Products

FTD BCE

Overview

One tube multiplex for detection AND quantification of BKV, Epstein-Barr virus, cytomegalovirus 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:

  • BK virus
  • Epstein-Barr virus (EBV)
  • cytomegalovirus (CMV)
  • Internal control

Specimen

The quantitative validation of FTD BCE 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 urine, EDTA blood, plasma and serum.

In case human urine, EDTA blood or serum are intended to use for quantitative analysis, the procedure has to be validated by the user.

Storage

-20° C

Shelf life

12 months

Equipment

EXTRACTION:

  • NucliSENS® easyMAG® (bioMérieux)
  • QIAamp Mini Elute virus Spin or QIAamp viral RNA kit - manual or in combination with QIAcube (Qiagen)
  • QIAsymphony SP in combination with DSP Virus/Pathogen and the DNA Mini kit (Qiagen)
  • RTP® Pathogen kit (STRATEC)
  • Duplicα®Prep (EuroClone)
  • Maxwell® 16 Tissue LEV Total (stool samples) & Maxwell® 16 Buccal Swab LEV (Promega)

AMPLIFICATION:

  • Applied Biosystems® 7500 / 7500 Fast (life technologies™)
  • Rotor-Gene 3000 / 6000 / Q (Qiagen)
  • CFX96® / DX® with CFX software (BIO-RAD)
  • LightCycler® 480 (Roche)
  • SmartCycler® with Life Science software 2.0d (Cepheid)


To find out if the extraction method or qPCR cycler available in your facility are compatible with our tests, please see our compatibility list or contact support@fast-trackdiagnostics.com