Patent ID: 6908735

Claim:
A method of determining whether an analyte polynucleotide is present in a test sample in an amount greater or less than a pre-determined value, comprising the steps of: obtaining a test sample to be analyzed for the presence of said analyte polynucleotide, said analyte polynucleotide being selected from the group consisting of a viral polynucleotide, a bacterial polynucleotide, a fungal polynucleotide, a protozoan polynucleotide, and a human polynucleotide; combining said test sample with an amount of a pseudo target; co-amplifying in a polynucleotide amplification reaction the pseudo target and any analyte polynucleotide contained in said test sample to produce amplification products that include a pseudo target amplicon and an analyte amplicon, wherein said analyte amplicon is produced in an amount that is dose-dependent on the amount of said analyte polynucleotide present in said test sample, and wherein said pseudo target and said analyte polynucleotide are co-amplified using the same set of two oligonucleotide primers; and quantitatively detecting said analyte amplicon using a detection system calibrated to indicate a positive result upon detecting an amount of analyte amplicon arising from co-amplification of said amount of said pseudo target and an amount of analyte polynucleotide equal to or greater than said pre-determined value, wherein the amount of said pseudo target in the combining step is greater than said pre-determined value and is sufficient to reduce production and to reduce a coefficient of variability of said analyte amplicon relative to analyte amplicon that would be produced in an identical polynucleotide amplification reaction that omitted said pseudo target, wherein said positive result indicates that said analyte polynucleotide is present in said test sample in an amount equal to or greater than said pre-determined value, wherein a negative result indicates that said analyte polynucleotide is present in said test sample in an amount less than said pre-determined value, and wherein said positive result and said negative result are determined without reference to the amount of pseudo target amplicon synthesized in the co-amplifying step.