Cobas Taqman HBV Test

Approval order statement

APPROVAL FOR COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM. THIS DEVICE IS INDICATED FOR: THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM OR PLASMA (EDTA), USING THE HIGH PURE VIRAL NUCLEIC ACID KIT FOR MANUAL SPECIMEN PREPARATION AND THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION. THE TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTION UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY CAN BE USED TO MEASURE HBV DNA LEVELS AT BASELINE AND DURING TREATMENT TO AID IN ASSESSING RESPONSE TO TREATMENT. THE RESULTS FROM THE COBAS TAQMAN HBV TEST MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH ADEFOVIR DIPIVOXIL. ASSAY PERFORMANCE FOR DETERMINING THE STATE OF HBV INFECTION HAS NOT BEEN ESTABLISHED. THE COBAS TAQMAN HBV TEST IS NOT INTENDED FOR USE AS A SCREENING TEST FOR BLOOD OR BLOOD PRODUCTS FOR THE PRESENCE OF HBV OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HBV INFECTION.