Fetal Fibronectin Rapid Test
ZOYENERA KUGWIRITSA NTCHITO
The StrongStep®Kuyeza kwa PROM ndi kuyesa kotanthauziridwa kowoneka bwino kwa immunochromatographic komwe kumagwiritsidwa ntchito pozindikira kuti fetal fibronectin m'matumbo a cervicovaginal.Kupezeka kwa fetal fibronectin mu cervicovaginal secretions pakati pa masabata 22, masiku 0 ndi masabata 34, masiku 6 a bere.kugwirizana ndi chiopsezo chokwera cha kubereka msanga.
MALANGIZO
Kubereka mwana asanakwane, kufotokozedwa ndi American College of Obstetricians ndi Gynecologists monga kubereka sabata la 37 la bere lisanakwane, ndizomwe zimayambitsa matenda ambiri omwe si a chromosomal perinatal komanso kufa.Zizindikiro zowopsa za kubereka mwana wosabadwayo ndi kutsekeka kwa chiberekero, kusintha kutulutsa kumaliseche, kutuluka magazi kunyini, kuwawa kwa msana, kusapeza bwino m'mimba, kutsekula m'chiuno, komanso kukokana.Njira zodziwira matenda omwe akuwopsezedwa kubadwa asanakwane amaphatikizira kuyang'anira zochitika za chiberekero ndi kuyesa kwa digito ya khomo lachiberekero, zomwe zimalola kuyerekezera kukula kwa khomo lachiberekero.Njirazi zasonyezedwa kuti ndizochepa, chifukwa kuchepa kochepa kwa chiberekero (< 3 centimita) ndi ntchito ya chiberekero imapezeka mwachizolowezi ndipo sizikutanthauza kuti kubadwa kwatsala pang'ono kubadwa.Ngakhale zolembera zingapo za serum biochemical zidawunikidwa, palibe zomwe zavomerezedwa kuti zigwiritsidwe ntchito pachipatala.
Fetal fibronectin (fFN), isoform ya fibronectin, ndi zomatira zovuta glycoprotein ndi molecular kulemera pafupifupi 500,000 daltons.Matsuura ndi ogwira nawo ntchito afotokoza za anti-monoclonal antibody yotchedwa FDC-6, yomwe imazindikira mwapadera III-CS, chigawo chomwe chimafotokozera za fetal isoform ya fibronectin.Maphunziro a Immunohistochemical a placentae awonetsa kuti fFN ndikutsekeredwa ku matrix owonjezera a dera lomwe limafotokoza mphambanomayunitsi a mayi ndi mwana m'chiberekero.
Fetal fibronectin imatha kudziwika mu khomo lachiberekero la amayi panthawi yomwe ali ndi pakati pogwiritsa ntchito monoclonal antibodybased immunoassay.Fetal fibronectin imachulukitsidwa m'mitsempha ya chiberekero panthawi yomwe ali ndi pakati koma imachepa kuchokera pa masabata 22 mpaka 35 pa mimba yabwino.Kufunika kwa kukhalapo kwake mu nyini m'masabata oyambirira a mimba sikumveka.Komabe, zingangowonetsa kukula kwabwino kwa anthu ochulukirapo a trophoblast ndi placenta.Kuzindikira kwa FFN mu chiberekero cha chiberekero pakati pa masabata 22, masiku 0 ndi masabata 34, masiku 6 oyembekezera amanenedwa kuti amagwirizana ndi kubereka mwana wosabadwa mwachizindikiro komanso pakati pa masabata 22, masiku 0 ndi masabata 30, masiku 6 mwa amayi apakati omwe alibe zizindikiro.
MFUNDO
The StrongStep®FFN Test imagwiritsa ntchito ukadaulo wa immunochromatographic, capillary flow technology.Njira yoyesera imafuna kusungunuka kwa fFN kuchokera ku swab ya nyini posakaniza swab mu Sample Buffer.Kenako chotchinga chosakanikirana chimawonjezedwa ku chitsanzo cha makaseti oyeserera bwino ndipo chisakanizocho chimasuntha motsatira nembanemba pamwamba.Ngati fFN ilipo pachitsanzocho, ipanga chophatikizika chokhala ndi anti-fFN antibody yolumikizana ndi tinthu tambiri tambiri.Vutoli lidzamangidwa ndi anti-fFN yachiwiri yomwe imakutidwa 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 fFN ndi sodium azide.Kwa ulamuliro Wakunja. |
| 1 Negative control swab (popempha kokha) | Mulibe fFN.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 (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.
KUSONKHALA KWA PECIMN NDI KUSUNGA
■ Gwiritsani ntchito zida za Dacron kapena Rayon zokhazokha zokhala ndi zitsulo zapulasitiki.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.
■ Kutuluka kwa khomo lachiberekero kumachokera ku nyini yakumbuyo ya nyini.Ndondomeko yosonkhanitsa ikufuna kukhala yofatsa.Kusonkhanitsa mwamphamvu kapena mwamphamvu, kofala kwa chikhalidwe cha tizilombo toyambitsa matenda, sikofunikira.Pakuwunika kwa speculum, musanapime kapena kusintha khomo lachiberekero kapena thirakiti la nyini, tembenuzani pang'ono nsonga yogwiritsira ntchito kuseri kwa fornix ya nyini kwa masekondi pafupifupi 10 kuti mutenge kutulutsa kwa khomo lachiberekero.Kuyesa kotsatira kukhutitsa nsonga yofunsira kungapangitse mayesowo kukhala osavomerezeka.Chotsani wogwiritsa ntchitoyo ndikuyesani monga momwe tafotokozera pansipa.
■ 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:
| Magulu awiri amitundu amawonekera pa nembanemba.Gulu limodzi limapezeka m'chigawo chowongolera (C) ndipo gulu lina limapezeka m'chigawo choyesera (T). |
| ZOSAVUTAZOTSATIRA:
| Gulu limodzi lokha lachikuda limawonekera m'chigawo chowongolera (C).Palibe gulu lowoneka bwino lomwe likuwoneka mdera loyesa (T). |
| YOSAVUTAZOTSATIRA:
| 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. Kuyeza uku kungagwiritsidwe ntchito pozindikira momwe fetal fibronectin imatuluka mu khomo lachiberekero.
2. Zotsatira za mayesero ziyenera kugwiritsidwa ntchito nthawi zonse pamodzi ndi deta zina zachipatala ndi ma laboratory kwa kasamalidwe ka odwala.
3. Zitsanzo ziyenera kupezeka musanayambe kufufuza kwa digito kapena kusintha kwa chiberekero.Kuwongolera khomo pachibelekeropo kungayambitse zotsatira zabodza.
4. Zitsanzo siziyenera kusonkhanitsidwa ngati wodwalayo wagonana mkati mwa maola 24 kuti athetse zotsatira zabodza.
5 Odwala omwe akuganiziridwa kuti atuluka m'mimba, placenta previa, kapena kutuluka magazi pang'ono kapena kumaliseche sayenera kuyezetsa.
6. Odwala omwe ali ndi cerclage sayenera kuyesedwa.
7. Makhalidwe a machitidwe a StrongStep®Kuyesa kwa fFN kumatengera kafukufuku wa amayi omwe ali ndi mimba ya singleton.Kugwira ntchito sikunatsimikizidwe kwa odwala omwe ali ndi mawere angapo, mwachitsanzo, mapasa.
8. Njira Yamphamvu®Kuyesa kwa fFN sikunapangidwe kuti kuchitidwe pakang'ambika kwa amniotic nembanemba ndipo kuphulika kwa nembanemba ya amniotic kuyenera kutsatiridwa musanayese.
ZINTHU ZOCHITIKA
Table: StrongStep® fFN Test vs. Mayeso amtundu wina wa fFN
| Kutengeka Kwachibale: 97.96% (89.13% -99.95%)* Zachibale: 98.73% (95.50% -99.85%) * Pangano Lalikulu: 98.55% (95.82% -99.70%) * * 95% Nthawi Yodalirika |
| Mtundu wina |
| ||
| + | - | Zonse | |||
| StrongStep®fFn Yesani | + | 48 | 2 | 50 | |
| - | 1 | 156 | 157 | ||
|
| 49 | 158 | 207 | ||
Analytic sensitivity
Kuchuluka kotsika kwambiri kwa fFN pachitsanzo chotengedwa ndi 50μg/L.
Pakati pa amayi omwe ali ndi zizindikiro, milingo yokwera (≥ 0.050 μg/mL) (1 x 10-7 mmol/L) ya fFN pakati pa masabata 24, masiku 0 ndi masabata 34, masiku 6 amasonyeza kuwonjezeka kwa chiwopsezo cha kubereka mu ≤ 7 kapena ≤ masiku 14 kuchokera chitsanzo chosonkhanitsa.Pakati pa amayi asymptomatic, kuchuluka kwa fFN pakati pa masabata a 22, masiku 0 ndi masabata a 30, masiku 6 amasonyeza chiopsezo chowonjezereka cha kubereka mu ≤ masabata a 34, masiku 6 oyembekezera.Kudulidwa kwa 50 μg/L fFN kunakhazikitsidwa mu kafukufuku wambiri wopangidwa kuti awunike kugwirizana pakati pa mawu a fetal fibronectin pa nthawi ya mimba ndi kubereka mwana asanakwane.
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 | a0.033 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 |
| MgSO4•7H2O 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
1. American College of Obstetricians ndi Gynecologists.Preterm Labor.Technical Bulletin, Nambala 133, October, 1989.
2. Creasy RK, Resnick R. Maternal and Fetal Medicine: Mfundo ndi Zochita.Philadelphia: WB Saunders;1989.
3. Creasy RK, Merkatz IR.Kupewa kubadwa asanakwane: malingaliro azachipatala.Obstet Gynecol 1990;76(Suppl 1):2S–4S.
4. Morrison JC.Kubadwa mwana asanakwane: chithunzithunzi choyenera kuthetsedwa.Obstet Gynecol 1990;76(Suppl 1):5S-12S.
5. Lockwood CJ, Senyei AE, Dische MR, Casal DC, et al.Fetal fibronectin mu khomo lachiberekero ndi ukazi ngati cholosera za kubereka msanga.Chingelezi Chatsopano J Med 1991; 325:669-74.
BUKHU LOPHUNZITSIRA LA ZIZINDIKIRO
|
| Nambala yakatalogi |  | Kuchepetsa kutentha |
 | Onani malangizo ogwiritsira ntchito |
| Batch kodi |
 | Chida chachipatala cha in vitro diagnostic |  | Gwiritsani ntchito |
 | Wopanga |  | Muli zokwaniramayesero |
 | Osagwiritsanso ntchito |  | Woyimira wovomerezeka mu European Community |
 | CE yolembedwa molingana ndi IVD Medical Devices Directive 98/79/EC | ||
Malingaliro a kampani Liming Bio-Products Co., Ltd.
No. 12 Huayuan Road, Nanjing, Jiangsu, 210042 PR China.
Tel: (0086)25 85476723 Fax: (0086)25 85476387
Imelo:sales@limingbio.com
Webusayiti: www.limingbio.com
www.stddiagnostics.com
www.stidiagnostics.com
WellKang Ltd.(www.CE-marking.eu) Tel: +44(20)79934346
29 Harley St., London WIG 9QR,UK Fax: +44(20)76811874
StrongStep® Fetal Fibronectin Rapid Test Chipangizo
Kubereka mwana asanakwane, kufotokozedwa ndi American College of Obstetricians ndi Gynecologists monga kubereka sabata la 37 la bere lisanakwane, ndizomwe zimayambitsa matenda ambiri omwe si a chromosomal perinatal komanso kufa.Zizindikiro zowopsa za kubereka mwana wosabadwayo ndi kutsekeka kwa chiberekero, kusintha kutulutsa kumaliseche, kutuluka magazi kunyini, kuwawa kwa msana, kusapeza bwino m'mimba, kutsekula m'chiuno, komanso kukokana.Njira zodziwira matenda omwe akuwopsezedwa kubadwa asanakwane amaphatikizira kuyang'anira zochitika za chiberekero ndi kuyesa kwa digito ya khomo lachiberekero, zomwe zimalola kuyerekezera kukula kwa khomo lachiberekero.
StrongStep® Fetal Fibronectin Rapid Test ndi kuyesa kotanthauziridwa kowoneka bwino kwa immunochromatographic komwe kumagwiritsidwa ntchito pozindikira kuti fetal fibronectin mu katulutsidwe ka khomo lachiberekero ndi izi:
Yosavuta kugwiritsa ntchito:njira imodzi pakuyezetsa koyenera
Mwachangu:Mphindi 10 zokha zomwe zimafunikira panthawi yomwe wodwalayo akuyendera
Zopanda zida:zipatala zochepetsa magwero kapena malo azachipatala atha kuyesa izi
Zaperekedwa:kutentha kwa chipinda (2 ℃-30 ℃)
