Diagnostic Kit quia testosterone (Fluorescence Immunochromatographic Asay)
Diagnostic Kit quia testosterone(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 testosterone (Fluorciscen Immunochromatographic) est fluorescence immunochromatographic Assay pro quantitatis Deprehensio testosterone (T) in Humanum Serum vel Plasma, quod est Auxiliary Diagnosis Reagent.All positivum debet confirmari ab aliis methodologies. Hoc test est in animo pro curis professional usum tantum.
Summary
Testosterone (T), quae habet molecular pondus 288,4 D.in circulatorii ratio, de XCVII% ad XCIX% of testosterone ligat ad Plasma proteins.among eos, LX% of testosterone in sanguine est tenetur ad sex% of testosterone in sanguine est tenetur ad sex% of testosterone in sanguine non tenetur ad sex% of testosterone ( Shbg), XXXVIII% tenetur ad albumin, et II% est liberum. In binding testosterone in sanguine non biologically activae, et solum liberum testosterone potest intrare in rastris cellulis ad exercent physiological effectus.
Principle procedendi
In membrana temptare fabrica est iactaret cum coniugato BSA et testosterone in test regionem et caprae anti lepus IGG in imperium regione. Venalicium Pad sunt iactaret fluorescence Mark anti testosterone antibody et lepus IGG in antecessum. Cum probatio sample, testosterone in sample miscere cum fluorescence notatum anti testosterone antibody et formare immune mixtisque. Sub actione immunochromatography, in universa influunt in directionem absorbent charta, cum complexu transierunt in test regionem, libero fluorescencentior erit combined cum testosterone in membranea concentration erit cum testosterone in membranea, et testosterone est negativa, quod est per modum influorendion Concentration de testosterone 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.
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
Testosterone normalis rhoncus: Male: 2.5-10.5ng / ml
Male: 0.25-1.0ng / 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 testosterone 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
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 | 0,5 NG / ML ad XX 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 |
E2 | 500ng / ml | |
PROG | 500ng / ml | |
COR | 500ng / ml | |
E3 | 13ng / ml | |
17β E2 | 13ng / ml |
References
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 |
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![]() | Store ad 2-30 ℃ |
![]() | Expiration Date |
![]() | Non reuse |
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![]() | 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