PROM Rapid Test
ZVIRI KUSHANDISA
The StrongStep®PROM bvunzo inoonekwa inodudzirwa, qualitative immunochromatographic bvunzo yekuona IGFBP-1 kubva kuamniotic fluid muvaginal secretions panguva yekuzvitakura.Muedzo uyu unoitirwa kuti ushandiswe nehunyanzvi kubatsira kuongorora kuputika kwefetus membranes (ROM) mumadzimai akazvitakura.
NHUNGAMIDZO
Iko kusanganiswa kweIGFBP-1 (insulin-yakafanana nekukura chinhu chinosunga mapuroteni-1) muamniotic fluid ndeye 100 kusvika ku1000 nguva yakakwirira kudarika muserum yaamai.IGFBP-1 haisi kazhinji inowanikwa mumudzimai, asi mushure mekuputika kwe fetal membranes, amniotic fluid ine huwandu hwepamusoro hweGFBP-1 inosanganiswa nekubuda kwechikadzi.Mukuedza kweStrongStep® PROM, muenzaniso wekubuda kwemukadzi unotorwa nepolyester swab isina utachiona uye mufananidzo wacho unoburitswa muSpecimen Extraction Solution.Kuvapo kwe IGFBP-1 mumhinduro kunoonekwa uchishandisa yekukurumidza bvunzo mudziyo.
PRINCIPLE
The StrongStep®PROM Test inoshandisa ruvara immunochromatographic, capillary kuyerera tekinoroji.Maitirwo ebvunzo anoda solubilization yeIGFBP-1 kubva kumukadzi swab nekusanganisa swab muSample Buffer.Ipapo iyo yakasanganiswa sampu buffer inowedzerwa kune bvunzo kaseti sampuli zvakanaka uye musanganiswa unofamba uchitevedza membrane pamusoro.Kana IGFBP-1 iripo mumuenzaniso, inoumba yakaoma ine yekutanga anti- IGFBP-1 antibody yakasanganiswa kune mavara mavara.Iyo yakaoma inozosungwa neyechipiri anti- IGFBP-1 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 IGFBP-1 uye sodium azide.Zvekutonga kunze. |
| 1 Negative control swab (pakukumbira chete) | Haina IGFBP-1.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.
SPECIMN KUCHENGA UYE KUCHENGETA
Shandisa chete Dacron kana Rayon yakanamirwa sterile swabs ine epurasitiki shafts.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.
∎ Muenzaniso unowanikwa pachishandiswa tsvina yepolyester swab.Muenzaniso unofanirwa kuunganidzwa usati waita ongororo yedhijitari uye / kana transvaginal ultrasound.Chenjerera kuti usabate chero chinhu chine swab usati watora sampuli.Nyatsopinza muromo wetsvina musikarudzi yakananga kushure kwefornix kusvika kuramba kwaitwa.Neimwe nzira iyo sampuli inogona kutorwa kubva kumashure fornix panguva yekuongororwa sterile speculum.Iyo swab inofanira kusiiwa mubeche kwe 10-15 seconds kuti ikwanise kubata chibereko.Dhonza swab kunze zvakanaka!.
■ 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. Hapana kududzira kwehuwandu kunofanirwa kuitwa zvichienderana nemhedzisiro yebvunzo.
2.Usashandise bvunzo kana homwe yayo yealuminium foil kana zvisimbiso zvehomwe zvisina kumira zvakanaka.
3.A positive StrongStep®PROM mhedzisiro yebvunzo, kunyangwe ichiona kuvepo kweamniotic fluid mumuenzaniso, haiwane nzvimbo yekuputika.
4.Sezviyedzo zvose zvekuongorora, zvigumisiro zvinofanira kududzirwa muchiedza chezvimwe zviwanikwa zvekliniki.
5.Kana kuputika kwe fetal membranes kwakaitika asi kubuda kweamniotic fluid kwapera maawa anopfuura 12 isati yatorwa mufananidzo, IGFBP-1 inogona kunge yakasvibiswa nemaprotease mumudzimai uye muedzo unogona kupa chigumisiro chisina kunaka.
PERFORMANCE CHARACTERISTICS
Tafura: StrongStep®PROM Test vs. Imwe mhando PROM Muedzo
|
Relative Sensitivity: |
| Imwe mhando |
| ||
| + | - | Total | |||
| StrongStep®PROM Test | + | 63 | 3 | 66 | |
| - | 2 | 138 | 140 | ||
|
| 65 | 141 | 206 | ||
Analytic sensitivity
Iyo yakaderera inoonekwa huwandu hweIGFBP-1 mumuenzaniso wakatorwa ndeye 12.5 μg/l.
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 | 0.033 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
Erdemoglu naMungan T. Kukosha kwekuona insulini-yakafanana nekukura chinhu chinosunga mapuroteni-1 mu cervicovaginal secretions: kuenzanisa ne nitrazine test uye amniotic fluid volume assessment.Acta Obstet Gynecol Scand (2004) 83:622-626.
Kubota T uye Takeuchi H. Kuongorora kwe insulini-yakafanana nekukura chinhu chinosunga mapuroteni-1 sechinhu chekuongorora chekuputika kwemembrane.J Obstet Gynecol Res (1998) 24:411-417.
Rutanen EM et al.Ongororo yekukurumidza tambo bvunzo ye insulin-yakafanana nekukura chinhu chinosunga mapuroteni-1 mukuongororwa kweakatsemuka fetus membranes.Clin Chim Acta (1996) 253:91-101.
Rutanen EM, Pekonen F, Karkkainen T. Kuyera kwe insulini-yakafanana nekukura kweprotein-1 mumuromo wekervical / vaginal secretions: kuenzanisa neROM-check Membrane Immunoassay mukuongororwa kwekuputika kwe fetal membranes.Clin Chim Acta (1993) 214:73-81.
RUGWARO RWEZVIRATIDZO
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| 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 | ||
