Mayeso Ofulumira a PROM

Kufotokozera Kwachidule:

REF 500170 Kufotokozera 20 Mayesero/Bokosi
Mfundo yodziwira Immunochromatographic assay Zitsanzo Kutuluka kumaliseche
Cholinga Chogwiritsidwa Ntchito Mayeso ofulumira a StrongStep® PROM ndi mayeso owoneka bwino, oyeserera a immunochromatographic kuti azindikire IGFBP-1 kuchokera ku amniotic fluid mu ukazi wapakati pa nthawi yapakati.


Tsatanetsatane wa Zamalonda

Zolemba Zamalonda

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

ZOYENERA KUGWIRITSA NTCHITO
The StrongStep®Mayeso a PROM ndi mayeso owoneka bwino, owoneka bwino a immunochromatographic kuti azindikire IGFBP-1 kuchokera ku amniotic fluid mu ukazi wapakati pa nthawi yapakati.Mayesowa amapangidwa kuti agwiritsidwe ntchito ndi akatswiri kuti azindikire kuphulika kwa nembanemba ya fetal (ROM) mwa amayi apakati.

MAU OYAMBA
Kuchuluka kwa IGFBP-1 (insulin-monga kukula kwa chinthu chomwe chimamanga mapuloteni-1) mu amniotic fluid ndi 100 mpaka 1000 nthawi zambiri kuposa mu seramu ya amayi.IGFBP-1 nthawi zambiri sichipezeka mu nyini, koma pambuyo pa kuphulika kwa nembanemba ya fetal, amniotic fluid yokhala ndi kuchuluka kwa IGFBP-1 imasakanikirana ndi ukazi.Mu mayeso a StrongStep® PROM, chitsanzo cha ukazi chimatengedwa ndi swab wosabala poliyesitala ndipo chitsanzocho amachichotsa mu Specimen Extraction Solution.Kukhalapo kwa IGFBP-1 mu yankho kumadziwika pogwiritsa ntchito chipangizo choyesera mwachangu.

MFUNDO
The StrongStep®Mayeso a PROM amagwiritsa ntchito ukadaulo wa immunochromatographic, capillary flow technology.Njira yoyesera imafuna kusungunula kwa IGFBP-1 kuchokera pansalu ya nyini mwa kusakaniza swab mu Sample Buffer.Kenako chotchinga chosakanikirana chimawonjezedwa ku chitsanzo cha makaseti oyeserera bwino ndipo chisakanizocho chimasuntha motsatira nembanemba pamwamba.Ngati IGFBP-1 ilipo pachitsanzo, ipanga zovuta ndi anti- IGFBP-1 antibody yolumikizana ndi tinthu tating'ono.Zovutazo zidzamangidwa ndi anti-anti-IGFBP-1 antibody yachiwiri yokutidwa pa nembanemba ya nitrocellulose.Mawonekedwe a mzere woyesera wowonekera pamodzi ndi mzere wowongolera adzawonetsa zotsatira zabwino.

ZAMBIRI ZA KIT

20 Aliyense packed zida zoyesera

Chida chilichonse chimakhala ndi mzere wokhala ndi ma conjugate amitundu ndi ma reagents okhazikika omwe amakutidwa kale m'magawo ofananirako.

2M'zigawoBafa botolo

0.1 M Phosphate buffered saline (PBS) ndi 0.02% sodium azide.

1 Positive control swab
(popempha kokha)

Muli IGFBP-1 ndi sodium azide.Kwa ulamuliro Wakunja.

1 Negative control swab
(popempha kokha)

Mulibe IGFBP-1.Kwa ulamuliro wakunja.

20 M'zigawo machubu

Kukonzekera kwa zitsanzo ntchito.

1 Malo ogwirira ntchito

Malo osungiramo mbale ndi machubu.

1 Ikani phukusi

Pakuti malangizo ntchito.

ZINTHU ZOFUNIKA KOMA ZOSAPATSIDWA

Chowerengera nthawi Kuti mugwiritse ntchito nthawi.

KUSAMALITSA
■ Kwa akatswiri mu m'galasi diagnostic ntchito kokha.
■ Osagwiritsa ntchito pambuyo pa tsiku lotha ntchito lomwe lasonyezedwa pa phukusi.Osagwiritsa ntchito mayeso ngati thumba lake lazojambula lawonongeka.Osagwiritsanso ntchito mayeso.
■ Chida ichi chili ndi zinthu zochokera ku ziweto.Chidziwitso chotsimikizika cha chiyambi ndi/kapena ukhondo wa nyama sizimatsimikizira kusakhalapo kwa tizilombo toyambitsa matenda.Chifukwa chake, tikulimbikitsidwa kuti mankhwalawa atengedwe ngati atha kupatsirana, ndikusamalidwa motsatira njira zodzitetezera nthawi zonse (musalowe kapena kutulutsa mpweya).
Pewani kuipitsidwa ndi tizitsanzo pogwiritsira ntchito chidebe chatsopano chosonkhanitsira chitsanzo chilichonse chomwe mwapeza.
Werengani ndondomeko yonse mosamala musanayese.
■ Osadya, kumwa kapena kusuta m'malo omwe zitsanzo ndi zida.Gwirani zitsanzo zonse ngati zili ndi tizilombo toyambitsa matenda.Yang'anirani njira zodzitetezera polimbana ndi zoopsa za tizilombo toyambitsa matenda munthawi yonseyi ndikutsata njira zoyendetsera zotayira moyenera.Valani zovala zodzitchinjiriza monga makhoti a mu labotale, magolovesi otayika komanso zoteteza maso mukayesedwa.
■ Osasinthanitsa kapena kusakaniza ma reagents osiyanasiyana.Osasakaniza zisoti za botolo la yankho.
■ Chinyezi ndi kutentha kungawononge zotsatira zake.
■ Ntchito yoyesa ikamalizidwa, tayani ma swabs mosamala mutawasunga pa 121°C kwa mphindi zosachepera 20.Kapenanso, amatha kuthandizidwa ndi 0.5% sodium hypochloride (kapena bulitchi ya m'nyumba) kwa ola limodzi asanatayidwe.Zida zoyesera zomwe zimagwiritsidwa ntchito ziyenera kutayidwa molingana ndi malamulo akomweko, aboma ndi/kapena aboma.
■ Musagwiritse ntchito maburashi a cytology ndi odwala oyembekezera.

KUSINTHA NDI KUKHALA
■ Zida ziyenera kusungidwa pa 2-30°C mpaka tsiku lotha ntchito litasindikizidwa pa thumba lomata.
■ Mayeso ayenera kukhala muthumba lomata mpaka atagwiritsidwa ntchito.
■ Osazizira.
■ Chisamaliro chiyenera kutengedwa poteteza zigawo za mu chida ichi kuti zisaipitsidwe.Osagwiritsa ntchito ngati pali umboni wa kuipitsidwa ndi ma virus kapena mvula.Kuipitsidwa kwachilengedwe kwa zida zogawira, zotengera kapena zopangira zida kungayambitse zotsatira zabodza.

KUSONGA ZINTHU NDI KUSINTHA
Gwiritsani ntchito ma Dacron okha kapena ma Rayon okhala ndi timitengo tapulasitiki.Ndibwino kuti mugwiritse ntchito swab yoperekedwa ndi wopanga zida (Ma swabs mulibe mu kitchi, kuti mudziwe zambiri, lemberani wopanga kapena wogawa wakomweko, nambala yamakatalo ndi 207000).Ma swabs ochokera kwa ogulitsa ena sanatsimikizidwe.Swabs ndi nsonga za thonje kapena matabwa a matabwa saloledwa.
Chitsanzo chimapezedwa pogwiritsa ntchito swab ya poliyesitala wosabala.Zitsanzozi ziyenera kusonkhanitsidwa musanapange mayeso a digito ndi/kapena transvaginal ultrasound.Samalani kuti musakhudze chilichonse ndi swab musanatenge chitsanzo.Mosamala lowetsani nsonga ya swab mu nyini kupita ku posterior fornix mpaka kukana kukwaniritsidwe.Kapenanso chitsanzocho chikhoza kutengedwa kuchokera ku posterior fornix panthawi ya kafukufuku wosabala wa speculum.Chovalacho chizisiyidwa kumaliseche kwa masekondi 10-15 kuti chizitha kuyamwa kumaliseche.Kokani swab mosamala!.
■ Ikani swab ku chubu chochotsa, ngati mayeso atha kuyendetsedwa nthawi yomweyo.Ngati kuyezetsa msanga sikutheka, zitsanzo za odwala ziyenera kuikidwa mu chubu chowuma choyendetsa kuti chisungidwe kapena kunyamula.Masamba amatha kusungidwa kwa maola 24 kutentha kwa chipinda (15-30 ° C) kapena sabata imodzi pa 4 ° C kapena osapitirira miyezi 6 pa -20 ° C.Zitsanzo zonse ziyenera kuloledwa kufika kutentha kwa 15-30 ° C musanayese.

NTCHITO
Bweretsani zoyeserera, zoyeserera, zotchingira ndi/kapena zowongolera ku kutentha kwachipinda (15-30°C) musanagwiritse ntchito.
■ Ikani chubu choyera cha M'zigawo m'malo osankhidwa a malo ogwirira ntchito.Onjezani 1ml ya Buffer Yotulutsa ku chubu chochotsa.
■ Ikani chitsanzo cha swab mu chubu.Sakanizani mwamphamvu yankholo potembenuza swab mwamphamvu kumbali ya chubu kwa nthawi zosachepera khumi (pomwe ili pansi pa madzi).Zotsatira zabwino kwambiri zimapezeka pamene chitsanzocho chikusakanikirana mwamphamvu mu yankho.
■ Finyani madzi ochuluka momwe mungathere kuchokera pa swab potsina mbali ya chubu yofewa pamene swab ikuchotsedwa.Osachepera 1/2 ya yankho lachitsanzo la bafa liyenera kukhala mu chubu kuti kusuntha kwa capillary kokwanira kuchitike.Ikani kapu pa chubu chochotsedwa.
Tayani swab mu chidebe choyenera cha zinyalala za biohazardous.
■ Zitsanzo zotengedwa zimatha kusungidwa kutentha kwa mphindi 60 popanda kusokoneza zotsatira za mayeso.
■ Chotsani mayesowo m’thumba lake lomatapo, ndikuchiyika pamalo oyera, osalala.Lembani chipangizocho ndi chizindikiritso cha wodwala kapena chowongolera.Kuti mupeze zotsatira zabwino, kuyesako kuyenera kuchitidwa mkati mwa ola limodzi.
■ Onjezani madontho atatu (pafupifupi 100 µl) a zitsanzo zotengedwa mu Extraction Tube ku chitsime cha pa kaseti yoyesera.
Pewani kukokera thovu la mpweya pachitsanzo (S), ndipo musagwetse njira iliyonse pawindo loyang'ana.
Mayeso akayamba kugwira ntchito, mudzawona mtundu ukusuntha pa nembanemba.
■ Dikirani kuti magulu achikuda awonekere.Zotsatira zake ziyenera kuwerengedwa pa mphindi zisanu.Osatanthauzira zotsatira pambuyo pa mphindi zisanu.
Tayani machubu oyeserera ndi Makaseti Oyesera mu chidebe choyenera cha zinyalala zowopsa.
KUTANTHAUZIRA ZOTSATIRA

ZABWINOZOTSATIRA:

Fetal Fibronectin Rapid Test Device001

Magulu awiri amitundu amawonekera pa nembanemba.Gulu limodzi limapezeka m'chigawo chowongolera (C) ndipo gulu lina limapezeka m'chigawo choyesera (T).

ZOSAVUTAZOTSATIRA:

Fetal Fibronectin Rapid Test Device001

Gulu limodzi lokha lachikuda limawonekera m'chigawo chowongolera (C).Palibe gulu lowoneka bwino lomwe likuwoneka mdera loyesa (T).

YOSAVUTAZOTSATIRA:

Fetal Fibronectin Rapid Test Device001

Gulu lowongolera likulephera kuwonekera.Zotsatira za mayeso aliwonse omwe sanapange gulu lowongolera pa nthawi yowerengera yotchulidwa ziyenera kutayidwa.Chonde onaninso ndondomekoyi ndikubwerezanso kuyesa kwatsopano.Vuto likapitilira, siyani kugwiritsa ntchito zidazo nthawi yomweyo ndipo funsani wofalitsa wapafupi.

ZINDIKIRANI:
1. Kuchulukira kwa mtundu m'chigawo choyesera (T) kungasiyane malinga ndi kuchuluka kwa zinthu zomwe zili pachiwonetserocho.Koma mulingo wa zinthu sizingadziwike ndi mayesowa.
2. Kusakwanira kwa sipimeni yachitsanzo, njira yolakwika ya kachitidwe, kapena kuyesa zomwe zidatha nthawi yake ndizifukwa zomwe zimapangitsa kuti gulu lowongolera lilephereke.

KUKHALA KWAKHALIDWE
■ Ulamuliro wa machitidwe amkati akuphatikizidwa muyeso.Gulu lachikuda lomwe likuwonekera m'chigawo chowongolera (C) limatengedwa ngati njira yoyendetsera bwino mkati.Imatsimikizira kuchuluka kwachitsanzo chokwanira komanso njira zolondola zamachitidwe.
■ Njira zowongolera zakunja zitha kuperekedwa (pongopempha) m'makiti kuwonetsetsa kuti mayeso akuyenda bwino.Komanso, Zowongolera zitha kugwiritsidwa ntchito kuwonetsa magwiridwe antchito oyenera ndi woyesa.Kuti muyese kuwongolera kwabwino kapena koyipa, malizitsani masitepe omwe ali mugawo la Test Procedure posamalira chowongolera mofanana ndi kansalu kakang'ono.

ZOPEZA AMAYESA
1. Palibe kutanthauzira kochulukira komwe kumayenera kupangidwa kutengera zotsatira za mayeso.
2.Musagwiritse ntchito mayeso ngati thumba lake la aluminiyamu kapena zisindikizo za m'thumba sizili bwino.
3.A positiveStrongStep®Zotsatira zoyezetsa za PROM, ngakhale zimazindikira kupezeka kwa amniotic fluid muzatsanzo, sizipeza pomwe panang'ambika.
4.Mofanana ndi mayesero onse a matenda, zotsatira ziyenera kutanthauziridwa mogwirizana ndi zomwe zapezeka m'chipatala.
5.Ngati kuphulika kwa nembanemba ya fetal kwachitika koma kutuluka kwa amniotic fluid kwatha maola oposa 12 asanatengedwe chitsanzo, IGFBP-1 ikhoza kuchepetsedwa ndi ma proteases mu nyini ndipo mayesero angapereke zotsatira zoipa.

ZINTHU ZOCHITIKA

Tabulo: StrongStep®Mayeso a PROM vs. Mayeso amtundu wina wa PROM

Kutengeka Kwachibale:
96.92% (89.32% -99.63%) *
Zachibale:
97.87% (93.91% -99.56%)*
Pangano Lalikulu:
97.57% (94.42% -99.21%) *
* 95% Nthawi Yodalirika

 

Mtundu wina

 

+

-

Zonse

StrongStep®GARA Yesani

+

63

3

66

-

2

138

140

 

65

141

206

Analytic sensitivity
Chiwerengero chotsika kwambiri cha IGFBP-1 mu chitsanzo chochotsedwa ndi 12.5 μg / l.

Zinthu Zosokoneza
Chisamaliro chiyenera kutengedwa kuti chisayipitse chopaka kapena khomo lachiberekero ndi mafuta odzola, sopo, mankhwala opha tizilombo, kapena zopaka.Mafuta opaka kapena zonona zimatha kusokoneza mayamwidwe a chithunzicho pachopaka.Sopo kapena mankhwala ophera tizilombo amatha kusokoneza machitidwe a antibody-antigen.
Zinthu zomwe zitha kusokoneza zidayesedwa pazambiri zomwe zitha kupezeka m'matumbo a cervicovaginal.Zinthu zotsatirazi sizinasokoneze kuyesa pamene kuyesedwa pamiyeso yomwe yasonyezedwa.

Mankhwala Kukhazikika Mankhwala Kukhazikika
Ampicillin 1.47 mg/mL Prostaglandin F2 0.033 mg/mL
Erythromycin 0.272 mg/mL Prostaglandin E2 0.033 mg/mL
Mkodzo Wamayi 3 Trimester 5% (mphindi) 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 pa 1.49 mg/mL BetadineR Cleanser 10 mg/mL
Ritodrine 0.33 mg/mL K-YR Jelly 62.5 mg/mL
Dermicidol R2000 25.73 mg/mL    

MALO OGWIRITSIRA NTCHITO
Erdemoglu ndi Mungan T. Kufunika kwa kuzindikira insulini-monga kukula kwa chinthu chomanga mapuloteni-1 mu chiberekero cha chiberekero: poyerekeza ndi mayeso a nitrazine ndi amniotic fluid volume assessment.Acta Obstet Gynecol Scand (2004) 83: 622-626.
Kubota T ndi Takeuchi H. Kuwunika kwa insulini-monga kukula kwa chinthu chomangira mapuloteni-1 ngati chida chodziwira kuphulika kwa nembanemba.J Obstet Gynecol Res (1998) 24:411-417.
Rutanen EM et al.Kuwunika kwa kuyezetsa kwachangu kwa mizere ya insulin-monga kukula kwa chinthu chomangirira protein-1 pakuzindikira kwa nembanemba ya fetal yosweka.Clin Chim Acta (1996) 253:91-101.
Rutanen EM, Pekonen F, Karkkainen T. Kuyeza kwa insulini-monga kukula kwa chinthu kumangiriza mapuloteni-1 mu chiberekero / nyini zotsekemera: poyerekeza ndi ROM-fufuzani Membrane Immunoassay pozindikira kuti kuphulika kwa fetal nembanemba.Clin Chim Acta (1993) 214:73-81.

BUKHU LOPHUNZITSIRA LA ZIZINDIKIRO

Fetal Fibronectin Rapid Test Device-1 (1)

Nambala yakatalogi

Fetal Fibronectin Rapid Test Device-1 (7)

Kuchepetsa kutentha

Fetal Fibronectin Rapid Test Device-1 (2)

Onani malangizo ogwiritsira ntchito

Fetal Fibronectin Rapid Test Device-1 (8)

Batch kodi

Fetal Fibronectin Rapid Test Device-1 (3)

Chida chachipatala cha in vitro diagnostic

Fetal Fibronectin Rapid Test Device-1 (9)

Gwiritsani ntchito

Fetal Fibronectin Rapid Test Device-1 (4)

Wopanga

Fetal Fibronectin Rapid Test Device-1 (10)

Muli zokwaniramayesero

Fetal Fibronectin Rapid Test Device-1 (5)

Osagwiritsanso ntchito

Fetal Fibronectin Rapid Test Device-1 (11)

Woyimira wovomerezeka mu European Community

Fetal Fibronectin Rapid Test Device-1 (6)

CE yolembedwa molingana ndi IVD Medical Devices Directive 98/79/EC


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