RevoDx HCV qPCR Kit
RevoDx HCV qPCR Kit is a real-time RT-PCR test intended for quantification of Hepatitis C virus (HCV) RNA in human serum or plasma (EDTA) using RevoDx Viral Nucleic Acid Purification Kit and BIO-RAD CFX96 Real-Time PCR Detection System for amplification, detection and analysis. RevoDx HCV qPCR Kit is intended to assist in the management of patients with chronic HCV infection and to form a strategy for anti-viral therapy in conjunction with all relevant clinical and laboratory findings. RevoDx HCV qPCR Kit is not intended to screen blood and blood products for the presence of HCV RNA or to confirm the diagnosis of infection with HCV.
Negative results do not preclude HCV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
RevoDx HCV qPCR Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
The RevoDx HCV qPCR Kit is to be used with BIO-RAD CFX96 and Tianlong Gentier 96 Real-Time PCR Detection Systems. But the RevoDx HCV qPCR Kit may also be compatible with most real-time PCR detection systems with the channels FAM and HEX
- Validated for use with fresh or frozen human serum or plasma collected in EDTA anticoagulant.
- Quantification Standards ranging from 1 x 10^4 IU/mL to 1 x 10^7 IU/mL
- Exogenous internal control
- The Limit of Detection (LoD) value is 14 IU/mL
- Linear range is between 35 IU/mL and 1 x 10^9 IU/mL Diagnostic specificity is ≥ 99%
- Can detect and quantify all HCV genotypes
- Whole system failure rate is ≤1 %
- For research use only