Internal / External Process Controls

Quality assurance concepts for highly sensitive molecular pathogen identification must ensure that negative results are due to negative samples and not caused by flaws in the process. Therefore a stringent process control has to undergo the same procedures as the sample itself – without compromising the limit of detection of the tests.

 

Cube Dx' Internal Process Control (IPC) consists of frozen biological material, which is dissolved within the sample. IPC undergoes the same extraction procedures – an aliquot of the resulting DNA solution is amplified in a separate PCR vessel. Both qPCR (during the amplification process) and probes on the hybcell (during the identification process) finally confirm the presence of the internal process control.

 

Cube Dx' External Process Controls (EPC) are quantified inactivated bacterial or fungal cells in different concentrations (frozen). They are intended to safeguard the stability of the molecular pathogen ID processes over time. Periodic usage of EPCs documents the laboratories ability to detect minimum levels of bacterial and fungal DNA.

IPC

20 µL frozen solution of bacterial cells

Use togehter with PCR-Box IPC
 

PCR-Box IPC

12,5 µL eluate, 70-80min.

Detection of IPC-DNA, use togehter with IPC

 

EPC S.aureus 1000/10000

20 µL frozen solution of 1000/10000 genomes of Staphylococcus aureus

Use periodically to outcome of MDX pathogen identification

 

EPC C.albicans 1000/10000

20 µL frozen solution of 1000/10000 genomes of Candida albicans

Use periodically to check outcome of MDX pathogen identification