Uvavanyo olukhawulezayo lwe-PROM

Inkcazelo emfutshane:

I-REF 500170 Inkcazo Iimvavanyo ezingama-20/Ibhokisi
Umgaqo wokufumanisa Uvavanyo lwe-Immunochromatographic Imizekelo Ukuphuma kwilungu lobufazi
Usetyenziso olucetywayo Uvavanyo olukhawulezayo lwe-StrongStep® PROM luvavanyo olubonakalayo olutolikwayo, olusemgangathweni lwe-immunochromatographic ukufunyanwa kwe-IGFBP-1 kwi-amniotic fluid kwi-vaginal secretions ngexesha lokukhulelwa.


Iinkcukacha zeMveliso

Iithegi zeMveliso

PROM Rapid Test Device12
PROM Rapid Test Device14
PROM Rapid Test Device16

UKUSETYENZISWA OKUHLOSIWEYO
Inyathelo Eliqinileyo®Uvavanyo lwe-PROM luvavanyo olubonwayo, uvavanyo lwe-immunochromatographic lokubona i-IGFBP-1 kwi-amniotic fluid kwi-vaginal secretions ngexesha lokukhulelwa.Uvavanyo lwenzelwe ukusetyenziswa kobuchwephesha ukunceda ukuxilonga ukugqabhuka kwe-fetus membranes (ROM) kubasetyhini abakhulelweyo.

INTSHAYELELO
I-concentration ye-IGFBP-1 (i-insulin-efana ne-insulin-efana ne-protein-1) kwi-amniotic fluid ngamaxesha angama-100 ukuya kuma-1000 aphezulu kune-serum yomama.I-IGFBP-1 ayiqhelekanga kwi-vagina, kodwa emva kokuphuka kweembrane ze-fetal, i-amniotic fluid ene-concentration ephezulu ye-IGFBP-1 ixuba kunye ne-vaginal secretions.Kuvavanyo lwe-StrongStep® PROM, isampuli ye-vaginal secretion ithathwa nge-polyester swab eyinyumba kwaye i-specimen ikhutshwe kwi-Specimen Extraction Solution.Ubukho be-IGFBP-1 kwisisombululo bufunyenwe usebenzisa isixhobo sokuvavanya ngokukhawuleza.

UMGAQO
Inyathelo Eliqinileyo®Uvavanyo lwe-PROM lusebenzisa umbala we-immunochromatographic, iteknoloji yokuhamba kwe-capillary.Inkqubo yovavanyo ifuna i-solubilization ye-IGFBP-1 kwi-swab ye-vaginal ngokuxuba i-swab kwi-Sample Buffer.Emva koko i-buffer yesampuli edibeneyo yongezwa kwisampuli yekhasethi yovavanyo kakuhle kwaye umxube ufuduka ecaleni komphezulu we-membrane.Ukuba i-IGFBP-1 ikhona kwisampuli, iya kwenza i-complex kunye ne-anti-IGFBP-1 antibody edibeneyo edibeneyo kwiinqununu ezinemibala.Emva koko i-complex iya kubotshwa yi-anti-IGFBP-1 yesibini ye-antibody efakwe kwi-nitrocellulose membrane.Ukubonakala komgca wovavanyo olubonakalayo kunye nomgca wokulawula kuya kubonisa umphumo omuhle.

AMANQAKU EKIT

20 Umntu ngamnye packizixhobo zovavanyo lwe-ed

Isixhobo ngasinye sinomgca onama-conjugates anemibala kunye nee-reagents ezisebenzayo ezifakwe ngaphambili kwiindawo ezihambelanayo.

2UkutsalwaBuffer vial

I-0.1 M I-Phosphate buffered saline (PBS) kunye ne-0.02% ye-sodium azide.

1 I-swab yolawulo oluhle
(ngesicelo kuphela)

Iqulethe i-IGFBP-1 kunye ne-sodium azide.Kulawulo lwangaphandle.

1 Iswab yokulawula engalunganga
(ngesicelo kuphela)

Ayiqulathanga IGFBP-1.Kulawulo lwangaphandle.

20 Imibhobho yokukhupha

Ukulungiselela imizekelo yokusetyenziswa.

1 Indawo yokusebenzela

Indawo yokugcina i-buffer vials kunye netyhubhu.

1 Faka iphakheji

Ngomyalelo wokusebenza.

IZINTO EZIFUNEKAYO KODWA AKUNIKEZWE

Isibali-xesha Ukusetyenziswa kwexesha.

UKULUMKELA
■ Ukusetyenziswa koxilongo lwe-in vitro kuphela.
■ Musa ukusebenzisa emva komhla wokuphelelwa kwawo oboniswe kwiphakheji.Musa ukulusebenzisa uvavanyo ukuba isingxobo sefoyile saso sonakalisiwe.Musa ukuphinda usebenzise iimvavanyo.
∎ Le khithi iqulethe iimveliso zezilwanyana.Ulwazi oluqinisekisiweyo lwemvelaphi kunye / okanye ubume bococeko lwezilwanyana aluqinisekisi ngokupheleleyo ukungabikho kwee-agent ze-pathogenic ezihambisayo.Kuyacetyiswa ke ngoko ukuba ezi mveliso ziphathwe njengenokosulela, kwaye ziphathwe ngokuqwalasela imiqathango yokhuseleko yesiqhelo (ungagilisi okanye ukusezele umoya).
■ Kuphephe ukungcoliseka ngokunqamlezileyo kwesampulu ngokusebenzisa isikhongozeli esitsha somfanekiso womfanekiso ofunyenweyo.
■ Funda inkqubo yonke ngocoselelo phambi kokwenza naluphi na uvavanyo.
∎ Ungatyi, ungaseli okanye utshaye kwindawo apho imizekelo neekhithi ziphathwa.Phatha yonke imizekelo ngokungathi inee-arhente ezosulelayo.Qwalasela izilumkiso ezimiselweyo malunga nobungozi be-microbiological kuyo yonke inkqubo kwaye ulandele iinkqubo ezisemgangathweni zokulahla ngokufanelekileyo iisampulu.Nxiba iimpahla ezikhuselayo ezifana needyasi zaselabhoratri, iiglavu ezilahlwayo kunye nokhuseleko lwamehlo xa imizekelo ivavanywa.
■ Musa ukutshintshiselana okanye uxube ii-reagents ezivela kwiindawo ezahlukeneyo.Musa ukuxuba iminqwazi yebhotile yesisombululo.
∎ Ukufuma kunye nobushushu bunokuba nefuthe elibi kwiziphumo.
∎ Xa inkqubo yokuvavanya igqityiwe, lahla i-swabs ngononophelo emva kokuba i-autoclaving kubo kwi-121 ° C ubuncinane imizuzu engama-20.Kungenjalo, banokunyangwa nge-0.5% ye-sodium hypochloride (okanye i-bleach-hold house) iyure enye ngaphambi kokulahlwa.Izinto zokuvavanya ezisetyenzisiweyo kufuneka zilahlwe ngokuhambelana nemigaqo yasekhaya, yelizwe kunye / okanye ye-federal.
■ Musa ukusebenzisa iibrashi ze-cytology kunye nezigulane ezikhulelweyo.

UKUGCINWA NOZINZI
∎ Ikhithi kufuneka igcinwe kwi-2-30°C de kube ngumhla wokuphelelwa kwexesha uprintwe kwisingxobo esivaliweyo.
■ Uvavanyo kufuneka luhlale kwisingxobo esivaliweyo de lusetyenziswe.
■ Musa ukuba ngumkhenkce.
∎ Iinkathalo kufuneka zithathwe ukukhusela amalungu ale khithi ekosulelweni.Musa ukusebenzisa ukuba kukho ubungqina bokungcoliseka kwe-microbial okanye imvula.Ungcoliseko lwebhayoloji lwezixhobo zokukhupha, izikhongozeli okanye iirejenti kunokukhokelela kwiziphumo ezingezizo.

UKUQOKELELWA KOMSEBENZI NOKUGCINWA
Sebenzisa kuphela i-Dacron okanye iRayon eneencam ezinencapha ezingentsholongwane ezineeshafu zeplastiki.Kucetyiswa ukuba usebenzise i-swab ebonelelwe ngumenzi wekhithi (Ii-swabs aziqulathanga kule khithi, ngolwazi lokuodola, nceda uqhagamshelane nomenzi okanye umsasazi wendawo, inombolo yekhathalogu yi-207000).Iiswabs ezivela kwabanye ababoneleli azikaqinisekiswa.I-swabs eneengcebiso zekotoni okanye i-shafts yokhuni ayikhuthazwa.
■ Isampulu ifunyanwa kusetyenziswa iswabhu yepolyester engenazintsholongwane.Isampulu kufuneka iqokelelwe phambi kokuba kwenziwe uvavanyo lwedijithali kunye/okanye i-ultrasound ye-transvaginal.Qaphela ukuba ungachukumisi nantoni na ngeswab phambi kokuba uthathe isampuli.Ngononophelo faka incam ye-swab kwi-vagina ukuya kwi-fornix yangasemva de kube ukuchasana kuhlangatyezwane.Ngenye indlela isampuli inokuthathwa kwi-fornix yangasemva ngexesha loviwo lwe-speculum oyinyumba.I-swab kufuneka ishiywe kwilungu lobufazi imizuzwana eyi-10-15 ukuyivumela ukuba ifunxe incindi yelungu lobufazi.Tsala i-swab ngononophelo!.
■ Beka i-swab kwityhubhu yokukhupha, ukuba uvavanyo lunokwenziwa ngokukhawuleza.Ukuba uvavanyo olukhawulezileyo alunakwenzeka, iisampuli zesigulane kufuneka zifakwe kwi-tube yokuthutha eyomileyo yokugcina okanye ukuthutha.Iiswabs zinokugcinwa iiyure ezingama-24 kwiqondo lobushushu legumbi (15-30°C) okanye iveki enye kwi-4°C okanye hayi ngaphezulu kweenyanga ezi-6 kwi-20°C.Zonke iisampuli kufuneka zivunyelwe ukufikelela kwiqondo lokushisa kwe-15-30 ° C ngaphambi kokuvavanya.

INKQUBO
Zisa iimvavanyo, imizekelo, isithinteli kunye/okanye nolawulo kwiqondo lobushushu begumbi (15-30°C) phambi kokusetyenziswa.
■ Beka ityhubhu ecocekileyo yokutsalwa kwindawo echongiweyo yendawo yokusebenza.Yongeza i-1ml ye-Extraction Buffer kwityhubhu yokukhupha.
■ Faka i-swab yomzekelo kwityhubhu.Hlanganisa ngamandla isisombululo ngokujikeleza i-swab ngamandla kwicala letyhubhu ubuncinane amaxesha alishumi (ngelixa lifakwe emanzini).Iziphumo ezilungileyo zifumaneka xa i-specimen ixutywe ngamandla kwisisombululo.
∎ Khupha ulwelo oluninzi kangangoko kunokwenzeka kwiswab ngokucinezela icala letyhubhu ethambileyo yokutsalwa njengoko kususwa iswab.Ubuncinci i-1/2 yesisombululo se-buffer yesampuli kufuneka ihlale kwi-tube ukwenzela ukuba ukufuduka okwaneleyo kwe-capillary kwenzeke.Beka ikepusi kwityhubhu ekhutshiweyo.
Lahla i-swab kwisikhongozeli esifanelekileyo senkunkuma ye-biohazardous.
∎ Imizekelo ekhutshiweyo inokugcina ubushushu begumbi imizuzu engama-60 ngaphandle kokuchaphazela iziphumo zovavanyo.
■ Susa uvavanyo kwisingxobo salo esivaliweyo, kwaye ulubeke kwindawo ecocekileyo, ethe tyaba.Faka ileyibhile kwisixhobo ngesazisi sesigulane okanye solawulo.Ukufumana iziphumo ezingcono, uvavanyo kufuneka lwenziwe kwiyure enye.
■ Yongeza amathontsi ama-3 (malunga ne-100 µl) yesampulu ekhutshiweyo kwi-Extraction Tube kwiqula lesampulu ekwikhasethi yovavanyo.
Kuphephe ukubambisa amaqamza omoya kwiqula elingumzekelo (S), kwaye musa ukulahla nasiphi na isisombululo kwifestile yokuphonononga.
Njengoko uvavanyo luqala ukusebenza, uya kubona umbala uhamba kwi-membrane.
■ Lindela amabhanti anemibala avele.Isiphumo kufuneka sifundwe ngemizuzu emi-5.Musa ukutolika umphumo emva kwemizuzu emi-5.
Lahla iityhubhu zovavanyo ezisetyenzisiweyo kunye neeCassettes zoVavanyo kwisikhongozeli esifanelekileyo senkunkuma enobungozi.
UKUTOLIKWA KWEZIPHUMO

OKUHLEIZIPHUMO:

Fetal Fibronectin Rapid Test Device001

Iibhanti ezimbini ezinemibala zivela kwi-membrane.Elinye iqela livela kummandla wolawulo (C) kwaye elinye ibhendi libonakala kwindawo yovavanyo (T).

EZINGAMBIIZIPHUMO:

Fetal Fibronectin Rapid Test Device001

Ibhanti enye kuphela enemibala ibonakala kwindawo yokulawula (C).Akukho bhanti yemibala ebonakalayo ibonakala kwindawo yovavanyo (T).

AKUMELELEYOIZIPHUMO:

Fetal Fibronectin Rapid Test Device001

Ibhendi yolawulo ayibonakali.Iziphumo zalo naluphi na uvavanyo olungakhange luvelise ibhendi yolawulo ngexesha lokufunda elichaziweyo mazichithwe.Nceda ujonge inkqubo kwaye uphinde ngovavanyo olutsha.Ukuba ingxaki iyaqhubeka, yeka ukusebenzisa ikhithi ngoko nangoko kwaye uqhagamshelane nomsasazi wakho wendawo.

PHAWULA:
1. Ubunzima bombala kwingingqi yovavanyo (T) bunokwahluka ngokuxhomekeka kugxininiso lwezinto ezijoliswe kuzo ezikhoyo kumzekelo.Kodwa inqanaba lezinto alinakumiselwa ngolu vavanyo lomgangatho.
2. Umthamo onganeleyo wesampulu, inkqubo yokusebenza engachanekanga, okanye ukwenza iimvavanyo eziphelelwe lixesha zezona zizathu zinokwenzeka zokungaphumeleli kwebhendi yolawulo.

ULAWULO LWEMEKO
■ Ulawulo lwenkqubo lwangaphakathi lubandakanyiwe kuvavanyo.Ibhendi enemibala ebonakala kwindawo yolawulo (C) ithathwa njengolawulo olulungileyo lwangaphakathi.Iqinisekisa umthamo owaneleyo wesampuli kunye nobuchule benkqubo obuchanekileyo.
■ Ulawulo lwenkqubo lwangaphandle lunokubonelelwa (ngesicelo kuphela) kwiikhithi zokuqinisekisa ukuba iimvavanyo zisebenza ngokufanelekileyo.Kwakhona, uLawulo lunokusetyenziswa ukubonisa ukusebenza kakuhle ngumqhubi wovavanyo.Ukwenza uvavanyo oluchanekileyo okanye olubi, gcwalisa amanyathelo kwicandelo leNkqubo yoVavanyo ephatha i-swab yokulawula ngendlela efanayo ne-specimen swab.

IMIDA YOVAVANYO
1. Akukho toliko yobungakanani kufuneka yenziwe ngokusekelwe kwiziphumo zovavanyo.
2.Ungalusebenzisi uvavanyo ukuba isingxobo sefoil ye-aluminiyam okanye amatywina epokhi akachanekanga.
3.Inyathelo elilungileyo elomeleleyo®Isiphumo sovavanyo lwe-PROM, nangona sibona ubukho be-amniotic fluid kwisampulu, ayifumani indawo yokugqabhuka.
4.Njengazo zonke iimvavanyo zokuxilonga, iziphumo kufuneka zitolikwe ngokubhekiselele kwezinye iziphumo zeklinikhi.
I-5.Ukuba ukuphuka kwe-fetus membranes kuye kwenzeka kodwa ukuvuza kwe-amniotic fluid kuyekile ngaphezu kweeyure ze-12 ngaphambi kokuba i-specimen ithathwe, i-IGFBP-1 inokutshatyalaliswa ngama-proteases kwi-vagina kwaye uvavanyo lunokunika isiphumo esibi.

IIMPAWU ZOKUSEBENZA

Itheyibhile:StrongStep®Uvavanyo lwe-PROM vs. Olunye uvavanyo lwe-prom yohlobo

Uvakalelo olunxulumeneyo:
96.92% (89.32% -99.63%)*
Iinkcukacha Ngokuhambelanayo:
97.87% (93.91% -99.56%)*
IsiVumelwano sisonke:
97.57% (94.42% -99.21%)*
*95% iThutyana lokuzithemba

 

Olunye uphawu

 

+

-

Iyonke

Inyathelo elinamandla®IPROM Uvavanyo

+

63

3

66

-

2

138

140

 

65

141

206

Uvakalelo lohlalutyo
Ixabiso eliphantsi elibonakalayo le-IGFBP-1 kwisampuli ekhutshwe yi-12.5 μg / l.

Izinto eziphazamisayo
Kufuneka kuthatyathwe unonophelo ukuba ungangcolisi umfaki-sicelo okanye ukukhutshwa komlomo wesibeleko ngezithambiso, iisepha, izibulali ntsholongwane, okanye iikhrimu.Izithambiso okanye iikhrimu zinokuphazamisana ngokwasemzimbeni ekufunxeni komzekelo kumfaki-sicelo.Iisepha okanye izibulali ntsholongwane zinokuphazamisana ne-antibody-antigen reaction.
Izinto ezinokuthi zibe nokuphazamisa ziye zavavanywa kugxininiso ezinokufumaneka ngokufanelekileyo kwiimfihlo zomlomo wesibeleko.Ezi zinto zilandelayo azizange ziphazamise kuvavanyo xa zivavanywa kumanqanaba abonisiwe.

Iziyobisi Ukugxila Iziyobisi Ukugxila
Ampicillin 1.47 mg/mL Prostaglandin F2 0.033 mg/mL
Erythromycin 0.272 mg/mL Prostaglandin E2 0.033 mg/mL
Umchamo Woomama 3rd Trimester 5% (vol) MonistatR (miconazole) 0.5 mg/mL
Oxytocin 10 IU/mL Indigo Carmine 0.232 mg/mL
Terbutaline 3.59 mg/mL Gentamicin 0.849 mg/mL
Dexamethasone 2.50 mg/mL BetadineR Gel 10 mg/mL
MgSO47H2O 1.49 mg/mL BetadineR Cleanser 10 mg/mL
I-Ritodrine 0.33 mg/mL Ijeli ye-K-YR 62.5 mg/mL
DermicidolR 2000 25.73 mg/mL    

IINGCACISO ZONCWADI
I-Erdemoglu kunye ne-Mungan T. Ukubaluleka kokufumanisa i-insulin-efana nokukhula kwento ebopha iprotheyini-1 kwiimfihlo ze-cervicovaginal: xa kuthelekiswa novavanyo lwe-nitrazine kunye novavanyo lwe-amniotic fluid.Acta Obstet Gynecol Scand (2004) 83: 622-626.
I-Kubota T kunye ne-Takeuchi H. Uvavanyo lwe-insulin-efana nokukhula kwento ebophelelayo iprotheni-1 njengesixhobo sokuxilonga ukuphulwa kweembrane.J Obstet Gynecol Res (1998) 24: 411-417.
Rutanen EM et al.Uvavanyo lovavanyo olukhawulezayo lwe-strip ye-insulin-efana ne-insulin factor ebopha iprotein-1 ekuxilongweni kweembrane ze-fetus eziqhekekileyo.UClin Chim Acta (1996) 253:91-101.
I-Rutanen EM, i-Pekonen F, i-Karkkainen T. Umlinganiselo we-insulin-efana nokukhula kwento ebophelelayo kwiprotheyini-1 kwintsholongwane yomlomo wesibeleko / yangasese: xa kuthelekiswa ne-ROM-check Membrane Immunoassay ekuxilongweni kweembrane ze-fetus eziqhekekileyo.UClin Chim Acta (1993) 214: 73-81.

ULUHLU LWEIMPAWU

Fetal Fibronectin Rapid Test Device-1 (1)

Inombolo yekhathalogu

Fetal Fibronectin Rapid Test Device-1 (7)

Umlinganiselo wobushushu

Fetal Fibronectin Rapid Test Device-1 (2)

Qhagamshelana nemiyalelo yokusetyenziswa

Fetal Fibronectin Rapid Test Device-1 (8)

Ikhowudi yebhetshi

Fetal Fibronectin Rapid Test Device-1 (3)

Isixhobo soxilongo lwe-in vitro

Fetal Fibronectin Rapid Test Device-1 (9)

Sebenzisa nge

Fetal Fibronectin Rapid Test Device-1 (4)

Umenzi

Fetal Fibronectin Rapid Test Device-1 (10)

Iqulathe okwaneleyoiimvavanyo

Fetal Fibronectin Rapid Test Device-1 (5)

Musa ukuphinda usebenzise

Fetal Fibronectin Rapid Test Device-1 (11)

Ummeli ogunyazisiweyo kuLuntu lwaseYurophu

Fetal Fibronectin Rapid Test Device-1 (6)

I-CE iphawulwe ngokwe-IVD Medical Devices Directive 98/79/EC


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