In vitro nucleic acid amplification test for the qualitative detection of HCV viral RNA in human whole blood.
Early HCV infection during the “window” period may be incorrectly diagnosed by immunoassays as HCV proteins and/or antibodies to the HCV virus are not yet detectable. The SAMBA Qual Whole Blood Tests are NAT tests, allowing earlier detection than current immunoassays. The SAMBA II HCV Qual Whole Blood Test is an in vitro nucleic acid-based amplification test for the qualitative detection of Hepatitis C Virus (HCV) in human whole blood collected via heel/finger-stick or venepuncture. The test is intended for use in clinical or point-of-care settings as an aid in the diagnosis of active HCV infection in adults or infants and to confirm cure upon completion of treatment. The test is also meant for high-risk groups such as HIV-1 infected individuals or niche populations such as prisoners and IV drug abusers.
The test is not intended for HCV screening in blood donations.
The SAMBA HCV Qual Whole Blood test uses a small volume of whole blood, which can be easily obtained from a finger or heel prick to detect the presence of the HCV RNA.
Test kits contain all reagents and consumables. The SAMBA II test kits also include a collection kit including adjustable lancet, alcohol wipes, powder-free gloves, sample collection tube and sample tracking card.
