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Herpesvirus Ornamentum pro Alpha, Fetoprotein(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 quia Alpha, Fetroprotein (Fluorescence Immunochromatographic) est a fluorescence immunochromatographic pro quantitatis deprehensio Alpha-Fetoprotein (Afp ad Auxiliaribus Serum aut Plasma, quod est maxime ad Auatocellular Carcinoma. Omnes positivum sample debet confirmari ab aliis methodologies. Hoc test est in animo pro curis professional usum tantum.
Summary
Alpha, Fetoprotein (Afp) est unus ex communiter usus tumore markeder.it est a glycoprotein cum molecular pondus 70,000 et saccharo in IV% .it est maxime synthesized a foetus iecoris, sequitur vitellus sac.the foetus coepit VI hebdomades, perveniens ad apicem XII ad XV hebdomades, sero concentration of I ad III g / l et umbilicum sanguinem ad nativitatis X ad C mg / l: I ad II annis adulta XC ad D ng / ml in medio; normalis humana serum afp contentus est inter II et VIII NG / ml, sed plures morbos, praesertim Hepatitis, afficit afp valorem.
Principle procedendi
Membrana in test fabrica est iactaret cum anti Afp antibody in test regionem et caprae anti lepus IGG antibody in imperium regionem. Lable codex tunicata fluorescen intitulatum anti Afp antibody et lepus IGG in antecessum. Cum probatio positivum sample, in Afp antigen in sample miscere cum fluorescence intitulatum anti Anti Afp, et forma 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 AFP coating antibody, forms new complex.AFP level is positively correlated with fluorescence signal, and the concentration of AFP In sample potest deprehendi a fluorescit immunoassay.
Reagentia et materiae suppleverunt
25T sarcina components:
.Test card singulos ffoyle pouched cum a desiccant 25t
.Sample Dilents 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 20μl Serum vel Pure Sample to Diluent Sample, 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
AFP: <10NG / ml
Commendatur quod quisque laboratorium statuam suam normalem range representing sua patientes estote population.
Test eventus et interpretatione
.The supra notitia est effectus afp Reagent test et suggesserant ut quisque laboratorium debet constituere a range de AFP 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.
. NOVAE NOTA NOTA NUMBER NOTIC
.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 | 1ng / ml ad 1000ng / ml | Relativum deviation: -15% ad + XV%. |
Linear Correlation coefficiente (R) ≥0,9900 | ||
Accuratio | Et recuperatio rate erit in LXXXV% - CXV%. | |
Repeatability | CV≤15% | |
Specifica (nemo substantiae ad interpensed temptavit impedire in asay) | Interpensatus | Intercessio |
Acetaminophen | 1500μg / ml | |
Acidum acetylsalicylic | 10mg / ml | |
Cea | 500μg / ml | |
Hemoglobin | 200μg / ml | |
transferret | 100μg / ml | |
Equus radicula peroxidase | 2000μg / ml | |
LH | 200miu / ml | |
Fsh | 200miu / ml | |
HCG | 20000miu / ml | |
Tsh | 200μiu / ml | |
BSA | 5mg / ml | |
Vinblastine | 500μg / ml | |
Cisplatin | 1000μg / ml | |
Azathiopline | 30mg / l | |
Bleomycin | 100μu / 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