CLINICAL-STUDY OF THE EFFECTIVENESS OF A DUAL AMPLIFIED IMMUNOASSAY (IDEIA PCE CHLAMYDIA) FOR THE DIAGNOSIS OF MALE URETHRITIS

A clinical study of patients with male urethritis (n=316) was undertak en to determine the sensitivity potential for a new dual amplified imm unoassay (IDEIA. PCE Chlamydia(TM)). Increased sensitivity (98.8%, 84/ 85) was obtained for IDEIA PCE Chlamydia(TM) compared to a conventiona l antigen detection test (IDEIA Chlamydia(TM), 81.2%, 69/85) when test ing urine samples. In a smaller patient population (n=104) the positiv ity rate for the first-void urine tested with IDEIA PCE Chlamydia(TM) of 30.8% (32/104) was similar to the 27.9% (29/104) obtained from uret hral swabs tested with a DNA probe assay (PACE 2(TM)). The increased s ensitivity of the test was confirmed with a commercial PCR kit (Amplic or(TM)) and nested PCR. The IDELA PCE Chlamydia(TM) kit has the sensit ivity potential to be a clinically reliable alternative for detecting Chlamydia trachomatis.