TABLE 2.

Test controls necessary for performance of diagnostic PCR^a

Type of control	Description
IAC	Containing chimeric nonrelevant DNA added to master mixture and to be amplified by the same primer set as the target DNA but with an amplicon size visually distinguishable from the target amplicon
Processing positive control	Negative sample spiked with sufficient amount of pathogen and processed throughout the entire protocol
Processing negative control	Negative sample spiked with sufficient amount of closely related, but nontarget strain processed throughout the entire protocol
Nontemplate control (blank)	Containing all reagents, but no target of IAC nucleic acids
Premise control	Tube containing master mixture left open in the PCR setup room to detect possible contaminating DNA in the environment (to be done at certain intervals as part of the quality assurance program)
Standard concentrations	3-4-samples containing 10-fold dilution concentrations of known number of target DNA copies in a range above the detection limit (necessary cutoff determination and for quantitative PCR)

^aSee reference 3.