Alinity m HCV Assay | 合法醫療器材資訊網

TheAlinitymHCVassayisaninvitroreversetranscription-polymerasechainreaction(RT-PCR)assayforboththedetectionandquantitationofhepatitisCvirus ...

INTENDED USE

The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human plasma (EDTA, Acid Citrate Dextrose) or serum, from HCV antibody positive individuals. The assay is intended for use as an aid in the diagnosis of active HCV infection in individuals with antibody evidence of HCV infection, and to aid in the management of patients with known active HCV infection, including Sustained Virologic Response (SVR) determination.

The results from the Alinity m HCV assay must be interpreted within the context of all relevant clinical and laboratory findings.

The Alinity m HCV assay is not intended to be used in screening blood, plasma, serum, tissue or tissue donors for HCV.

LIMITATIONS OF THE PROCEDURE