Ikimenyetso cyumutima Ikizamini cyihuta - POCT Ihingura & Abashoramari

Ibicuruzwa

Inzobere Yumutima Yumutima Yumwanya & Ingaragu - Urutonde rwibimenyetso

Kuva kumurongo umwe - marike cassettes kugeza kumutima wumutima wihuta kwisuzumisha ikizamini combo panel, muri zahabu ya colloidal na numero ya fluorescence kumiterere yihutirwa ningingo - ya - gukoresha ubuvuzi.

Ibyerekeye Uru Rwego

Niki Ikimenyetso Cyumutima Ikizamini Cyihuta?

Ikizamini cyumutima POCT gipima byihuse poroteyine zasohotse mugihe imitsi yumutima ihangayitse cyangwa yakomeretse. Cardiac troponin I na T (cTnI / cTnT) ni umutima cyane - ibimenyetso byihariye byo gukomeretsa myocardial; CK - MB izamuka nyuma hanyuma ifasha gusuzuma refarction; myoglobin izamuka kare ariko ntabwo ari umutima - wihariye; NT - proBNP yerekana guhagarika urukuta rwumutima mumutima - gusuzuma kunanirwa; na D - dimer ishyigikira umurimo - hejuru yibintu bikekwa kuba tromboembolique.

Urutonde

Troponin I Ikizamini Cyihuta, Ikarita Yumutima Troponin T, CK - MB Cassette Yihuta Yihuta, Myoglobin Ikizamini Cyihuta, NT - proBNP Cassette Yihuta Yihuta na D - Dimer Rapid Ikizamini.

Imiterere

Ingaragu - marike cassettes wongeyeho 3 - muri - 1 Ikizamini cyumutima (cTnI + CK - MB + Myo) kumwanya - gukingira idirishya, hamwe na Cardiac Combo Rapid Test Kit.

Uburyo

Colloidal zahabu itembera kugirango isuzumwe byihuse, hamwe na fluorescence immunoassay yo kwibanda ku bwinshi binyuze mu gusesengura.

Ubuyobozi bwa Tekinike

Ikimenyetso Cyumutima Cyumutima Ikizamini cyihuse

Ingingo - ya - care protocole yo gukoresha umwuga kandi byihutirwa. Buri gihe ukurikire IFU; ibisubizo bisaba ibisobanuro byubuvuzi hamwe na ECG hamwe no gupima serial.

Kusanya Icyitegererezo

Kusanya amaraso yose (urutoki cyangwa imitsi), serumu cyangwa plasma kubikoresho IFU.

Tegura Icyitegererezo

Hindura ingano yagenwe muri buffer / diluent nkuko byasobanuwe muri IFU.

Koresha Igikoresho

Ongeraho icyitegererezo cyateguwe kuri cassette neza, cyangwa ushyire karitsiye mubisesengura bya fluorescence.

Soma & Guhuza

Soma mu buryo bugaragara mugihe cyagenwe, cyangwa usome agaciro kagereranijwe uhereye kubisesengura, hanyuma uhuze na ECG, ibimenyetso nibipimo bikurikirana kuri protocole yubuvuzi.

Ikoranabuhanga

Fluorescence Immunoassay & Ikoranabuhanga ryinshi

Fluorescence immunoassay yumutima yumutima yumutima byombi byumye - amakarito ya fluorescence hamwe nisesengura ryuzuye kugirango tumenye neza neza cTnI, CK - MB, myoglobin na NT - proBNP muminota mike, mugihe imiterere ya zahabu ya colloidal itanga umutima wihuse wumutima wa enzyme yihuta yipimisha ibikoresho byihutirwa - byombi byubatswe mubikorwa byihutirwa.

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Kumenya ako kanya

10 - Isomero rito ryo gusoma, rifite akamaro kubutegetsi bwa AMI - muri / amategeko - hanze.

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Kumva neza

0.5 ng / mL cTnI LoD ihujwe nubuyobozi bwa ESC.

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Igihagararo cyo hejuru

24 - ukwezi kuramba, kubika ubushyuhe bwicyumba (2–30 ° C).

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Gusoma byoroshye

Guhuza kubigaragara byujuje ubuziranenge & fluorescence ibisubizo byuzuye.

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Imikorere yoroshye

Imwe - intambwe hamwe na buffer & cassette; nta centrifugation cyangwa pre - kwivuza bisabwa.

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Inganda nini

Imirongo yikora itanga umusaruro ~ 500K + ibizamini byumutima kuri buri mwanya.

Kubahiriza amabwiriza

Impamyabumenyi & Ibyemezo byemewe

Ibikoresho byubuhumekero byubuhumekero bikozwe muburyo bwemewe bwo gucunga neza kandi bigasukurwa ku masoko akomeye ku isi.

Icyemezo cya ISO 13485

Icyemezo cya ISO 9001

Icyemezo cya MDSAP

Burezili ANVISA BGMP

Koresha Imanza

Ni hehe Ikizamini Cyumutima Ikoreshwa Byihuta?

Yashizweho kugirango ashyigikire protocole yo kurwanya indwara mu nzego zose z’ibikorwa remezo byubuzima.

Emergency Department & Chest-Pain Triage

Ishami ryihutirwa & Isanduku - Kubabara

Shigikira ibyago byihuse kurwego rwa ECG hamwe na protocole ya troponine.

Ambulance & Pre - Ibitaro

Fasha isuzuma hakiri kare munzira, nkigitekerezo kimwe mubyemezo byubuvuzi - gufata.

Indwara z'umutima & Umutima - Amavuriro yananiwe

NT - proBNP inkunga mumutima - gusuzuma kunanirwa kwitabwaho ninzobere.

Abatanga & OEM Ibirango

Ikirangantego cTnI / CK - MB / Myo / NT - proBNP igizwe numuyoboro wubuvuzi wabigize umwuga kwisi yose.

Inkunga & Serivisi

Ibibazo Bikunze Kubazwa & Ibisubizo

Troponine, CK - MB, myoglobin na NT - proBNP bipima iki?

Troponine (I / T) ni umutima cyane - ikimenyetso cyihariye cyumutima - gukomeretsa imitsi; CK - MB ifasha gusuzuma reinfarction; myoglobin izamuka kare ariko ntabwo ari umutima - wihariye; NT - proBNP yerekana umutima wumutima wumutima - gusuzuma kunanirwa. Bakoreshwa hamwe na ECG nibisubizo byubuvuzi.

Ikizamini kimwe cyihuta cya troponine gishobora kwemeza cyangwa kwirinda indwara y'umutima?

Oya. Igisubizo kimwe hakiri kare - harimo n'ikibi - ntigishobora kwemeza cyangwa gukuraho infira ya myocardial. Gusuzuma bisaba ECG, gusuzuma ivuriro no gupima troponine ikurikirana byasobanuwe numuvuzi. Ibi bizamini ni imfashanyo gusa.

Ubuzima bwo kubika nububiko bumeze bute?

Mubisanzwe amezi 24 uhereye kubikorwa, bibitswe bifunze kuri 2-30 ° C. Emeza ibicuruzwa byihariye IFU.

Umutima Wumutima

Umufatanyabikorwa hamwe nu ruganda rwahujwe na IVD mu Bushinwa kugirango habeho ibikoresho byinshi byerekana umutima. Dutanga iherezo - kugeza - kurangiza kwihererana - cTnI, CK - MB, myoglobin, NT - proBNP na D - ibikoresho bya dimer muburyo bwa zahabu ya colloidal cyangwa fluorescence, hamwe nibipfunyika byanditseho hamwe nindimi nyinshi IFUs - kubakwirakwiza nibirango bisuzumwa kwisi yose.

Ikoreshwa rya Multiplex

Huza ibipimo byihariye (urugero, SARS - CoV - 2 + ibicurane A / B + RSV + ADV) muri kimwe 3 - muri - 1, 4 - muri - 1, cyangwa 5 - muri - 1 cassette yikizamini ukurikije ibyifuzo byawe byo mu karere.

Ikirango cyihariye & Gupakira

Serivise yuzuye yubukorikori bwa pouches, byinshi - ururimi IFU yinjiza (Amabwiriza yo Gukoresha), hamwe namakarito yo kugurisha yo hanze ajyanye nibiranga ikirango cyawe.

Inkunga yo Gutanga Amabwiriza

Dutanga ibyangombwa bya tekiniki byuzuye, ubushakashatsi bwo kwemeza imikorere, hamwe namakuru yubuvuzi kugirango twihutishe Minisiteri yubuzima y’ibanze cyangwa CE IVDR kwiyandikisha.

Menyesha

Witegure Inkomoko Yizewe
Ikizamini cyumutima?

Cataloge itondekanya, OEM multiplex yihariye, cyangwa kugisha inama amabwiriza - itsinda ryacu ryo kugurisha ryishura imbereAmasaha 24ku minsi y'akazi hamwe n'amagambo yatanzwe.

Amapaki yubusa NDA kubisabwe Subiza mu masaha 24