Ikhithi yokuhlola esheshayo ye-Cardiac Marker - Umkhiqizi we-POCT Nomthumeli ngaphandle

Iphothifoliyo Yomkhiqizo

Iphaneli Yethu Yomaka Ochwepheshe Benhliziyo & Eyodwa-Ibanga Lomaka

Kusukela kumakhasethi e-single-umaka ukuya kuphaneli yekhithi yekhithi yokuhlola yenhliziyo eyodwa, ngegolide eli-colloidal kanye nefomethi ye-fluorescence yomthamo wezimo eziphuthumayo kanye nephoyinti-lo-ngokunakekela.

Mayelana Nalesi Sigaba

Yiziphi Izivivinyo Ezisheshayo Ze-Cardiac Marker?

Uhlolo lwe-POCT lomaka lwenhliziyo lukala ngokushesha amaprotheni akhululwa lapho umsipha wenhliziyo ucindezelekile noma ulimele. I-Cardiac troponin I ne-T (cTnI/cTnT) yizinhliziyo eziphakeme-izimpawu ezithize zokulimala kwe-myocardial; I-CK-MB ikhuphuka ngokuhamba kwesikhathi futhi isize ukuhlola ukubuyisela kabusha; i-myoglobin ikhuphuka ngaphambi kwesikhathi kodwa ayiyona inhliziyo-eqondile; I-NT-proBNP ibonisa ukucindezelwa kodonga lwe-ventricular enhliziyweni-ukuhlola ukwehluleka; kanye ne-D-dimer isekela ukusebenza-kwezehlakalo ezisolwayo ze-thromboembolic.

Ibanga Lomaka

I-Troponin I Rapid Test Kit, Ikhithi Yokuhlola Ye-Cardiac Troponin T, CK-MB Ikhasethi Lokuhlola Elisheshayo, Ikhithi Yokuhlola Esheshayo ye-Myoglobin, NT-proBNP Rapid Test Cassette kanye ne-D-Dimer Rapid Test Kit.

Amafomethi

Amakhasethi-omaka oyedwa kanye nokuhlola umaka wenhliziyo ongu-3-in-1 (cTnI + CK-MB + Myo) okwesikhathi-ukufakwa kwewindi, kanye nekhithi yokuhlola esheshayo ye-Cardiac Combo.

Izindlela

I-Colloidal gold lateral flow yokuhlolwa kwekhwalithi okusheshayo, kanye ne-fluorescence immunoassay yokugxila komthamo nge-analyzer.

Umhlahlandlela Wezobuchwepheshe

Inqubo Yokuhlola Okusheshayo Yokumaka Wenhliziyo Okuvamile

I-point-of-protocol yokunakekelwa kokusetshenziswa kochwepheshe kanye nezimo eziphuthumayo. Njalo landela IFU; imiphumela idinga ukuchazwa komtholampilo nge-ECG kanye nokuhlolwa kwe-serial.

Qoqa Isampula

Qoqa igazi eliphelele (uthi lweminwe noma i-venous), i-serum noma i-plasma ngokwekhithi ye-IFU.

Lungiselela Isampula

Dlulisa ivolumu eshiwo ku-buffer/diluent njengoba kuchazwe ku-IFU.

Faka Kudivayisi

Engeza isampula elilungisiwe kukhasethi kahle, noma ulayishe i-cartridge ku-analyzer ye-fluorescence.

Funda futhi Uhlobanise

Funda ngokubonakalayo phakathi nesikhathi esishiwo, noma funda inani lenani elivela kumhlaziyi, bese uhlobanisa ne-ECG, izimpawu kanye nezilinganiso ze-serial ngephrothokholi ngayinye yomtholampilo.

I-Core Technology

I-Fluorescence Immunoassay & Quantitative Technology

Iplathifomu yethu ye-fluorescence immunoassay cardiac marker ihambisana omile-amakhatriji e-fluorescence ane-compact analyzer ukuze abike ukugxila okunembile kwe-cTnI, CK-MB, myoglobin kanye ne-NT-proBNP ngemizuzu, kuyilapho amafomethi egolide e-colloidal ahlinzeka ngekhwalithi esheshayo ye-enzyme yenhliziyo hhayi inketho edingekayo ye-enzyme yenhliziyo kanye nenketho yekhithi yokuhlola yokunakekelwa okuphuthumayo

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Ukutholwa Okusheshayo

10-Ukufundwa komthamo okuncane, okuwusizo kumthetho we-AMI-in/rule-out.

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Ukuzwela Okuphezulu

0.5 ng/mL cTnI LoD iqondaniswe nemihlahlandlela ye-ESC.

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Superior Stability

24-inyanga yokuphila kweshelufu, isitoreji segumbi lokushisa (2-30°C).

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I-Flexible Readout

Ukuhambisana kwemiphumela yobuningi bekhwalithi ne-fluorescence.

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Umsebenzi Owenziwe Lula

One-isinyathelo esinebhafa&ikhasethi; akukho centrifugation noma pre-treatment edingekayo.

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Ukukhiqiza Okunokwehla

Ukukhiqizwa kwemigqa ezenzakalelayo ekhiqizayo ~500K+ ukuhlolwa kwenhliziyo ngokushintshana ngakunye.

Ukuthobela Umthetho

Izitifiketi Nokugunyazwa Kwemithetho

Amaphaneli ethu e-pathogen okuphefumula akhiqizwa ngaphansi kwesistimu yokulawula ikhwalithi eqinisekisiwe futhi asulwa ezimakethe ezinkulu zomhlaba.

Isitifiketi se-ISO 13485

Isitifiketi se-ISO 9001

Isitifiketi se-MDSAP

IBrazil ANVISA BGMP

Sebenzisa Amacala

Kusetshenziswa kuphi Ukuhlola Okusheshayo Kwe-Cardiac Marker?

Iklanyelwe ukusekela izinqubo zokulawula ukutheleleka kuwo wonke amazinga engqalasizinda yokunakekelwa kwezempilo.

Emergency Department & Chest-Pain Triage

Umnyango Wezimo Eziphuthumayo Nesifuba-Ukuhlola Ubuhlungu

Sekela ukuhlukaniswa kwengozi okusheshayo eceleni kwe-ECG kanye nezivumelwano ze-serial troponin.

I-Ambulance & Pre-Hospital

Usizo lokuhlola kusenesikhathi endleleni, njengengxenye eyodwa yokwenza izinqumo zomtholampilo.

I-Cardiology & Heart-Mitholampilo Yokuhluleka

Ukusekelwa kwe-NT-proBNP enhliziyweni-ukuhlolwa kokwehluleka ngaphansi kokunakekelwa okukhethekile.

Abasabalalisi nama-OEM Brands

I-cTnI/CK-MB/Myo/NT-proBNP esezingeni eliphezulu yamashaneli omtholampilo ochwepheshe emhlabeni wonke.

Ukusekela Namasevisi

Imibuzo Evame Ukubuzwa Nezisombululo

Ilinganisa ini i-troponin, CK-MB, myoglobin ne-NT-proBNP?

I-Troponin (I/T) iwuphawu olukhulu lwenhliziyo-olukhethekile lwenhliziyo-ukulimala kwemisipha; I-CK-MB isiza ukuhlola i-reinfarction; i-myoglobin ikhuphuka ngaphambi kwesikhathi kodwa ayiyona inhliziyo-eqondile; I-NT-proBNP ibonisa ukucindezelwa kodonga lwenhliziyo enhliziyweni-ukuhlola ukwehluleka. Zisetshenziswa kanye ne-ECG kanye nemiphumela yomtholampilo.

Ingabe ukuhlolwa okukodwa kwe-troponin okusheshayo kungaqinisekisa noma kukhiphe isifo senhliziyo?

Cha. Umphumela wangaphambi kwesikhathi owodwa - okuhlanganisa nenegethivu - awukwazi ukuqinisekisa noma ukukhipha i-myocardial infarction. Ukuxilongwa kudinga i-ECG, ukuhlolwa komtholampilo kanye nezilinganiso ze-serial troponin ezihunyushwa udokotela. Lezi zivivinyo ziwusizo kuphela.

Ithini impilo yeshelufu nesimo sokugcina?

Imvamisa, izinyanga ezingama-24 kusukela ekukhiqizweni, zigcinwa zivaliwe ku-2-30°C. Qinisekisa ngokumelene nomkhiqizo othize we-IFU.

Izixazululo Zokumaka Wenhliziyo

Uzakwethu nefekthri ye-IVD edidiyelwe mpo e-China ukuze uthole ukunikezwa kwekhithi yokuhlola yomaka wenhliziyo. Sihlinzeka ngendawo yokugcina - ukuya-ekugcineni — cTnI, CK-MB, myoglobin, NT-proBNP kanye ne-D-dimer amadivayisi ngefomethi yegolide eli-colloidal noma e-fluorescence, anokufakwa okunegama kanye nama-IFU ezilimi eziningi-e-

Amaphaneli e-Multiplex ngokwezifiso

Hlanganisa amapharamitha athile (isb., i-SARS-CoV-2 + Flu A/B + RSV + ADV) ibe yikhasethi yokuhlola ethi 3-in-1, 4-in-1, noma 5-in-1 ngokusekelwe ezidingweni zakho zesifunda zesifo.

Ilebula yangasese nokupakishwa

Izinsiza ezigcwele zokuklama izikhwama ze-foil, ukufakwa kwe-IFU kwezilimi eziningi (Iziyalezo Zokusetshenziswa), namabhokisi okuthengisa angaphandle enzelwe ubuwena bomkhiqizo.

Ukwesekwa Kokugcwalisa Okusemthethweni

Sihlinzeka ngemibhalo yezobuchwepheshe ebanzi, izifundo zokuqinisekisa ukusebenza, kanye nedatha yomtholampilo ukuze kusheshiswe ukubhaliswa koMnyango Wezempilo wendawo noma i-CE IVDR.

Xhumana nathi

Ilungele Ukuthola Umthombo Othembekile
Amakhithi Okuhlola Umaka Wenhliziyo?

Ama-oda ekhathalogi, ukwenza ngokwezifiso kwe-OEM multiplex, noma ukubonisana nokulawula — ithimba lethu lonjiniyela bezokuthengisa liphendula ngaphakathiAmahora angu-24ngezinsuku zebhizinisi ngekhotheshini eyenzelwe wena.

Amaphakethe amasampula wamahhala NDA ngesicelo Phendula phakathi namahora angu-24