|
Approval for the amplicor hepatitis c virus (hcv) test, v2.0. The device is indicated for: the qualitative detection of hcv rna in human serum or plasma from blood collected in edta (edta plasma). The test detects by reverse-transcribing target hcv rna into cdna, amplifying cdna by polymerase chain reaction (pcr), hybridizing amplified cdna with an oligonucleotide probe that binds enzyme, and catalyzing conversion of substrate to a colored product that is recognized by a microwell plate reader. The amplicor hcv test, v2.0 is indicated for patients who have evidence of liver disease and antibody evidence of hcv infection, and who are suspected to be actively infected with hcv. Detection of hcv rna indicates that the virus is replicating and therefore is evidence of active infection.
|
