This is a CLIA Waived TestSOMState of Michigan.docx
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This is a CLIA Waived TestSOMState of Michigan.docx
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ThisisaCLIAWaivedTestSOMStateofMichigan
ThisisaCLIAWaivedTest-SOM-StateofMichigan
BacterialVaginosisDetection:
OPOMBVBlueTestRL.57.01
MichiganRegionalLaboratorySystemJuly2008
A.Introduction
1.Intendeduse:
TheOSOMBVBLUETestisanenzymeactivitytestforuseinthe
detectionofvaginalfluidspecimensforsialidaseactivity,anenzyme
producedbybacterialpathogenssuchasGardnerellavaginalis,
Bacteroidesspp.,Prevotellaspp.,andMobiluncusspp.TheOSOM
BVBLUETestisindicatedforuseinwomensuspectedofhaving
BacterialVaginosis(BV),e.g.,womenwithvaginaldischargetypicalof
BVand/orwomenwithprevioushistoryofBV,asanaidinthediagnosis
ofBVinfection.Testresultsshouldbeconsideredinconjunctionwith
otherclinicalandpatientinformation(seeLimitationsoftheProcedure).
Summaryandexplanationofthetest:
2.
Vaginosisoneofthemostcommonreasonsthatwomenvisitobstetricians
orgynecologists(1–3).Thecausativeagentsofthisconditionare
bacteriasuchasGardnerellavaginalis,Bacteroidesspp.,Prevotellaspp.
andMobiluncusspp.ComplicationsassociatedwithBVinclude
salpingitis,endometritis,post-hysterectomyinfections,recurrentUTI’s,
andanincreasedriskofPIDandHIV(5–7).BVpresentsaserious
dangerinwomen,duetoitssignificantassociationwithplacentalinfection,
10).Studieshaveprematureruptureofmembranes,andpretermbirth(8–
shownelevatedsialidaseactivityinwomenwithBVandanincreasedrisk
forpretermbirthandlowbirthweightinfantsinpatientsexhibiting
elevatedsialidaseactivity(4,11–15).TheOSOMBVBLUETestis
designedtoprovideaclear,simpleindicationofelevatedsialidaseactivity
inpatientvaginalfluidsamples.Thegenerationofablueorgreencolor
indicatesapositivetestresult;ayellowcolorindicatesanegativetest
result.
3.Principlesofthetest
TheOSOMBVBLUETestincludesachromogenicsubstrateofbacterial
sialidase.Inthetestprocedure,avaginalfluidsampleisplacedintheBV
TestVessel.Thesamplethenreactswiththechromogenicsubstrate.A
DeveloperSolutionisaddedafterthereaction.Ifthesamplehasahigh
levelofsialidase,ablueorgreencolorwillbeseenintheBVTestVessel
orontheheadoftheswab.Ifthesamplehasnosialidase,orhasverylow
levels,ayellowcolorwillbeseenintheBVTestVessel.
B.Specimencollectionandstorage:
1.Collectspecimenswithaswabfromthelowerone-thirdofthevaginal
wall.Collectingspecimensfromthecervixshouldbeavoidedbecause:
a.itmightincreaserisktoOBpatients,and
b.cervicalsialidaseactivityisusuallyhigherthanvaginalsialidase
activity.
2.Donotusespecimensfrompatientswhohave:
Page1of7
BacterialVaginosisDetection:
OPOMBVBlueTestRL.57.01
MichiganRegionalLaboratorySystemJuly2008
a.usedavaginalcreamorointmentproduct,
b.douched,or
c.usedspermicides,vaginallubricantsorfemininesprayswithin72
hoursoftesting.
3.Testthepatientspecimenassoonaspossibleaftercollection.4.Iftestingisnotperformedimmediately,storetheswabseitheratroom
temperatureforupto48hoursorrefrigeratedforupto7days.5.Totransportpatientspecimens,placeeachswabinaclean,drycontainer
suchasaplasticorglasstube.Donotuseanytransportmedia.Afalse
negativeresultmayoccurifinsufficientsampleiscollectedorthesample
isobtainedfromapatientundergoingantimicrobialtherapy.
C.ReagentsandSupplies
.1.Materialsprovided
a.25TestVesselseachcontaining0.25mgIBX-4041componentin
0.5mLofanaqueouspotassiumacetatebuffersolution(49mg/mL;
0.5M;pH5.5-6.0)
b.1DeveloperSolutionBottlecontaining10.0mLofanaqueous
sodiumhydroxidesolution(40mg/mL;1.0M;pH>11.0)
c.SterileSwabs
d.1DirectionalInsert
.Materialsrequiredbutnotprovided2
a.OSOMBVBLUEControlKit
b.Timer
3.Warningsandprecautions
a.Forinvitrodiagnosticuseonly.
b.Donotuseaftertheexpirationdateprintedonthekit.
c.Donotstorethekitattemperaturesabove26?
C(79?
F).
d.Donotstorethekitinstronglight.
e.Followlaboratorysafetyguidelinesinthecollection,handling,
storageanddisposalofpatientspecimensandallitemsexposedto
patientspecimens.
f.Usedtestsshouldneverbere-used.
g.Thisproductisintendedforvaginalfluiduseonly.4.Storageandstability
a.Storethetestkitatcontrolledtemperature,2?
–26?
C(36?
-79?
F),
outofdirectsunlight.Storethetestvesselsinsidethebox.Kit
contentsarestableuntiltheexpirationdateprintedontheouter
box.
NOTE:
Iftemperaturesinyourfacilitymayexceed26?
C(79?
F),
thekitshouldberefrigeratedwhennotinusetoensurethatthe
componentsremainstableuntiltheexpirationdateprintedonthe
packaging.Allowthekittocometoroomtemperaturebefore
runningthetest.
Page2of7
BacterialVaginosisDetection:
OPOMBVBlueTestRL.57.01
MichiganRegionalLaboratorySystemJuly2008
b.Storethecontrolkitat2?
–8?
C(38?
-46?
F).Donotfreeze.The
kitisstableuntiltheexpirationdateshownonthelabel.5.Indicationsofinstability:
a.Signsofpossibleproductinstabilityinclude:
1)AbluecolorinaBVTestVesselwhenonedropof
DeveloperSolutionisaddedtotheBVTestVesselinthe
absenceofapatientspecimen.
2)Positivecontroldoesnotgiveexpectedresults.
3)Negativecontroldoesnotgiveexpectedresults.
D.Safety
Humanspecimensmayharborinfectiousagents.Usestandard(universal)precautionswhenworkingwiththesematerialsincludingglovesandeyeprotection.
E.QualityControl
1.InternalQualityControls.TheOSOMBVBLUETestcontainstwotypes
ofinternalqualitycontrolwitheachtestrun.Fordailyqualitycontrol,the
manufacturerrecommendsdocumentingthesecontrolsoneachdayof
testing:
a.Type1InternalControl:
Beforeaddingapatientspecimen,inspect
theTestVessel.Itshouldcontainacolorlessliquidwithout
precipitates(sediment).Ifthetestingvesselcontainsaprecipitate,
thetestisinvalid.DonotusetheTestVessel.
.Type2InternalControl:
TheOSOMBVBLUETesthasatwo-b
colorresultformat:
blue/greenispositive,yellowisnegative.
Afterrunningthetestaccordingtotheinstructionsforuse,the
appearanceofeitherauniformyellow,blue,orgreencolorinthe
testingvesselorablueorgreencolorontheswabassuresproper
mixingofthereagentandsamplehasoccurred.
c.Interpretationofresults.
1)Ifthetestfailstoprovideeitherablue,green,orayellow
colorresult,thetestisinvalid.
2)DonotreportpatientresultsifeitheroftheInternalQuality
Controlsdoesnotproduceexpectedresults.
2.ExternalQualityControls.ExternalControlsareusedtotestthatthe
reagentsareworkingproperly.ExternalControlsalsoverifythatthetest
procedureisperformedcorrectly.
a.AControlKitthatcontainsapositivecontrolandanegative
controlmaybepurchasedseparatelyfromGenzymeDiagnostics,
CatalogNo.184.
b.Controlsmustyieldexpectedresultsforboththepositiveand
negativeexternalcontrolsbeforeclientsamplesmaybetestedand
reported.
c.IfQCtestingfails:
1)Checkexpirationdatesofthetestkitandcontrols.
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BacterialVaginosisDetection:
OPOMBVBlueTestRL.57.01
MichiganRegionalLaboratorySystemJuly2008
2)Ensuretheinstructionsfortestingwerefollowedcorrectly.
3)Repeatthetest.
d.Ifthecontrolsstilldonotperformasexpected,contactGenzyme
TechnicalServiceat1-800-332-1042.
3.Frequencyofexternalcontrols
a.Eachweek(Monday–Friday/Saturday)oftestingpriortotesting
anyclientsamples.
b.Eachnewlot
c.Eachnewshipment
d.Eachnewuntrainedoperator.
F.Stepbystepinstructions–ExternalControls
1.Removethecontrolkitfromtherefrigeratorpriortouse.Allowthe
controlkittowarmtoroomtemperaturebeforeuse.
2.Ifthetestkitisstoredinarefrigerator,removeitpriortouse.Allowthe
testkittowarmtoroomtemperaturebeforeuse.
3.PositiveControl
a.Removeonetestvesselandthedevelopersolutionfromthetestkit
priortouse.Removethecapfromthetestvessel.
b.AddonedropofBVBluePositiveControlthetheBVtestvessel.
c.PuttheheadofaswabfromthetestkitintothesolutionintheBV
testvessel.LettheBVtestvesselcontainingtheswabstandfor10
98.6?
F).minutesbetween17?
and37?
C,(62.6?
–
d.AddonedropofdevelopersolutiontotheBVtestvessel
containingtheswab.Gentlyswirlthemixture.
e.Readtheresultsimmediatelyafterthedevelopersolution.4.NegativeControl
a.Removeonetestvesselandthedevelopersolutionfromthetestkit
priortouse.Removethecapfromthetestvessel.
b.AddonedropofBVBluePositiveControlthetheBVtestvessel.
c.PuttheheadofaswabfromthetestkitintothesolutionintheBV
testvessel.LettheBVtestvesselcontainingtheswabstandfor10
minutesbetween17?
and37?
C,(62.6?
–98.6?
F).
d.AddonedropofdevelopersolutiontotheBVtestvessel
containingtheswab.Gentlyswirlthemixture.
e.Readtheresultsimmediatelyafterthedevelopersolution.5.Expectedresults
a.PositiveControlResult:
Thepositivecontrolwillproduceablue
orgreencolorinthetestvesseland/orontheheadoftheswab.
NOTE:
Inthecaseofweakpositiveresults,taketheswaboutof
thevesseltodetermineinablueorgreencolorispresentonthe
swab.
b.NegativeControlResult:
Thenegativecontrolwillproducea
yellowc
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