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