The US Army seeks to commercialize through licensing a straightforward, effective, universal exogenous internal positive control (UEIPC) for monitoring inhibitors of PCR. This versatile innovation allows for confirmation of negative results as a true negative. It is most suitable for Taqman® based assays. The Joint Program Executive Office of the Department of Defense has chosen this as the solution for its internal positive control. The UEIPC is also incorporated in a new diagnostic test for Leishmania that DOD is submitting to the FDA for approval.
The internal positive control of the current invention is a cloned fragment of DNA with a novel sequence which has no known homology to published sequence data. The novel sequence resulted from site directed mutagenesis of Bacillus anthracis. This sequence can be used in any probe-based PCR assay with specific primers and probes. This technology will determine the presence or absence of PCR inhibitors in a diagnostic sample and the assay can either be run alone or multiplexed with a target assay. This method is most fully developed for Taqman based PCR. This basic construct has been expanded to work with RNA-based PCR (RT-PCR).
- Performance – responsive to a broad range of inhibitors, even in complex samples
- Universality – can be used with any dye set or PCR instrument
- Flexibility - the primers and probes are separate, so the assay can be optimized for use as an independent assay or multiplexed with other agent specific assays
- Two US Patents: 7,005,267; 7,052,848
- Inventors may be available for consultation and collaboration