A U.S. Patent for “Compositions and Methods for Detecting a Biological Contaminant” was awarded to Regeneron on June 2nd, 2020. The present invention is a method of detecting the presence or absence of a biological contaminant comprising the steps of: (a) combining (i) a positive amplification control plasmid (PAC) sample, wherein the PAC comprises a unique artificial plasmid-specific sequence (UAPS), a target amplification polynucleotide sequence (TAP), and a nucleic acid extraction control (NEC) nucleotide sequence, (ii) a unique detection probe (UDP), (iii) a TAP forward oligonucleotide primer, (iv) a TAP reverse oligonucleotide… Learn More