Cobas HCV Test

Approval order statement

APPROVAL FOR THE COBAS HCV. THIS DEVICE IS INDICATED FOR: COBAS HCV IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR BOTH THE DETECTION AND QUANTITATION OF HEPATITIS C VIRUS (HCV) RNA, IN HUMAN EDTA PLASMA OR SERUM, OF HCV ANTIBODY POSITIVE OR HCV-INFECTED INDIVIDUALS. SPECIMENS CONTAINING HCV GENOTYPES 1 TO 6 ARE VALIDATED FOR DETECTION AND QUANTITATION IN THE ASSAY. COBAS HCV IS INTENDED FOR USE AS AN AID IN THE DIAGNOSIS OF HCV INFECTION IN THE FOLLOWING POPULATIONS: INDIVIDUALS WITH ANTIBODY EVIDENCE OF HCV WITH EVIDENCE OF LIVER DISEASE, INDIVIDUALS SUSPECTED TO BE ACTIVELY INFECTED WITH HCV ANTIBODY EVIDENCE, AND INDIVIDUALS AT RISK FOR HCV INFECTION WITH ANTIBODIES TO HCV. DETECTION OF HCV RNA INDICATES THAT THE VIRUS IS REPLICATING AND THEREFORE IS EVIDENCE OF ACTIVE INFECTION.COBAS HCV IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED PATIENTS UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY CAN BE USED TO MEASURE HCV RNA LEVELS AT BASELINE, DURING TREATMENT, AT THE END OF TREATMENT, AND AT THE END OF FOLLOW UP OF TREATMENT TO DETERMINE SUSTAINED OR NON-SUSTAINED VIRAL RESPONSE. THE RESULTS MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.COBAS HCV HAS NOT BEEN APPROVED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF HCV IN BLOOD OR BLOOD PRODUCTS. ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH CERTAIN DIRECT-ACTING ANTIVIRAL AGENTS (DAA) REGIMENS. NO INFORMATION IS AVAILABLE ON THE ASSAYS PREDICTIVE VALUE WHEN OTHER DAA COMBINATION THERAPIES ARE USED.