Theoriginalrapidtestfordetectingprematureruptureoffetalmembranes
Actim®PROMistheworld’sfirstrapidtestforreliablydetectingprematureruptureoffetalmembranes(PROM)inallpatients.Thesuperiorperformanceoftheeasy-to-userapidtesthasrevolutionizedpregnancymonitoringformillionsofwomen.
PROMisthemostcommonidentifiablecauseofpretermbirthsandamajorcauseofmaternalandfetalmorbidity.CorrectPROMdiagnosisisimportanttoguidetreatmentandtominimizecomplications.However,PROMsymptomsdifferbetweenpatients,whichmakesdiagnosisdifficult.
TheoriginalActimPROMtestisthefastestandmostaccuraterapidtestonthemarket:itgivesreliableresultsinminutes,eveninthepresenceofbloodorotherinterferingsubstances,makingthetestsuitableforallwomenwithsUSPectedPROM.AsActimPROMhasbeencarefullydesignedtodetectevennon-visIBLerupturesinfetalmembranes,correcttreatmentcanbestartedearly.AccuratePROMdiagnosistargetstreatmenttothosewhoneedit,whichimprovespatientsafetyandreducescosts.
- FirstrapidtestthatreliablydetectsPROM,evenbeforeanyclinicallyvisiblesigns
- Canbeusedatanygestationalage
- Easy-to-useone-stepdipsticktest
- Givestestresultsatthebedsideinjust5minutes,withsamplingcompletedinseconds–withorwithoutspeculum
- Testresultsarenotaffectedbyblood,intercourse,semen,urine,vaginalmedications,lubricants,bathingproducts,orinfections
- Thetestkitcontainsallnecessarymaterialsandcanbestoredatroomtemperature
- Availableinmultiplepackagesizes
HowActimPROMworks
TheActim®PROMrapidtestisbasedonhighlyspecificmonoclonalantibodiesthatbindtotheinsulin-likegrowthfactorbindingprotein-1(IGFBP-1)presentinamnioticfluidinhighamounts.Amnioticfluidisnormallynotfoundinthevagina,butwhenfetalmembranesrupture,amnioticfluidleaksintothevaginaandtheIGFBP-1concentrationquicklyrisesandremainshighuntildelivery.ActimPROMdetectsIGFBP-1invaginalswabsamplesandhelpstoidentifymembraneruptures.
Thankstoitshighsensitivity,ActimPROMdetectsevenlowconcentrationsofIGFBP-1causedbymicro-rupturesinthefetalmembrane.ThesetinyrupturescannotbedetectedwithtrADItionalmethods,butareclinicallyrelevantastheycaninducedelivery,causeinfections,andthreatenthehealthofbothmotherandchild.
BecauseActimPROMisspecifictoamnioticfluidIGFBP-1,testscanbecompletedeveninthepresenceofbloodandotherbodilyfluids,infections,andmedicalproducts.
AboutIGFBP-1
- HighlyspecificbioMarker
- Producedindecidualcellsandsecretedintoamnioticfluid
- Existsinlargeamountsinamnioticfluid
- IGFBP-1inavaginalsampleindicatespresenceofamnioticfluid
TABLE1.ActimPROMhasoutstandingsensitivity,specificity,andaccuracyinPROMdiagnosis.(Erdemoglu&Mungan,2004)
| Sensitivity% | Specificity% | Accuracy | |
| ActimPROMtest | 97 | 97 | 97 |
| Nitrazinetest | 97 | 16 | 56 |
| AFI<80mm | 94 | 91 | 92 |
TABLE2.ClinicalevidenceofaccuratePROMdiagnosiswithActimPROM.
| Numberofpatients | Sensitivity% | Specificity% | PPV% | NPV% | |
| Rutanenetal.,1996 | 130 | 100 | 95 | 93 | 100 |
| Ragoshetal.,1996 | 75 | 100 | 83 | 83 | 100 |
| JainandMorris,1998 | 100 | 100 | 89 | 76 | 100 |
| KubotaandTakeuchi,1998 | 90 | 95 | 93 | 90 | 96 |
| Akercanetal.,2005 | 87 | 100 | 92 | 84 | 100 |
HowActimPROMhelps
Traditionally,diagnosisofPROMhasbeenbasedonavarietyofclinicalsymptoms.Asthesymptomscanbeverydifferentbetweenpatients,PROMdiagnosishasoftendifficult,inaccurate,andtime-consuming.RapidandreliablePROMdiagnosiswithActim®PROMimprovespatientcareandsavesvaluableresources.
ActimPROMisatrustedoptioninover70countriesanditismentionedinseveralnationaltreatmentguidelines.
ActimPROMsaveslives,time,andmoney
- Medicalattentioncanbedirectedtopatientswhoneedit
- Unnecessaryuseofmedicationandtheirside-effectscanbeavoided
- Unrequiredlaborinductionsareminimized
- Reducesavoidablehospitalvisitsandpatienttransfers
- Givesexpectingmotherspeaceofmind
HowtouseActimPROM
Actim®PROMtestkitcontainsallnecessarymaterialsandcanbestoredat:
- Roomtemperature:2–25°C
- Upto30°Cfor2months
Collectsamplewithorwithoutspeculum
Holdtheswabinvaginafor10-15seconds.
IfActimPROMiscombinedwithActimPartus,separatesamplesneedtobetakenforthetwotests.AvaginalsampleisusedforActimPROMtest,whilethesampleforActimPartustestmustbetakenfromthecervix.
Extractspecimen
PlacetheswabintheSpecimenExtractionSolution,swirlaroundvigorouslyfor10-15seconds,anddiscardtheswab.
Activatethetest,step1
Placetheyellowdipareaintotheextractedsampleandholditthereuntilyouseetheliquidfrontentertheresultarea.
Activatethetest,step2
Removethedipstickfromthesolutionandplaceitinahorizontalposition.
Interpretresults
Apositiveresultcanbereadassoonasitbecomesvisible.Twobluelines=membranesareruptured.
Anegativeresultshouldbeconfirmedat5minutes.Oneblueline=membranesareintact.
ActimPROMcanbeinterpreteddigitallywithActim®1ngeniinstrument
HowtoorderActimPROM
Actim®PROMtestkitsareavailableinmultiplepackagesizes.Alltestkitscontaininstructionsforuseandindividuallypackedtestpouchesincluding:
- Dipstick
- SpecimenExtractionSolutiontube
- Sterilepolyesterswab
- Briefinstructionsforuse
Orderinginformation
- ActimPROM20testkit,ref:30832ETAC
- ActimPROM10testkit,ref:30831ETAC
- ActimPROM1testkit,ref:30830ETAC
- ActimPROMControls,ref:30800ETAC
Actim®PROMControlsareintendedtobeusedwithActimPROMtestforexternalqualitycontrol.Thecontrolsmayalsobeusedtodemonstratenegativeresultsandweakandstrongpositiveresults.Thecontrolsetincludesnegative,lowpositive,andhighpositivecontrolsaswellasreconstitutionsolution.
- ActimPROMIEMA(ELISA)test,ref:10851ETMB
ActimPROMbrochures
| ActimPROMbrochure,English | Download |
| ActimPROMbrochure,Spanish | Download |
| ActimPROMbrochure,Chinese | Download |
| ActimPROMbrochure,Finnish | Download |
ActimPROMinstructionsforuse
| ActimPROMtestIFU | Download |
| ActimPROMControlsIFU | Download |
Technicaldocuments
| DeclarationofConformityActimPROMtest | Download |
| DeclarationofConformityActimPROMControls | Download |
| MSDSActimPROMtest | Download |
| MSDSActimPROMControls | Download |
| ISO13485:2016certificate | Download |
| ISO13485:2003CMDCAScertificate | Download |
Scientificdocuments
| ActimPROMpublications | Download |
| ActimPROMstudysummaryKallioniemietal. | Download |
| ActimPROMstudysummaryKubotaetal. | Download |
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