Isivivinyo Esisheshayo se-PROM
UKUSETSHENZISWA OKUHLOSIWE
Isinyathelo Esiqinile®Ukuhlolwa kwe-PROM kuwukuhlola okuhunyushwe ngokubonakalayo, kwekhwalithi ye-immunochromatographic ukuze kutholwe i-IGFBP-1 ku-amniotic fluid ekusithekeni kwesitho sangasese sowesifazane ngesikhathi sokukhulelwa.Ukuhlola kuhloselwe ukusetshenziswa ngochwepheshe ukusiza ukuhlonza ukugqashuka kolwelwesi lwengane (ROM) kwabesifazane abakhulelwe.
ISINGENISO
Ukugxila kwe-IGFBP-1 (isici sokukhula esifana ne-insulin esibopha amaprotheni-1) ku-amniotic fluid siphindwe izikhathi eziyi-100 kuya kweziyi-1000 kuneserum kamama.I-IGFBP-1 ngokuvamile ayitholakali esithweni sangasese sowesifazane, kodwa ngemva kokugqashuka kolwelwesi lwengane, uketshezi lwe-amniotic olunokuhlushwa okuphezulu kwe-IGFBP-1 luxubana nokuphuma kwesitho sangasese sowesifazane.Ekuhlolweni kwe-StrongStep® PROM, isifanekiso sokuphuma kwesitho sangasese sowesifazane sangasese sithathwa ngeswabhu ye-polyester eyinyumba bese isampula sikhishelwa ku-Specimen Extraction Solution.Ukuba khona kwe-IGFBP-1 kusixazululo kutholwa kusetshenziswa idivayisi yokuhlola esheshayo.
ISIMISO
Isinyathelo Esiqinile®I-PROM Test isebenzisa umbala we-immunochromatographic, ubuchwepheshe bokugeleza kwe-capillary.Inqubo yokuhlola idinga ukuxazululeka kwe-IGFBP-1 kusuka ku-swab yesitho sangasese sowesifazane ngokuxuba i-swab ku-Sample Buffer.Bese isampula yebhafa exubile yengezwa kusampula yekhasethi lokuhlola kahle bese ingxube ifuduka eduze kolwelwesi olungaphezulu.Uma i-IGFBP-1 ikhona kusampula, izokwakha inkimbinkimbi ene-anti- IGFBP-1 antibody eyinhloko ehlanganiswe nezinhlayiya ezinemibala.I-complex izobe isiboshwa i-anti-IGFBP-1 yesibili antibody ehlanganiswe kulwelwesi lwe-nitrocellulose.Ukubonakala komugqa wokuhlola obonakalayo kanye nolayini wokulawula kuzobonisa umphumela omuhle.
IZINTO ZEKHITHI
| 20 Ngamunye packed amadivayisi wokuhlola | Idivayisi ngayinye iqukethe umucu onama-conjugate anemibala nama-reagents asebenzayo ambozwe ngaphambilini ezindaweni ezihambisanayo. |
| 2IsizindaIsitsha sebhafa | 0.1 M I-Phosphate buffered saline (PBS) kanye ne-0.02% sodium azide. |
| 1 Positive control swab (ngesicelo kuphela) | Iqukethe IGFBP-1 kanye sodium azide.Okokulawula kwangaphandle. |
| 1 I-swab yokulawula engalungile (ngesicelo kuphela) | Ayiqukethe i-IGFBP-1.Okokulawula kwangaphandle. |
| 20 Amashubhu okukhipha | Ukusetshenziswa kokulungiswa kwezibonelo. |
| 1 Indawo yokusebenza | Indawo yokugcina ama-buffer vials namashubhu. |
| 1 Faka iphakheji | Ukuze uthole imiyalelo yokusebenza. |
IZINTO EZIDINGEKAYO KODWA AKUNIKEZWE
| Isikhathi | Ukusebenzisa isikhathi. |
IZINYATHELO ZOKUZIVIKELA
■ Okokusetshenziswa kochwepheshe be-vitro diagnostic kuphela.
■ Ungasebenzisi ngemva kosuku lokuphelelwa yisikhathi olukhonjiswe ephaketheni.Ungakusebenzisi ukuhlolwa uma isikhwama se-foil sonakele.Ungaphinde usebenzise ukuhlola.
■ Le khithi iqukethe imikhiqizo yezilwane.Ulwazi oluqinisekisiwe lwemvelaphi kanye/noma isimo sokuhlanzeka kwezilwane akuqinisekisi ngokuphelele ukungabikho kwezifo ezithathelwanayo.Ngakho-ke, kuyanconywa ukuthi le mikhiqizo iphathwe njengamandla athelelekayo, futhi isingathwe ngokuqaphela izinyathelo ezivamile zokuphepha (ungadli noma uhogele).
■ Gwema ukungcoliswa ngokwehlukana kwezibonelo ngokusebenzisa isiqukathi esisha sokuqoqa isifanekiso sesampula ngayinye etholiwe.
■ Funda yonke inqubo ngokucophelela ngaphambi kokwenza noma yiziphi izivivinyo.
∎ Ungadli, ungaphuzi noma ungabhemi endaweni lapho kuphathwa khona amasampula namakhithi.Bamba zonke izifanekiso njengokungathi ziqukethe izinto ezithathelwanayo.Qaphela izinyathelo ezimisiwe zokubhekana nobungozi be-microbiological kuyo yonke inqubo futhi ulandele izinqubo ezijwayelekile zokulahlwa okufanele kwezibonelo.Gqoka izingubo zokuzivikela njengamajazi aselabhorethri, amagilavu alahlwayo kanye nokuvikela amehlo lapho izibonelo zihlolwa.
■ Ungashintshisani noma uhlanganise ama-reagents avela ezindaweni ezahlukene.Ungahlanganisi amakepisi ebhodlela esixazululo.
■ Umswakama nezinga lokushisa kungaba nomthelela omubi emiphumeleni.
■ Uma inqubo yokuhlola isiqediwe, lahla ama-swabs ngokucophelela ngemva kokuwafaka ngokuzenzakalelayo ku-121°C okungenani imizuzu engu-20.Kungenjalo, zingelashwa nge-0.5% sodium hypochloride (noma i-bleach yasendlini) ihora elilodwa ngaphambi kokulahlwa.Izinto zokuhlola ezisetshenzisiwe kufanele zilahlwe ngokuhambisana nemithetho yendawo, yesifunda kanye/noma yenhlangano.
∎ Ungasebenzisi amabhulashi e-cytology neziguli ezikhulelwe.
ISITOREJI NOKUZInza
■ Ikhithi kufanele igcinwe ku-2-30°C kuze kufike usuku lokuphelelwa yisikhathi kuphrintiwe esikhwameni esivaliwe.
■ Ukuhlolwa kufanele kuhlale esikhwameni esivaliwe kuze kusetshenziswe.
■ Ungafrizi.
■ Kufanele kuqikelelwe ukuvikela izingxenye ezikule kit ekungcoleni.Ungasebenzisi uma kunobufakazi bokungcoliswa kwamagciwane noma imvula.Ukungcoliswa kwebhayoloji kwezinto ezisetshenziswayo zokusaphaza, iziqukathi noma ama-reagents kungaholela emiphumeleni engamanga.
UKUQOQWA KANYE NESIGCINISO
Sebenzisa kuphela i-Dacron noma i-Rayon enezici eziyinyumba ezinama-plastic shafts.Kunconywa ukusebenzisa i-swab ehlinzekwe ngumkhiqizi wakhithi(Ama-swabs awaqukethwe kule khithi, ukuze uthole imininingwane yoku-oda, sicela uxhumane nomkhiqizi noma umsabalalisi wendawo, inombolo yekhathalogi ithi 207000).Ama-swabs avela kwabanye abahlinzeki awakaqinisekiswa.Ama-swabs anamathiphu kakotini noma ama-shafts okhuni awanconywa.
■ Isampula litholwa kusetshenziswa i-polyester swab eyinyumba.Isampula kufanele iqoqwe ngaphambi kokuhlolwa kwedijithali kanye/noma i-ultrasound ye-transvaginal.Qaphela ukuthi ungathinti lutho nge-swab ngaphambi kokuthatha isampula.Faka ngokucophelela ichopho le-swab esithweni sangasese sowesifazane ngasemuva kwe-fornix kuze kube yilapho kuhlangatshezwana nayo.Kungenjalo isampula ingathathwa ku-fornix yangemuva ngesikhathi sokuhlolwa kwe-speculum okuyinyumba.I-swab kufanele ishiywe esithweni sangasese imizuzwana eyi-10-15 ukuyivumela ukuthi imunce ukukhishwa kwesitho sangasese sowesifazane.Khipha i-swab ngokucophelela!.
■ Beka i-swab eshubhuni yokukhipha, uma ukuhlolwa kungase kuqalwe ngokushesha.Uma ukuhlolwa okusheshayo kungenzeki, amasampula esiguli kufanele afakwe eshubhuni elomile lokuthutha ukuze agcinwe noma athuthwe.Ama-swabs angase agcinwe amahora angu-24 ekamelweni lokushisa (15-30°C) noma isonto eli-1 ku-4°C noma kungabi ngaphezu kwezinyanga eziyisi-6 ku -20°C.Zonke izibonelo kufanele zivunyelwe ukuthi zifinyelele izinga lokushisa lekamelo lika-15-30 ° C ngaphambi kokuhlolwa.
INQUBO
Letha izivivinyo, izifanekiso, isigcinalwazi kanye/noma izilawuli ekamelweni lokushisa (15-30°C) ngaphambi kokusetshenziswa.
■ Beka ishubhu Lokukhipha elihlanzekile endaweni emisiwe yendawo yokusebenza.Engeza i-1ml ye-Extraction Buffer kushubhu yokukhipha.
■ Faka i-swab yesifanekiso eshubhuni.Hlanganisa ngamandla isixazululo ngokuzungezisa i-swab ngamandla ohlangothini lweshubhu okungenani izikhathi eziyishumi (ngenkathi ucwile emanzini).Imiphumela emihle kakhulu itholakala uma isifanekiso sixutshwe ngamandla esixazululweni.
∎ Khama uketshezi oluningi ngangokunokwenzeka ku-swab ngokucindezela uhlangothi lweshubhu yokukhipha eguquguqukayo njengoba kukhishwa i-swab.Okungenani i-1/2 yesixazululo sebhafa yesampula kufanele ihlale kushubhu ukuze kwenzeke ukufuduka kwe-capillary okwanele.Faka ikepisi kushubhu ekhishiwe.
Lahla i-swab esitsheni esifanelekile sikadoti we-biohazardous.
■ Izibonelo ezikhishiwe zingagcina izinga lokushisa elilingana negumbi imizuzu engama-60 ngaphandle kokuphazamisa umphumela wokuhlolwa.
■ Khipha isivivinyo esikhwameni saso esivaliwe, bese usibeka endaweni ehlanzekile, esezingeni.Lebula idivayisi ngesihlonzi sesiguli noma sokulawula.Ukuze uthole umphumela omuhle kakhulu, ukuhlolwa kufanele kwenziwe phakathi nehora elilodwa.
■ Engeza amaconsi angu-3 (cishe u-100 µl) wesampula ekhishiwe ku-Extraction Tube emthonjeni wesampula ekhasethi lokuhlola.
Gwema ukuvalela amabhamuza omoya endaweni yesifanekiso (S), futhi ungashiyi noma yisiphi isisombululo efasiteleni lokubuka.
Njengoba ukuhlola kuqala ukusebenza, uzobona umbala unyakaza kulwelwesi.
■ Linda kuze kuvele amabhendi anombala.Umphumela kufanele ufundwe ngemizuzu emi-5.Ungahumushi umphumela ngemuva kwemizuzu emi-5.
Lahla amashubhu okuhlola asetshenzisiwe kanye Namakhasethi Okuhlola esitsheni esifanelekile sikadoti we-biohazardous.
UKUTONGULWA KWEMIPHUMELA
| OKUHLERESULT:
| Amabhande amabili anombala avela kulwelwesi.Ibhendi eyodwa ivela endaweni yokulawula (C) kanti elinye ibhendi livela endaweni yokuhlola (T). |
| OKUBIRESULT:
| Ibhande elilodwa kuphela elinemibala elivela endaweni yokulawula (C).Alikho ibhande elinemibala elivelayo endaweni yokuhlola (T). |
| AKUMALIRESULT:
| Ibhendi yokulawula iyehluleka ukuvela.Imiphumela yanoma yikuphi ukuhlola okungakhiqizanga ibhande lokulawula ngesikhathi esishiwo sokufunda kufanele ilahlwe.Sicela ubuyekeze inqubo bese uphinda ngokuhlolwa okusha.Uma inkinga iqhubeka, yeka ukusebenzisa ikhithi ngokushesha futhi uxhumane nomsabalalisi wangakini. |
QAPHELA:
1. Ukushuba kombala endaweni yokuhlola (T) kungase kuhluke kuye ngokugxila kwezinto ezihlosiwe ezikhona kusifanekiso.Kodwa izinga lezinto alikwazi ukunqunywa yilolu hlolo lwekhwalithi.
2. Ivolumu yesampula enganele, inqubo yokusebenza engalungile, noma ukwenza izivivinyo eziphelelwe yisikhathi yizizathu okungenzeka kakhulu zokwehluleka kwebhande lokulawula.
IKHWALITHI YOKULAWULA
■ Izilawuli zenqubo zangaphakathi zifakiwe ekuhlolweni.Ibhendi enombala evela endaweni yokulawula (C) ibhekwa njengokulawula kwangaphakathi okuhle kwenqubo.Iqinisekisa ivolumu eyanele yesifanekiso kanye nendlela yenqubo efanele.
■ Izilawuli zenqubo zangaphandle zinganikezwa (ngesicelo kuphela) kumakhithi ukuze kuqinisekiswe ukuthi ukuhlola kusebenza kahle.Futhi, Izilawuli zingase zisetshenziselwe ukukhombisa ukusebenza kahle komsebenzisi wokuhlola.Ukuze wenze ukuhlola kokulawula okuphozithivu noma okunegethivu, qedela izinyathelo zesigaba Senqubo Yokuhlola ukuphatha i-swab yokulawula ngendlela efanayo ne-specimen swab.
IMIKHAWULO YOKUHLOLA
1. Akukho ncazelo yobuningi okufanele yenziwe ngokusekelwe emiphumeleni yokuhlolwa.
2.Ungasebenzisi isivivinyo uma isikhwama sayo se-aluminium foil noma izimpawu zesikhwama zingaphelele.
3.Isinyathelo esihle Esiqinile®Umphumela wokuhlolwa we-PROM, nakuba ithola ubukhona be-amniotic fluid kusampula, ayitholi isayithi lokugqabuka.
4.Njengazo zonke izivivinyo zokuxilonga, imiphumela kufanele ihunyushwe ngokuhambisana nokunye okutholwe emitholampilo.
5.Uma ukuphuka kolwelwesi lwengane kwenzekile kodwa ukuvuza kwe-amniotic fluid kunqamukile ngaphezu kwamahora angu-12 ngaphambi kokuba isifanekiso sithathwe, i-IGFBP-1 kungenzeka ukuthi yehliswe ama-protease esithweni sangasese futhi ukuhlolwa kungase kunikeze umphumela ongemuhle.
IZIMPAWU ZOKUSEBENZA
Ithebula: StrongStep®Ukuhlolwa kwe-PROM vs. Okunye Ukuhlolwa kwe-PROM yomkhiqizo
|
Ukuzwela Okuhlobene: |
| Olunye uhlobo |
| ||
| + | - | Isamba | |||
| StrongStep®I-PROM Hlola | + | 63 | 3 | 66 | |
| - | 2 | 138 | 140 | ||
|
| 65 | 141 | 206 | ||
Ukuzwela kokuhlaziya
Inani eliphansi elibonakalayo le-IGFBP-1 kusampula ekhishiwe ngu-12.5 μg/l.
Izinto Eziphazamisayo
Kufanele kuqashelwe ukuthi ungangcolisi ofaka isicelo noma uketshezi lomlomo wesibeletho ngezinto zokuthambisa, izinsipho, izibulala-magciwane, noma okhilimu.Izinto zokuthambisa noma okhilimu zingaphazamisa ngokomzimba ukumuncwa kwesifanekiso kumfakisicelo.Izinsipho noma izibulala-magciwane zingaphazamisa ukusabela kwe-antibody-antigen.
Izinto ezingaba ukuphazamisa zihlolwe ekugxiliseni okungase kutholakale ngokuphusile ekusithekeni komlomo wesibeletho.Izinto ezilandelayo aziphazamisanga ekuhlolweni lapho zihlolwa emazingeni abonisiwe.
| Into | Ukugxila | Into | Ukugxila |
| I-Ampicillin | 1.47 mg/mL | I-Prostaglandin F2 | 0.033 mg/mL |
| I-Erythromycin | 0.272 mg/mL | I-Prostaglandin E2 | 0.033 mg/mL |
| Umchamo Womama 3rd Trimester | 5% (ivolumu) | I-MonistatR (miconazole) | 0.5 mg/mL |
| I-Oxytocin | 10 IU/mL | I-Indigo Carmine | 0.232 mg/mL |
| I-Terbutaline | 3.59 mg/mL | I-Gentamicin | 0.849 mg/mL |
| I-Dexamethasone | 2.50 mg/mL | I-BetadineR Gel | 10 mg/mL |
| MgSO4•7H2O | 1.49 mg/mL | I-BetadineR Cleanser | 10 mg/mL |
| I-Ritodrine | 0.33 mg/mL | I-K-YR Jelly | 62.5 mg/mL |
| I-DermicidolR 2000 | 25.73 mg/mL |
IZIKHOMBISI ZEZINCWADI
U-Erdemoglu noMungan T. Ukubaluleka kokuthola isici sokukhula esifana ne-insulin esibopha amaprotheni-1 ekusithekeni komlomo wesibeletho: ukuqhathanisa nokuhlolwa kwe-nitrazine nokuhlola umthamo we-amniotic fluid.Acta Obstet Gynecol Scand (2004) 83:622-626.
U-Kubota T no-Takeuchi H. Ukuhlolwa kwesici sokukhula esifana ne-insulin esibopha i-protein-1 njengethuluzi lokuxilonga lokuqhekeka kolwelwesi.J Obstet Gynecol Res (1998) 24:411-417.
Rutanen EM et al.Ukuhlolwa kokuhlolwa kwe-strip esheshayo kwesici sokukhula esifana ne-insulin esibopha iphrotheni-1 ekuxilongweni kolwelwesi lwengane ephukile.UClin Chim Acta (1996) 253:91-101.
I-Rutanen EM, i-Pekonen F, i-Karkkainen T. Ukulinganisa kwesici sokukhula esifana ne-insulin esibophezela amaprotheni-1 ekusithekeni komlomo wesibeletho / sowesifazane sangasese: ukuqhathanisa ne-ROM-hlola i-Membrane Immunoassay ekuxilongweni kwe-fetus ephukile.UClin Chim Acta (1993) 214:73-81.
UHLU LWEZIMFANEKISO
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| Inombolo yekhathalogi |  | Ukunciphisa izinga lokushisa |
 | Bheka imiyalelo yokusetshenziswa |
| Ikhodi yeqoqo |
 | In vitro diagnostic device medical |  | Sebenzisa nge |
 | Umkhiqizi |  | Iqukethe okwaneleizivivinyo |
 | Ungaphinde usebenzise |  | Oqokelwe ukumela abanye ogunyaziwe ku-European Community |
 | I-CE imakwe ngokuya nge-IVD Medical Devices Directive 98/79/EC | ||
