousamountsof waterto rinseslidesaftercompletion of the
test.
4. Do not use reagentsafterthe expirationdate.

S P E C IME N S
Usefreshlycollectedserum.The serumspecimenshouldbe stored
refrigerated.
lf the testingis to be prolongedin excessof 24 hours,
serumshouldbe frozen.Bacterial contaminationmaycauseprotein
denaturation. All sera to be tested shouldbe clear and free of
bacterialcontamination.

REAGENTPREPARATION
Rose BengalBrucellaantigenand controlsare readyto use. No
preparation
is required.

P R OC E D U R E
1. Bringreagentsand serumspecimens to roomtemperature.
2. Deliver30;rlof the serumsampleto a circleon the whiteslide.
Use a cleanpipet(or pipettip) for eachspecimen.
3. Mix the RoseBengalBrucellaantigengentlybutthoroughly.
Usingthe dropperprovided,deliverone drop(30p1) of the
reagentto eachserumsample.
4. Usinga cleanmixingstickfor eachspecimen, mixthe serum
and the reagentand spreadoverthe entirecircle.
5. Rotatethe slidefor 4 minutes.
6. Observeundera brightlightsourcefor the presenceof
agglutination.

ROSEBEI{GALBRUCELLA
ANTIGEI{ PAGE2 OF 4
RESULTS
POSITIVE: A positiveresultis indicated (clumping)
by agglutination
of the bacterial
suspension.
NEGATIVE:A negativeresult is indicatedby the absenceof
agglutination.

OU A L IT YC ONTROL
It is recommended thata Brucellapositiveand a Brucellanegative
controlbe testedalongwith the patientserumfor qualitycontrol
p u rp o se s.
U se CENOGENICS' BRUCELLA POSITIVE CONTROL
and BRUCELLANEGATIVE CONTROLin placeof patientsample
and performtestas described above.

L IMIT A T IONOF
S THE PROCEDURE
1 . Agglutininsare not alwaysproducedin bacterialinfections.
2. Crossreactionsmay occurin certainpathologies. For
instance,Tularemia may produceagglutinins
infections to
Brucellaantigens.
3. Vaccinations may producecrossreactingantibodies.

EXPECTED VALUES
Agglutininsare producedslowlyduringthe acutephaseof inlection
and continuetc form duringthe convalescent phaseof infection.
The titer of the concentrationof antibodyrises considerably
betweenacute infectionand convalescence. Therefore,a rise in
titerbetweenserumcollectedduring-the acute,or febrile,stageof
infection
and serumcollectedduringthe convalescentstagecanbe
of diagnostic
significance.

R E F E R E N C ES
1. D ye r,R .E .,J.A,M.A.,124:1165,1944.
2 . F e l i x,A ., B ri t.Md.J., 11:597,1- 942-
3. Spink,W.W.,Amer.J. Clin.Path.,22:201,1952.
4 . We l ch H 1936.
, . & Stuar t,C.A.,J. Lab.Clin.Med.,21' .411,
5. Nicoletti, R, J. Am. Vet.Med.Assoc.,151:1778-1793,1967.
6. Morgan,W.J,,et al, Vet.Rec.,85:636-640, 1969.
7 . R o se ,J.E .,Roepke,M.H.,Am .J. Vet.Res.,18:550- 555,1957.

ANTIGEN
BRUCELLA
ROSEBENGAL PAGE3 OF 4
 CE NO G E NI CSCO RP O RA T I O N
Registeredto ISO 9001 and ISO 13488
Morganville,N.J. 07751

Printedin U.s.A.
PG-0697-02

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ANTIGEN PAGE4 OF 4