A multicentric clinical study was conducted on representative sera from 1,738 European and U.S. subjects for the evaluation of new anti-hepatitis A virus enzyme immunoassays from Bio-Rad Laboratories. Comparison with reference DiaSorin S.p.A. tests confirmed the good performance of Bio-Rad assays (99.85% and 99.47% overall agreement in detecting total antibodies and IgM, respectively).
Multicentric Evaluation of New Commercial Enzyme Immunoassays for the Detection of Immunoglobulin M and Total Antibodies against Hepatitis A Virus / Arcangeletti M.C.; Dussaix E.; Ferraglia F.; Roque-Afonso A.M.; Graube A.; Chezzi C.. - In: CLINICAL AND VACCINE IMMUNOLOGY. - ISSN 1556-6811. - 18(8)(2011), pp. 1391-1394. [10.1128/CVI.00403-10]