PROM Rapid Test
YUAV TSUM SIV
Lub StrongStep®PROM kuaj yog ib qho kev txhais lus pom, zoo immunochromatographic kuaj rau kev kuaj pom ntawm IGFBP-1 los ntawm cov kua dej amniotic hauv qhov chaw mos thaum cev xeeb tub.Qhov kev ntsuam xyuas no yog npaj rau kev siv tshaj lij los pab txheeb xyuas qhov tawg ntawm lub hauv nruab nrog cev (ROM) hauv cov poj niam cev xeeb tub.
Taw qhia
Qhov concentration ntawm IGFBP-1 (insulin-zoo li kev loj hlob zoo li kev khi cov protein-1) hauv cov kua dej amniotic yog 100 txog 1000 npaug ntau dua li cov ntshav niam.IGFBP-1 feem ntau tsis muaj nyob rau hauv qhov chaw mos, tab sis tom qab rupture ntawm fetal membranes, amniotic kua nrog ib tug siab concentration ntawm IGFBP-1 sib tov nrog rau qhov chaw mos secretions.Nyob rau hauv StrongStep® PROM xeem, ib qho piv txwv ntawm qhov chaw mos tso pa tawm nrog lub cev tsis muaj polyester swab thiab cov qauv raug muab rho tawm rau hauv Cov Tshuaj Extraction.Lub xub ntiag ntawm IGFBP-1 nyob rau hauv cov kev daws teeb meem yog kuaj pom siv cov cuab yeej ntsuas ceev.
PRINCIPLE
Lub StrongStep®PROM Test siv xim immunochromatographic, capillary flow technology.Cov txheej txheem xeem yuav tsum tau solubilization ntawm IGFBP-1 los ntawm qhov chaw mos swab los ntawm kev sib xyaw cov swab hauv Sample Buffer.Tom qab ntawd cov qauv sib xyaw tsis yog ntxiv rau cov qauv ntsuas cov qauv zoo thiab cov sib xyaw ua ke nyob ntawm daim nyias nyias.Yog hais tias IGFBP-1 nyob rau hauv cov qauv, nws yuav tsim ib tug complex nrog thawj anti- IGFBP-1 antibody conjugated rau xim hais.Tom qab ntawd lub complex yuav raug khi los ntawm qhov thib ob anti- IGFBP-1 antibody coated rau ntawm nitrocellulose membrane.Cov tsos ntawm cov kab kuaj pom pom nrog rau cov kab tswj yuav qhia tau qhov txiaj ntsig zoo.
KIT COMPONENTS
| 20 Ib leeg pack ibed cov khoom siv kuaj | Txhua lub cuab yeej muaj ib txoj hlua nrog cov xim sib txuas thiab cov reactive reagents pre-coated ntawm cov cheeb tsam sib thooj. |
| 2Kev rho tawmTsis pub vial | 0.1 M Phosphate buffered saline (PBS) thiab 0.02% sodium azide. |
| 1 Zoo tswj swab (ntawm kev thov nkaus xwb) | Muaj IGFBP-1 thiab sodium azide.Rau sab nraud tswj. |
| 1 Negative tswj swab (ntawm kev thov nkaus xwb) | Tsis muaj IGFBP-1.Rau kev tswj sab nraud. |
| 20 Extraction tubes | Rau kev npaj cov qauv siv. |
| 1 Chaw ua haujlwm | Qhov chaw tuav tsis tau vials thiab raj. |
| 1 Pob ntawv ntxig | Rau kev qhia ua haujlwm. |
Cov khoom yuav tsum tau tab sis tsis muab
| Timer | Rau kev siv sijhawm. |
COV KEV CEEV FAJ
■ Rau kev kuaj mob hauv vitro nkaus xwb.
■ Tsis txhob siv tom qab hnub tas sij hawm teev nyob rau hauv pob.Tsis txhob siv qhov kev ntsuam xyuas yog tias nws lub hnab ntawv ci puas lawm.Tsis txhob rov siv cov kev ntsuam xyuas.
■ Cov khoom siv no muaj cov khoom ntawm tsiaj keeb kwm.Cov ntaub ntawv pov thawj paub txog keeb kwm thiab / lossis kev huv ntawm cov tsiaj tsis tuaj yeem lav qhov tsis muaj cov kab mob kis tau.Yog li, nws tau pom zoo tias cov khoom no raug kho raws li qhov muaj feem kis tau, thiab ua raws li kev tiv thaiv kev nyab xeeb ib txwm muaj (tsis txhob noj lossis nqus pa).
■ Tsis txhob kis tus kab mob sib kis los ntawm kev siv lub thawv ntim khoom tshiab rau txhua tus qauv tau txais.
■ Nyeem tag nrho cov txheej txheem ua tib zoo ua ntej ua ib qho kev xeem.
■ Tsis txhob noj, haus lossis haus luam yeeb hauv thaj chaw uas cov khoom siv thiab cov khoom siv raug coj mus.Kov tag nrho cov qauv zoo li lawv muaj cov kab mob sib kis.Ua raws li kev tiv thaiv kev tiv thaiv kab mob microbiological thoob plaws hauv cov txheej txheem thiab ua raws li cov txheej txheem rau kev pov tseg cov qauv.Hnav cov khaub ncaws tiv thaiv xws li cov tsho hauv chav kuaj, cov hnab looj tes pov tseg thiab tiv thaiv qhov muag thaum kuaj cov qauv.
■ Tsis txhob sib pauv lossis sib xyaw cov tshuaj reagents los ntawm ntau ntau.Tsis txhob sib tov tshuaj lub raj mis caps.
■ Cov av noo thiab qhov kub thiab txias tuaj yeem cuam tshuam qhov tshwm sim.
■ Thaum txoj kev ntsuam xyuas tiav lawm, muab cov swabs pov tseg kom zoo tom qab autoclaving lawv ntawm 121 ° C rau tsawg kawg 20 feeb.Xwb, lawv tuaj yeem kho nrog 0.5% sodium hypochloride (los yog cov tshuaj dawb hauv tsev) rau ib teev ua ntej muab pov tseg.Cov khoom siv kuaj yuav tsum raug muab pov tseg raws li cov cai hauv zos, xeev thiab/lossis tseem fwv.
■ Tsis txhob siv cytology txhuam nrog cov neeg mob cev xeeb tub.
KHOOM THIAB STABILITY
■ Cov khoom siv yuav tsum khaws cia ntawm 2-30 ° C kom txog rau thaum hnub tas sij hawm luam tawm ntawm lub hnab ntim khoom.
■ Qhov kev sim yuav tsum nyob twj ywm hauv lub hnab kaw kom txog thaum siv.
■ Tsis txhob khov.
■ Yuav tsum tau saib xyuas kom tiv thaiv cov khoom hauv cov khoom siv no kom tsis txhob muaj kab mob.Tsis txhob siv yog tias muaj pov thawj ntawm microbial paug los yog nag lossis daus.Kev kis kab mob lom ntawm cov khoom siv tshuaj, ntim lossis cov tshuaj reagents tuaj yeem ua rau cov txiaj ntsig tsis raug.
TXOJ CAI TSHUAJ TIV THAIV THIAB SAIB
Siv tsuas yog Dacron los yog Rayon tipped sterile swabs nrog yas shafts.Nws raug nquahu kom siv cov swab muab los ntawm cov chaw tsim khoom (Cov swabs tsis muaj nyob rau hauv cov khoom siv no, rau cov ntaub ntawv xaj, thov hu rau cov chaw tsim khoom lossis tus neeg muag khoom hauv zos, tus lej cataloge yog 207000).Swabs los ntawm lwm tus neeg muab khoom tsis tau raug lees paub.Swabs nrog paj rwb tswv yim los yog ntoo shafts tsis pom zoo.
■ Ib qho qauv tau txais los ntawm kev siv lub tshuab tsis muaj polyester.Cov qauv yuav tsum tau sau ua ntej ua cov kev kuaj digital thiab / lossis transvaginal ultrasound.Saib xyuas kom tsis txhob kov dab tsi nrog lub swab ua ntej coj tus qauv.Ua tib zoo ntxig qhov ntxeev ntawm qhov swab mus rau hauv qhov chaw mos mus rau tom qab fornix kom txog thaum tsis sib haum.Xwb tus qauv tuaj yeem raug coj los ntawm lub posterior fornix thaum lub sij hawm kuaj tsis muaj menyuam.Lub swab yuav tsum tau tso rau hauv qhov chaw mos rau 10-15 vib nas this kom nws nqus tau qhov chaw mos.Rub lub swab tawm kom zoo!.
■ Muab lub swab tso rau hauv lub raj rho tawm, yog tias qhov kev sim yuav khiav tam sim ntawd.Yog tias tsis tuaj yeem kuaj tam sim ntawd, cov qauv neeg mob yuav tsum muab tso rau hauv lub raj xa dej qhuav rau kev khaws cia lossis thauj.Cov swabs yuav khaws cia rau 24 teev ntawm chav tsev kub (15-30 ° C) lossis 1 lub lis piam ntawm 4 ° C lossis tsis pub tshaj 6 lub hlis ntawm -20 ° C.Tag nrho cov qauv yuav tsum tau tso cai kom ncav cuag qhov kub ntawm 15-30 ° C ua ntej kuaj.
txheej txheem
Nqa cov kev ntsuam xyuas, piv txwv, tsis thiab / lossis kev tswj rau hauv chav sov (15-30 ° C) ua ntej siv.
■ Muab ib lub raj Extraction huv rau hauv qhov chaw ua haujlwm.Ntxiv 1ml ntawm Extraction Buffer rau lub raj rho tawm.
■ Muab cov ntaub so ntswg tso rau hauv lub raj.Nquag sib tov cov tshuaj los ntawm tig lub swab quab yuam tawm tsam sab ntawm lub raj rau tsawg kawg kaum zaug (thaum submerged).Cov txiaj ntsig zoo tshaj plaws yog tau txais thaum cov qauv sib xyaw ua ke hauv cov tshuaj.
■ Nyem tawm cov kua dej ntau npaum li qhov ua tau los ntawm qhov swab los ntawm pinching sab ntawm lub raj hloov tau yooj yim thaum lub swab raug tshem tawm.Yam tsawg kawg 1/2 ntawm cov qauv buffer tov yuav tsum nyob twj ywm rau hauv lub raj kom txaus capillary tsiv teb tsaws tshwm sim.Muab lub hau tso rau ntawm lub raj xa tawm.
Muab pov tseg lub swab nyob rau hauv ib lub thawv uas tsim nyog biohazardous pov tseg.
■ Cov qauv muab rho tawm tuaj yeem khaws cia hauv chav sov li 60 feeb yam tsis muaj kev cuam tshuam rau qhov kev xeem.
■ Tshem tawm qhov kev xeem los ntawm nws lub hnab kaw, thiab muab tso rau ntawm qhov chaw huv, theem.Sau lub cuab yeej nrog tus neeg mob lossis kev tswj xyuas tus kheej.Yuav kom tau txais qhov txiaj ntsig zoo tshaj plaws, qhov kev ntsuam xyuas yuav tsum tau ua hauv ib teev.
■ Ntxiv 3 tee (kwv yees li 100 µl) ntawm cov qauv rho tawm los ntawm Extraction Tube rau cov qauv zoo ntawm cov ntawv xeem.
Tsis txhob tso cov npuas npuas hauv qhov zoo (S), thiab tsis txhob tso cov tshuaj hauv qhov pom kev.
Raws li qhov kev sim pib ua haujlwm, koj yuav pom cov xim txav mus rau hauv daim nyias nyias.
■ Tos kom cov xim liab tshwm.Cov txiaj ntsig yuav tsum tau nyeem ntawm 5 feeb.Tsis txhob txhais cov txiaj ntsig tom qab 5 feeb.
Muab pov tseg cov raj uas siv thiab Test Cassettes rau hauv lub thawv uas tsim nyog biohazardous pov tseg.
Kev txhais lus ntawm qhov tshwm sim
| POSITIVETSEEM CEEB:
| Ob lub xim dawb tshwm rau ntawm daim nyias nyias.Ib pawg tshwm nyob rau hauv cheeb tsam tswj (C) thiab lwm pab pawg tshwm nyob rau hauv cheeb tsam xeem (T). |
| NEEGATIVETSEEM CEEB:
| Tsuas yog ib qho xim dawb tshwm nyob rau hauv cheeb tsam tswj (C).Tsis muaj cov xim dawb tshwm nyob hauv cheeb tsam xeem (T). |
| INVALIDTSEEM CEEB:
| Tswj band tsis tshwm sim.Cov txiaj ntsig los ntawm ib qho kev xeem uas tsis tau tsim ib pawg tswj hwm ntawm lub sijhawm nyeem ntawv yuav tsum muab pov tseg.Thov tshuaj xyuas cov txheej txheem thiab rov ua dua nrog kev sim tshiab.Yog tias muaj teeb meem tshwm sim, txiav tawm siv cov khoom siv tam sim ntawd thiab tiv tauj koj tus neeg muag khoom hauv zos. |
CEEB TOOM:
1. Qhov kev siv ntawm cov xim hauv cheeb tsam kuaj (T) yuav txawv nyob ntawm seb qhov concentration ntawm cov khoom siv nyob rau hauv cov qauv.Tab sis cov tshuaj theem tsis tuaj yeem txiav txim siab los ntawm qhov kev xeem zoo no.
2. Cov khoom ntim tsis txaus, cov txheej txheem ua haujlwm tsis raug, lossis ua cov ntawv xeem tas sij hawm yog qhov feem ntau yog vim li cas rau kev tswj hwm band tsis ua haujlwm.
QUALITY CONTROL
■ Kev tswj cov txheej txheem sab hauv muaj nyob rau hauv qhov kev xeem.Ib pawg xim xim tshwm nyob rau hauv cheeb tsam tswj (C) yog suav tias yog ib qho kev tswj hwm zoo sab hauv.Nws lees paub qhov ntim cov qauv txaus thiab cov txheej txheem raug.
■ Kev tswj cov txheej txheem sab nraud tuaj yeem muab tau (ntawm kev thov nkaus xwb) hauv cov khoom siv los xyuas kom meej tias cov kev sim ua haujlwm zoo.Tsis tas li ntawd, Cov Kev Tswj yuav raug siv los ua kom pom qhov ua tau zoo los ntawm tus neeg teb xov tooj xeem.Txhawm rau ua qhov kev ntsuam xyuas zoo lossis qhov tsis zoo, ua kom tiav cov kauj ruam hauv Tshooj Txheej Txheem Kev Kho Hniav tswj kev tswj hwm tib yam li cov khoom siv swab.
TXOJ CAI TSHUAJ TIV THAIV
1. Tsis muaj kev txhais lus ntau npaum li cas raws li qhov ntsuas tau.
2.Tsis txhob siv qhov kev ntsuam xyuas yog tias nws lub hnab ntawv aluminium lossis cov ntsaws ruaj ruaj ntawm lub hnab tsis zoo.
3.A zoo StrongStep®PROM qhov kev sim, txawm tias kuaj pom muaj cov kua dej amniotic hauv cov qauv, tsis pom qhov chaw ntawm qhov tawg.
4.Raws li nrog rau tag nrho cov kev kuaj mob, cov txiaj ntsig yuav tsum tau txhais nyob rau hauv lub teeb ntawm lwm yam kev kuaj pom.
5.Yog hais tias rupture ntawm fetal daim nyias nyias tau tshwm sim tab sis qhov to ntawm amniotic kua tau tso tseg ntau tshaj 12 teev ua ntej cov qauv coj mus kuaj, IGFBP-1 tej zaum yuav degraded los ntawm proteases nyob rau hauv qhov chaw mos thiab qhov kev kuaj yuav muab ib tug tsis zoo tshwm sim.
TXOJ CAI TSHIAB
Table: StrongStep®PROM Test vs. Lwm hom PROM Test
|
txheeb ze Sensitivity: |
| Lwm hom |
| ||
| + | - | Tag nrho | |||
| StrongStep®PROM Kuaj | + | 63 | 3 | 66 | |
| - | 2 | 138 | 140 | ||
|
| 65 | 141 | 206 | ||
Analytic rhiab heev
Tus nqi qis tshaj plaws ntawm IGFBP-1 hauv cov qauv rho tawm yog 12.5 μg / l.
Cov khoom cuam tshuam
Kev saib xyuas yuav tsum tsis txhob ua kom tsis txhob kis tus kab mob los yog lub ncauj tsev menyuam zais zis nrog cov roj nplua nyeem, xab npum, tshuaj tua kab mob, lossis tshuaj pleev.Lubricants los yog cream yuav cuam tshuam lub cev nqus cov qauv mus rau lub applicator.Cov xab npum lossis tshuaj tua kab mob tuaj yeem cuam tshuam nrog cov tshuaj tiv thaiv kab mob-antigen.
Cov tshuaj muaj peev xwm cuam tshuam tau raug kuaj ntawm cov concentrations uas tej zaum yuav pom muaj nyob rau hauv lub ncauj tsev menyuam secretions.Cov tshuaj hauv qab no tsis cuam tshuam rau qhov kev ntsuam xyuas thaum kuaj ntawm cov qib qhia.
| Tshuaj | Nco ntsoov | Tshuaj | Nco ntsoov |
| Ampicillin | 1.47 mg/ml | Prostaglandin F2 | 0.033 mg/ml |
| Erythromycin | 0.272 mg/ml | Prostaglandin E2 | 0.033 mg/ml |
| Maternal Urine 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 |
| MgSO 4•7h2 ua | 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 |
LITERATURE REFERENCES
Erdemoglu thiab Mungan T. Qhov tseem ceeb ntawm kev kuaj pom cov tshuaj insulin zoo li kev loj hlob ntawm cov protein-1 hauv cervicovaginal secretions: kev sib piv nrog nitrazine kuaj thiab ntsuas qhov ntim ntawm cov kua amniotic.Acta Obstet Gynecol Scand (2004) 83:622-626.
Kubota T thiab Takeuchi H. Kev ntsuam xyuas ntawm kev loj hlob zoo li insulin zoo li khi protein-1 raws li cov cuab yeej kuaj mob rau kev tawg ntawm daim nyias nyias.J Obstet Gynecol Res (1998) 24:411-417.
Rutanen EM et al.Kev soj ntsuam ntawm kev kuaj kab mob sai sai rau kev loj hlob zoo li insulin zoo li kev khi cov protein-1 hauv kev kuaj mob ntawm cov kab mob hauv plab ruptured.Clin Chim Acta (1996) 253:91-101.
Rutanen EM, Pekonen F, Karkkainen T. Kev ntsuas kev loj hlob zoo li insulin-zoo li kev khi cov protein-1 hauv tsev menyuam hauv plab / qhov chaw mos: kev sib piv nrog ROM-check Membrane Immunoassay hauv kev kuaj mob ntawm ruptured fetal membranes.Clin Chim Acta (1993) 214:73-81.
GLOSSARY NTAWM SYMBOLS
|
| Catalog tus lej |  | Kev txwv kub |
 | Tshawb xyuas cov lus qhia rau kev siv |
| Batch code |
 | Cov cuab yeej kho mob hauv vitro diagnostic |  | Siv los ntawm |
 | Chaw tsim tshuaj paus |  | Muaj txaus raukuaj |
 | Tsis txhob rov siv dua |  | Tso cai sawv cev hauv European Community |
 | CE cim raws li IVD Medical Devices Directive 98/79/EC | ||
