Determination of the Patient Infected Status (PIS)

All participants had their specimens resulted from the Aptima™ and Probetec™ systems. If there was discordance between those two results then the BD MAX™ CT/GC/TV result was used as a tiebreaker. To determine the PIS, there needed to be agreement between two of the three comparator assay results. If at least two comparator results did not match, the PIS was considered indeterminate. Possible outcomes of the PIS by organism included infected, not infected and indeterminate. We defined PIS definitions a priori in the study protocol.