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The results of two commercially available C. trachomatis detection assays did not agree when used to test urine samples from men.

A comparison of two methods for detection of Chlamydia trachomatis in the male urethra.
Opaneye AA, Bashford J, Ashton V.  

J R Soc Health. 2002;122:58-60.

Summary:

Question
How do an enzyme immunoassay for the detection of C. trachomatis antigen and a strand displacement amplification assay for the detection of C. trachomatis DNA compare for screening urine samples from men for C. trachomatis infection?

Design
This study describes a direct comparison of two commercially available assays for the detection of C. trachomatis in urine samples from men.

Participants
Sixty-one men between 17 and 57 years of age, attending a genitourinary medicine department in the UK were tested. Twenty-two men had reported symptoms (discharge, discomfort, or combination). Criteria for participant selection were not stated.

Description of Tests and Diagnostic Standard
Urethral samples were collected first, using a plastic loop and then a swab, followed by collection of urine samples. The urine samples were tested for C. trachomatis DNA with the BD Probe Tec strand displacement amplification (SDA) assay. The assay is based on the simultaneous amplification and detection of target DNA using primers and a fluorescent probe. Each sample was also tested in a separate well for the amplification of a reaction control to rule out sample inhibition. The urethral swabs were tested for C. trachomatis antigen with the Abbott IMX Select chlamydia assay. The assay is an enzyme immunoassay (EIA) that uses microparticles to bind extracted C. trachomatis LPS, which is detected by antibodies and a fluorescent substrate. Positive samples were confirmed by testing with either a blocking reaction or an immunofluorescent antibody test.

Main Outcome Measures
The EIA and SDA results for each specimen were compared.

Main Results
Seven patients tested positive for C. trachomatis by either assay: 2 by EIA only, 3 by SDA only, and 2 by both assays . The characteristics of these 7 patients are shown in the table

Characteristics of patients positive for Chlamydia trachomatis by SDA and/or EIA
Symptoms EIA (Abbott IMX) SDA (BD Probe Tec)
+ + +
+ + +
neg neg +
+ neg +
+ neg +
neg + neg
neg + neg

Authors' Conclusions
No conclusion can be made as to which of these two assays performed better for screening these men for C. trachomatis infection.

Source of funding: None given

For correspondence: Abayomi Opaneye, Department of Genitourinary Medicine, Middlebrough General Hospital, Ayresome Green Lane, Middlesbrough, Cleveland TS5 5AZ, England.

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