Anovelwaytodiagnoseacutepancreatitisonthespot
Actim®Pancreatitisisauniquepoint-of-caretesttoreliablyscreenacutepancreatitiswhenspeedisvital.
Acutepancreatitisisacommoninflammatoryconditionassociatedwithhighmorbidity,mortality,andhospitalizationcosts.Earlytreatmentiscriticalwhenacutepancreatitisoccurs,butthenonspecificsymptomsmakediagnosischallenging.
Basedontrypsinogen-2,themostaccuratebioMarkeravailable,ActimPancreatitisistheonlytestthatcanidentifyacutepancreatitisatanyphaseofinflammation.Asaresult,severepancreatitisisdiagnosedearly,patientscanbetreatedefficiently,andunnecessarytreatment,CT-scans,andcostsareavoided.
- Reliablyrulesoutacutepancreatitisfromsimpleurinesample
- Canbeusedatanystageofthedisease
- Moresensitiveandspecificthanamylaseandlipasetests
- Easy-to-useone-stepdipsticktest
- Givestestresultsatthebedsideinjust5minutes
- Nolaboratoryresourcesorsampleprocessingisneeded
- Thetestkitcontainsallnecessarymaterialsandcanbestoredatroomtemperature
- Availableinmultiplepackagesizes
HowActimPancreatitisworks
Actim®Pancreatitisrapidtestisbasedonhighlyspecificmonoclonalantibodiesthatdetectthepancreaticenzymetrypsinogen-2inurine.Trypsinogen-2istheoptimalbiomarkerforacutepancreatitis.Itispresentthroughoutpancreaticinflammation–fromthebeginninguntildaysafterthesymptomshavestarted.
AsActimPancreatitisdetectstrypsinogen-2concentrationsaslowas50μg/landupto100,000μg/l,itcanreliablydetectbothadvancedsymptomaticacutepancreatitisaswellasearlyasymptomaticpancreatitis.
Witheven100%sensitivity,ActimPancreatitisidentifiestheriskofacutepancreatitisalsoinpatientswhowouldlikelybemissedifusingamylaseorlipasetests.
Becauseofitsextremelyhigh(99%)negativepredictivevalue(NPV),ActimPancreatitiscanreliablyruleoutpancreatitiseveninasymptomaticpatients.Forthisreason,negativetestresultsdonothavetobeverifiedwithCTscansorothertests.
ABOUTTRYPSINOGEN-2
- Producedbypancreaticacinarcells
- Secretedintopancreaticjuiceasaproenzyme,trypsinogen
- Urinarytrypsinogen-2levelsarestronglyelevatedinacutepancreatitis,andremainelevatedfordays,orevenweeks
TABLE1. ActimPancreatitissurpassesbothlipaseandamylasetestingindetectingandrulingourpancreatitiswith100%sensitivity.
| Sensitivity% | Specificity% | |
| ActimPancreatitistest | 100 | 96 |
| Lipase3N | 53 | 99 |
| Amylase3N | 41 | 95 |
TABLE2. ActimPancreatitisisahighlysensitiveandspecificscreeningtoolforacutepancreatitis.WithahighNPV,Actimpancreatitisisabletoconfidentlydeterminepatientsthatarenotexperiencingpancreatitis,alsoamongthoseatriskofpost-ERCPacutepancreatitis.
| Reference | Subjects | AP | Sensitivity% | Specificity% | PPV% | NPV% |
| Kemppainenetal.,1997 | 500 | 53 | 94 | 95 | 68 | 99 |
| Kylänpää-Bäcketal.,2000 | 525 | 45 | 96 | 92 | 54 | 99,6 |
| Kylänpää-Bäcketal.,2002 | 237 | 29 | 93 | 92 | 63 | 99 |
| Chenetal.,2005 | 165 | 67 | 90 | 86 | 81 | 92 |
| Jangetal.,2007 | 191 | 19 | 100 | 96 | – | – |
| Post-ERCP-patients | ||||||
| Kemppainenetal.,1997 (quantitativetest,6hpostoperation) | 106 | 11 | 81 | 97 | – | – |
| Sankaralingametal.,20017 (dipsticktest,1hpostoperation) | 29 | 5 | 100 | 91 | 66 | 100 |
| Sankaralingametal.,20017 (dipsticktest,4hpostoperation) | 29 | 5 | 100 | 96 | 80 | 100 |
HowActimPancreatitishelps
Thereiscurrentlynogoldenstandardfordiagnosingacutepancreatitis.Actim®Pancreatitisissuperiortootheravailableoptions,becauseitis
- basedontrypsinogen-2,which,unlikeamylase,isspecifictothepancreasandstayselevatedforevenweeks
- moresensitivethanlipase-basedtests
- easytoperform,lowcost,andrADIation-free,asopposedtoCTscans
ActimPancreatitisisthefirstandonlydipsticktestthatenablesdiagnosisofacutepancreatitisonthespot–withouttheneedforsampleprocessingorlaboratoryequipment.Rapidandreliablebedsidediagnosisallowstimelytreatmentandreducesdiagnosticcosts.
WithActimPancreatitis,pancreaticinflammationresultingfromendoscopicretrogradecholangiopancreatography(ERCP)canalsobereliablyexcluded,allowinglow-riskpatientstobedischargedsoonaftertheprocedure.
ActimPancreatitissaveslives,time,andmoney
- Quickandreliablescreening
- Medicalattentioncanbedirectedtopatientswhoneedit
- UnnecessaryexpensiveCTscanscanbeavoided
- Noneedforlaboratoryfacilities
- Reducesavoidablehospitalvisitsandpatienttransfers
HowtouseActimPancreatitis
Actim®Pancreatitistestkitcontainsallnecessarymaterialsandcanbestoredatroomtemperature:2–25°C
- Samplecollection
Collecturinesample,min.500μl
- Activatethetest
Placetheyellowdipareaintothesampleandholditthereuntilyouseetheliquidfrontentertheresultarea.
Removethedipstickfromthesampleandplaceithorizontal.
- Interpretresults
ApositiveresultcanbereadassoonasitbecomesvisIBLe.Twobluelines=symptomsmaybeduetoacutepancreatitisandmoreinvestigationisneeded.
Anegativeresultshouldbeconfirmedat5minutes.Oneblueline=symptomsarenotduetoacutepancreatitis.
HowtoorderActimPancreatitis
Actim®Pancreatitistestkitsareavailableinmultiplepackagesizes.Alltestkitscontain:
- Dipsticks(individuallypacked)
- Instructionsforuse
Orderinginformation
- ActimPancreatitis20testkit,ref:32732ETAC
- ActimPancreatitis10testkit,ref:32731ETAC
- ActimPancreatitisControls,ref:32700ETAC
Actim®PancreatitisControlsareintendedtobeusedwiththeActimPancreatitistestforexternalqualitycontrol.Thecontrolsmayalsobeusedtodemonstratenegativeresultsandweakandstrongpositiveresults.Thecontrolsetincludesnegative,lowpositive,andhighpositivecontrolsaswellasreconstitutionsolution.
ActimPancreatitisbrochures
| ActimPancreatitisbrochure,English | Download |
| ActimPancreatitisbrochure,Finnish | Download |
ActimPancreatitisinstructionsforuse
| ActimPancreatitistestIFU | Download |
| ActimPancreatitisControlsIFU | Download |
Technicaldocuments
| DeclarationofConformityActimPancreatitistest | Download |
| DeclarationofConformityActimPancreatitisControls | Download |
| MSDSActimPancreatitistest | Download |
| MSDSActimPancreatitisControls | Download |
| ISO13485:2016certificate | Download |
| ISO13485:2003CMDCAScertificate | Download |
ActimPancreatitisscientificdocuments
| ActimPancreatitispublications | Download |
| ActimPancreatitisstudysummary,ERCP | Download |
| ActimPancreatitisstudysummary,Kemppainen | Download |
Medix Biochemica，一家享誉世界的芬兰公司，三十余年来一直专注于体外诊断相关原料、尤其是体外诊断试剂核心组份、如单克隆抗体、抗原等原料的供应，涵盖了炎症、激素、肿瘤、甲状腺、心血管、糖尿病、骨代谢、肾损伤、传染病、血清学等领域。 自1994年起公司所有产品均通过体外培养技术生产，并遵循ISO13485以及FDA质量管理条例(QSR)。通过体外培养生产工艺及生产过程中的数百个质量控制点，有效避免了小鼠腹水的个体差异及非特异性蛋白导致的抗体批间差，批产量达200克、质量稳定可靠，并因此成为世界范围内体外诊断用单克隆抗体的首选供应商之一。 为了更贴近国内企业，更好地理解和满足国内企业的需要、支持国内IVD行业的发展，Medix Biochemica于2016年2月29日成立中国全资子公司---上海墨迪斯医疗技术有限公司，并于2017年8月在上海成立应用实验室，这也是外资IVD原料企业在国内的第一个应用实验室。 公司将立足中国，逐步进行本地化合作、研发、和生产，真正做到植根国内，为国内体外诊断试剂的发展和国产化添砖加瓦。
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