SERION ELISAclassic - virion\serion
SERION ELISAclassic - virion\serion
SERION ELISAclassic - virion\serion
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Pos: 46 /Ar bei tsanl eitungen ELISA cl assic/Gültig für all e D okumente/ELISA classic/Leistungsmer kmale/Kapi tel überschrift Leistungsmer kmale @ 0\mod_1184676089844_18.doc @ 2103 @ 1<br />
Pos: 47 /Ar bei tsanl eitungen ELISA cl assic/Gültig für all e D okumente/ELISA classic/Leistungsmer kmale/Kapi tel überschrift: Sensiti vität und Spezi fität @ 0\mod_1190013251494_18.doc @ 9925 @ 2<br />
Pos: 49 /Ar bei tsanl eitungen ELISA cl assic/Gültig für all e D okumente/ELISA classic/Leistungsmer kmale/Kapi tel überschrift Präzisi on @ 0\mod_1184676568397_18.doc @ 2118 @ 2<br />
8.7 Reference Range of healthy Individuals<br />
EN<br />
Pos: 45 /Ar bei tsanl eitungen ELISA cl assic/Gültig für nur ein D okument/Testauswertung/Echovir us/Echovir us: R eferenzber eich gesunder Pr obanden @ 11\mod_1335175182890_18.doc @ 50922 @<br />
Testing of random blood donor sera, collected in the region of southern Germany, with the<br />
<strong>SERION</strong> ELISA classic Echovirus IgA, IgG and IgM tests resulted in the following<br />
distribution. From 105 sera tested with the <strong>SERION</strong> ELISA classic Echovirus IgA test, 95<br />
(90.5 %) were negative, six sera (5.7 %) reacted positive and four sera (3.8 %) were<br />
considered borderline. Of 50 sera, 46 (92.0 %) were negative when tested with the<br />
<strong>SERION</strong> ELISA classic Echovirus IgG test, three (6.0 %) sera yielded a positive result and<br />
one serum (2.0 %) were evaluated as borderline. In addition, results from testing 50 sera<br />
in the <strong>SERION</strong> ELISA classic Echovirus IgM test were as follows; 49 sera (98.0 %) were<br />
tested negative, no sera were positive and one sample (2.0 %) sera was evaluated as<br />
borderline.<br />
9 PERFORMANCE CHARACTERISTICS<br />
9.1 Sensitivity and Specificity<br />
Pos: 48 /Ar bei tsanl eitungen ELISA cl assic/Gültig für nur ein D okument/Leistungsmer kmal e/Echovir us/Echovir us: Sensiti vi tät und Spezifität @ 11\mod_1335172499563_18.doc @ 50820 @<br />
The performance characteristics of the <strong>SERION</strong> ELISA classic Echovirus IgA, IgG and IgM<br />
tests were calculated using the results from an in-house study utilising more than 40 sera<br />
from patients with suspected current infection, in addition to over 80 sera from blood<br />
donors and pregnant women. The immunoassays were validated using the <strong>SERION</strong><br />
ELISA classic Echovirus tests based on inactivated virus particles as a reference.<br />
Borderline results were not included in the calculation of specificity and sensitivity.<br />
Performance Characteristics Sensitivity Specificity<br />
<strong>SERION</strong> ELISA classic Echovirus IgA 95.7 % 97.9 %<br />
<strong>SERION</strong> ELISA classic Echovirus IgG 95.2 % 95.3 %<br />
<strong>SERION</strong> ELISA classic Echovirus IgM 93.3 % > 99 %<br />
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