Thereliablewaytoidentifyandruleouttheriskofpretermdelivery
Actim®Partusisafastandreliablepoint-of-caretesttoidentifypregnantwomenwitharealriskofpretermorimminentdelivery,evenbeforevisIBLesigns.
Pretermdelivery(birththatoccursbeforethe37thweekofpregnancy)istheleADIngcauseofnewbornmorbidityandmortality.Earlydetectionofhigh-riskpregnanciesischallenging.Halfofpregnantwomenexperienceassociatedsymptoms,yetonly20%oftheseareatrealriskofimmediateorpretermdelivery.
ActimPartusisasimpleandaccuraterapidtesttoidentifyorruleouttheriskofpretermdeliveryfromweek22untilbirth.Thetestcanbeusedforallpregnantwomen,anditisreliableeveninthepresenceofinterferingsubstances.AnegativeActimPartusresultindicatesthatimminentdeliveryishighlyunlikely;low-riskpatientscanthusreturnhome,overtreatmentisavoided,andvaluableresourcesaresaved.
- Reliablyrulesouttheriskofimminentorpretermdeliverywhenfetalmembranesareunbroken
- Canbeusedfromweek22onwards
- Easy-to-useone-stepdipsticktest
- Givestestresultsatthebedsideinjust5minutes,withsamplingcompletedinseconds
- Testresultsarenotaffectedbyurine,intercourse,semen,vaginalmedications,lubricants,bathingproducts,orinfections
- Thetestkitcontainsallnecessarymaterialsandcanbestoredatroomtemperature
- Availableinmultiplepackagesizes
HowActimPartusworks
Actim®Partusidentifiestheriskofpretermdeliverythroughasimplecervicalswabsample.Therapidtestisbasedonhighlyspecificmonoclonalantibodiesthatbindtothephosphorylatedformofinsulin-likegrowthfactorbindingprotein-1(phIGFBP-1).phIGFBP-1isproducedinthedecidua,butleaksintothecervixwhenthedeciduaandchoriondetach.
ApositiveActimPartustestresultindicatesthepresenceoftissuedamage,whichmayleadtopretermdelivery.Anegativetestresult,inturn,meansthattherearenosignificantchangesinthechoriodeciduallayer.Deliveryisthereforeveryunlikelywithinthenext1–2weeks,evenifthepatienthascontractions.ActimPartusisdesignedtogivereliableanswersinminutes,tosupportclinicaldecision-making.
ActimPartushasaveryhigh(98%)negativepredictivevalue(NPV).Therefore,anegativetestresultrulesouttheriskofimminentorpretermdelivery.
BecauseActimPartusisspecifictophIGFBP-1,testscanbecompletedeveninthepresenceofsemen,urine,infections,andmedicalproducts.
ABOUTPHIGFBP-1
- Producedbydecidua
- Leaksintothecervixwhendeciduaandchoriondetach
- phIGFBP-1inacervicalswabisanindicatorfortissuedamage
TABLE1.ClinicalevidenceofActimPartusasapredictorofdeliverywithin7days.
| Reference | Numberofpatients | GA(wk) | Sensitivity% | Specificity% | PPV% | NPV% |
| Tripathietal.,2016 | 468 | 28-36 | 95 | 92 | 86 | 97 |
| Azlinetal.,2010 | 51 | 24-36 | 80 | 94 | 57 | 98 |
| BrikSpinellietal.,2010 | 276 | 24-34 | 73 | 66 | 22 | 95 |
| Taniretal.,2009 | 68 | 24-37 | 93 | 79 | 56 | 98 |
| Erogluetal.,2007 | 51 | 24-35 | 83 | 84 | 42 | 97 |
| Tingetal.,2007 | 94 | 24-34 | 69 | 78 | 39 | 92 |
| Lembetetal.,2002 | 36 | 20-36 | 94 | 85 | 83 | 94 |
HowActimPartushelps
Identifyingpatientswhohaveharmlesscontractionsfromthoseatrealriskofpretermdeliverycanbedifficult.Inpractice,thismeansthatover-diagnosisandover-treatmentarecommon.
ActimPartus®isalreadyinuseallovertheworldandithasbeenincludedin severalnationaltreatmentguidelines.
ActimPartussaveslives,time,andmoney
- Medicalattentioncanbedirectedtopatientswhoneedit
- Earlyidentificationofhigh-riskpregnanciesallowstimelytreatment
- Low-riskpatientswhodonotneedimmediatecarecanbesenthome
- Unnecessaryuseofmedicationandtheirside-effectscanbeavoided
- Reducesunrequiredhospitalizationandpatienttransfers
- Givesexpectingmotherspeaceofmind
HowtouseActimPartus
TheActim®Partustestkitcontainsallnecessarymaterialsandcanbestoredat:
- Roomtemperature:2–25°C
- Upto30°Cfor2months
- Collectacervicalsecretionsampleusingaspeculum
Holdtheswabinfor10-15seconds.
IfActimPartusiscombinedwithActimPROM,separatesamplesneedtobetakenforthetwotests.ThesampleforActimPartustestmustbetakenfromthecervix,whileavaginalsampleisusedforActimPROMtest.
- Extractspecimen
PlacetheswabintheSpecimenExtractionSolution,swirlaroundvigorouslyfor10-15seconds,anddiscardtheswab.
- Activatethetest,step1
Placetheyellowdipareaintotheextractedsampleandholditthereuntilyouseetheliquidfrontentertheresultarea.
- Activatethetest,step2
Removethedipstickfromthesolutionandplaceitinahorizontalposition.
- Interpretresults
Apositiveresultcanbereadassoonasitbecomesvisible.Twobluelines=riskofpretermorimminentdeliveryishigh.
Anegativeresultshouldbeconfirmedat5minutes.Oneblueline=pretermorimminentdeliveryishighlyunlikely.
ActimPartuscanbeinterpreteddigitallywithActim®1ngeniinstrument
HowtoorderActimPartus
Actim®Partustestkitsareavailableinmultiplepackagesizes.Alltestkitscontaininstructionsforuseandindividuallypackedtestpouchesincluding:
- Dipstick
- SpecimenExtractionSolutiontube
- Sterilepolyesterswab
- Briefinstructionsforuse
Orderinginformation:
- ActimPartus10testkit,ref.31931ETAC
- ActimPartus1testkit,ref.31930ETAC
- ActimPartusSampleCollectionkit,ref.31935ETAC
Including20buffers+20swabs
- ActimPartusControls,ref:31900ETAC
Actim®PartusControlsareintendedtobeusedwiththeActimPartustestforexternalqualitycontrol.Thecontrolsmayalsobeusedtodemonstratenegativeresultsandweakandstrongpositiveresults.Thecontrolsetincludesnegative,lowpositive,andhighpositivecontrolsaswellasreconstitutionsolution.
ActimPartusbrochures
| ActimPartusbrochure,English | Download |
| ActimPartusbrochure,Spanish | Download |
| ActimPartusbrochure,Chinese | Download |
| ActimPartusbrochure,Finnish | Download |
ActimPartusinstructionsforuse
| ActimPartustestIFU | Download |
| ActimPartusControlsIFU | Download |
Technicaldocuments
| DeclarationofConformityActimPartustest | Download |
| DeclarationofConformityActimPartusControls | Download |
| MSDSActimPartustest | Download |
| MSDSActimPartusControls | Download |
| ISO13485:2016certificate | Download |
| ISO13485:2003CMDCAScertificate | Download |
Scientificdocuments
| ActimPartuspublications | Download |
| ActimPartusstudysummaryTaniretal. | Download |
| ActimPartusstudysummaryKekkietal. | Download |
