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SERION ELISAclassic - virion\serion

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Pos: 1 /Arbeitsanl eitung en ELISA classi c/Gültig für nur ein Dokument/U pdate/U pdate: Echovirus @ 11\mod_1335249184703_18.doc @ 51044 @<br />

Pos: 6 /Arbeitsanl eitung en ELISA classi c/Gültig für alle D okumente/ELISA cl assic/Allgemei ne T exte ELISA cl assic/Kapitelüberschrift "Diag nostische Bedeutung" @ 0\mod_1177351537598_18.doc @ 221 @ 1<br />

Pos: classic/Allgemeine @ 4\mod_1255336385816_18.doc 2 /Arbeitsanleitungen Texte ELISA @ classic/Einleitung classic/Gültig 21165 @ für "Enzymimmunoassay"<br />

alle Dokumente/ELISA<br />

<strong>SERION</strong> ELISA classic Echovirus IgA/IgG/IgM<br />

Enzyme-immunoassay for determination of human antibodies<br />

for in vitro diagnostic use<br />

Dokument/Bestellnummern/Echovirus: 0\mod_1188370705487_18.doc Pos: 3 /Arbeitsanleitungen ELISA @ 6809 classic/Gültig @ Bestellnummern für nur ein @<br />

<strong>SERION</strong> ELISA classic Echovirus IgA Order Nr.: ESR135A<br />

<strong>SERION</strong> ELISA classic Echovirus IgG Order Nr.: ESR135G<br />

<strong>SERION</strong> ELISA classic Echovirus IgM Order Nr.: ESR135M<br />

Pos: classic/Allgemeine 0\mod_1177351044007_18.doc 4 /Arbeitsanleitungen Texte ELISA @ 170 classic/Kapitelüberschrift classic/Gültig @ 1 für alle Dokumente/ELISA<br />

"Anwendungsbereich" @<br />

1 INTENDED USE<br />

Pos: 5 /Arbeitsanl eitung en ELISA classi c/Gültig für nur ein Dokument/Anwendungsber eich/Echovirus: Anwendungsber eich @ 11\mod_1335164233519_18.doc @ 50667 @<br />

The <strong>SERION</strong> ELISA classic Echovirus IgA, IgG and IgM tests are qualitative and<br />

quantitative immunoassays for the demonstration of human antibodies, in serum or<br />

plasma, directed against ECHO viruses. The differential detection of the different antibody<br />

classes facilitates the confirmation of contact with the organism and supports the<br />

categorisation of the disease stage.<br />

2 DIAGNOSTIC RELEVANCE<br />

Pos: 7 /Arbeitsanl eitung en ELISA classi c/Gültig für nur ein Dokument/Di agnostische Bedeutung/Echovir us: Diagnostische Bedeutung @ 11\mod_1335167509699_18.doc @ 50718 @<br />

Coxsackieviruses A and B, as well as the ECHO viruses, have a worldwide distribution<br />

and all belong to the Picornaviridae family, genus Enterovirus. These virus groups are<br />

similar in their biological characteristics and epidemiology with a primarily faecal-oral<br />

transmission strategy but also being capable of spread via aerosols. Person to person<br />

transmission is mainly by smear infection with the portal of entry being either the<br />

alimentary canal or the respiratory tract. The viruses reach the reticuloendothelial system<br />

and other target organs such as the myocardium, meninges or skin, via the blood<br />

circulation.<br />

While infections in tropical areas tend to be all year round, in temperate zones infections<br />

are at their peak in the summer months and decline in the autumn. Small children are most<br />

often infected, however in non-immune older children and adults, infection can lead to<br />

severe disease. The incubation time lies anywhere between 12 hours and 35 days.<br />

Over 90 % of all Enterovirus infections are asymptomatic or result only in mild, short<br />

duration general malaise affecting the upper respiratory tract, such as sore throat with or<br />

without rhinitis which is often associated with fever. In adults symptoms may be<br />

pharyngitis, tonsillitis and flu-like symptoms. In particular, ECHO viruses are responsible<br />

for epidemics in new born children and babies with rhinitis, pharyngitis, bronchitis and<br />

pneumonia in hospitals and other institutions.<br />

ECHO viruses may cause a panoply of disease conditions, such as aseptic meningitis,<br />

encephalitis, ataxia, Guillain-Barré-Syndrome, exanthema, diarrhoea, hepatitis and foetal<br />

damage. Less frequently paralysis, epidemic myalgia, pericarditis, myocarditis may occur.<br />

Individuals with congenital or induced immunodeficiency are prone to viral persistence<br />

following infection which may lead to chronic diseases such as enteritis, arthritis, CNS<br />

disease or chronic heart disease. The role that ECHO viruses play in the etiology of<br />

juvenile diabetes mellitus (type1/IDMM) has been discussed in the literature.<br />

english 2

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