Fetal Fibronectin Rapid Test
ZVINODA KUSHANDISA
The StrongStep®PROM bvunzo inoonekwa yakadudzirwa immunochromatographic bvunzo inoitirwa kuti ishandiswe pakuonekwa kweiyo fetal fibronectin mucervicovaginal secretions.Kuvapo kwe fetal fibronectin mu cervicovaginal secretions pakati pemavhiki makumi maviri nemaviri, mazuva 0 nemavhiki makumi matatu nemana, mazuva matanhatu ekuzvitakurayakabatana nenjodzi yakakwira yekusununguka kusati kwasvika.
KUTUNGAMIRIRA
Kusununguka kusati kwasvika, kunotsanangurwa neAmerican College of Obstetricians uye Gynecologists sekusununguka isati yasvika vhiki ye37 yekuzvitakura, inokonzera ruzhinji rwevasiri-chromosomal perinatal morbidity uye kufa.Zviratidzo zvekutyisidzirwa kusununguka nguva isati yakwana zvinosanganisira kudhonzwa kwechibereko, kushanduka kwekubuda kwenhengo yesikarudzi, kubuda ropa kunhengo yesikarudzi, kurwadza kwemusana, kusanzwa zvakanaka mudumbu, BP, uye kukakama.Diagnostic modalities yekuzivikanwa kwekutyisidzirwa kusati kwasvika kusati kwasvika kunosanganisira uterine basa rekutarisa uye kushanda kwedigital cervical test, iyo inobvumira fungidziro yezviyero zvekervical.Idzi nzira dzakaratidzwa kuva shoma, sezvo kuderera kwekervical dilatation (<3 centimeters) uye uterine basa rinowanzoitika uye hazvireve kuti kuongororwa kwekukurumidza kusati kwasvika.Nepo akati wandei serum biochemical mamaki akaongororwa, hapana akave akagamuchirwa zvakanyanya kuti ashandiswe kukiriniki kushandiswa.
Fetal fibronectin (fFN), an isoform ye fibronectin, yakaoma adhesive glycoprotein ine molecular huremu hunosvika 500,000 daltons.Matsuura nevashandi pamwe navo vakatsanangura monoclonal antibody inonzi FDC-6, inonyatsoziva III-CS, dunhu rinotsanangura fetal isoform yefibronectin.Immunohistochemical zvidzidzo zve placentae zvakaratidza kuti fFN iriyakavharirwa kune extracellular matrix yedunhu rinotsanangura jirayezvikamu zvaamai ne fetal mukati mechibereko.
Fetal fibronectin inogona kuwanikwa mucervicovaginal secretions yevakadzi panguva yese yekuzvitakura nekushandisa monoclonal antibodybased immunoassay.Fetal fibronectin inokwidziridzwa mucervicovaginal secretions panguva yekuzvitakura kwekutanga asi inoderedzwa kubva pamasvondo makumi maviri nemaviri kusvika makumi matatu nemashanu pakuzvitakura kwakajairika.Kukosha kwekuvapo kwayo mumukadzi mumavhiki ekutanga ekuzvitakura hakunzwisiswi.Nekudaro, inogona kungoratidzira kukura kwakajairika kweiyo extravillous trophoblast huwandu uye placenta.Kuonekwa kwefFN mu cervicovaginal secretions pakati pemavhiki makumi maviri nemaviri, mazuva 0 uye mavhiki makumi matatu nemana, 6 mazuva ekuberekwa kunonzi kunobatanidza nekusununguka kusati kwasvika mune zviratidzo uye pakati pemavhiki makumi maviri nemaviri, mazuva 0 uye mavhiki makumi matatu, mazuva matanhatu mumadzimai ane pamuviri asymptomatic.
PRINCIPLE
The StrongStep®fFN Test inoshandisa color immunochromatographic, capillary flow tekinoroji.Maitirwo ebvunzo anoda solubilization yefFN kubva kubheji yemukadzi nekusanganisa swab muSample Buffer.Ipapo iyo yakasanganiswa sampu buffer inowedzerwa kune bvunzo kaseti sampuli zvakanaka uye musanganiswa unofamba uchitevedza membrane pamusoro.Kana fFN iripo mumucherechedzo, inoumba yakaoma ine yekutanga anti- fFN antibody yakabatanidzwa kune mavara ane mavara.Iyo yakaoma inozosungwa neyechipiri anti- fFN antibody yakavharwa pane nitrocellulose membrane.Kuonekwa kwemutsara wekuedza unooneka pamwe chete nemutsara wekutonga ucharatidza chibereko chakanaka.
KIT COMPONENTS
| 20 Mumwe nomumwe packed test zvishandiso | Chishandiso chega chega chine tambo ine mavara conjugates uye reactive reagents pre-yakavharwa kumatunhu anoenderana. |
| 2ExtractionBuffer vial | 0.1 M Phosphate buffered saline (PBS) uye 0.02% sodium azide. |
| 1 Positive control swab (pakukumbira chete) | Iine fFN uye sodium azide.Zvekutonga kunze. |
| 1 Negative control swab (pakukumbira chete) | Haina fFN.Nokuda kwekutonga kwekunze. |
| 20 Extraction tubes | Kushandisa mienzaniso yekugadzirira. |
| 1 Workstation | Nzvimbo yekubata buffer vials nemachubhu. |
| 1 Pakeji isa | Kurairirwa kushanda. |
ZVINHU ZVINODIWA ASI ZVISINA KUPIWA
| Timer | Yekushandisa nguva. |
ZVEKUNGWARIRIRA
■ Kushandiswa kwenyanzvi in vitro diagnostic chete.
■ Usashandise mushure mekupera kwezuva rakaratidzwa pasuru.Usashandise bvunzo kana foil pouch yayo yakuvadzwa.Usashandise zvakare bvunzo.
∎ Kiti iyi ine zvigadzirwa zvemhuka.Ruzivo rwakasimbiswa rwekwakabva uye/kana hutsanana hwemhuka haruvimbise zvachose kusavapo kweanotapurirana pathogenic agents.Naizvozvo, zvinokurudzirwa kuti zvigadzirwa izvi zvibatwe sezvingangotapukira, uye zvibatiswe uchicherekedza akajairwa ekuchengetedza ekuchengetedza (usamedze kana inhale).
∎ Dzivisa kusvibiswa kwezvienzaniso nekushandisa mudziyo mutsva wekuunganidza wemuenzaniso wega wega wawanikwa.
■ Verenga maitiro ese nemazvo usati waita chero bvunzo.
∎ Usadye, kunwa kana kuputa munzvimbo inobatirwa sampuli nekiti.Bata zvienzaniso zvese sekunge zvine zvirwere zvinotapukira.Chengetedza chenjedzo dzakamisikidzwa panjodzi dzehutachiona hwehutachiona mukati memaitiro ese uye uteedzere maitiro akajairwa ekurasa kwakaringana zvienzaniso.Pfekai zvipfeko zvinodzivirira zvakaita semabhachi emurabhoritari, magirovhosi anoraswa uye anodzivirira maziso kana zvidhori zvaongororwa.
■ Usachinjane kana kusanganisa reagents kubva mujenya rakasiyana.Usasanganise mhinduro yemabhodhoro caps.
∎ Hunyoro uye tembiricha zvinogona kukanganisa mhedzisiro.
∎ Kana maitiro ekuongorora apera, rasa swabs nekuchenjerera mushure mekuita autoclaving pa 121°C kweinenge maminitsi makumi maviri.Neimwe nzira, vanogona kurapwa ne0.5% sodium hypochloride (kana imba-inobata bleach) kweawa imwe isati yaraswa.Zvishandiso zvekuyedza zvakashandiswa zvinofanirwa kuraswa zvinoenderana nenharaunda, nyika uye / kana federal mitemo.
∎ Usashandise cytology brushes nevarwere vane pamuviri.
KUCHENGA UYE KUgadzikana
∎ Kiti inofanira kuchengetwa pa2-30°C kusvikira zuva rekupera basa radhindwa pahomwe yakavharwa.
■ Muedzo unofanira kuramba uri muhomwe yakavharwa kusvikira washandiswa.
■ Usaomesa nechando.
∎ Hanya dzinofanira kutorwa kudzivirira zvikamu zvekiti iyi kubva pakusvibiswa.Usashandise kana paine humbowo hwekusvibiswa kwehutachiona kana kunaya.Biological kusvibiswa kwemidziyo yekuparadzira, midziyo kana reagents kunogona kutungamirira kumhedzisiro yenhema.
PECIMEN KUCHENGA UYE KUCHENGETA
■ Shandisa chete Dacron kana Rayon yakapfava isina mbereko ine simbi dzepurasitiki.Zvinokurudzirwa kushandisa swab inopihwa nemugadziri wekiti (Iyo swabs haisi mukiti iyi, kune ruzivo rwekuodha, ndapota taura nemugadziri kana muparidzi wenzvimbo, nhamba yecatalog i207000).Swabs kubva kune vamwe vatengesi haina kusimbiswa.Swabs dzine mazano ekotoni kana shafts yemapuranga hazvikurudzirwi.
∎ Kuvharirwa kweCervicovaginal kunowanikwa kubva kumashure kwefornix yesikarudzi.Nzira yekuunganidza inotarisirwa kuve yakapfava.Kuunganidza kwakasimba kana kwakasimba, kwakajairika kune tsika dzemicrobiological, hazvidiwi.Munguva yekuongorora kwespeculum, kusati kwaitwa chero kuongororwa kana kubatwa kweiyo cervix kana turakiti remukadzi, zvinyoro tenderedza iyo yeapplicator tip kuyambuka posterior fornix yemukadzi kweanenge masekonzi gumi kuti utore cervicovaginal secretions.Kuedza kunotevera kugutsa zano remushandisi kunogona kukanganisa bvunzo.Bvisa mushandisi uye ita bvunzo sekurairwa pazasi.
■ Isai swab pachubhu yekudhonza, kana bvunzo ichigona kuitwa nekukasika.Kana kuyedzerwa nekukasira kusingaite, sampuli dzevarwere dzinofanirwa kuiswa muchubhu yekutakura yakaoma yekuchengetera kana kutakura.Iyo swabs inogona kuchengetwa kwemaawa makumi maviri nemana patembiricha yekamuri (15-30 ° C) kana vhiki 1 pa4 ° C kana isingapfuure 6 mwedzi pa -20 ° C.Mienzaniso yose inofanira kubvumirwa kusvika kune tembiricha yekamuri ye15-30 ° C isati yaedzwa.
PROCEDURE
Huya nemiedzo, zvienzaniso, buffer uye/kana zvidzoreso kune tembiricha yemumba (15-30°C) usati washandisa.
■ Isa yakachena Extraction chubhu munzvimbo yakatarwa yenzvimbo yekushanda.Wedzera 1ml yeKubvisa Buffer kune chubhu yekubvisa.
∎ Isai specimen swab muchubhu.Sanganisa zvine simba mhinduro nekutenderedza swab zvine simba padivi pechubhu kakapetwa kagumi (ichiri pasi pemvura).Mhedzisiro yakanakisa inowanikwa kana sampuli yakasanganiswa zvine simba mumhinduro.
∎ Sveta mvura yakawanda sezvinobvira kubva muswabhi nekudzvanya padivi pechubhu inopfakanyika yekubvisa painobviswa swab.Inenge 1/2 yesample buffer solution inofanira kuramba iri muchubhu kuti capillary migration yakakwana iitike.Isa chivharo pachubhu yakabviswa.
Rasa swab mune yakakodzera biohazardous tsvina mugaba.
∎ Mienzaniso yakatorwa inogona kuramba iri pakamuri yekushisa kwemaminetsi makumi matanhatu pasina kukanganisa mhedzisiro yebvunzo.
■ Bvisa bvunzo muhomwe yayo yakavharwa, woiisa panzvimbo yakachena, yakaenzana.Nyora mudziyo nemurwere kana chitupa chekudzora.Kuti uwane mhedzisiro yakanaka, iyo assay inofanirwa kuitwa mukati meawa imwe.
■ Wedzera madonhwe matatu (angangoita 100 µl) emuenzaniso wakatorwa kubva muExtraction Tube kune tsime remuenzaniso pakaseti yebvunzo.
Dzivisa kuteya mabhuru emhepo mumuenzaniso mutsime (S), uye usadonhedze chero mhinduro muhwindo rekutarisa.
Sezvo bvunzo inotanga kushanda, iwe uchaona ruvara ruchifamba nepakati pe membrane.
■ Mirira kuti bhendi (ma) mavara rionekwe.Chigumisiro chinofanira kuverengwa pamaminitsi mashanu.Usadudzire mhinduro mushure memaminitsi mashanu.
Rasa machubhu ebvunzo akashandiswa uye Makaseti Ekuyedza mune yakakodzera biohazardous tsvina mugaba.
DUDZIRIRO YEMIZVO
| POSITIVERESULT:
| Mabhandi maviri ane mavara anoonekwa pa membrane.Rimwe bhendi rinoonekwa mudunhu rekutonga (C) uye rimwe bhendi rinoonekwa mudunhu rekuyedza (T). |
| NEGATIVERESULT:
| Bhandi rimwe chete remavara rinoonekwa munharaunda yekutonga (C).Hapana bhendi reruvara rinooneka munharaunda yekuyedza (T). |
| INVALIDRESULT:
| Control bhendi ratadza kuoneka.Mibairo kubva kune chero bvunzo iyo isina kuburitsa control band panguva yakatarwa yekuverenga inofanira kuraswa.Ndokumbira utarise maitiro uye dzokorora nebvunzo nyowani.Kana dambudziko rikaramba riripo, rega kushandisa kit nekukasira uye bata muparidzi wenzvimbo yako. |
CHERECHEDZA:
1. Kusimba kweruvara munzvimbo yekuyedza (T) kunogona kusiyana zvichienderana nekusangana kwezvinhu zvakanangwa zviripo mumuenzaniso.Asi nhanho yezvinhu haigone kutsanangurwa neiyi bvunzo yemhando.
2. Kusakwana specimen vhoriyamu, isiriyo maitiro ekushanda, kana kuita bvunzo dzapera nguva ndizvo zvikonzero zvinonyanya kukonzeresa kutadza kwebhandi.
HUNHU KUDZORA
■ Kudzora kwemaitiro emukati kunosanganisirwa muyedzo.Bhendi remavara rinoonekwa munharaunda yekudzora (C) inoonekwa seyemukati yakanaka maitiro ekudzora.Inosimbisa huwandu hwakakwana hwemuenzaniso uye inogadzirisa maitiro maitiro.
■ Zvidzoreso zvekunze zvinogona kupihwa (pakukumbira chete) mumakiti kuona kuti bvunzo dziri kushanda nemazvo.Zvakare, Zvidzoreso zvinogona kushandiswa kuratidza kuita kwakaringana nemushandisi webvunzo.Kuti uite bvunzo yakanaka kana yakaipa, zadzisa matanho ari muchikamu cheTest Procedure uchibata control swab nenzira yakafanana neyemuenzaniso swab.
ZVIKATAURWA ZVOKUYEDZA
1. Ichi chiedzo chinogona kushandiswa chete pakuongorora kwehutano hwe fetal fibronectin mune cervicovaginal secretions.
2. Migumisiro yekuedza inofanira kushandiswa nguva dzose pamwe chete nedzimwe dhigirii uye laboratory data yehutano hwevarwere.
3. Mienzaniso inofanira kuwanikwa isati yasvika pakuongorora kwedhijitari kana kushandiswa kwemuromo wechibereko.Kubata muromo wechibereko kunogona kutungamirira kune mhedzisiro yenhema.
4. Mienzaniso haifaniri kuunganidzwa kana murwere akaita zvepabonde mukati meawa 24 kuti abvise migumisiro yenhema.
5. Varwere vane kufungidzirwa kana kuzivikanwa kwepa placenta abruption, placenta previa, kana kubuda ropa kuri pakati nepakati kana kwakanyanyisa kunhengo yesikarudzi havafanirwe kuongororwa.
6. Varwere vane cerclage havafaniri kuongororwa.
7. Maitiro ekuita kweStrongStep®fFN bvunzo yakavakirwa pazvidzidzo muvakadzi vane singleton gestations.Kuita hakuna kusimbiswa kune varwere vane mazamu akawanda, semuenzaniso, mapatya.
8. The StrongStep®FFN bvunzo haifanirwe kuitwa pamberi pekutsemuka kweamniotic membranes uye kuputika kweamniotic membranes kunofanirwa kubviswa isati yaitwa bvunzo.
PERFORMANCE CHARACTERISTICS
Tafura: StrongStep® fFN Test vs. Imwe mhando fFN Test
| Relative Sensitivity: 97.96% (89.13% -99.95%)* Relative Specificity: 98.73% (95.50% -99.85%)* Chibvumirano Chese: 98.55% (95.82% -99.70%)* *95% Ruvimbo Interval |
| Imwe mhando |
| ||
| + | - | Total | |||
| StrongStep®fFn Test | + | 48 | 2 | 50 | |
| - | 1 | 156 | 157 | ||
|
| 49 | 158 | 207 | ||
Analytic sensitivity
Huwandu hwakaderera hunoonekwa hwefFN mumuenzaniso wakatorwa i50μg/L.
Pakati pevakadzi vane zviratidzo, mazinga akakwirira (≥ 0.050 μg/mL) (1 x 10-7 mmol/L) yefFN pakati pemavhiki makumi maviri nemana, mazuva 0 nemavhiki makumi matatu nemana, mazuva matanhatu anoratidza njodzi yakawedzera yekusununguka mukati ≤ 7 kana ≤ mazuva gumi nemana kubva muenzaniso wekuunganidza.Pakati pevakadzi vasina zviratidzo, mazinga akakwirira eFFN pakati pemavhiki e22, mazuva 0 uye mavhiki makumi matatu, mazuva matanhatu anoratidza kuwedzera kwengozi yekusununguka mu ≤ mavhiki makumi matatu nemana, mazuva matanhatu ekuberekwa.Iyo cutoff ye50 μg/L fFN yakavambwa mune yakasarudzika ongororo yakaitwa kuti iongorore kushamwaridzana pakati pe fetal fibronectin kutaura panguva yekuzvitakura uye kubereka kusati kwasvika.
Zvinopindira
Kungwarira kunofanirwa kutorwa kusasvibisa mushandisi kana cervicovaginal secretion nemafuta ekuzora, sipo, mishonga inouraya utachiona, kana makirimu.Mafuta ekuzora kana makirimu anogona kukanganisa kunyura kwemuenzaniso pamushandisi.Sipo kana mishonga inouraya utachiona inogona kukanganisa maantibody-antigen reaction.
Zvinogona kupindira zvinhu zvakaedzwa pane zvakasungwa zvinogona kuwanikwa zvine mutsindo mukuvanzika kwecervicovaginal.Zvinhu zvinotevera hazvina kupindira muyedzo kana zvakaedzwa pamatanho akaratidzwa.
| Substance | Concentration | Substance | Concentration |
| Ampicillin | 1.47 mg/mL | Prostaglandin F2 | a0.033 mg/mL |
| Erythromycin | 0.272 mg/mL | Prostaglandin E2 | 0.033 mg/mL |
| Weti Yaamai 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 |
| MgSO4•7H2O | 1.49 mg/mL | BetadineR Cleanser | 10 mg/mL |
| Ritodrine | 0.33 mg/mL | K-YR Jelly | 62.5 mg/mL |
| DermicidolR 2000 | 25.73 mg/mL |
ZVINHU ZVINOTAURWA
1. American College of Obstetricians uye Gynecologists.Preterm Labor.Technical Bulletin, Nhamba 133, Gumiguru, 1989.
2. Creasy RK, Resnick R. Maternal and Fetal Medicine: Mitemo uye Kuita.Philadelphia: WB Saunders;1989.
3. Creasy RK, Merkatz IR.Kudzivirira kuberekwa kusati kwasvika: maonero ekliniki.Obstet Gynecol 1990;76(Suppl 1):2S–4S.
4. Morrison JC.Kuberekwa nguva isati yakwana: dambanemazwi rakakodzera kugadziriswa.Obstet Gynecol 1990;76(Suppl 1):5S-12S.
5. Lockwood CJ, Senyei AE, Dische MR, Casal DC, et al.Fetal fibronectin mumutsipa wekervical uye vaginal secretions sechinhu chinofanotaura nezvekubereka kusati kwasvika.New English J Med 1991;325:669–74.
RUGWARO RWEZVIRATIDZO
|
| Catalog nhamba |  | Kuderedza tembiricha |
 | Bvunza mirayiridzo yekushandisa |
| Batch code |
 | In vitro diagnostic medical device |  | Shandisa by |
 | Mugadziri |  | Rine zvakakwana zvemiedzo |
 | Usashandise zvakare |  | Mumiriri ane mvumo muEuropean Community |
 | CE yamaka maererano neIVD Medical Devices Directive 98/79/EC | ||
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StrongStep® Fetal Fibronectin Rapid Test Device
Kusununguka kusati kwasvika, kunotsanangurwa neAmerican College of Obstetricians uye Gynecologists sekusununguka isati yasvika vhiki ye37 yekuzvitakura, inokonzera ruzhinji rwevasiri-chromosomal perinatal morbidity uye kufa.Zviratidzo zvekutyisidzirwa kusununguka nguva isati yakwana zvinosanganisira kudhonzwa kwechibereko, kushanduka kwekubuda kwenhengo yesikarudzi, kubuda ropa kunhengo yesikarudzi, kurwadza kwemusana, kusagadzikana kwemudumbu, BP, uye kukakama.Diagnostic modalities yekuzivikanwa kwekutyisidzirwa kusati kwasvika kusati kwasvika kunosanganisira uterine basa rekutarisa uye kushanda kwedigital cervical test, iyo inobvumira fungidziro yezviyero zvekervical.
StrongStep® Fetal Fibronectin Rapid Test inoonekwa yakadudzirwa immunochromatographic bvunzo inoitirwa kuti ishandiswe pakuonekwa kweiyo fetal fibronectin mu cervicovaginal secretions ine anotevera maitiro:
Mushandisi ane hushamwari:nhanho-imwe nzira mukuyedzwa kwemhando
Kurumidzamaminitsi gumi chete anodiwa panguva yekushanya kwemurwere mumwe chete
Zvekushandisa zvisina:zvipatara zvinomisa zvipatara kana zvipatara zvinogona kuita bvunzo iyi
Delivered:tembiricha yekamuri (2℃-30℃)
