Ikhithi yokuxilonga (igolide le-Colloidal) le-Calprotectin
Ikhithi yokuxilonga(Igolide le-Colloidal)ngoba Calprotectin
Ukusetshenziswa kwe-in vitro diagnostic kuphela
Sicela ufunde le phakheji ngokucophelela ngaphambi kokuyisebenzisa futhi ulandele ngokuqinile imiyalelo. Ukuthembeka kwemiphumela yokuhlolwa akunakuqinisekiswa uma kukhona ukuchezuka emiyalweni ekule kokufakwa kwephakheji.
UKUSETSHENZISWA OKUHLOSIWE
I-Diagnostic Kit ye-Calprotectin(cal) iyi-colloidal gold immunochromatographic assay yokunqunywa kwe-semiquantitative ye-cal evela endle yomuntu, enenani elibalulekile lokuxilonga lesifo samathumbu esivuvukalayo. Lokhu kuhlola kuyi-reagent yokuhlola. Wonke amasampula amahle kufanele aqinisekiswe ngezinye izindlela. Lokhu kuhlolwa kuhloselwe ukusetshenziswa ngochwepheshe bezempilo kuphela. Okwamanje, lokhu kuhlolwa kusetshenziselwa i-IVD, izinsimbi ezengeziwe azidingeki.
ISIFINYEZO
I-Cal iyi-heterodimer, eyakhiwe nge-MRP 8 kanye ne-MRP 14. Itholakala kuma-neutrophils cytoplasm futhi evezwa kuma-mononuclear cell membranes. I-Cal iyi-acute phase proteins, inesigaba esizinzile cishe isonto elilodwa endle yomuntu, kunqunywa ukuthi ibe umaka wesifo samathumbu okuvuvukala. Ikhithi iwukuhlola okulula, okubukwayo kwe-semiqualitative okuthola i-cal endle yomuntu, inokuzwela okuphezulu kokutholwa kanye nokucaciswa okuqinile. Ukuhlolwa okusekelwe kumgomo wokusabela wesangweji wama-antibodies aphindwe kabili kanye nobuchwepheshe bokuhlaziya i-immunochromatographic assay, kunganikeza umphumela phakathi nemizuzu eyi-15.
ISIMISO SENKQUBO
Umucu une-anti cal coating McAb endaweni yokuhlola kanye ne-anti-rabbit IgG yamasosha omzimba endaweni yokulawula, eboshelwe ku-membrane chromatography kusengaphambili. Iphedi elinelebula limbozwe ngegolide eli-colloidal elibhalwe ukuthi i-anti cal McAb kanye ne-colloidal yegolide elibhalwe ukuthi i-rabbit IgG antibody kusengaphambili. Lapho kuhlolwa isampula ephozithivu, i-cal kusampula ihlanganiswe negolide eli-colloidal elibhalwe ukuthi i-anti cal McAb, futhi yakhe i-immune complex, njengoba ivunyelwe ukufuduka eduze komugqa wokuhlola, inkimbinkimbi ye-cal conjugate ithwetshulwa yi-anti cal coating McAb kulwelwesi kanye nesimo. “I-anti cal coating McAb-cal-colloidal gold ebhalwe ukuthi anti cal McAb” inkimbinkimbi, ibhande lokuhlola elinemibala livele endaweni yokuhlola. Ukuqina kombala kuhlotshaniswa kahle nokuqukethwe kwekhalori. Isampula elibi alikhiqizi ibhendi yokuhlola ngenxa yokungabikho kwe-colloidal gold conjugate cal complex. Akunandaba ukuthi i-cal ikhona kusampula noma cha, kunomugqa obomvu ovela endaweni eyireferensi nendawo yokulawula ikhwalithi, ethathwa njengamazinga ebhizinisi angaphakathi ekhwalithi.
AMA-REAGENTS KANYE NEZINTO EZINIKEZELWAYO
25T izingxenye zephakheji:
.Ikhadi lokuhlola i-foil ngayinye efakwe esikhwameni se-desiccant
.Izihlanjululi zesampula: izithako ngu-20mM pH7.4PBS
.Ukudideka
.Faka iphakheji
IZINTO EZIDINGEKAYO KODWA AKUNIKEZWE
Isitsha seqoqo lesampula, isibali sikhathi
UKUQOQWA KANYE NESIGCINISO ESAMPULA
Sebenzisa isitsha esihlanzekile esilahlwayo ukuqoqa isampula yendle entsha, bese ihlolwa ngokushesha. Uma ingeke ihlolwe ngokushesha, sicela igcinwe ku-2-8°C amahora angu-12 noma ibellow -15°C izinyanga ezi-4.
INQUBO YOKUHLOLA
1.Khipha udondolo lwesampula, ulufake esampuleni yobulongwe, bese ubuyisela induku yesampula, uyiqinise bese uyinyakazisa kahle, phinda isenzo izikhathi ezi-3. Noma kusetshenziswa isampula elinamathiselwe isampula lendle elingu-50mg, bese lifaka ishubhu lesampula lobulongwe eliqukethe isampula lokuhlanjululwa, bese liyisikulufa ngokuqinile.
2.Sebenzisa amasampula e-pipette alahlwayo thatha isampula yendle elincanyana esigulini sohudo, bese wengeza amathonsi ama-3 (cishe 100uL) eshubhuni lokusampula le-fecal bese unyakazisa kahle, ubeke eceleni.
3.Khipha ikhadi lokuhlola esikhwameni se-foil, ulibeke etafuleni lezinga bese ulimaka.
4.Khipha isivalo kushubhu yesampula bese ulahla amathonsi amabili okuqala esampula ehlanjululiwe, engeza amaconsi ama-3 (cishe u-100uL) alikho ibhamuza elihlanjululwe isampula lime mpo futhi kancane ungene emthonjeni wesampula wekhadi eline-dispette enikeziwe, qala isikhathi.
5.Umphumela kufanele ufundwe phakathi kwemizuzu engu-10-15, futhi awuvumelekile ngemva kwemizuzu engu-15.
IMIPHUMELA YOKUHLOLA NOKUTOLIZWA
Imiphumela yokuhlolwa | Ukutolika | |
① | Ibhendi yereferensi ebomvu kanye nebhande lokulawula elibomvu libonakala endaweni engu-R nesifunda esingu-C, akukho okubomvuibhendi yokuhlola endaweni ye-T. | Kusho ukuthi okuqukethwe kwe-faecescalprotectin yomuntu kungaphansi kwe-15μg/g, okuyi-aizinga elijwayelekile. |
② | Ibhendi yereferensi ebomvu kanye nebhande lokulawula elibomvu livela endaweni engu-R nesifunda esingu-C, kanye neumbala webhendi yereferensi ebomvu umnyama kuneibhendi yokuhlola ebomvu. | Okuqukethwe indle yomuntu i-calprotectin iphakathi kuka-15μg/g no-60μg/g. Lokho kungase kubeezingeni elivamile, noma kungase kube khona ingoziI-Irritable Bowel Syndrome. |
③ | Ibhendi yereferensi ebomvu kanye nebhande lokulawula elibomvu livela endaweni engu-R nesifunda esingu-C, kanye neumbala webhendi yereferensi ebomvu uyafana neibhendi yokuhlola ebomvu. | Okuqukethwe indle yomuntu i-calprotectin ingu-60μg/g, futhi kunengozi ekhonaisifo samathumbu esivuthayo. |
④ | Ibhendi yereferensi ebomvu kanye nebhande lokulawula elibomvu livela endaweni engu-R nesifunda esingu-C, kanye neumbala webhendi yokuhlola ebomvu umnyama kunobomvuibhendi yereferensi. | Ikhombisa okuqukethwe kwe-faecescalprotectin yomuntu kungaphezu kuka-60μg/g, futhi laphokuyingozi ekhona yokuvuvukala kwamathumbuisifo. |
⑤ | Uma ibhendi yereferensi ebomvu ne-red control bandis ingabonwa noma ivele ibonwe eyodwa kuphela, ukuhlolwa kuwukuthikuthathwa njengokungavumelekile. | Phinda ukuhlola usebenzisa ikhadi elisha lokuhlola. |
UKUGCINWA NOKUZInza
Ikhithi iyisikhathi seshelufu sezinyanga ezingama-24 kusukela ngosuku lokukhiqizwa kwayo. Gcina amakhithi angasetshenzisiwe ku-2-30°C. Ungavuli isikhwama esivaliwe kuze kube yilapho usulungele ukwenza isivivinyo.
IZIXWAYISO NEZIQINISEKISO
I-1.Ikhithi kufanele ivalwe futhi ivikelwe kumswakama1.
2.Ungasebenzisi isampuli ebekwe isikhathi eside kakhulu noma iqhwa eliphindaphindiwe futhi incibilika ukuze ihlolwe
3.Amasampula e-Fecal adlulele noma ukujiya angenza amasampula ahlanjululwe ekhadini lokuhlola elingcolile, sicela ubeke isampula elihlanjululwe nge-centrifuge futhi uthathe i-supernatant iyohlolwa.
I-4.I-Misoperation, isampula eningi noma encane ingaholela ekuphambukeni kwemiphumela.
UMKHAWULO
1.Lo mphumela wokuhlolwa ngowenkomba yomtholampilo kuphela, akufanele usebenze njengesisekelo sokuxilongwa nokwelashwa kweziguli, ukuphathwa komtholampilo kweziguli kufanele kucatshangelwe ngokugcwele kuhlanganiswe nezimpawu zakhona, umlando wezokwelapha, okunye ukuhlolwa kwaselabhorethri, impendulo yokwelashwa, i-epidemiology nokunye. ulwazi2.
2.Le rejenti isetshenziselwa ukuhlola indle kuphela. Ingase ingatholi umphumela onembile uma isetshenziselwa amanye amasampula afana namathe nomchamo nokunye.
IZIKHOMBISI
[1] Izinqubo kazwelonke zokuhlolwa komtholampilo(uhlelo lwesithathu, 2006).Umnyango wezempilo womnyango.
[2] Izinyathelo zokulawulwa kokubhaliswa kwe-in vitro diagnostic reagents. I-China Food and Drug Administration, No. 5 oda, 2014-07-30.
Ukhiye wezimpawu ezisetshenzisiwe:
In Vitro Diagnostic Medical Device | |
Umkhiqizi | |
Gcina ku-2-30 ℃ | |
Usuku lokuphelelwa isikhathi | |
Ungaphinde Usebenzise | |
ISEXWAYISO | |
Bheka Imiyalo Yokusetshenziswa |
I-Xiamen Wiz Biotech CO., LTD
Ikheli:3-4 Floor,NO.16 Building,Bio-medical Workshop,2030 Wengjiao West Road,Haicang District,361026,Xiamen,China
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