Diagnostic Kit Total thyroxine (Fluorescence Immunochromatographic Asay)
Diagnostic ornamentum ad totalis thyrrogyine (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 totalis thyroxine (fluorescit immunochromatographic) est a fluorochromatographic Assay pro quantitatis de totalis thyroxine (Tt4) in Humanum Serum vel Plasma, quod est maxime ad aestimandas thyroide.It sample debet confirmari ab aliis methodologies. Hoc test est in animo pro curis professional usum tantum.
Summary
Thyroxine (T4) est secretus a glandula et m. pondus est 777d. T4 T4 (Total T4, TT4) in Serum L temporibus, quod de Serum T3. Inter eos, 99,9% of Tt4 ligat Serum thyroxine proteins (tbp), et liber T4 (Free T4, FT4) est minus quam 0.05%. T4 et T3 participare regulans corporis metabolicae munus. Tt4 mensuris sunt ad aestimandas thyroid munus et diagnosis morbos. Clinice, TT4 est certa indicator ad diagnosis et efficaciam observationis hyperthyroidism et hypothyroidism.
Principle procedendi
Membrana in test fabrica est iactaret cum conjugate BSA et T4 in test regionem et hircum anti lepus IGG in imperium regionem. Venalicium Pad sunt iactant fluorescens marcam anti T4 antibody et lepus IGG in antecessum. Cum probatio sample, tt4 in sample miscere cum fluorescence notatum anti T4, et forma immune mixtisque. Sub actione immunochromatography, in universa influunt in directionem absorbent charta, cum complexu transierunt in test regionem, libero fluorescencenta erit combined cum t4 in membranea concentration et cum tt4 est negans per membranam ad fallore signo, et Concentration TT4 in sample potest deprehendi a Fluorescence immunoassay asay.
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.
3.Take de test card de ffoyle peram.
4.Insert in test card in card socors, scan in QR code, determinare test item.
5.Add 20μl Serum vel Plasma Sample ad solutionem et miscere bene.
6.Add 20μl B solutio ad superius mixtum et miscere bene.
Relinquere mixtisque20minuta.
Addere 80μl mixtisque ut sample bene de card.
Click in "vexillum test" puga pyga, post X minuta, instrumentum erit automatice deprehendere test card, quod potest legi eventus a ostentationem screen instrumenti et record / print in test results.
Refer ad disciplinam Portable immune analyzer (wiz-a101).
Expectata values
Tt4 normalis range: 55-140NMOL / l
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 Tt4 est altior quam referat 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
.The ornamentum est XVIII menses PLUTEUM-vita a date de fabricantibus. Store ad insolita rhoncus ad 2-30 ° c. Nolite rigabant. Noli ultra expirata.
.Do non aperire signatum massa usque ad vos es paratus ad praestare a test, et unum-usu test suggesserant adhiberi sub requiritur environment (temperatus 2-35 ℃, humiditas 40-90%) in LX min sicut cito fieri potest.
.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 | 20nMol / L ad 320nMol / l | 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 | |
T3 | 500ng / 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