One tube multiplex for detection AND quantification of hepatitis B virus and internal control.Principle
Multiplex Real-Time PCR for detection of pathogen genes by TaqMan® technology.
Fast-track diagnostics has decided to follow decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices: quantification standards have to be provided that allow the quantification of pathogens in International Units per millilitre (IU/ml) if available. The standards for absolute quantification that are included in FTD kits are correlated with World Health Organisation standards. These standards are calibrated following extensive international studies and play an important role for the traceability and comparability of results between laboratories. Although FTD understands that certain customers, in particular clinicians, still prefer copies per ml, there are no internationally agreed standard in copies per ml and no internationally agreed formulae to convert IU to copies. Nevertheless, if you feel you still wish to use copies per ml, we will be happy to confirm your conversion calculations (based on your experimental data) for FTD kits.Targets
One tube multiplex PCR:
- Hepatitis B DNA
- Internal control
The quantitative validation of FTD Hepatitis B DNA was done with extracted nucleic acid from human EDTA or Citrate plasma with NucliSENS® easyMag® and ABI® 7500.
In clinical performance evaluation studies the test was also successfully qualitatively used with human EDTA plasma and serum.
In case human EDTA serum is intended to use for quantitative analysis, the procedure has to be validated by the user. Be aware that in serum samples the sensitivity of the test can be reduced.Storage