Clinical study of the effectiveness of a dual amplified immunoassay IDEIA PCE Chlamydia for the diagnosis of male urethritis

Abstract

A clinical study of patients with male urethritis n =316 was undertaken to determine the sensitivity potential for a new dual amplified immunoassay IDEIA PCE ChlamydiaTM . Increased sensitivity 98.8 , 84 85 was obtained for IDEIA PCE ChlamydiaTM compared to a conventional antigen detection test IDEIA ChlamydiaTM, 81.2 , 69 85 when testing urine samples. In a smaller patient population n =104 the positivity rate for the first void urine tested with IDEIA PCE ChlamydiaTM of 30.8 32 104 was similar to the 27.9 29 104 obtained from urethral swabs tested with a DNA probe assay PACE 2TM . The increased sensitivity of the test was confirmed with a commercial PCR kit AmplicorTM and nested PCR. The IDEIA PCE ChlamydiaTM kit has the sensitivity potential to be a clinically reliable alternative for detecting Chlamydia trachomatis .