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Diagnostic Kit Total Totolothyronine(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 Total Totothyronine (Fluorochromatographic Assay) est fluorescence immunochromatographic pro quantitatis deprehensio totalis triiodothyron (tt3) in Human Serum vel Plasma, quod est maxime ad aestimandas thyroidei positivum sample debet confirmari ab aliis methodologies. Hoc test est in animo pro curis professional usum tantum.
Summary
Triodothyronine (T3) M. pondus 651d. Est pelagus activae forma thyroid hormone. Summa T3 (T3 T3, TT3) in Serum dividitur in binding and Free genera. 99,5% of Tt3 ligat ad Serum thyrrogyine binding proteins (tbp), et liber T3 (liberum T3) Rationes ad 0.2 ad 0.4%. T4 et T3 participare in maintaining et regulanting corpus est metabolicae munus munus mensuras sunt ad aestimandas thyroid munus et diagnosis morborum. Volume Tt3 est certa indicator pro diagnosis et efficaciam observationis hyperthyroidism et hypothyroidisidism.The determinatio T3 est magis significant pro diagnosis de hyperthyroidism quam T4.
Principle procedendi
Membrana in test fabrica est iactaret cum conjugate BSA et T3 in test regionem et caprae anti lepus IGG in imperium regione. Venalicium Pad sunt iactaret fluorescens marcam anti T3 antibody et lepus IGG in antecessum. Cum probatio sample, tt3 in sample miscere cum fluorescence notatum anti T3 antibody, et forma immune mixtisque. Sub actione immunochromatography, in universa influunt in directionem absorbent charta, cum complexu transierunt in test regionem, libero fluorescency erit cum tt3 in tt3 in tt3 est in sample, et concentration est per tt3 in Fluorescency, et concentration est negativa in tt3 in sample potest deprehendatur a Fluorescence ImmunoassaSay est in specimen, et in Fluorescentia immunoassaassay in speculatione potest deprehendatur a Fluorescence Immunoassay Ave.
Reagentia et materiae suppleverunt
25T sarcina components:
.Test card singulos ffoyle pouched cum a desiccant 25t
.A solution 25t
.B solution I
.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
In test procedure instrumenti animadverto the immunoanalyzer manual. In reagent test procedure est ut sequitur
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 30μl Serum vel Plasma Sample ad solutionem, et miscere bene.
7.Add 20μl B solutio ad superius mixturam, et miscere bene.
8.Lave mixtisque ad XX minutes.
9.Add 80μl mixtisque ad sample bene de card.
10.Click in "Latin test" puga pyga, post X minuta, instrumentum et automatically deprehendere in test card, quod potest lego eventus ex ostentationem screen of instrumentum, et record / print in test results.
11.Refer ad disciplinam Portable immune analyzer (wiz-a101).
Expectata values
Tt3 normalis range: 0,5-2.5ng / ml
Commendatur quod quisque laboratorium statuam suam normalem range representing sua patientes estote population.
Test eventus et interpretatione
.The supra notitia est reference intervallum statutum pro deprehendatur notitia huius ornamentum, et hoc est suggesserant ut quisque laboratorium debet constituere a refertione intervallo ad relevant orci significationem de populatio in hac regione.
.The concentration of Tt3 est altior quam reference range et physiologica mutationes vel accentus responsio debet esse excluded.indeed abnormes, si non miscere orci indicium diagnosi.
.The results of hunc modum sunt tantum applicabiles ad referat range statutum per modum, et eventus non directe comparari cum aliis modis.
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 unum-usu test est suggesserant utendum sub requiritur environment (temperatus 2-35 ℃, humiditas 40-90%) in LX min quam celerrime.
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 effectus est solum ad orci reference, ut non serve sicut solum ex pro orci diagnosis et curatio, in aegris orci administratione sit comprehensive considerationem combined cum suis symptoms, medical history, aliis officinarum examination, curatio responsio, epidemiology et alia notitia.
.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 | 0,25 NG / ML ad X NG / 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 |
Hemoglobin | 200μg / ml | |
transferret | 100μg / ml | |
Horseradish peroxidase | 2000μg / ml | |
rt3 | 13ng / ml | |
T4 | 200ng / ml |
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