Accurate quantitation is critical to aid in diagnosis and faster initiation of Hepatitis C treatment. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.
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
For in vitro diagnostic use
|ABBOTT ALINITY m HCV ASSAY PERFORMANCE1-5|
|Claim||Viral load monitoring and confirmation of active HCV infection|
|Time to Result||< 115 min|
|Standardization||4th WHO International Standard for Hepatitis C Virus RNA, NIBSC code: 06/102|
|Probe Design||Dual probe design; robust genotyping detection|
|Target Region||Conserved 5’ UTR Region|
|Genotypes||1, 2, 3, 4, 5, 6|
Plasma: Acid Citrate Dextrose (ACD); K2EDTA; K3EDTA, Plasma Preperation Tubes (PPT)
Serum: Serum; Serum separator tubes (SST), Serum Rapid-Clot Tube
Sensitivity / Limit of Detection (LoD)
Plasma: Probe Analysis determined that the concentration of HCV RNA detected with 95% probability was 8.50 IU/mL
Serum: Probe Analysis determined that the concentration of HCV RNA detected with 95% probability was 7.96 IU/mL
IU/mL or log IU/mL
Plasma: SD ≤ 0.19 log IU/mL
Serum: SD≤ 0.23 log IU/mL
Negative, Low Positive, and High Positive controls
|Sample Input Volume||600 µL|
|Calibrator||2 Calibrator Levels|
|Internal Control||Armored RNA (Pumpkin)|
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