Army

Universal Internal Positive Control for PCR

Straightforward, effective control that confirms negative results as a true negative. In use by DoD.

Medical & Biotechnology

Data ImageThe 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).

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