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Approval for the elecsys anti-hbs immunoassay and elecsys precicontrol anti-hbs. The elecsys anti-hbs immunoassay is indicated for: the qualitative determination of total antibodies to the hepatitis b surface antigen (hbsag) in human serum and plasma (edta). The electrochemilumin-escence immunoassay "eclia" is intended for use on the roche elecsys 2010 immunoassay analyzer. Assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following hbv vaccination, or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The detection of anti-hbs is indicative of laboratory diagnosis of seroconversion from hepatitis b virus (hbv) infection. The elecsys precicontrol anti-hbs is indicated for: the precicontrol anti-hbs is used for quality control of the elecsys anti-hbs immunoassay on the elecsys 2010 immunoassay analyzer. The performance of the precicontrol anti-hbs has not been established with any other anti-hbs assay.
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