Umhla ziyi-19 kuNhlaba yiSuku Lomhlaba Lokuqwashisa Ngezifo Ezibangelwa Yi-IBD, ezinikele ekuqwashiseni umphakathi ngesifo samathumbu esivuvukalayo (i-IBD) kanye nokunakekela iziguli ze-IBD. I-IBD ihlanganisa kakhulu i-ulcerative colitis (UC) kanye nesifo sikaCrohn (CD). Kuyisifo samathumbu esivuvukalayo esingamahlalakhona, esiphinde sibuye esilimaza kakhulu ikhwalithi yokuphila kweziguli. Kulesi senzakalo, siyajabula ukwabelana ngocwaningo lwakamuva olwenziwe yi-Union Hospital, iTongji Medical College, iHuazhong University of Science and Technology, esebenzise i-Ikhithi Yokuhlola yeCalprotectin(Ukuhlolwa kwe-Fluorescence Immunochromatography, FICA)kanyeIsihlaziyi Sokuvivinya I-Immunoassay Esiqhubekayo se-WIZ-A202yathuthukiswa yithi, inikeza izinkomba ezibalulekile zokuphathwa kwezifo zeziguli ze-UC.

Isizinda Socwaningo: Ukufuna Izinkomba Zokuqapha Ezingcono Ezingahlaseli ze-UC

I-Colonoscopy "iyindinganiso yegolide" yokuhlola umsebenzi wesifo se-endoscopic ku-UC, kodwa ayingeneki futhi ayibekezeleleki kahle yiziguli, okwenza ukuqapha njalo kube nzima. Izimpawu ze-serum ezifana ne-Iphrotheni e-C-reactive (CRP) kanye nesilinganiso se-erythrocyte sedimentation (ESR) asinazo izici ezithile futhi asihambisani kahle nokuvuvukala kwamathumbu.

I-calprotectin yendle (FC), uphawu lokuvuvukala oluqondene namathumbu oluvela kuma-neutrophils, seluyithuluzi elibalulekile elingahlaseli ekuphathweni kwe-IBD. Kodwa-ke, imingcele ye-FC iyahlukahluka kakhulu ezindleleni ezahlukene zokuthola ngenxa yokuntuleka kwamanani ajwayelekile okusika. I-Fluorescence immunochromatography assay (FICA) iyindlela yokuthola esheshayo nelula, kodwa amanani ayo okusika emtholampilo afanele adinga ukuqinisekiswa okwengeziwe.

Izinhloso Nezindlela Zocwaningo

1) Izinhloso Zocwaningo: Lolu cwaningo luhlose ukuhlola ubudlelwano phakathi kwe-FC etholwe yi-FICA kanye nomsebenzi wesifo se-clinical/endoscopic ku-UC, kanye nokunquma amanani afanele okunquma umsebenzi wesifo.

2)Inani Labantu Abacwaningwayo: Iziguli eziyi-110 ezitholakale zine-UC ezalaliswa esibhedlela i-Union Hospital, iTongji Medical College, iHuazhong University of Science and Technology phakathi kukaJanuwari 2021 noJuni 2022.

3) Indlela Yokuthola: I-FC ilinganiswe kusetshenziswaIsihlaziyi Sokuvivinya I-Immunoassay Esiqhubekayo se-WIZ-A202 kanye nokuhambisanaIkhithi ye-Calprotectin FICAkithi

4) Izindlela Zokuhlola: Umsebenzi wezokwelapha uhlolwe nge-partial Mayo score (pMS); umsebenzi we-endoscopic uhlolwe yi-Ulcerative Colitis Endoscopic Index of Severity (UCEIS) kanye ne-Mayo Endoscopic Score (MES).

Imiphumela Yocwaningo Oluyinhloko

1. Amazinga e-FC ahlobene kakhulu nomsebenzi wesifo.

Amazinga e-FC abonise ukuhlobana okuphawulekayo okuhle ne-pMS (r=0.609), i-UCEIS (r=0.751), kanye ne-MES (r=0.635) (konke ku-P<0.001), okunokuxhumana okungcono kunoI-CRPkanye ne-ESR. Ubudlelwano phakathi kwe-FC nomsebenzi we-endoscopic babuqine kakhulu.

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2. Kunqunywe amanani aphelele okusika.

Ithagethi Yokubikezela Umkhawulo ofanele (μg/g) Ukuzwela Ukucaciswa
Umsebenzi wezokwelapha (pMS ≥ 3) ≥57.38 78.02% 100%
Umsebenzi we-Endoscopic (UCEIS ≥ 1 / MES ≥ 1) ≥53.30 71.57–73.74% 100%

3. I-FC ibonise ukusebenza okuhle kakhulu ekuhlukaniseni i-UC esebenzayo.

Ukuhlaziywa kwejika le-ROC kubonise ukuthi i-AUC ye-FC yokubikezela umsebenzi wezokwelapha yayingu-0.9456, kanti ekubikezeleni umsebenzi we-endoscopic kwakuyi-0.9075 (UCEIS) kanye ne-0.9118 (MES), konke kuphakeme kakhulu kune-CRP kanye ne-ESR.

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4. Ukukhululwa kwesifo emtholampilo akusho ukukhululwa kwe-endoscopic.

Phakathi kweziguli eziyi-11 ezithole ukuxolelwa emitholampilo (pMS < 3) kodwa zisenomsebenzi we-endoscopic, eziyi-10 (90.91%) zazinamazinga e-FC angaphansi kwama-53.30 μg/g. Lokhu kusikisela ukuthi ngisho noma amazinga e-FC ejwayelekile, ezinye iziguli kungenzeka azizange zifinyelele ekwelapheni kwe-endoscopic, futhi i-colonoscopy ayikakwazi ukushintshwa ngokuphelele.

Iziphetho Zocwaningo

  • Ukutholwa kwe-FC okusekelwe ku-FICA kuyisibonakaliso esihle somsebenzi wezokwelapha kanye nowe-endoscopic ku-UC.
  • Kunconywa ukunqunywa okungu-57.38 μg/g ukuze kuhlolwe umsebenzi wezokwelapha.
  • Kunconywa ukunqunywa okungu-53.30 μg/g ukuze kuhlolwe umsebenzi we-endoscopic (umkhawulo ophansi usiza ekuthuthukiseni ukuzwela).
  • I-FC inganciphisa ngempumelelo ama-colonoscopy angadingekile futhi ithuthukise ukusetshenziswa kwezinsiza zezokwelapha.

Ukuthuthukisa Ukuxilongwa Okunembile Nokwelashwa Kwe-IBD-Baysen Esebenzayo

I-Xiamen Baysen Medical yathuthukiswa ngokuzimelaIkhithi Yokuhlola yeCalprotectin (Ukuhlolwa kwe-Fluorescence Immunochromatography) kanyeIsihlaziyi Sokuvivinya I-Immunoassay Esiqhubekayo se-WIZ-A202inikeza izinzuzo ezilandelayo:

 Ikhithi Yokuhlola yeCalprotectin (Ukuhlolwa Kwe-Fluorescence Immunochromatography)

I-CAL-01

Indawo: Ukuhlolwa Kwenani Lomtholampilo

I-FICA isebenzisa indlela yesandwich ye-double-antibody ukuthola i-FC, ikhombisa ukuhlobana okuhle ne-ELISA, futhi ingahlola ngempumelelo umsebenzi we-IBD.

Izinzuzo Zomkhiqizo:

  • Okusheshayo Nokulula:Imiphumela itholakala ngemizuzu eyi-15 kuphela
  • Ukusebenza okulula: Akukho mishini eyinkimbinkimbi edingekayo; ifanele izikhungo zezokwelapha kuwo wonke amazinga
  • Imiphumela Ethembekile:Ubudlelwano obuhle nomsebenzi wezokwelapha kanye ne-endoscopic
  • Izidingo Zesampula Ezicacile: Inqubo yokusampula ejwayelekile iqinisekisa ikhwalithi yokuhlola

Izicelo:Ukuhlolwa kweziguli zangaphandle, ukuqapha iziguli ezilaliswe esibhedlela, ukulandelwa kokwelashwa, kanye nokubambisana ocwaningweni

A202
Indawo:Ihambisana ngesikhathi esisodwa namapulatifomu amaningi afaka phakathi i-fluorescence immunoassay, indlela ye-colloidal gold, kanye nendlela ye-latex.

Izinzuzo Zomkhiqizo:

  • Ukuhambisana Kohlobo Lwesampula Oluphelele: Iyakwazi ukuhlola igazi, umchamo, kanye namasampula endle
  • Ukuhambisana Okuhle: Ivumela indlela yegolide ye-colloidal, indlela ye-latex, kanye ne-fluorescence immunoassay
  • Kuphephile Ngokwezinto Eziphilayo:Ukuqoqwa kwamakhadi kadoti okuzenzakalelayo ukuze kulahlwe kalula futhi kuphephile
  • Ukusampula Okuqhubekayo:Ifakwe igumbi lokufukamela elinezindawo eziningi, elivumela ukulayishwa nokuhlolwa kwesampula okungaphazanyiswa
  • Ukuqashelwa Okuhlakaniphile: Ihlonza ngokuzenzakalelayo izinto zokuhlola kanye nendlela yokusebenza
  • Ukusebenzisana Kwedatha:Isekela ukuxhumana ne-LIS yesibhedlela (Uhlelo Lolwazi Lwelabhorethri)

Lolu cwaningo luqinisekisa ukubaluleka okubalulekile komtholampilo kokutholwa kwe-FC okusekelwe ku-FICA ekuphathweni kwe-UC, okuhlinzeka ngethuluzi elinamandla lokuqapha iziguli ze-IBD ngendlela engahlaseli.

Emhlabeni jikelele, izinga le-IBD liyanda njalo. Ukuxilongwa kusenesikhathi, ukwelashwa okujwayelekile, kanye nokuqapha kwesayensi kubalulekile ekuthuthukiseni imiphumela yesiguli. Njenge-biomarker engahlaseli, elula, futhi eqondile kakhulu, i-calprotectin yendle iguqula imodeli yokuphathwa kwesifo se-IBD.

Thina iBaysen/Wizbiotech sisalokhu sizibophezele ocwaningweni nasekuthuthukiseni imikhiqizo yokuxilonga ehlobene ne-IBD, sinikeze odokotela neziguli izixazululo zokuhlola ezinembile nezilula, futhi sisebenzisana ukuvikela impilo yamathumbu.


Isikhathi sokuthunyelwe: Meyi-19-2026