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 undertaken to determine the sensitivity potential for a new dual amplified immunoassay (IDEIA PCE Chlamydia). Increased sensitivity (98.8%, 84/85) was obtained for IDEIA PCE Chlamydia compared to a conventional antigen detection test (IDEIA Chlamydia, 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 Chlamydia of 30.8% (32/104) was similar to the 27.9% (29/104) obtained from urethral swabs tested with a DNA probe assay (PACE 2). The increased sensitivity of the test was confirmed with a commercial PCR kit (Amplicor) and nested PCR. The IDEIA PCE Chlamydia kit has the sensitivity potential to be a clinically reliable alternative for detecting Chlamydia trachomatis.
Hirose
T
T
Department of Urology, Sapporo Medical University School of Medicine, Japan. tonooka@sapmed.ac.jp
Iwasawa
A
A
Satoh
T
T
Itoh
N
N
Tsukamoto
T
T
Gohro
T
T
Miyagishi
T
T
Ikegaki
S
S
Saka
T
T
Nishimura
M
M
Yamazaki
K
K
Hayashi
K
K
Yoshida
H
H
Hagiwara
T
T
D002690:Chlamydia Infections / Q000175:diagnosis* / Q000652:urine; D002692:Chlamydia trachomatis / Q000302:isolation & purification; D005069:Evaluation Studies as Topic; D005832:Genital Diseases, Male / Q000175:diagnosis* / Q000652:urine; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008297:Male; D012680:Sensitivity and Specificity; D014526:Urethritis / Q000175:diagnosis* / Q000652:urine