Ukuhlolwa Okusheshayo Kwe-Fetal Fibronectin

Incazelo emfushane:

REF 500160 Ukucaciswa 20 Izivivinyo/Ibhokisi
Umgomo wokutholwa Ukuhlolwa kwe-Immunochromatographic Izibonelo Izimfihlo ze-Cervicovaginal
Ukusetshenziswa Okuhlosiwe I-StrongStep® Fetal Fibronectin Rapid Test ukuhlola okuhunyushwa ngokubonwa kwe-immunochromatographic okuhloswe ukuthi kusetshenziselwe ukutholwa kwekhwalithi ye-fetal fibronectin ekuphumeni komlomo wesibeletho.


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Fetal Fibronectin Rapid Test Device22
Fetal Fibronectin Rapid Test Device23
Fetal Fibronectin Rapid Test Device25

UKUSETSHENZISWA OKUHLOSIWE
Isinyathelo Esiqinile®Ukuhlolwa kwe-PROM ukuhlola okuhunyushwe ngokubonakalayo kwe-immunochromatographic okuhloswe ukuthi kusetshenziselwe ukutholwa kwekhwalithi ye-fetal fibronectin ekusithekeni komlomo wesibeletho.Ukuba khona kwe-fetal fibronectin ekusithekeni komlomo wesibeletho phakathi kwamaviki angama-22, izinsuku ezi-0 namaviki angama-34, izinsuku eziyi-6 zokukhulelwaokuhambisana nengozi ephakeme yokulethwa ngaphambi kwesikhathi.

ISINGENISO
Ukubeletha ngaphambi kwesikhathi, okuchazwa yi-American College of Obstetricians and Gynecologists njengokubeletha ngaphambi kweviki lama-37 lokukhulelwa, kunesibopho seningi lokugula nokufa kwabantu okungezona i-chromosomal.Izimpawu zokubeletha okusongelwa ngaphambi kwesikhathi zihlanganisa ukufinyela kwesibeletho, ukushintsha kokukhishwa kwesitho sangasese sowesifazane, ukopha esithweni sangasese, ubuhlungu beqolo, ukungaphatheki kahle kwesisu, umfutho we-pelvic, kanye nokumakwa.Izindlela zokuxilonga zokuhlonza ukubeletha okusongelwa ngaphambi kwesikhathi zihlanganisa ukuqapha umsebenzi wesibeletho kanye nokusebenza kokuhlolwa komlomo wesibeletho kwedijithali, okuvumela ukulinganiswa kobukhulu bomlomo wesibeletho.Lezi zindlela ziboniswe zilinganiselwe, njengoba ukunwetshwa okuncane komlomo wesibeletho (< 3 centimeters) kanye nomsebenzi wesibeletho kwenzeka ngokujwayelekile futhi akukona ngempela ukuxilonga ukulethwa kokubeletha okuseduze.Yize omaka be-serum biochemical abambalwa behloliwe, abekho abamukelwe kabanzi ukuthi basetshenziswe emtholampilo.

I-Fetal fibronectin (fFN), i-isoform ye-fibronectin, iyi-glycoprotein enamathelayo eyinkimbinkimbi enesisindo samangqamuzana esilinganiselwa ku-500,000 daltons.UMatsuura kanye nozakwabo bachaze i-monoclonal antibody ebizwa ngokuthi i-FDC-6, ebona ngokuqondile i-III-CS, isifunda esichaza isoform ye-fetus ye-fibronectin.Ucwaningo lwe-Immunohistochemical lwe-placentae lubonise ukuthi i-fFN injaloivalelwe ku-matrix engaphandle kweseli yesifunda echaza ukuhlanganaamayunithi kamama kanye ne-fetus ngaphakathi kwesibeletho.

I-Fetal fibronectin ingatholwa ekusithekeni komlomo wesibeletho kwabesifazane ngesikhathi sokukhulelwa kusetshenziswa i-monoclonal antibodybased immunoassay.I-Fetal fibronectin ikhuphuka ekuphumeni komlomo wesibeletho ngesikhathi sokukhulelwa kusencane kodwa iyehla isuka emavikini angama-22 kuye kwangama-35 ekukhulelweni okujwayelekile.Ukubaluleka kokuba khona kwayo esithweni sangasese phakathi namasonto okuqala okukhulelwa akuqondakali.Kodwa-ke, kungase kumane kubonise ukukhula okuvamile kwe-extravillous trophoblast labantu kanye ne-placenta.Ukutholwa kwe-fFN ekukhiqizweni komlomo wesibeletho phakathi kwamaviki angama-22, izinsuku ezi-0 namaviki angama-34, ukukhulelwa kwezinsuku eziyi-6 kubikwa ukuthi kuhlotshaniswa nokubeletha ngaphambi kwesikhathi ngezimpawu naphakathi kwamasonto angama-22, izinsuku eziyi-0 namaviki angama-30, izinsuku eziyi-6 kwabesifazane abakhulelwe abangenazimpawu.

ISIMISO
Isinyathelo Esiqinile®Ukuhlolwa kwe-fFN kusebenzisa ubuchwepheshe be-color immunochromatographic, capillary flow technology.Inqubo yokuhlola idinga ukuxazululeka kwe-fFN 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-fFN ikhona kusampula, izokwakha inkimbinkimbi enama-anti-fFN amasosha omzimba ahlanganiswe nezinhlayiya ezinemibala.I-complex izobe isiboshwa i-anti-fFN yesibili antibody egcotshwe 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 i-fFN ne-sodium azide.Okokulawula kwangaphandle.

1 I-swab yokulawula engalungile
(ngesicelo kuphela)

Ayiqukethe i-fFN.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 NEKUGCINWA KWEPECIMEN
■ Sebenzisa kuphela i-Dacron noma i-Rayon enezici eziyinyumba ezinezinsimbi zepulasitiki.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.
∎ Ukukhishwa komlomo wesibeletho kutholwa ngemuva kwe-fornix yesitho sangasese sowesifazane.Inqubo yokuqoqa ihloselwe ukuba mnene.Iqoqo elinamandla noma elinamandla, elivamile kumasiko e-microbiological, alidingekile.Ngesikhathi sokuhlolwa kwe-speculum, ngaphambi kwanoma yikuphi ukuhlolwa noma ukuxhashazwa komlomo wesibeletho noma umgudu wesitho sangasese sowesifazane, zungezisa kancane ithiphu lesifake isicelo ku-fornix yangemuva yesitho sangasese sowesifazane cishe imizuzwana eyi-10 ukuze umunce ukukhishwa komlomo wesibeletho.Imizamo elandelayo yokugcwalisa ithiphu lomfakisicelo ingase yenze uhlolo lungavumelekile.Susa umfakisicelo futhi wenze ukuhlolwa njengoba kuqondiswe ngezansi.
■ 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:

Fetal Fibronectin Rapid Test Device001

Amabhande amabili anombala avela kulwelwesi.Ibhendi eyodwa ivela endaweni yokulawula (C) kanti elinye ibhendi livela endaweni yokuhlola (T).

OKUBIRESULT:

Fetal Fibronectin Rapid Test Device001

Ibhande elilodwa kuphela elinemibala elivela endaweni yokulawula (C).Alikho ibhande elinemibala elivelayo endaweni yokuhlola (T).

AKUMALIRESULT:

Fetal Fibronectin Rapid Test Device001

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. Lokhu kuhlola kungasetshenziswa kuphela ukuze kutholwe ikhwalithi ye-fetal fibronectin ekusithekeni komlomo wesibeletho.
2. Imiphumela yokuhlolwa kufanele ngaso sonke isikhathi isetshenziswe ngokuhambisana nenye idatha yomtholampilo neyelabhorethri yokuphathwa kwesiguli.
3. Izibonelo kufanele zitholwe ngaphambi kokuhlolwa kwedijithali noma ukuguqulwa komlomo wesibeletho.Ukuxhashazwa komlomo wesibeletho kungase kuholele emiphumeleni engelona iqiniso.
4. Izifanekiso akufanele ziqoqwe uma isiguli siye saya ocansini phakathi kwamahora angu-24 ukuze kuqedwe imiphumela emihle engamanga.
5. Iziguli ezine-placenta esisolekayo noma ezaziwayo, ukopha kwe-placenta previa, noma ukopha okumaphakathi noma okukhulu esithweni sangasese akufanele zihlolwe.
6. Iziguli ezine-cerclage akufanele zihlolwe.
7. Izici zokusebenza zeStrongStep®Ukuhlolwa kwe-fFN kusekelwe ocwaningweni kwabesifazane abane-singleton gestration.Ukusebenza akuzange kuqinisekiswe ezigulini ezikhulelwe izikhathi eziningi, isb, amawele.
8. Isinyathelo Esiqinile®Ukuhlolwa kwe-fFN akuhloselwe ukuthi kwenziwe lapho kukhona ukugqabuka kolwelwesi lwe-amniotic futhi ukuphuka kolwelwesi lwe-amniotic kufanele kukhishwe ngaphambi kokwenza ukuhlolwa.

IZIMPAWU ZOKUSEBENZA

Ithebula: I-StrongStep® fFN Test vs. Enye i-brand fFN Test

Ukuzwela Okuhlobene:

97.96% (89.13%-99.95%)*

Ukucaciswa Okuhlobene:

98.73% (95.50% -99.85%)*

Isivumelwano Sisonke:

98.55% (95.82%-99.70%)*

*95% Isikhawu Sokuzethemba

 

Olunye uhlobo

 

+

-

Isamba

StrongStep®fFn Hlola

+

48

2

50

-

1

156

157

 

49

158

207

Ukuzwela kokuhlaziya
Inani eliphansi elitholakalayo le-fFN kusampula ekhishiwe ngu-50μg/L.
Phakathi kwabesifazane abanezimpawu, amazinga aphakeme (≥ 0.050 μg/mL) (1 x 10-7 mmol/L) we-fFN phakathi kwamaviki angu-24, izinsuku ezingu-0 namaviki angu-34, izinsuku ezingu-6 zibonisa ingozi eyengeziwe yokubeletha ≤ 7 noma ≤ izinsuku ezingu-14 kusukela iqoqo lesampula.Phakathi kwabesifazane abangabonakali, amazinga aphakeme e-fFN phakathi kwamaviki angu-22, izinsuku ezingu-0 namaviki angu-30, izinsuku ezingu-6 zibonisa ingozi eyengeziwe yokubeletha kumaviki angu-≤ angu-34, izinsuku ezingu-6 zokukhulelwa.I-cutoff ye-50 μg/L fFN yasungulwa ocwaningweni lwe-multicenter olwenziwa ukuze kuhlolwe ukuhlobana phakathi kwe-fetal fibronectin expression phakathi nokukhulelwa kanye nokubeletha ngaphambi kwesikhathi.

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 a0.033 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
MgSO47H2O 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
1. Ikolishi LaseMelika Lodokotela Ababelethisayo kanye Nodokotela Bezifo Zabesifazane.Umsebenzi Wangaphambi Kwesikhathi.I-Technical Bulletin, Inombolo 133, Okthoba, 1989.
2. I-Creasy RK, i-Resnick R. Imithi Yomama Nengane: Izimiso Nomkhuba.EPhiladelphia: WB Saunders;1989.
3. Creasy RK, Merkatz IR.Ukuvimbela ukuzalwa ngaphambi kwesikhathi: umbono womtholampilo.I-Obstet Gynecol 1990;76(Suppl 1):2S–4S.
4. Morrison JC.Ukuzalwa ngaphambi kwesikhathi: iphazili okufanele ixazululwe.I-Obstet Gynecol 1990;76(Suppl 1):5S-12S.
5. Lockwood CJ, Senyei AE, Dische MR, Casal DC, et al.I-Fetal fibronectin ekusithekeni komlomo wesibeletho nesitho sangasese sowesifazane njengesibikezelo sokulethwa ngaphambi kwesikhathi.IsiNgisi Esisha J Med 1991;325:669–74.
UHLU LWEZIMFANEKISO

Fetal Fibronectin Rapid Test Device-1 (1)

Inombolo yekhathalogi

Fetal Fibronectin Rapid Test Device-1 (7)

Ukunciphisa izinga lokushisa

Fetal Fibronectin Rapid Test Device-1 (2)

Bheka imiyalelo yokusetshenziswa

Fetal Fibronectin Rapid Test Device-1 (8)

Ikhodi yeqoqo

Fetal Fibronectin Rapid Test Device-1 (3)

In vitro diagnostic device medical

Fetal Fibronectin Rapid Test Device-1 (9)

Sebenzisa nge

Fetal Fibronectin Rapid Test Device-1 (4)

Umkhiqizi

Fetal Fibronectin Rapid Test Device-1 (10)

Iqukethe okwaneleizivivinyo

Fetal Fibronectin Rapid Test Device-1 (5)

Ungaphinde usebenzise

Fetal Fibronectin Rapid Test Device-1 (11)

Oqokelwe ukumela abanye ogunyaziwe ku-European Community

Fetal Fibronectin Rapid Test Device-1 (6)

I-CE imakwe ngokuya nge-IVD Medical Devices Directive 98/79/EC

Inkampani Liming Bio-Products Co., Ltd.
No. 12 Huayuan Road,Nanjing, Jiangsu, 210042 PR China.
Ucingo: (0086)25 85476723 Ifeksi: (0086)25 85476387
I-imeyili:sales@limingbio.com
Iwebhusayithi: www.limingbio.com
www.stddiagnostics.com
www.stidiagnostics.com
I-WellKang Ltd.(www.CE-marking.eu) Ucingo: +44(20)79934346
29 Harley St., London WIG 9QR,UK Fax: +44(20)76811874

I-StrongStep® Fetal Fibronectin Rapid Test Device

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Ukubeletha ngaphambi kwesikhathi, okuchazwa yi-American College of Obstetricians and Gynecologists njengokubeletha ngaphambi kweviki lama-37 lokukhulelwa, kunesibopho seningi lokugula nokufa kwabantu okungezona i-chromosomal.Izimpawu zokubeletha okusongelwa ngaphambi kwesikhathi zihlanganisa ukufinyela kwesibeletho, ukushintsha kokuphuma koketshezi esithweni sangasese sowesifazane, ukopha esithweni sangasese, ubuhlungu beqolo, ukungakhululeki kwesisu, umfutho we-pelvic, kanye nokuklabalasa.Izindlela zokuxilonga zokuhlonza ukulethwa okusongelayo ngaphambi kwesikhathi zihlanganisa ukuqapha umsebenzi wesibeletho kanye nokusebenza kokuhlolwa komlomo wesibeletho kwedijithali, okuvumela ukulinganiswa kobukhulu bomlomo wesibeletho.

I-StrongStep® Fetal Fibronectin Rapid Test ukuhlola okuhunyushwe ngokubonwa kwe-immunochromatographic okuhloswe ukuthi kusetshenziselwe ukutholwa kwekhwalithi ye-fetal fibronectin ekuphumeni komlomo wesibeletho enezici ezilandelayo:
Kuyasebenziseka:inqubo yesinyathelo esisodwa ekuhlolweni kwekhwalithi
Ngokushesha:imizuzu eyi-10 kuphela edingekayo ngesikhathi sokuvakasha kwesiguli esifanayo
Amathuluzi:izibhedlela ezikhawulela umthombo noma indawo yomtholampilo ingenza lokhu kuhlola
Kulethiwe:izinga lokushisa legumbi (2℃-30℃)


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