Reliability of the Amplicor internal control to disclose false-negative Chlamydia trachomatis PCR results.

Abstract Four possibly false-negative samples were detected when 514 male urine specimens were tested in the Amplicor™ Chlamydia trachomatis assay. In three of the four samples, the inhibition could be reduced by removal of urine supernatant. Under partially inhibitory conditions, after spiking with 50 C. trachomatis elementary bodies/ml specimen, a selective inhibition of the C. trachomatis target amplification and a preferential internal control amplification was observed. We conclude that a positive internal control signal might be misleading in inhibitory specimens with low amount of C. trachomatis .