Ukuhlolwa okusheshayo okusheshayo

Incazelo emfushane:

Inkonti encane 500170 Ukucacisa Izivivinyo / ibhokisi / ibhokisi
Isimiso sokutholwa Immunochrochrographic assay Izindola Ukukhipha isitho sangasese sowesifazane
Ukusetshenziswa okuhlosiwe Ukuhlolwa okusheshayo kwe-CROSTSTEP


Imininingwane Yomkhiqizo

Amathegi Omkhiqizo

I-Prom Rapid Test SeppenCEMEME12
I-Prom Rapid Test SeppenDEOPERE14
I-Prom Rapid Test SeppenCEMEME16

Ukusetshenziswa okuhlosiwe
I-grontstep®Ukuhlolwa kwe-Prom kungukuhlolisisa okubonakalayo, ukuhlolwa kwe-Immunochrogamaygraphic okutholwe i-IGFBP-1 kusuka ku-amniotic fluid encazelweni yangasese yangasese ngesikhathi sokukhulelwa. Ukuhlolwa kwenzelwe ukusetshenziswa kobungcweti ukusiza ukuthola ukuqhekeka kolwelwesi lwe-fetal (ROM) kwabesifazane abakhulelwe.

Ukuqalisa
Ukuhlushwa kwe-IGFBP-1 (i-insulin-efana nokukhula kwesici esibophayo protein-1) ku-amniotic fluid kuyizikhathi eziyi-100 kuye kwezingu-1000 eziphakeme kune-serum maternal. I-IGFBP-1 ayivamisile ukuba khona esithweni sangasese sowesifazane, kepha ngemuva kokuqhekeka kolwelwesi lwe-fetal, i-amniotic fluid enokuhlangana okuphezulu kwe-IGFBP-1 ukuxubanisa nokuxubha kwangasese. Ku-ProvestStep® Tempty Test, okucacisiwe kwemfihlo yangasese kuthathwa nge-polyester swab oyinyumba kanye ne-specimen kukhishwe kwikhambi lokukhishwa kwe-specimen. Ukuba khona kwe-IGFBP-1 kukhambi kutholwa kusetshenziswa idivaysi yokuhlola okusheshayo.

Isimiso
I-grontstep®I-Prom Test isebenzisa umbala we-immunochrogatographic, ubuchwepheshe bokugeleza kwe-capillary. Inqubo yokuhlola idinga ukuvumelanisa kwe-IGFBP-1 kusuka ku-swab yesitho sangasese sowesifazane ngokuxuba i-swab ku-buffer yesampula. Ngemuva kwalokho kufakwa i-buffer yesampula exubekile kusampula ye-cassette yokuhlola kahle bese kuthi ingxube ifuduka endaweni ye-membrane. Uma i-IGFBP-1 ikhona kwisampula, izokwakha i-Complex nge-anti- nd anti- 1 eyi-antibody evamile ehlanganiswe nezinhlayiya ezinemibala. I-Complex izobe isiboshwa yi-anti- nd anti- 1 1 ehlanganiswe ngolwelwesi lweNitrocellulose. Ukuvela komugqa wokuhlola obonakalayo kanye nomugqa wokulawula kuzokhombisa umphumela omuhle.

Izakhi zekhithi

20 Ngawodwa puhlamvu lwecololo endaweniAmadivayisi wokuhlola we-ED

Idivaysi ngayinye iqukethe umucu onezimbotshana ezinemibala kanye nokuphendula okusebenzayo kuqala ezifundeni ezihambisanayo.

2IsizindaBuffer vial

0.1 m phosphate buffered saline (PBS) no-0.02% sodium Azide.

1 Ukulawula okuhle Swab
(ngesicelo kuphela)

Aqukethe i-IGFBP-1 ne-sodium Azide. Ngokulawulwa kwangaphandle.

1 Ukulawula Okungalungile Swab
(ngesicelo kuphela)

Ayiqukethe i-iGFBP-1. Ngokulawulwa kwangaphandle.

20 Amashubhu we-Extraction

Okwezinkulumo zokulungiselela ama-specimens.

1 I-WorkStation

Beka ukubamba ama-buffer vials namashubhu.

1 Faka iphakheji

Ukufundiswa ukusebenza.

Izinto ezidingekayo kodwa azinikeziwe

Umninisikhathi Ngokusetshenziswa kwesikhathi.

IZINYATHELO ZOKUZIVIKELA
■ Ngochwepheshe ekusetshenzisweni kokuxilongwa kwe-vitro kuphela.
■ Ungasebenzisi ngemuva kokuphelelwa isikhathi usuku olukhonjiswe kwiphakheji. Ungasebenzisi isivivinyo uma isikhwama saso se-foil silimele. Musa ukusebenzisa kabusha izivivinyo.
■ Le kit iqukethe imikhiqizo yemvelaphi yezilwane. Ulwazi oluqinisekisiwe lwemvelaphi kanye / noma isimo sokuhlanzeka kwezilwane alwenzi ngokuphelele ukungabikhona kwama-ejenti ahambisanayo ama-pathogenic. Ngakho-ke, kutuswa ukuthi le mikhiqizo iphathwe njengokuthethelela, futhi isingathekile ukubuka izinyathelo zokuphepha ezijwayelekile (ungangeni noma inhale).
■ Gwema ukungcoliswa kwe-sper specimens ngokusebenzisa isitsha esisha sokuqoqa esibonakalayo sohlobo ngalunye olutholwayo.
■ Funda yonke inqubo ngokucophelela ngaphambi kokwenza noma yiziphi izivivinyo.
■ Ungadli, phuza noma ubheme endaweni lapho ama-specimens namakhithi aphathwa khona. Bamba zonke izinhlobo ezinjengokungathi ziqukethe abezi ezithathelwanayo. Bheka izinyathelo zokuqapha ezisungulwe ngokumelene nezingozi ze-microbiological kuyo yonke inqubo bese ulandela izinqubo ezijwayelekile zokulahlwa kahle kwezinhlamvu. Gqoka izingubo zokuvikela ezifana namajazi welabhoratri, amagilavu ​​alahlwayo nokuvikelwa kwamehlo lapho ama-specimens ayavuma.
■ Musa ukushintshanisa noma hlanganisa ama-reagents kusuka kunkambiso ehlukile. Musa ukuxuba izixazululo zamabhodlela.
■ umswakama kanye nokushisa kungathinta kabi imiphumela.
■ Lapho inqubo ye-Assay iphothuliwe, lahla ama-swabs ngokucophelela ngemuva kokuwafaka ngokuzenzakalela ku-121 ° C ukuthola imizuzu engama-20. Ngenye indlela, bangalashwa nge-0.5% sodium hypochloride (noma i-per-cal bleach) ihora elilodwa ngaphambi kokulahlwa. Izinto zokuhlola ezisetshenzisiwe kufanele zilahlwe ngokuya ngemithetho yendawo, yombuso kanye / noma noma ye-federal.
■ Ungasebenzisi amabhulashi e-cytolology ngeziguli ezikhulelwe.

Ukugcinwa nokuqina
■ Ikhithi kufanele igcinwe ngo-2-30 ° C kuze kufike usuku lokuphelelwa yisikhathi esibhalwe esikhwameni esivaliwe.
■ Ukuhlolwa kumele kuhlale esikhwameni esivalekile kuze kube yilapho kusetshenziswa.
■ ungabazi.
■ Ukunakekelwa kufanele kuthathwe ukuvikela izakhi kule kit ekungcolisweni. Ungasebenzisi uma kunobufakazi bokungcoliswa kwe-microbial noma kwezulu. Ukungcoliswa kwemvelo kokuhambisa izinsiza, iziqukathi noma ama-reagents kungaholela emiphumeleni yamanga.

Ukuqoqwa kweqoqo nesitoreji
Sebenzisa kuphela i-dacron noma i-rayon efihliwe ngama-swabs oyinyumba ngemigodi yepulasitiki. Kuncoma ukusebenzisa i-swab enikezwe ngumenzi weKits (ama-swabs awaqukethwe kule kit, imininingwane yoku-oda, sicela uxhumane nomenzi noma umsabalalisi wendawo, inombolo yekhathalogi ingu-207000). Ama-Swabs avela kwabanye abahlinzeki awakaqinisekiswa. Ama-Swabs anezeluleko zekotini noma imigodi yokhuni ayinconywa.
■ Kutholwa isampula kusetshenziswa umshini oyinyumba oyinyumba. Isampula kufanele iqoqwe ngaphambi kokwenza ukuhlolwa kwedijithali kanye / noma i-transvaginal ultrasound. Qikelela ukuthi ungathinti lutho nge-swab ngaphambi kokuthatha isampula. Faka ngokucophelela ithiphu le-swab ungene esithweni sangasese ngokubhekela i-fornix engemuva kuze kube yilapho ukumelana kuhlangatshezwa. Ngenye indlela isampula ingathathwa e-Tongerior Fornix ngesikhathi sokuhlolwa kwe-specile julem. I-swab kufanele ishiywe esithweni sangasese semizuzwana eyi-10-15 ukuvumela ukuthi idonse imfihlo yangasese. Donsela ukubhukuda ngokucophelela!.
■ Beka i-swab ku-tube yokukhishwa, uma ukuhlolwa kungaqhutshwa ngokushesha. Uma ukuhlolwa okusheshayo kungenzeki, amasampula wesiguli kufanele abekwe kwi-tube esomile yokuhamba ukuze agcinwe noma ezokuthutha. Ama-swabs angagcinwa amahora angama-24 emazingeni okushisa asekamelweni (15-30 ° C) noma isonto eli-1 ku-4 ° C noma kungabi ngaphezu kwenyanga engu-6 ku-20 ° C. Zonke izinhlobo zezinhlobo kufanele zivunyelwe ukufinyelela ekushiseni kwegumbi le-15-30 ° C ngaphambi kokuhlolwa.

Indlela yokwenza izinto
Letha izivivinyo, ama-specimentens, ama-buffer kanye / noma izilawuli zokushisa kwegumbi (15-30 ° C) ngaphambi kokusebenzisa.
■ Beka i-tube yokususa ehlanzekile endaweni ebekiwe ye-workstation. Faka i-1ml yokukhishwa kwe-buffer ku-tube ye-extraction.
■ Beka i-specimen swab ku-tube. Hlanganisa isixazululo ngokuqinile ngokujikeleza i-swab ngamandla ngokumelene nohlangothi lwe-tube okungenani izikhathi eziyishumi (ngenkathi ifakwe ngaphakathi). Imiphumela emihle itholakala lapho i-specimen ixubene ngamandla kwikhambi.
■ hlikihla uketshezi oluningi ngangokunokwenzeka kusuka ku-swab ngokucindezela uhlangothi lwe-tube ye-extraction eguquguqukayo njengoba kususwa i-swab. Okungenani okungu-1/2 kwesixazululo sesampula yesampula kumele kuhlale ku-tube yokufuduka okune-capillary okwanele. Faka i-cap ku-tube ekhishwe.
Lahla i-swab esitsheni esisheshayo se-biohazarduous.
■ Izinhlobo ze-specimens ezikhishwe zingagcina ekushiseni kwegumbi imizuzu engama-60 ngaphandle kokuthinta umphumela wokuhlolwa.
■ Khipha isivivinyo esikhwameni sayo esivalekile, bese uyibeka endaweni ehlanzekile, yezinga. Faka ilebuli insiza ngesineke noma sokulawula ukukhonjwa. Ukuthola umphumela omuhle kakhulu, i-assay kufanele yenziwe kungakapheli ihora elilodwa.
■ Faka amaconsi ama-3 (cishe ama-100
Gwema ukudonsa ama-bubble air e-specimen (futhi ungalahli noma yisiphi isixazululo ewindini lokubheka.
Njengoba ukuhlolwa kuqala ukusebenza, uzobona umbala uhamba ngaphesheya kwe-membrane.
■ Lindela ama-band (s) anemibala ukuze avele. Umphumela kufanele ufundwe ngemizuzu engu-5. Ungahumushi umphumela ngemuva kwemizuzu engu-5.
Lahla amashubhu wokuhlola asetshenzisiwe kanye nama-cassette wokuhlola esitsheni esifanele semfucumfucu elungile.
Ukuchazwa kwemiphumela

-QinisileUmphumela:

I-Fetal Fibronectin Rapid Test Verction001

Amabhendi amabili anemibala avela ku-membrane. Ibhendi eyodwa ivela esifundeni sokulawula (c) kanti elinye ibhendi livela esifundeni sokuhlola (T).

-PhikisayoUmphumela:

I-Fetal Fibronectin Rapid Test Verction001

I-band eyodwa enemibala kuphela evela esifundeni sokulawula (c). Alikho ibhande elinombala elibonakalayo elivela esifundeni sokuhlola (T).

-NgenamandlaUmphumela:

I-Fetal Fibronectin Rapid Test Verction001

I-Control band yehluleka ukuvela. Imiphumela kusuka kunoma yikuphi ukuvivinya okungakhiqizi ibhendi yokulawula ngesikhathi sokufunda esicacisiwe kufanele kulahlwe. Sicela ubuyekeze inqubo bese uphinda ngovivinyo olusha. Uma inkinga iqhubeka, yeka ukusebenzisa ikhithi ngokushesha bese uthinta umsabalalisi wakho wangakini.

Qaphela:
1. Ukuqina kombala esifundeni sesifunda (T) kungahluka ngokuya ngokuhlushwa kwezinto ezihlosiwe ezikhona ku-specimen. Kepha izinga lezinto alikwazi ukunqunywa yilolu vivinyo.
2. IVolumu Enganele Enganele, Inqubo Engalungile yokusebenza, noma ukwenza izivivinyo eziphelelwe yisikhathi yizizathu ezingenzeka kakhulu zokulawulwa kwebhendi.

IKHWALITHI YOKULAWULA
■ Izilawuli zenqubo yangaphakathi zifakiwe esivivinyweni. Ibhendi enemibala evela esifundeni sokulawula (C) ibhekwa njengethuluzi langaphakathi lezinqubo ezinhle. Iqinisekisa ivolumu eyanele lenqubomgomo nenqubo efanele inqubo.
■ Izilawuli zenqubo zangaphandle zingahlinzekwa (ngesicelo kuphela) kumakhithi wokuqinisekisa ukuthi izivivinyo zisebenza kahle. Futhi, izilawuli zingasetshenziswa ukukhombisa ukusebenza okufanele ngo-opharetha wokuhlola. Ukwenza isivivinyo sokulawula esihle noma esingesihle, gcwalisa izinyathelo ezisengxenyeni yenqubo yokuhlola elapha i-Swew Swab ngendlela efanayo ne-stab swimen.

Ukulinganiselwa kokuhlolwa
1. Akunakuchazwa okulinganiselwe okufanele kwenziwe ngokususelwa emiphumeleni yokuhlola.
2.Ungasebenzisi isivivinyo uma i-aluminium foil pauch yayo noma izimpawu zesikhwama azinakwenzeka.
3.Asekho okuhle okuqinile®Umphumela wokuhlolwa kwe-PROM, yize uthola ukuba khona koketshezi lwe-amniotic kusampula, akutholakali indawo yokuqhuma.
I-4.As ngakho konke ukuhlolwa kokuxilonga, imiphumela kumele ihunyushwe ngokukhanya kwezinye izitho zomtholampilo.
5.Ukuvela kokuqhuma kolwelwesi lwe-fetus senzekile kepha ukuvuza koketshezi lwe-amniotic sekuphelile amahora angaphezu kwangu-12 ngaphambi kokuba kuthathwe ama-specimen, i-IGFBP-1 kungenzeka ukuthi yacekelwa phansi ngamaphrofeyiya esithweni sangasese sowesifazane kanye nokuhlolwa kunganikeza umphumela omubi.

Izici Zokusebenza

Ithebula: Strongstep®I-Prom Test vs Enye i-Brand Prom Test

Ukuzwela okuhlobene:
96.92% (89.32% -99.63%) *
Ukucaciswa okuhlobene:
97.87% (93.91% -99.56%)
Isivumelwano Sekukonke:
97.57% (94.42% -99.21%) *
* 95% isikhawu sokuzethemba

 

Olunye uhlobo

 

+

-

-Nke

I-strongstep®Isiphepho Ukuzama

+

63

3

66

-

2

138

140

 

65

141

206

Ukuzwela kokuhlaziya
Inani eliphansi elibonakalayo le-IGFBP-1 kusampula elikhishwe liyi-12.5 μg / l.

Izinto zokuphazamisayo
Ukunakekelwa kumele kuthathwe ukungcolisa umfakisicelo noma ama-cervicovaginal secrefice ngezithako, insipho, ama-disinfectants, noma okhilimu. Ama-lubracs noma okhilimu angaphazamisa ngokomzimba ukumuncwa kwe-specimen ku-profator. Insipho noma ama-disinferant angaphazamisa ukusabela kwe-antibody-antigen.
Kuhlolwe izinto ezingaphazamisayo ezihlolwe ekugxiliseni okungenzeka ukuthi zitholakale ngokunengqondo kuthola. Izinto ezilandelayo azizange ziphazamise e-Assay lapho zihlolwe emazingeni akhonjisiwe.

Into Ukuqoqana Into Ukuqoqana
I-Ampicillin I-1.47 MG / ML Prostaglandin f2 0.033 MG / ML
Erythromycin 0.272 MG / ML Prostaglandin e2 0.033 MG / ML
Umchamo we-maternal umchamo 3rd trimester I-5% (Vol) UMonistaTR (MiConazole) 0.5 MG / ML
Oxytocin I-IU / ml U-Indigo Carmine 0.232 Mg / ML
Terbutaline I-3.59 MG / ML I-Gendgicicin 0.849 MG / ML
Dexamethasone I-2.50 mg / ml Ijeli ye-betadiner 10 mg / ml
MGSO47h2o 1.49 MG / ML Isicoci se-betadiner 10 mg / ml
Ritodrine 0.33 MG / ML K-yr Jelly 62.5 mg / ml
I-DermiciDol 2000 25.73 MG / ML    

Izincwadi
U-Erdemoglu noMungan T. Ukubaluleka kokuthola ukukhula okufana nokukhula kwe-insulin okubophayo protein-1 encazelweni ye-cervicovaginal: ukuqhathanisa nokuhlolwa kwe-nitrazine kanye nokuhlolwa kwevolumu ye-amniotic fluid. I-Acta isetthi ye-gynecol scand (2004) 83: 622-626.
I-Kubota T no-Takeuchi H. Ukuvalwa kokukhula okufana nokukhula kwe-insulin J Itred Gynecol res (1998) 24: 411-417.
URutanen Em et al. Ukuhlolwa kokuhlolwa kwe-strip okusheshayo kwe-insulin-efana nokukhula kwesici esibophayo protein-1 ekuhlolweni kwama-membranes we-fetus. Cling Chim Acta (1996) 253: 91-101.
I-Rutanen em, Pekonen F, Karkkainen T. Ukulinganiswa kokukhula kwe-insulin-efana nesici esibophayo protein-1 ku-Cervical / vaginal Secreitions: Qhathanisa ne-Rom-Checkmbrane Immunoassass ekuhlolweni kwama-membrane we-fetus. Clim Chim Acta (1993) 214: 73-81.

Uhlu lwezimpawu

I-Fetal Fibronectin Rapid Test Seppep-1 (1)

Inombolo yekhathalogi

I-Fetal Fibronectin Rapid Test Viptom-1 (7)

Ukushisa kokushisa

I-Fetal Fibronectin Rapid Vivice-1 (2)

Bheka imiyalo yokusebenzisa

I-Fetal Fibronectin Rapid Test Viptom-1 (8)

Ikhodi ye-batch

I-Fetal Fibronectin Rapid Test - 1 (3)

Kudivayisi yezokwelapha yokuxilongwa kwe-vitro

I-Fetal Fibronectin Rapid Test Viptom-1 (9)

Sebenzisa ngo

I-Fetal Fibronectin Rapid Test Viptom-1 (4)

Umenzi

I-Fetal Fibronectin Rapid Test Vider-1 (10)

Iqukethe eyanele ukuhlolwa

I-Fetal Fibronectin Rapid Test Viptom-1 (5)

Ungaphinde usebenzise kabusha

I-Fetal Fibronectin Rapid Test Vipto-1 (11)

Ummeleli ogunyaziwe emphakathini waseYurophu

I-Fetal Fibronectin Rapid Test - 1 (6)

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


  • Okwedlule:
  • Olandelayo:

  • Bhala umyalezo wakho lapha bese usithumela kithi