Hepatitis C Virus (HCV) PCR Kit
Manufacturer:
Description
The HCV detection is based on the amplification of a single-copy 5′ UTR RNA sequence and the measurement of fluorescence increase.
The mechanism of duplex targeting ensures maximum sensitivity and specificity and enables detection of the virus in a sample before seroconversion
Technical Features
Specifications:
- Target Sequence: Conservative region of 5´ UTR sequence
- Analytical Specificity: HCV genotype 1-8, 100%
- Analytical Sensitivity (LoD): reaches up to 53.505 IU/ml
- Diagnostic Specificity 100% (CI95% : 99.07% – 100%)
- Diagnostic Sensitivity 100% (CI95% : 95.39% – 100%)
- Reporting Units IU/µl
- Quality management system is certified in compliance with the requirements of the standard ISO 13485 ed.2:2016
- External Quality Assessment: regularly tested by QCMD and Instand e.V. External Quality Assessment Panels
- Required Detection Channels FAM, HEX
- Compatible with a wide range of Real-time PCR devices (LightCycler® 2.0 / 480, Applied Biosystems 7300 / 7500 Real-Time PCR System, Rotor-Gene 3000 / 6000 κα)
- Stable at -20 ± 5 °C
- The components are stable for a maximum of 6 repeated freezing / thawing cycles
- Regulatory Status CE₁₀₂₃ IVD
Format
- 25/50/100 reactions
Shelf life
- 18 months from production date
Sample
- Plasma (EDTA, citrate), Serum
Test time
- 75 min
Results