Urethral and endocervical swabs and self-collected vaginal swabs (SCVSs) and urine specimens are all used as samples for diagnosis of urogenital infection with Chlamydia trachomatis. We have now determined chlamydial organism load in matched specimens from different anatomic sites and examined its relation to clinical signs and symptoms in men and women. Organism load was measured with assays based on the ligase chain reaction or real-time PCR analysis. The mean organism loads in 58 infected men were 1,200 and 821 elementary bodies (EBs) per 100 l of sample for first-void urine (FVU) and urethral swabs, respectively (P > 0.05). Organism load in FVU samples or urethral swabs was positively associated with symptoms (P < 0.01) and clinical signs (P < 0.01) in men. The mean organism loads in 73 infected women were 2,231, 773, 162, and 47 EBs/100 l for endocervical swabs, SCVSs, urethral swabs, and FVU samples, respectively (P < 0.001 for each comparison). Only the presence of multiple symptoms or clinical signs was associated with organism load in women. These results show that FVU is a suitable noninvasive sample type for men, given the fact that its chlamydial load did not differ significantly from that of urethral swabs. Given their higher organism load compared with FVU, SCVSs are the preferred noninvasive sample type for women.Urogenital infection with Chlamydia trachomatis is the most commonly reported bacterial sexually transmitted infection (STI) and continues to be a major public health problem worldwide (4, 35). Given that most chlamydial infections are asymptomatic in both men and women, they often remain undiagnosed and untreated and therefore provide a reservoir for the disease (33). Infection of the upper genital tract may lead to complications, such as epididymitis in men and pelvic inflammatory disease in women. The inflammation and subsequent tissue scarring associated with the latter can lead to more serious sequelae (4).Effective control of chlamydial infection within a population requires early diagnosis and prompt treatment of asymptomatic individuals (28). Targeted and regular screening is also recommended for people in high-risk groups or with a past history of genital chlamydial infection (14). The most common sites of infection in women are the cervix and urethra. Infected cells are shed from the endocervix into the vagina and are present in vaginal secretions. Infected epithelial cells from the urethra and the associated C. trachomatis elementary bodies (EBs) can also be detected in first-void urine (FVU) (3, 16). Potentially suitable clinical specimens for detection of chlamydial infection in women thus include urethral, vaginal, and endocervical swabs, self-inserted tampons, and FVU samples (3, 12). For screening programs, noninvasive specimens, such as vaginal swabs, tampons, and FVU, are preferable to invasive urethral and endocervical swabs because they overcome several barriers associated with the traditional diagnostic pathway (5, 11). Sensitivity of C. trachomatis detection with vag...
First-void urine (FVU) is the preferred specimen for the diagnosis of urogenital Chlamydia trachomatis infection in men. We have developed FirstBurst, a urine collection device that collects the first 4 to 5 ml of FVU and yields a specimen with a sixfold higher C. trachomatis organism load than the regular urine cup by quantitative PCR (32,533 versus 5,271 plasmids/ml; P < 0.0001). Consequently, the use of FirstBurst to collect a urine sample improved the sensitivity of a rapid test for Chlamydia over testing of samples collected with a urine cup (82 versus 47% sensitivity using PCR as a reference; P < 0.0015).Urogenital infection with Chlamydia trachomatis is the most commonly reported bacterial sexually transmitted infection and continues to be a major public health problem worldwide (5, 17). Untreated C. trachomatis infections can lead to serious sequelae such as pelvic inflammatory disease in women and epididymitis in men (5). A large proportion of infected individuals either have mild symptoms or are asymptomatic (2). Thus, screening of high-risk populations has been recommended (4).The use of the invasive and painful urethral swab is a major barrier to screening of asymptomatic men and is a key factor in male nonattendance at genitourinary medicine clinics (7, 16). However, the development of highly sensitive nucleic acid amplification tests (NAATs) has allowed the use of first-void urine (FVU) for C. trachomatis diagnosis. FVU has become the specimen of choice for the diagnosis of urethral C. trachomatis infection in men by NAATs, since it is noninvasive and yet allows the detection of infected epithelial cells and associated C. trachomatis particles (3, 9). The volume of FVU has been defined arbitrarily as the first 20 to 30 ml of the initial flush of urine, which is thought to contain the highest concentration of diagnostically relevant components, such as C. trachomatis elementary bodies or antigens or inflammation-related enzymes (6). However, the optimal volume for an FVU specimen is unknown, and early attempts to study the organism load in FVU fractions have encountered difficulties due to the lack of a suitable sample collection device. At present, collection volumes for FVU ranging from 5 to 40 ml for men (8,15) and from 10 to 50 ml for women (13) are deemed to be acceptable samples.We have developed a novel FVU collection device called FirstBurst (10), which allows the convenient collection of the first 4 to 5 ml of FVU without dilution by the subsequent urine stream (Fig. 1A). We compared the C. trachomatis organism loads of FirstBurst-and urine cup-collected specimens and evaluated the sensitivity of a novel rapid test for Chlamydia using these two urine specimen types. In addition, we quantified the organism loads in four fractions of FVU from C. trachomatis-infected men by using a tandem of FirstBurst devices to further define the C. trachomatis load of the FVU specimen.Participants for the study comparing C. trachomatis loads between the FirstBurst device and the urine cup and for the study ...
(range: 1.3×10 2 -1.4×10 7 bacteria/swab) was observed.
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