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Sample translations submitted: 1
English to Serbian: One Step Test for HCG (Colloidal Gold) For in vitro Diagnostic Use General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English One Step Test for β2-MG (Colloidal Gold)
For In Vitro Diagnostic Use
Manual
INTENDED USE
One Step Test for β2-MG (Colloidal Gold) applies colloidal gold immunochromatography to detect beta2-microglobulin (β2-MG) in serum, plasma or whole blood samples quantitatively. Measurement of β2-MG is useful for the detection and evaluation of glomerular fitration rate, renal transplantation and renal function.
SUMMARY
β2-MG is an 11.8-kD protein, which forms one of the chains of the major histocompatibility complex (MHC) class I molecule normally present on the surface of every nucleated cell in the human body. Ninety percent of β2-MG is eliminated via glomerular filtration and almost completely reabsorbed by the proximal tubules. β2-MG is present in small amounts in serum, csf, and urine of normal people, and to a much greater degree in the urine and plasma of patients with tubular proteinemia, renal failure, or kidney transplants.
Among the uremic toxins in the "middle molecule" range, β2-MG is certainly one of the most frequently studied compounds. Its serum level increases with the progression of chronic kidney disease, to reach very high concentrations in patients with end-stage kidney disease. It is the major protein component of dialysis-related amyloidosis, a dramatic complication which results from high extracellular concentration and posttranslational modification of β2-MG and a number of other promoters of amyloid fibril formation and deposition in osteo-articular tissues. Effective removal of β2-MG can be achieved with highly effective hemodialysis and hemodiafiltration techniques but predialysis session serum levels cannot be normalized. The prevalence and severity of β2-MG amyloidosis appear to have decreased in the last 20 years, although its occurrence may simply be delayed.
PRINCIPLE OF THE EXAMINATION METHOD
The test uses an anti-human β2-MG monoclonal antibody conjugated with colloidal gold and another anti-human β2-MG monoclonal antibody coated on the test line. After the sample (serum, plasma or whole blood) is applied to the test strip, the gold-labelled anti-human β2-MG monoclonal antibody binds to the β2-MG in sample and forms a marked antigen-antibody complex. This complex moves to the test card detection zone by capillary action, then be captured on the test line by another anti-human β2-MG monoclonal antibody resulting in a purplish red streak appears on the test line. The color intensity of the test line increases in proportion to the amout of β2-MG in sample.
When inserting test card into the FIA8000 Quantitative Immunoassay Analyzer (hereafter referred to as FIA8000), the concentration of β2-MG in sample will be measured and displayed on the screen. The values will be stored in FIA8000 and available for downloading on demand. The result can be transmitted to the laboratory or hospital information system, if it is connected to FIA8000.
CONTENTS
A kit contains:
1. Foil bag, which contains one test card and one desiccant 25
2. Manual 1
3. SD card 1
4. Blood sample diluent 25
A test card consists of:
A plastic shell and a reagent strip which is composed of a sample pad, nitrocellulose membrane (a colloidal gold-labelled anti-human β2-MG monoclonal antibody is coated at the border of the nitrocellulose membrane and sample pad, the test line is coated with another anti-human β2-MG monoclonal antibody, and the control line is coated with rabbit anti-mouse IgG antibody), absorbent paper and liner.
Blood sample diluent:
Phosphate buffered saline, proteins, detergent, preservative, stabilizer.
Translation - Serbian Test u jednom koraku za određivanje beta2-mikroglobulina (β2-MG) (Koloidno zlato) u svrhu In vitro dijagnostičke upotrebe
Uputstvo za upotrebu
NAMENA
Test u jednom koraku za određivanje beta2-mikroglobulina (β2-MG) (Koloidno zlato) primenjuje imunohromatografiju koloidnim zlatom u svrhu otkrivanja beta2-mikroglobulina (β2-MG) u uzorcima seruma, plazme ili cele krvi kvantitativno. Merenje β2-MG-a je korisno kod detekcije i evaluacije brzine glomerularne fitracije, transplantacije bubrega i funkcije bubrega.
REZIME
β2-MG je 11.8-kD protein, koji formira jedan od lanaca molekula klase I glavnog kompleksa histokompatibilnosti (GKH) koji je u normalnim okolnostima prisutan na površini svake ćelije s jedrom u ljudskom organizmu. Devet posto β2-MG-a se eliminiše glomerularnom filtracijom a gotovo u potpunosti reabsorbuje uz pomoć proksimalnih tubula. β2-MG je prusutan u malim količinama u serumu, moždano-kičmenoj tečnosti, i mokraći zdravih osoba, a u većoj meri u mokraći i plazmi pacijenata sa tubularnom proteinemijom, bubrežnom insuficijencijom ili presađenim bubregom.
Od svih uremičnih toksina iz grupe “srednjih molekula”, β2-MG je sigurno jedno od najčešće proučavanih jedinjenja. Njegov nivo u serumu raste sa napredovanjem hronične bolesti bubrega dostižući vrlo visoke koncentracije kod pacijenata sa krajnjom fazom bolesti bubrega. To je glavna proteinska komponenta dijalizne amilodioze, dramatične komplikacije koja je rezultat visoke ekstracelularne koncentracije i posttranslacione modifkacije β2-MG-a i velikog broja promotera formiranja i akumulacije amiloidnih fibrila u osteoartikularnim tkivima. Efikasno odstranjivanje β2-MG-a se može postići pomoću visoko efikasnih tehnika hemodijalize i hemodijafiltracije ali se nivoi u serumu nakon predijalizne sesije ne mogu normalizovati. U poslednjih 20 godina čini se da su se rasprostranjenost i težina β2-MG amiloidoze smanjili, mada se njeno javljanje može samo odložiti.
PRINCIP METODE ISPITIVANJA
Test koristi anti-humano β2-MG monoklonsko antitelo konjugovano sa koloidnim zlatom i još jednim anti-humanim β2-MG monoklonskim antitelom obloženim na test liniji. Nakon što se uzorak (serum, plazma ili cela krv) nanese na test traku, anti-humano β2-MG monoklonsko antitelo obeleženo zlatnim koloidnim česticama vezuje se za β2-MG u uzorku i formira označeni kompleks antigen-antitelo. Ovaj kompleks se pomera ka detekcionoj zoni test kartice pomoću kapilarnosti i biva absorbovan na test liniji još jednim anti-humanim β2-MG monoklonskim antitelom rezultirajući ljubičasto crvenom prugom koja se javlja se na test liniji. Intenzitet boje test linije raste proporcionalno količini β2-MG u uzorku.
Kada ubacite test karticu u FIA8000 Kvantitativni analizator imunoeseja (u daljem tekstu: FIA8000), koncentracija β2-MG u uzorku će biti izmerena i prikazana na ekranu. Vrednosti testa će biti čuvane u FIA8000 i dostupne za preuzimanje na zahtev. Rezultat može biti prenesen do laboratorijskog ili bolničkog informacionog sistema, ukoliko je povezan sa FIA8000.
SADRŽAJ
Komplet sadrži:
1. Dojpak vrećicu, koja sadrži jednu test karticu i jedan desikant......25
2. Uputstvo.........................................................................................1
3. Bezbedonosnu digitalnu karticu (SD).............................................1
4. Diluent za razblaživanje uzorka krvi...............................................25
Test kartica se sastoji od:
Plastične školjke i reagens trake koja se sastoji od podloge za uzorak, nitrocelulozne membrane (koloidno anti-humano β2-MG monoklonsko antitelo je obloženo na granici nitrocelulozne membrane i podloge za uzorak, test linija je obložena još jednim anti-humanim β2-MG monoklonskim antitelom, a kontrolna linija obložena je zečijim anti-mišijim lgG antitelom), upijajućeg papira i obloge.
Diluent za razblaživanje uzorka krvi:
Fosfatni puferovani slani rastvor, proteini, deterdžent, prezervativ, stabilizator.
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Experience
Years of experience: 16. Registered at ProZ.com: Feb 2016.
I think of myself as extremely versatile and competent, eager to acquire further knowledge in all fields of expertise. As a part of a team I have always managed to achieve good results. By finding answers in different sources as well as in communication with other colleagues I always try to overcome obstacles in work. The people who work with me find me dependable and responsible. Together we display excellent performance and achieve brilliant results when translating.
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