background title Sample 1
To capture HBsAg from the sample it has a unique mixture of monoclonal antibodies,
including a human monoclonal antibody binding to a previously unidentified
epitope(6) outside the major immunodominant region (called the a-determinant).
This is combined with HRP-labeled anti-HBs (ovine) conjugate leading to extremely
sensitive detection of HBsAg while maintaining a good specificity.
Subsequently HRP-labeled anti-HBs (ovine) conjugate is added and incubation is
continued. If HBsAg is present, a solid phase antibody/HBsAg/enzyme-labeled antibody
complex is formed. Following washing and incubation with TMB
(tetramethylbenzidine) substrate a blue color is produced. The enzyme reaction is
stopped by the addition of a sulfuric acid solution, which changes the color to yellow.
background title Esempio 1
Per catturare l’antigene HBsAg dal campione, il test contiene una miscela unica di
anticorpi monoclonali, incluso un anticorpo monoclonale umano che si lega ad un
epitopo non identificato in precedenza esterno alla regione immunodominante
maggiore (chiamata a-determinante). Questo viene combinato con coniugato anti-HBs
(ovino) marcato con HRP permettendo una rilevazione estremamente sensibile di
HBsAg pur mantenendo una buona specificità.
Successivamente, viene aggiunto il coniugato (ovino) anti-HBs marcato con HRP
protraendo la durata dell’incubazione. In presenza di HBsAg, si forma un complesso tra
anticorpi alla fase solida / HBsAg / anticorpi marcati con l’enzima. Dopo il lavaggio e
l'incubazione con il substrato TMB (tetrametilbenzidina) si sviluppa una colorazione
blu. La reazione enzimatica viene bloccata dall'aggiunta di una soluzione di acido
solforico che induce un viraggio della colorazione sul giallo.
background title Sample 2
Fresh specimens may be stored for up to one week at 2 to 8 °C if free of microbial
contamination. If longer storage is required, specimens should be stored frozen
at –20 °C or below. Conditions that favor microbial growth should be avoided. The
quality of the specimens can be seriously affected by microbial growth, which may
lead to erroneous results.
Specimens should not be subjected to more than three freeze/thaw cycles as this can
lead to erroneous results. Heat inactivation at 56 °C for 30 minutes does not affect
the assay results.
background title Esempio 2
I campioni freschi possono essere conservati fino ad una settimana ad una
temperatura compresa tra 2 e 8 °C, se privi di contaminazione microbica. Qualora
sia necessario conservarli più a lungo, i campioni devono essere congelati ad una
temperatura di -20 °C o inferiore. E’ necessario evitare qualsiasi condizione che
possa favorire la crescita microbica. La qualità dei campioni può essere gravemente
compromessa da una crescita microbica, conducendo alla produzione di risultati
errati.
I campioni non devono essere soggetti a più di tre cicli di congelamento/scongelamento
perché tale pratica potrebbe alterare i risultati dei test. L'inattivazione al calore per
30 minuti a 56 °C non influenza i risultati del test.
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