Diagnostic Kit ad Cardiac Troponin I (Fluorescence Immunochromatographic Asay)
Diagnostic Kit ad Cardiac Troponin ego(Fluorizing Immunochromatographic Asay)
Nam in vitro diagnostic usu modo
Please legit hoc sarcina insert diligenter prior ad uti et stricte sequi instructiones. Reliability Assay praecessi non potest praestati si sunt aliqua deviationes ex instructiones in hoc sarcina inserta.
Intendebat usum
Diagnostic Kit ad Cardiac Troponin I (Fluorescence Immunochromatographic Asay) is a fluorochromatographic Assay pro quantitatis Deprehensio Cardiac Troponin I (CTNI) in Humanum Serum aut Plasma, quod est usus ad AuGinnosis AMI (acuti Myocardial Infarcion). Omnes positivum sample debet confirmari ab aliis methodologies. Hoc test est in animo pro curis professional usum tantum.
Summary
Ctni levels auctus aliquot horas post myocardial infarctione occurrit, pilious ad 12-16 horis et mansit elevatum 4-9 dies post myocardial infarctum occurrit. In global definition de tertia myocardial infarctione in MMXII, quod maluit biomarker-CTN (i vel T), habet altum myocardial TEXTUS specifica et alta orci sensibilitatem. Mutationes in concentratione CTN sunt essentialis ad diagnosis de Amici
Principle procedendi
Membrana in test fabrica est iactaret cum anti ctni antibody in test regionem et caprae anti lepus IGG antibody in imperium regionem. Lable PAD sunt iactant fluorescen intitulatum anti ctni antibody et lepus IGG in antecessum. Cum probatio positivum sample, ctni antigen in sample miscere cum fluorescence intitulatum anti ctni, et formam immune mixtisque. Under the action of the immunochromatography, the complex flow in the direction of absorbent paper, when complex passed the test region, it combined with anti cTnI coating antibody, forms new complex.cTnI level is positively correlated with fluorescence signal, and the concentration of cTnI In sample potest deprehendi a fluorescit immunoassay.
Reagentia et materiae suppleverunt
25T sarcina components:
Test card singulos ffoyle pouched cum a desiccant 25t
Sample diluents 25t
Package Insert I
Materials requiritur sed non provisum
Sample Collection Container, Timer
Sample Collection et Storage
1.The exempla probata potest esse serum, Heparin Anticoagult Pure Pureza et EDTA Anticoagulant Pure.
2.AcCording ad Latin Techniques Oratio Sample. Serum vel Plasma Sample potest tenentur refrigerated 2-8 ℃ ad 7days et cryopreservation infra -15 ° C ad VI mensibus.
3.All sample vitare Congelo-CALLUM CYCLII.
Procedure
Placere legit instrumentum operationem manual et sarcina inserta ante tentat.
1.Lay intrahunt omnes reagentia et exempla ad locus temperatus.
2.Open in portable immune analyzer (wiz-a101), Intra rationem password login secundum operationem modum instrumenti, et intrare deprehendatur interface.
3.Scan dentification codice confirmare test item.
4.Take de test card de ffoyle peram.
5.Insert in test card in card socors, scan in QR code, determinare test item.
6.Add 40μl Serum vel Pure Sample to Sample Diluent, et misce ..
7.Add 80μl sample solutio ad sample bene de card.
8.Click in "Latin Test" puga pyga, post XV minutes, instrumentum erit automatice deprehendere test card, quod potest legi eventus ex ostentationem screen in instrumenti, et record / print in test results.
9.Refer ad disciplinam Portable immune analyzer (wiz-a101).
Expectata values
ctni <0.3ng / ml
Commendatur quod quisque laboratorium statuam suam normalem range representing sua patientes estote population.
Test eventus et interpretatione
.The supra notitia est effectus CTNI Reagent test et id quod quisque laboratorium debet constituere a range of CTNI deprehensio values idoneam ad population in hac regione. Et super praecessi sunt enim reference tantum.
.The results of hunc modum sunt tantum applicentur ad reference Ranges statutum in hoc modum, et non est recta comparability cum aliis modi.
Umbra EtOthe factors potest etiam causa errores in deprehendendo results, comprehendo technica rationes, operational errores et alia sample factors.
Repono et stabilitatem
1.The ornamentum est XVIII menses PLUTEUM-vita a date de fabricantibus. Store ad insolita rhoncus ad 2-30 ° c. Nolite rigabant. Noli ultra expirata.
2.Do non aperire signatum massa usque ad vos es parati ad praestare a test et una-usu test suggesserant utendum sub requiritur environment (temperatus 2-35 ℃, humiditas 40-90%) in LX min ut cito quam maxime.
3.Sample diluent adhibetur statim postquam aperuit.
Monitus et cautiones
.The ornamentum sit signari et protected contra humorem.
.All positivum specimina erit convalescere ab aliis methodologies.
.All specimens et tractata est potentiale pollutant.
.Do non utor exspiravit Reagent.
.Do non intercedit Reagents inter Kits cum diversis sorte non ..
.Do non reuse test cards et nihil PROMPTIOCCULA.
.Misoperation, nimia aut parum specimen potest ad eventum deviationibus.
LImitatio
.As cum aliquo assau usus mus elibodarum, facultatem existit pro intercessiones ab humana anti-mus elencodies (Hama) in specimine. Specimens aegris qui accepit apparatu of Monoclonal antibodies ad diagnosi vel illic ut quae Hama. Tales specimina potest causare falsum positivum vel falsum negative praecessi.
.This test result is only for clinical reference, should not serve as the only basis for clinical diagnosis and treatment, the patients clinical management should be comprehensive consideration combined with its symptoms, medical history, other laboratory examination, treatment response, epidemiology and other information .
.This Reagent est solum usus est Serum et Plasma probat. Non potest obtinere accurate consequuntur, cum usus ad alia exempla ut saliva et urina etc.
Perficientur characteres
Lineamentum | 0,1ng / ml ad 40G / ml | Relativum deviation: -15% ad + XV%. |
Linear Correlation coefficiente (R) ≥0,9900 | ||
Accuratio | Et recuperatio rate erit in LXXXV% - CXV%. | |
Repeatability | CV≤15% | |
Specifica(Nulla ex substantiis ad interpensed temptavit impedivit in asay) | Interpensatus | Intercessio |
stni | 1000μg / l | |
CTNT | 1000μg / l | |
ABP | 1000μg / l | |
CK-MB | 1000μg / l | |
ctnc | 1000μg / l | |
sttt | 1000μg / l | |
Myo | 1000μg / l |
RE
1.hansen JH et al.hama intercessiones cum murine Monoclonal Antibody, secundum immunoassays [J] .j de Clin Immunoassay, 1993,16: 294-299.
2.Levinson ss.The natura heterophilic antibodies et partes in immunoassay intercessiones [J] .j de Clin Immunoassay, 1992,15, 108-114.
Key ad symbola usus:
![]() | In Vitro Diagnostic Medical fabrica |
![]() | Manufacturer |
![]() | Store ad 2-30 ℃ |
![]() | Expiration Date |
![]() | Non reuse |
![]() | Cautio |
![]() | Consule instructiones ad usum |
Xiamen Vivamus Biotech Co., Ltd
Oratio: 3-4 area, no.16 aedificationem, bio-medical officia, MMXXXX Wengjiao Occidentem Road, Haicang regio, (XXXVI) CXXVI, Xiamen, Sina
Tel: + 86-592-6808278
Fax: + 86-592-6808279